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A number of clinical trials have examined the effect of l-arginine on lipid profile in recent years ; however , the results remain equivocal . Therefore , the present study aims to summarise and quantitatively examine the available evidence on the effectiveness l-arginine supplementation on lipid parameters using a systematic review and meta-analytic approach . Online data bases including PubMed , Scopus , ISI Web of Science , Cochrane Library and Google Scholar were search ed up to April 2019 for r and omised controlled trials that examined the effect of l-arginine supplementation on lipid profile in adults . Treatment effects were expressed as weighted mean difference ( WMD ) and the corresponding st and ard error in concentrations of serum lipids . To estimate the overall effect of l-arginine supplementation , we used the r and om-effects model . In total , twelve studies were included in the systematic review . The meta- analysis revealed that l-arginine supplementation did not significantly change the concentrations of total cholesterol ( WMD : -5·03 mg/dl ; 95 % CI -10·78 , 0·73 ; P = 0·08 ; inconsistency index ( I2 ) = 39·0 % ) , LDL ( WMD : -0·47 mg/dl ; 95 % CI -3·61 , 2·66 ; P = 0·76 ; I2 = 0·0 % ) , or HDL ( WMD : 0·57 mg/dl ; 95 % CI -1·28 , 2·43 ; P = 0·54 ; I2 = 68·4 % ) . A significant reduction was observed only in serum TAG levels ( WMD : -7·04 mg/dl ; 95 % CI -11·42 , -2·67 ; P that l-arginine supplementation can significantly reduce blood TAG levels ; however , there is insufficient evidence to support its hypocholesterolaemic effects . To draw straightforward conclusions regarding generalised recommendations for l-arginine supplementation for improving lipid profile , there is a need for more well-controlled trials targeting exclusively patients with dyslipidaemia | [
"Background : Recently , the potential of L-arginine supplementation as a novel and effective strategy for weight loss and improving biochemical parameters in obese patients has been under consideration . Objectives : To evaluate the influence of 8-week oral L-arginine supplementation on body mass index ( BMI ) , waist circumference ( WC ) , triceps skinfold ( TS ) , subscapular skinfold ( SS ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , plasma fasting blood sugar ( FBS ) , glycated hemoglobin ( HbA1c ) , triglyceride ( TG ) , total cholesterol ( TC ) , low-density lipoprotein ( LDL ) , high-density lipoprotein ( HDL ) , and malondialdehyde ( MDA ) in patients with BMI values > 29.9 or visceral obesity ( WC > 102 cm in men or > 88 cm in women ) . Patients and Methods : Ninety obese patients were included in a single-blind r and omized controlled trial . Patients were r and omized to receive either L-arginine ( 3 or 6 g thrice daily ) or placebo for 8 weeks . Anthropometric and biochemical indices , dietary intake , and blood pressure values were measured at the baseline and after the 8-week intervention . Results : Significant decreases in anthropometric parameters , blood pressure ( SBP , DBP ) , FBS , HbA1c , LDL , MDA ( P TG ( P = 0.02 ) , and TC ( P = 0.002 ) and a significant increase in HDL ( P L-Arginine supplementation appears to improve anthropometric parameters , blood pressure values , and some blood biochemical indices associated with cardiovascular disease prevention",
"Background In the present study , the effect of arginine and leucine supplementation , and dietary protein level , were investigated in commercial crossbred pigs to clarify their individual or combined impact on plasma metabolites , hepatic fatty acid composition and mRNA levels of lipid sensitive factors . The experiment was conducted on fifty-four entire male pigs ( Duroc × Pietrain × Large White × L and race crossbred ) from 59 to 92 kg of live weight . Each pig was r and omly assigned to one of six experimental treatments ( n = 9 ) . The treatments followed a 2 × 3 factorial arrangement , providing two levels of arginine supplementation ( 0 vs. 1 % ) and three levels of basal diet ( normal protein diet , NPD ; reduced protein diet , RPD ; reduced protein diet with 2 % of leucine , RPDL ) . Results Significant interactions between arginine supplementation and protein level were observed across plasma lipids . While dietary arginine increased total lipids , total cholesterol , HDL-cholesterol , LDL-cholesterol , VLDL-cholesterol and triacylglycerols in NPD , the inverse effect was observed in RPD . Overall , dietary treatments had a minor impact on hepatic fatty acid composition . RPD increased 18:1c9 fatty acid while the combination of leucine and RPD reduced 18:0 fatty acid . Arginine supplementation increased the gene expression of FABP1 , which contributes for triacylglycerols synthesis without affecting hepatic fatty acids content . RPD , with or without leucine addition , upregulated the lipogenic gene CEBPA but downregulated the fat oxidation gene LPIN1 . Conclusions Arginine supplementation was responsible for a modulated effect on plasma lipids , which is dependent on dietary protein level . It consistently increased lipaemia in NPD , while reducing the correspondent metabolites in RPD . In contrast , arginine had no major impact , neither on hepatic fatty acids content nor on fatty acid composition . Likewise , leucine supplementation of RPD , regardless the presence of arginine , promoted no changes on total fatty acids in the liver . Ultimately , arginine , leucine and dietary protein reduction seem to be unrelated with fatty liver development",
"Our study aims at investigating a possible role for L-arginine and D-arginine in insulin-mediated glucose uptake . Twelve lean healthy subjects volunteered for the study and were su bmi tted to three euglycemic-hyperinsulinemic glucose clamps to investigate the effect of L-arginine ( 0.5 g/min in the last 60 minutes of the clamp ) , D-arginine ( 0.5 g/min in the last 60 minutes of the clamp ) , and saline 0.9 % NaCl on insulin-mediated glucose uptake . All tests were made in r and om order . In study 1 , L-arginine versus saline infusion was associated with a significant increase in blood flow ( 131 % + /- 7 % v 87 % + /- 5 % , P whole-body glucose disposal ( [ WBGD ] 61.4 + /- 4.4 v 41.3 + /- 3.5 mumol/kg fat-free mss [FFM].min , P oxidative and nonoxidative glucose metabolism was improved by L-arginine delivery . After adjustment for the change in blood flow , WBGD was still greater after L-arginine than after saline infusion . Along with L-arginine infusion and independently of the change in blood flow , the percent change in WBGD correlated with the percent change in plasma cGMP ( r = .55 , P D-Arginine infusion did not affect insulin-mediated glucose uptake . In particular , WBGD ( 42.1 + /- 3.4 v 41.3 + /- 3.5 mumol/kg FFM.min , P = NS ) was similar in both experimental conditions . Basal levels ( 2.8 + /- 0.2 v 2.7 + /- 0.3 nmol/L , P = NS ) and the insulin-mediated increase ( 43 % + /- 5 % v 39 % + /- 4 % , P = NS ) in plasma cGMP were also superimposable along with insulin plus D-arginine and insulin alone , respectively . Finally , blood flow ( 224 + /- 29 v 230 + /- 35 mL/min , P = NS ) was not different at baseline and was similarly stimulated ( 84 % + /- 4 % v 87 % + /- 5 % , P = NS ) by insulin infusion . In conclusion , L-arginine but not D-arginine stimulates insulin-mediated glucose uptake . Nitric oxide ( NO ) , the metabolic mediator for L-arginine , potentiates insulin-mediated glucose uptake through the increase in blood flow . Nevertheless , an independent effect of intracellular cGMP on WBGD can not be ruled out",
"Purpose The aim of this study is to evaluate the long-term influence of l-arginine intake on mineral concentration in patients with obesity and to assess the changes in lipid serum levels , fat content , and insulin resistance that result . Methods A r and omized double-blind placebo-controlled study was conducted . 88 obese patients were r and omly assigned to receive either 9 g of l-arginine or placebo daily , for 6 months . At baseline and after 6 months , selected anthropometrical measurements and blood biochemical analyses were performed and mineral levels were assessed . To assess insulin sensitivity , the gold-st and ard euglycemic clamp methodology was used . Results We found that 6 months of l-arginine supplementation result ed in significant increases in insulin sensitivity ( Δ1.1 mg/kg/min , P and zinc levels ( Δ1.5 μmol/L , P the change in zinc concentration in serum and the change in insulin sensitivity was observed ( R = 0.80 , P patients treated with l-arginine , a negative correlation between the change in zinc concentration in serum and the change in body fat content was noted ( R = −0.38 , P ) . Conclusions l-Arginine supplementation affects zinc status in obese patients . One beneficial influence is related to the improvements in insulin sensitivity ",
"Fifty-four entire male pigs ( Duroc × Pietrain × Large White × L and race ) from a commercial crossbred operation were used to investigate the effect of dietary Arg supplementation , protein reduction ( PR ) , and Leu supplementation on performance , carcass traits , and meat quality . Pigs weighing 58.9 ± 1.6 kg BW were r and omly assigned to 1 of 6 treatments ( n = 9 ) . The 6 dietary treatments were normal CP diet ( 16 % CP , NPD ) , reduced CP diet ( 13 % CP , RPD ) , reduced CP diet with Leu addition to 2.0 % ( RPDL ) , normal CP diet supplemented with 1 % Arg ( 16 % CP , Arg-NPD ) , reduced CP diet supplemented with 1 % Arg ( 13 % CP , Arg-RPD ) , and reduced CP diet with Leu addition to 2.0 % and supplemented with 1 % Arg ( 13 % CP , Arg-RPDL ) . Pigs were slaughtered at 91.7 ± 1.6 kg BW . Dietary Arg supplementation had no effect on intramuscular fat ( IMF ) content but produced meat off-flavor and increased meat tenderness and overall acceptability . The PR increased ( P ( 45 % to 48 % ) but negatively affected the growth performance of pigs . In addition , PR increased ( P . Leucine addition did not affect IMF content , back fat thickness , or loin weight . There was an increase of juiciness with PR and Leu addition , which accompanied the increase of IMF content with the low-CP diet . The PR increased meat deposition of 18:1c9 , SFA , MUFA , and PUFA , which were not correlated with any pork sensory trait . The main combined effect of Arg was an increased tenderness and overall acceptability of pork . In conclusion , it was confirmed that dietary CP reduction enhances pork eating quality but negatively affects growth performance and carcass characteristics of pigs",
"In hypercholesterolemic rabbits , oral L-arginine ( the substrate for endothelium derived nitric oxide ) attenuates endothelial dysfunction and atheroma formation , but the effect in hypercholesterolemic humans is unknown . Using high resolution external ultrasound , we studied arterial physiology in 27 hypercholesterolemic subjects aged 29+/-5 ( 19 - 40 ) years , with known endothelial dysfunction and LDL-cholesterol levels of 238+/-43 mg/dl . Each subject was studied before and after 4 wk of L-arginine ( 7 grams x 3/day ) or placebo powder , with 4 wk washout , in a r and omized double-blind crossover study . Brachial artery diameter was measured at rest , during increased flow ( causing endothelium-dependent dilation , EDD ) and after sublingual glyceryl trinitrate ( causing endothelium-independent dilation ) . After oral L-arginine , plasma L-arginine levels rose from 115+/-103 to 231+/-125 micromol/liter ( P EDD improved from 1.7+/-1.3 to 5.6+/-3.0 % ( P vascular responses . Lipid levels were unchanged after L-arginine and placebo . Dietary supplementation with L-arginine significantly improves EDD in hypercholesterolemic young adults , and this may impact favorably on the atherogenic process",
"BACKGROUND Oral amino acid intake reduces plasma glucose in Streptozotocin-induced diabetic rats . This study examined the effect of oral amino acid supplementation in patients with type 2 diabetes mellitus ( DM ) . MATERIAL / METHODS A double blind pilot clinical trial was conducted for a period of 2 months on 77 subjects with type 2 DM . Subjects of both sexes , ages 30 - 60 , were included in the trial . All were receiving oral antidiabetic tablets . They were divided into groups on the basis of oral supplementation : ( A ) lysine , ( B ) essential amino acids , ( C ) amino acids and vitamins ( fat and water-soluble ) , and ( D ) calcium phosphate ( control ) . The subjects were periodically examined for fasting and post-pr and ial plasma glucose , fasting and post-pr and ial immunoreactive insulin , plasma amino acids , glycosylated haemoglobin ( HbA1c ) , proteins and albumin in serum , urea and creatinine in plasma and sugar , and proteins and ketones in urine . RESULTS The results revealed a significant decrease in PP plasma glucose ( P Plasma Arginine was increased in group C from 3.84 to 9.24 mg/dl . There were no statistically significant changes seen in other parameters between groups and visits . CONCLUSIONS Oral supplementation with amino acids for patients with type 2 DM appears to decrease PP plasma glucose without any change in plasma insulin levels , perhaps due to improved insulin sensitivity . However , the long term effects of amino acids need further study",
"We recently noticed a possible triglyceride-lowering effect during dietary supplementation with L-arginine . The major limitation of prior studies on L-arginine , however , was that triglyceride levels were not the primary end point , and patients were not necessarily hypertriglyceridemic . Therefore , we conducted a 2-arm , r and omized , double-blind study in 33 hypertriglyceridemic patients to investigate the hypothesis that oral L-arginine may lower serum triglyceride levels in hypertriglyceridemic patients on and off statins . The study consisted of a 6-week run-in phase , 6 weeks of treatment with L-arginine ( n = 22 , 1.5 g bid ) or placebo ( n = 11 ) , and a 6-week extension period where simvastatin ( 20 mg qd ) was added . All patients received dietary advice during each study visit . Routine and lipid laboratory parameters were determined in the local routine clinical laboratory . Treatment with L-arginine alone had no effects on serum lipids compared to placebo . The combination of L-arginine with simvastatin led to a significantly stronger reduction in triglycerides compared to placebo plus simvastatin ( -140.5 + /- 149.2 mg/dL vs -56.1 + /- 85.0 mg/dL ; P = .048 ) . In addition , we found simvastatin-induced increases in aspartate transaminase and fibrinogen to be attenuated by L-arginine as compared to placebo . We conclude from our data that L-arginine enhances the effects of simvastatin on lipid metabolism , but it has no triglyceride-lowering effects when given alone",
"The present study was carried out to evaluate the effect of a low‐dose intravenous supplementation of l‐arginine on insulin‐mediated vasodilatation and insulin sensitivity . The study was performed in healthy subjects ( n = 7 ) and patients with obesity ( n = 9 ) and non‐insulin‐dependent diabetes mellitus ( NIDDM ) ( n = 9 ) . Insulin‐mediated vasodilatation was measured by venous occlusion plethysmography during the insulin suppression test , evaluating insulin sensitivity . Experiments were performed twice in each subject in the presence or absence of a concomitant infusion of l‐arginine ( 0.52 mg kg−1 min−1 ) . l‐Arginine restored the impaired insulin‐mediated vasodilatation observed in obesity ( 22.4 ± 4.1 % , P healthy subjects , no effect on insulin mediated‐vasodilatation was observed ( 24.8 ± 3.1 % vs. 21.4 ± 3.1 % ) . Insulin sensitivity was improved significantly ( P of l‐arginine . No effect of l‐arginine was observed on insulin , insulin‐like growth factor I ( IGF‐I ) , free fatty acids ( FFAs ) or C‐peptide levels during the insulin suppression test . Our data indicate that defective insulin‐mediated vasodilatation in obesity and NIDDM can be normalized by intravenous l‐arginine . Furthermore , l‐arginine improves insulin sensitivity in obese patients and NIDDM patients as well as in healthy subjects , indicating a possible mechanism that is different from the restoration of insulin‐mediated vasodilatation",
"As a substrate for nitric oxide synthesis , L-arginine may give the same protection as estrogen , but its other biologic effects may adversely affect atherogenesis . Therefore , possible endocrine and lipid effects of L-arginine were investigated in a double-blind , placebo-controlled , single crossover study . After r and omization , oral L-arginine ( 9 g ) or placebo was given daily for 1 month , with crossover to the alternate therapy after a 1-month washout period , to 10 postmenopausal women receiving no estrogen . Compared with placebo , L-arginine increased growth hormone ( 1.5+/-1.8 mg/L vs. 0.6+/-0.6 mg/L , P = .04 ) but had no effect on insulin and catecholamines . Total cholesterol , triglyceride , apolipoprotein E , and low- , very-low- , and high-density lipoprotein cholesterol levels were also unaffected . Lipoprotein(a ) measured by an immunoturbidimetric method was increased by L-arginine in 9 of 10 women relative to placebo ( 0.46+/-0.35 g/L vs. 0.38+/-0.30 g/L , P = .053 ) , and the changes in lipoprotein(a ) levels significantly correlated with the relative increase in growth hormone ( r = 0.85 , P = .03 ) . However , lipoprotein(a ) measured by an enzyme-linked immunosorbent assay failed to demonstrate significant changes . Lack of an increase by L-arginine in lipoprotein(a ) with a verifiable apolipoprotein(a ) isoform-independent method , despite an increase in growth hormone , questions the validity of previous observations for growth hormone-induced increases in lipoprotein(a ) . The observed lack of effect on major endocrine hormones and lipid profile support the safety of oral L-arginine administration",
"BACKGROUND The role of tumor necrosis factor alpha ( TNF-alpha ) , one of the adipose tissue products , in the pathogenesis of insulin resistance is well-documented . Many recent studies have shown beneficial influence of L-arginine supplementation on cardiovascular system . However , molecular mechanisms of its positive actions are not fully eluci date d. AIM The aim of the study was to evaluate the influence of L-arginine supplementation on tumor necrosis factor alpha , insulin resistance and selected anthropometric and biochemical parameters in patients with visceral obesity . PATIENTS AND METHODS 60 patients with visceral obesity were r and omly assigned to either receive 9 g of L-arginine or placebo for 3 months . 20 healthy lean subjects were used as control . Selected anthropometrical measurements and blood biochemical analyses were performed at baseline and after 3-months . TNF-alpha and its soluble receptor 2 ( sTNFR2 ) were assessed in both treated groups . Insulin resistance in the participants was evaluated according to the homeostasis model assessment -insulin resistance ( HOMA-IR ) protocol . RESULTS The concentration of insulin , TNF-a and sTNFR2 and HOMA-IR level in both obese groups significantly exceeded these observed in the control . Basal TNF-alpha and sTNFR2 concentrations were positively correlated with basal body mass index ( BMI ) , waist circumference , percent of body fat and HOMA-IR . We found that 3-month L-arginine supplementation result ed in significant decrease of HOMA-IR and insulin concentration . Only insignificant tendency to decrease of TNF-alpha and sTNFR2 was observed . CONCLUSIONS Our results confirm TNF-alpha role in the complex pathogenesis of insulin resistance in patients with visceral obesity . 3-months L-arginine supplementation in a dose of 9 g improves insulin sensitivity in patients with visceral obesity with no impact on tumor necrosis factor alpha concentration",
"Since the last publication of the recommendations for the management and treatment of dyslipidemia , new clinical trial data have emerged that support a more vigorous approach to lipid lowering in specific patient groups . The decision was made to up date the lipid guidelines in collaboration with the Canadian Cardiovascular Society . A systematic electronic search of medical literature for original research consisting of blinded , r and omized controlled trials was performed . Meta-analyses of studies of the efficacy and safety of lipid-lowering therapies , and of the predictive value of established and emerging risk factors were also review ed . All recommendations are evidence -based , and have been review ed in detail by primary and secondary review panels . Major changes include a lower low-density lipoprotein cholesterol ( LDL-C ) treatment target ( lower than 2.0 mmol/L ) for high-risk patients , a slightly higher intervention point for the initiation of drug therapy in most low-risk individuals ( LDL-C of 5.0 mmol/L or a total cholesterol to high-density lipoprotein cholesterol ratio of 6.0 ) and recommendations regarding additional investigations of potential use in the further evaluation of coronary artery disease risk in subjects in the moderate-risk category",
"Patients with NIDDM are at increased risk for coronary heart disease ( CHD ) . However , information on the predictive value of cardiovascular risk factors and the degree of hyperglycemia with respect to the risk for CHD in diabetic patients is still limited . Therefore , we carried out a prospect i ve study on risk factors for CHD , including a large number of NIDDM patients . At baseline , risk factor levels of CHD were determined in 1,059 NIDDM patients ( 581 men and 478 women ) , aged from 45 to 64 years . These patients were followed up to 7 years with respect to CHD events . Altogether , 158 NIDDM patients ( 97 men [ 16.7 % ] and 61 women [ 12.8 % ] ) died of CHD and 256 NIDDM patients ( 156 men [ 26.8 % ] and 100 women [ 20.9 % ] ) had a serious CHD event ( death from CHD or nonfatal myocardial infa rct ion ) . A previous history of myocardial infa rct ion , low HDL cholesterol level ( high non-HDL cholesterol ( > 5.2 mmol/l ) , high total triglyceride level ( > 2.3 mmol/l ) , and high fasting plasma glucose ( > 13.4 mmol/l ) were associated with a twofold increase in the risk of CHD mortality or morbidity , independently of other cardiovascular risk factors . High calculated LDL cholesterol level ( ≥4.1 mmol/l ) was significantly associated with all CHD events . The simultaneous presence of high fasting glucose ( > 13.4 mmol/l ) with low HDL cholesterol , low HDL – to – total cholesterol ratio , or high total triglycerides further increased the risk for CHD events up to threefold . Our 7-year follow-up study provides evidence that dyslipidemia and poor glycemic control predict CHD mortality and morbidity in patients with NIDDM",
"Context : The effect of L-arginine on risk factors of cardiovascular diseases ( CVD ) has mostly focused on western countries . Since cardiovascular diseases is the second cause of death in Iran and , as far as we are aware , there have been no studies about the effect of L-arginine on CVD risk factors , the aim of this trial was to assess the effects of L-arginine supplementation on CVD risk factors in healthy men . Objective : The purpose of this study was to evaluate the effect of low-dose L-arginine supplementation on CVD risk factors ( lipid profile , blood sugar and blood pressure ) in Iranian healthy men . Design , setting , participants : We conducted a double-blind r and omized controlled trial in 56 patients selected from sport clubs at the Isfahan University of Medical Science between November 2013 and December 2013 . Interventions : Healthy men received L-arginine supplementation ( 2000 mg daily ) in the intervention group or placebo ( 2000 mg maltodextrin daily ) in the control group for 45 days . Main outcome measure : The primary outcome measures were we measured the levels of fasting blood sugar , blood pressure and lipid profile including triglyceride ( TG ) , cholesterol , LDL and HDL in healthy subjects . It was hypothesized that these measures would be significantly improved in those receiving L-arginine supplementation . at the beginning and end of the study . Results : In this trial , we had complete data for 52 healthy participants with mean age of 20.85±4.29 years . At the end of study , fasting blood sugar ( P=0.001 ) and lipid profile ( triglycerideTG ( P the L-arginine group but we found no significant change in the placebo group . In addition , the reduction of fasting blood sugar and lipid profile in L-arginine was significant compared with placebo group . No significant changes were found about systolic ( P=0.81 ) and diastolic blood pressure either in L-arginine or placebo group . ( P=0.532 ) . Conclusion : The use of L-arginine significantly improved outcomes compared to placebo",
"It is known that L-arginine treatment can ameliorate endothelial dysfunction and insulin sensitivity in type 2 diabetes mellitus patients , but little is known on L-arginine effects on these variables in nondiabetic patients with stable cardiovascular disease ( coronary artery disease ) . We evaluated the effects of long-term oral L-arginine treatment on endothelial dysfunction , inflammation , adipokine levels , glucose tolerance , and insulin sensitivity in these patients . Sixty-four patients with cardiovascular disease previously su bmi tted to an aortocoronary bypass and not known for type 2 diabetes mellitus had an oral glucose load to define their glucose tolerance . Thirty-two patients with nondiabetic response were eligible to receive , in a double-blind r and omized parallel order , L-arginine ( 6.4 g/d ) or placebo for 6 months . An evaluation of insulin sensitivity index during the oral glucose load , markers of systemic nitric oxide bioavailability and inflammation , and blood flow was performed before and at the end of the treatment in both groups . Compared with placebo , L-arginine decreased asymmetric dimethylarginine levels ( P indices of endothelial dysfunction , and increased cyclic guanosine monophosphate ( P L-arginine to asymmetric dimethylarginine ratio ( P reactive hyperemia ( P L-arginine increased insulin sensitivity index ( P adiponectin ( P interleukin-6 and monocyte chemoattractant protein-1 levels . In conclusion , insulin resistance , endothelial dysfunction , and inflammation are important cardiovascular risk factors in coronary artery disease patients ; and L-arginine seems to have anti-inflammatory and metabolic advantages in these patients"
] | 41167068-06ff-11f0-808a-c43d1ab1c353 |
AIM To perform a systematic review and meta- analysis of r and omized controlled trials ( RCTs ) to evaluate the effect of probiotics in pregnancy on the incidence of gestational diabetes ( GDM ) and fasting plasma glucose ( FPG ) . METHODS A MEDLINE , EMBASE , Scopus and Cochrane search ( up to May 30th , 2019 ) was performed to identify RCTs of comparison of probiotics with placebo/active comparators in pregnant women . Principal endpoints were the incidence of GDM and the change of FPG . Other maternal and fetal outcomes were secondary endpoints . Mantel-Haenszel Odds Ratio with 95 % CI ( MH-OR ) was calculated for dichotomous outcomes , whereas st and ardized differences in means was calculated for continuous variables . ( PROSPERO registration CRD42019139889 ) . FINDINGS A total of 17 RCTs , all versus placebo , was identified . The overall quality of the trials was satisfactory . No effect of probiotics on incidence of GDM ( MH-OR : 0.77[0.51,1.16 ] , p=0.21,I2:62 % ) was observed , with a small but significant reduction of FPG ( mean difference -1.01 [-1.96,-0.06]mg/dl , p= 0.02 , I2:46 % ) . Among secondary endpoints , a significant reduction of maternal insulin ( both in women with or without diabetes ) was observed in the probiotics group . INTERPRETATION Probiotics during pregnancy do not reduce the incidence of GDM , with a very little ( statistically but not clinical ly significant ) reduction of fasting plasma glucose | [
"Balanced glucose metabolism ensures optimal fetal growth with long-term health implication s conferred on both mother and child . We examined whether supplementation of probiotics with dietary counselling affects glucose metabolism in normoglycaemic pregnant women . At the first trimester of pregnancy 256 women were r and omised to receive nutrition counselling to modify dietary intake according to current recommendations or as controls ; the dietary intervention group was further r and omised to receive probiotics ( Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 ; diet/probiotics ) or placebo ( diet/placebo ) in a double-blind manner , whilst the control group received placebo ( control/placebo ) . Blood glucose concentrations were lowest in the diet/probiotics group during pregnancy ( baseline-adjusted means 4.45 , 4.60 and 4.56 mmol/l in diet/probiotics , diet/placebo and control/placebo , respectively ; P = 0.025 ) and over the 12 months ' postpartum period ( baseline-adjusted means 4.87 , 5.01 and 5.02 mmol/l ; P = 0.025 ) . Better glucose tolerance in the diet/probiotics group was confirmed by a reduced risk of elevated glucose concentration compared with the control/placebo group ( OR 0.31 ( 95 % CI 0.12 , 0.78 ) ; P = 0.013 ) as well as by the lowest insulin concentration ( adjusted means 7.55 , 9.32 and 9.27 mU/l ; P = 0.032 ) and homeostasis model assessment ( adjusted means 1.49 , 1.90 and 1.88 ; P = 0.028 ) and the highest quantitative insulin sensitivity check index ( adjusted means 0.37 , 0.35 and 0.35 ; P = 0.028 ) during the last trimester of pregnancy . The effects observed extended over the 12-month postpartum period . The present study demonstrated that improved blood glucose control can be achieved by dietary counselling with probiotics even in a normoglycaemic population and thus may provide potential novel means for the prophylactic and therapeutic management of glucose disorders",
"Background Although several studies have found probiotics encouraging in prevention of gestational diabetes mellitus ( GDM ) , the evidence for the use of probiotics in diagnosed GDM is largely limited . The aim of this study was to assess the effect of a probiotic supplement capsule containing four bacterial strains on glucose metabolism indices and weight changes in women with newly diagnosed GDM . Methods Sixty-four pregnant women with GDM were enrolled into a double-blind placebo-controlled r and omized clinical trial . They were r and omly assigned to receive either a probiotic or placebo capsule along with dietary advice for eight consecutive weeks . The trend of weight gain along with glucose metabolism indices was assayed . Results During the first 6 weeks of the study , the weight gain trend was similar between the groups . However , in the last 2 weeks of the study , the weight gain in the probiotic group was significantly lower than in the placebo group ( p Fasting blood sugar ( FBS ) decreased in both intervention ( from 103.7 to 88.4 mg/dl ) and control ( from 100.9 to 93.6 mg/dl ) groups significantly , and the decrease in the probiotic group was significantly higher than in the placebo group ( p Insulin resistance index in the probiotic group had 6.74 % reduction over the study period ( p insulin resistance index ( 6.45 % ) , but the observed change in insulin resistance was not statistically significant . Insulin sensitivity index was increased in both groups . The post-intervention insulin sensitivity index in the probiotic group was not significantly different from placebo when adjusted for the baseline levels . Conclusions The probiotic supplement appeared to affect glucose metabolism and weight gain among pregnant women with GDM . This needs to be confirmed in other setting s before a therapeutic value could be approved",
"Abstract Synbiotics are known to exert multiple beneficial effects , including anti-inflammatory and antioxidative actions . This study was design ed to evaluate the effects of synbiotic administration on biomarkers of inflammation , oxidative stress , and pregnancy outcomes among gestational diabetic ( GDM ) women . This r and omized , double-blind , placebo-controlled clinical trial was carried out among 60 subjects with GDM who were not on oral hypoglycemic agents . Patients were r and omly assigned to consume either one synbiotic capsule containing Lactobacillus acidophilus strain T16 ( IBRC-M10785 ) , L. casei strain T2 ( IBRC-M10783 ) , and Bifidobacterium bifidum strain T1 ( IBRC-M10771 ) ( 2 × 109 CFU/g each ) plus 800 mg inulin ( HPX ) ( n = 30 ) or placebo ( n = 30 ) for 6 weeks . Compared with the placebo , synbiotic supplementation significantly decreased serum high-sensitivity C-reactive protein ( hs-CRP ) ( − 1.9 ± 4.2 vs. + 1.1 ± 3.5 mg/L , P = 0.004 ) , plasma malondialdehyde ( MDA ) ( − 0.1 ± 0.6 vs. + 0.3 ± 0.7 μmol/L , P = 0.02 ) , and significantly increased total antioxidant capacity ( TAC ) ( + 70.1 ± 130.9 vs. − 19.7 ± 124.6 mmol/L , P = 0.009 ) and total glutathione ( GSH ) levels ( + 28.7 ± 61.5 vs. − 14.9 ± 85.3 μmol/L , P = 0.02 ) . Supplementation with synbiotic had a significant decrease in cesarean section rate ( 16.7 vs. 40.0 % , P = 0.04 ) , lower incidence of hyperbilirubinemic newborns ( 3.3 vs. 30.0 % , P = 0.006 ) , and newborns ’ hospitalization ( 3.3 vs. 30.0 % , P = 0.006 ) compared with the placebo . Synbiotic supplementation did not affect plasma nitric oxide ( NO ) levels and other pregnancy outcomes . Overall , synbiotic supplementation among GDM women for 6 weeks had beneficial effects on serum hs-CRP , plasma TAC , GSH , and MDA ; cesarean section ; incidence of newborn ’s hyperbilirubinemia ; and newborns ’ hospitalization but did not affect plasma NO levels and other pregnancy outcomes . http://www.i rct .ir : www.i rct .ir : I RCT",
"The study aims to assess whether supplementation with the probiotic Lactobacillus rhamnosus HN001 ( HN001 ) can reduce the prevalence of gestational diabetes mellitus ( GDM ) . A double-blind , r and omised , placebo-controlled parallel trial was conducted in New Zeal and ( NZ ) ( Wellington and Auckl and ) . Pregnant women with a personal or partner history of atopic disease were r and omised at 14–16 weeks ’ gestation to receive HN001 ( 6 × 109 colony-forming units ) ( n 212 ) or placebo ( n 211 ) daily . GDM at 24–30 weeks was assessed using the definition of the International Association of Diabetes and Pregnancy Study Groups ( IADPSG ) ( fasting plasma glucose ≥5·1 mmol/l , or 1 h post 75 g glucose level at ≥10 mmol/l or at 2 h ≥8·5 mmol/l ) and NZ definition ( fasting plasma glucose ≥5·5 mmol/l or 2 h post 75 g glucose at ≥9 mmol/l ) . All analyses were intention-to-treat . A total of 184 ( 87 % ) women took HN001 and 189 ( 90 % ) women took placebo . There was a trend towards lower relative rates ( RR ) of GDM ( IADPSG definition ) in the HN001 group , 0·59 ( 95 % CI 0·32 , 1·08 ) ( P=0·08 ) . HN001 was associated with lower rates of GDM in women aged ≥35 years ( RR 0·31 ; 95 % CI 0·12 , 0·81 , P=0·009 ) and women with a history of GDM ( RR 0·00 ; 95 % CI 0·00 , 0·66 , P=0·004 ) . These rates did not differ significantly from those of women without these characteristics . Using the NZ definition , GDM prevalence was significantly lower in the HN001 group , 2·1 % ( 95 % CI 0·6 , 5·2 ) , v. 6·5 % ( 95 % CI 3·5 , 10·9 ) in the placebo group ( P=0·03 ) . HN001 supplementation from 14 to 16 weeks ’ gestation may reduce GDM prevalence , particularly among older women and those with previous GDM",
"Objective . This trial aims to examine the effects of a Probiotic Mixture ( VSL#3 ) on glycemic status and inflammatory markers , in women with GDM . Material s and Methods . Over a period of 8 weeks , 82 women with gestational diabetes were r and omly assigned to either an intervention group ( n = 41 ) which were given VSL#3 capsule or to a control group which were given placebo capsule ( n = 41 ) . Fasting plasma glucose , homeostatic model assessment of insulin resistance , glycosylated hemoglobin , high-sensitivity C-reactive protein , tumor necrosis factor-α , interleukin-6 , Interferon gamma , and interleukin-10 were measured before and after the intervention . Results . After 8 wk of supplementation FPG , HbA1c , HOMA-IR , and insulin levels remained unchanged in the probiotic and placebo groups . The comparison between the two groups showed no significant differences with FPG and HbA1c , but there were significant differences in insulin levels and HOMA-IR ( 16.6 ± 5.9 ; 3.7 ± 1.5 , resp . ) . Unlike the levels of IFN-g ( 19.21 ± 16.6 ) , there was a significant decrease in levels of IL-6 ( 3.81 ± 0.7 ) , TNF-α ( 3.10 ± 1.1 ) , and hs-CRP ( 4927.4 ± 924.6 ) . No significant increase was observed in IL-10 ( 3.11 ± 5.7 ) in the intervention group as compared with the control group . Conclusions . In women with GDM , supplementation with probiotics ( VSL#3 ) may help to modulate some inflammatory markers and may have benefits on glycemic control ",
"The perinatal nutritional environment impacts upon the health and well-being of mother and child also in the long term . The aim of the present study was to determine the safety and efficacy of perinatal probiotic-supplemented dietary counselling by evaluating pregnancy outcome and fetal and infant growth during the 24 months ' follow-up . Altogether , 256 women were r and omised at their first trimester of pregnancy into a control and a dietary intervention group . The intervention group received intensive dietary counselling provided by a nutritionist and were further r and omised , double-blind to receive probiotics ( Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 ; diet/probiotics ) or placebo ( diet/placebo ) . Firstly , probiotic intervention reduced the frequency of gestational diabetes mellitus ( GDM ) ; 13 % ( diet/probiotics ) v. 36 % ( diet/placebo ) and 34 % ( control ) ; P = 0.003 . Secondly , the safety of this approach was attested by normal duration of pregnancies with no adverse events in mothers or children . No significant differences in prenatal or postnatal growth rates among the study groups were detected . Thirdly , distinctive effects of the two interventions were detected ; probiotic intervention reduced the risk of GDM and dietary intervention diminished the risk of larger birth size in affected cases ; P = 0.035 for birth weight and P = 0.028 for birth length . The results of the present study show that probiotic-supplemented perinatal dietary counselling could be a safe and cost-effective tool in addressing the metabolic epidemic . In view of the fact that birth size is a risk marker for later obesity , the present results are of significance for public health in demonstrating that this risk is modifiable",
"Background / objectives : Owing to excess body weight and increased secretion of inflammatory cytokines primarily during the third trimester , pregnancy is associated with elevated insulin resistance . To our knowledge , no report is available indicating the effects of probiotic yoghurt consumption on serum insulin levels in pregnant women . This study was design ed to determine the effects of daily consumption of probiotic yoghurt on insulin resistance and serum insulin levels of Iranian pregnant women . Subjects/ methods : In this r and omized controlled clinical trial , 70 primigravida pregnant women with singleton pregnancy at their third trimester were participated . We r and omly assigned participants to consume 200 g per day of conventional ( n=33 ) or the probiotic group ( n=37 ) for 9 weeks . The probiotic yoghurt was a commercially available product prepared with the starter cultures of Streptococcus thermophilus and Lactobacillus bulgaricus , enriched with probiotic culture of two strains of lactobacilli ( Lactobacillus acidophilus LA5 ) and bifidobacteria ( Bifidobacterium animalis BB12 ) with a total of min 1 × 107 colony-forming units . Fasting blood sample s were taken at baseline and after 9-week intervention to measure fasting plasma glucose and serum insulin levels . Homeostatic model assessment of insulin resistance ( HOMA-IR ) was used to calculate insulin resistance score . Results : Although consumption of probiotic yogurt for 9 weeks did not affect serum insulin levels and HOMA-IR score , significant differences were found comparing changes in these variables between probiotic and conventional yogurts ( changes from baseline in serum insulin levels : + 1.2±1.2 vs + 5.0±1.1 μIU/ml , respectively , P=0.02 ; and in HOMA-IR score : −0.2±0.3 vs 0.7±0.2 , respectively , P=0.01 ) . Conclusions : It is concluded that in contrast to conventional yogurt , daily consumption of probiotic yogurt for 9 weeks maintains serum insulin levels and might help pregnant women prevent developing insulin resistance",
"BACKGROUND Recent studies have reported beneficial effects of probiotics on maternal glycemia in healthy pregnant women . Obesity significantly increases risk of impaired glucose tolerance in pregnancy , but glycemic effects of probiotics in this specific obstetric group require additional investigation . OBJECTIVE The aim of the Probiotics in Pregnancy Study was to investigate the effect of a probiotic capsule on maternal fasting glucose in obese pregnant women . DESIGN In this placebo-controlled , double-blind , r and omized trial , 175 pregnant women with an early pregnancy body mass index ( BMI ; in kg/m² ) from 30.0 to 39.9 were recruited from antenatal clinics at the National Maternity Hospital , Dublin , Irel and . Exclusion criteria were BMI 39.9 , prepregnancy or gestational diabetes , age Women were r and omly assigned to receive either a daily probiotic or a placebo capsule from 24 to 28 wk of gestation in addition to routine antenatal care . The primary outcome was the change in fasting glucose between groups from preintervention to postintervention . Secondary outcomes were the incidence of gestational diabetes and neonatal anthropometric measures . RESULTS In 138 women who completed the study ( 63 women in the probiotic group ; 75 women in the placebo group ) , mean ( ±SD ) early pregnancy BMI was 33.6 ± 2.6 , which differed significantly between probiotic ( 32.9 ± 2.4 ) and placebo ( 34.1 ± 2.7 ) groups . With adjustment for BMI , the change in maternal fasting glucose did not differ significantly between treated and control groups [ -0.09 ± 0.27 compared with -0.07 ± 0.39 mmol/L ; P = 0.391 ; B = -0.05 ( 95 % CI : -0.17 , 0.07 ) ] . There were also no differences in the incidence of impaired glycemia ( 16 % in the probiotic group compared with 15 % in the placebo group ; P = 0.561 ) , birth weight ( 3.70 kg in the probiotic group compared with 3.68 kg in the placebo group ; P = 0.723 ) , or other metabolic variables or pregnancy outcomes . A secondary analysis of 110 women , excluding antibiotic users and poor compliers , also revealed no differences in maternal glucose or other outcomes between groups . CONCLUSION Probiotic treatment of 4 wk during pregnancy did not influence maternal fasting glucose , the metabolic profile , or pregnancy outcomes in obese women",
"BACKGROUND To our knowledge , data on the effects of probiotic supplementation on glycaemic control and lipid concentrations in patients with gestational diabetes mellitus ( GDM ) are scarce . AIM The aim of the present study was to determine the effects of probiotic supplementation on glycaemic control and lipid profiles in GDM patients . METHODS Sixty pregnant women with GDM , primigravida and aged 18 - 40years , were divided into two groups to receive either probiotic capsules ( n=30 ) or a matching placebo ( n=30 ) in this r and omized double-blind , placebo-controlled trial . The patients in the probiotic group took a daily capsule that contained three viable freeze-dried strains : Lactobacillus acidophilus ( 2 × 10(9)CFU/g ) , L. casei ( 2 × 10(9)CFU/g ) and Bifidobacterium bifidum ( 2 × 10(9)CFU/g ) for 6weeks . The placebo group took capsules filled with cellulose for the same time period . Fasting blood sample s were taken at the beginning and end of the study to quantify the relevant markers . RESULTS After 6weeks of intervention , probiotic supplementation vs a placebo result ed in significant decreases in fasting plasma glucose ( -9.2±9.2mg/dL vs + 1.1±12.2mg/dL , P ) , serum insulin levels ( -0.8±3.1μIU/mL vs + 4.5±10.6μIU/mL , P=0.01 ) , homoeostasis model assessment ( HOMA ) for insulin resistance ( -0.4±0.9 vs + 1.1±2.5 , P=0.003 ) and HOMA for β-cell function ( + 1.1±9.8 vs + 18.0±42.5 , P=0.03 ) , and a significant increase in the quantitative insulin sensitivity check index ( + 0.007±0.01 vs -0.01±0.02 , P=0.007 ) . In addition , significant decreases in serum triglycerides ( -1.6±59.4mg/dL vs + 27.1±37.9mg/dL , P=0.03 ) and VLDL cholesterol concentrations ( -0.3±11.9mg/dL vs + 5.4±7.6mg/dL , P=0.03 ) were seen following supplementation with the probiotics compared with the placebo . However , no significant changes in other lipid profiles were seen with the intervention . CONCLUSION Overall , the results of our study have demonstrated that taking probiotic supplements for 6weeks in patients with GDM had beneficial effects on glycaemic control , triglycerides and VLDL cholesterol concentrations , although there was no effect on other lipid profiles",
"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",
"Abstract Aims / Introduction To evaluate the effect of probiotic supplements on insulin resistance in pregnant women with diet‐controlled gestational diabetes mellitus . Material s and Methods A r and omized , double‐blind , placebo‐controlled trial was carried out between June 2016 and February 2017 . Pregnant women with diet‐controlled gestational diabetes mellitus were enrolled in the study at 24–28 weeks‐of‐gestation and r and omized to receive either probiotic supplements containing Bifidobacterium and Lactobacillus or a placebo daily for four consecutive weeks . Primary outcomes were mean differences in insulin resistance ( homeostatic model assessment for insulin resistance ) , fasting insulin and fasting plasma glucose between the two groups . Secondary outcomes were changes in maternal weight after the intervention . Results Data from 28 patients in the probiotic group and 29 in the placebo group were analyzed . The changes in metabolic parameters after r and omization showed significant improvement in glucose metabolism in the probiotic group compared with the placebo group , including fasting plasma glucose ( 0.68 ± 5.88 vs 4.620 ± 7.78 mg/dL , mean difference −3.94 mg/dL , 95 % confidence interval −7.62 , −0.27 , P = 0.034 ) , fasting plasma insulin ( 1.11 ± 1.71 vs 3.77 ± 1.70 mIU/L , mean difference −2.67 mIU/L , 95 % confidence interval −3.57 , −1.76 , P = 0.001 ) and homeostatic model assessment for insulin resistance ( 0.25 ± 0.37 vs 0.89 ± 0.46 , mean difference −0.63 , 95 % confidence interval −0.86 , −0.41 , P = 0.001 ) . Weight gain during r and omization was similar between the two groups . Conclusions Four weeks of probiotic supplements in women with diet‐controlled gestational diabetes in the late second and early third trimester lowered fasting glucose and increased insulin sensitivity . Probiotic supplements may be considered as an adjunct treatment for glycemic control in these patients",
"Abstract Objective : This study was design ed to evaluate the effects of probiotic supplementation on biomarkers of inflammation , oxidative stress and pregnancy outcomes among subjects with gestational diabetes ( GDM ) . Methods : This r and omized , double-blind , placebo-controlled clinical trial was done among 60 subjects with GDM who were not on oral hypoglycemic agents . Patients were r and omly allocated to intake either probiotic capsule containing Lactobacillus acidophilus , Lactobacillus casei and Bifidobacterium bifidum ( 2 × 109 CFU/g each ) ( n = 30 ) or placebo ( n = 30 ) for six weeks . Results : Compared with the placebo , probiotic supplementation result ed in significant decreases in fasting plasma glucose ( FPG ) ( −5.3 ± 6.7 vs. + 0.03 ± 9.0 mg/dL , p = .01 ) , serum high-sensitivity C-reactive protein ( hs-CRP ) ( −2.2 ± 2.7 vs. + 0.5 ± 2.4 μg/mL , p concentrations ( −0.1 ± 0.8 vs. + 0.5 ± 1.5 μmol/L , p = .03 ) and MDA/TAC ratio ( −0.0003 ± 0.0008 vs. + 0.0009 ± 0.002 , p = .004 ) , and a significant increase in total antioxidant capacity ( TAC ) levels ( + 65.4 ± 103.3 vs. −37.2 ± 143.7 mmol/L , p = .002 ) . Probiotic supplementation did not affect pregnancy outcomes . Conclusions : Overall , probiotic supplementation among women with GDM for six weeks had beneficial effects on FPG , serum hs-CRP , plasma TAC , MDA and oxidative stress index , but did not affect pregnancy outcomes ",
"Background Adequate nutrition is essential during pregnancy and lactation to provide sufficient energy and nutrients to meet the nutritional requirements of the mother , fetus and infant . The primary objective of this study was to assess the effect of a maternal nutritional supplement enriched with probiotics during pregnancy and early lactation on the incidence of infant diarrhea . Methods Healthy , pregnant ( 24–28 weeks gestation ) women were r and omized 1:1:1 to receive either no supplement or two servings per day of an oral supplement ( 140 kcal/serving ) providing 7.9 g protein , multivitamin/minerals , and enriched or not with the probiotics Lactobacillus rhamnosus and Bifidobacterium lactis , from the third trimester of pregnancy until at least 2 months post-delivery . Incidence of infant diarrhea until 12 months post-delivery was analyzed by Poisson regression . The effect on maternal health , fetal growth , and infant growth and morbidity were also evaluated and analyzed by ANOVA . Results A total of 208 mother/infant pairs were included in the analysis . No significant difference in the incidence of infant diarrhea was observed between the three study groups . The mean maternal weight gains at delivery were similar among groups , despite an increase in caloric intake in the supplemented groups . No statistically significant differences between groups were observed in incidence of pregnancy-related or fetal adverse outcomes . Mean weight- , length- , BMI - and head circumference-for-age z-scores were below the WHO median value for all groups . Post-hoc analysis to compare the effect of the combined supplement groups versus the no supplement group on infant growth parameters showed , at 12 months , that the combined supplemented group had gained statistically significant more weight ( 8.97 vs. 8.61 kg , p = 0.001 ) and height ( 74.2 vs. 73.4 cm , p = 0.031 ) , and had a higher weight-for-age z-score ( − 0.62 vs. -0.88 , p = 0.045 ) than the no supplement group . Conclusions Maternal nutritional supplement with or without probiotics given during late pregnancy and early lactation was well tolerated and safe . Even though no difference in incidence of infant diarrhea was observed between the three groups , the analysis of the combined supplemented groups showed beneficial effects of maternal supplementation on infant weight and length gains at 12 months . Trial registration Clinical Trial.gov : NCT01073033 . Registered 17.02.2010",
"OBJECTIVE Given the role of gut microbiota in regulating metabolism , probiotics administered during pregnancy might prevent gestational diabetes mellitus ( GDM ) . This question has not previously been studied in high-risk overweight and obese pregnant women . We aim ed to determine whether probiotics ( Lactobacillus rhamnosus and Bifidobacterium animalis subspecies lactis ) administered from the second trimester in overweight and obese women prevent GDM as assessed by an oral glucose tolerance test ( OGTT ) at 28 weeks ’ gestation . Secondary outcomes included maternal and neonatal complications , maternal blood pressure and BMI , and infant body composition . RESEARCH DESIGN AND METHODS This was a double-blind r and omized controlled trial of probiotic versus placebo in overweight and obese pregnant women in Brisbane , Australia . RESULTS The study was completed in 411 women . GDM occurred in 12.3 % ( 25 of 204 ) in the placebo arm and 18.4 % ( 38 of 207 ) in the probiotics arm ( P = 0.10 ) . At OGTT , mean fasting glucose was higher in women r and omized to probiotics ( 79.3 mg/dL ) compared with placebo ( 77.5 mg/dL ) ( P = 0.049 ) . One- and two-hour glucose measures were similar . Preeclampsia occurred in 9.2 % of women r and omized to probiotics compared with 4.9 % in the placebo arm ( P = 0.09 ) . Excessive weight gain occurred in 32.5 % of women in the probiotics arm ( 55 of 169 ) compared with 46 % in the placebo arm ( 81 of 176 ) ( P = 0.01 ) . Rates of small for gestational age ( < 10th percentile ) were 2.4 % in the probiotics arm ( 5 of 205 ) and 6.5 % in the placebo arm ( 13 of 199 ) ( P = 0.042 ) . There were no differences in other secondary outcomes . CONCLUSIONS The probiotics used in this study did not prevent GDM in overweight and obese pregnant women",
"BACKGROUND Pregnancy interventions that improve maternal and infant outcomes are urgently needed in population s with high rates of obesity . We undertook the Healthy Mums and Babies ( HUMBA ) r and omized controlled trial to assess the effect of dietary interventions and or probiotics in a multiethnic population of pregnant women with obesity , living in an area of high deprivation . OBJECTIVES To determine whether a culturally tailored dietary intervention and or daily probiotic capsules in pregnant women with obesity reduces the co- primary outcomes of ( 1 ) excessive gestational weight gain ( mean > 0.27 kg/week ) and ( 2 ) birthweight . STUDY DESIGN We conducted a 2 × 2 factorial , r and omized controlled trial in women without diabetes at pregnancy booking , body mass index ≥30 kg/m2 , and a singleton pregnancy . At 12 + 0 to 17 + 6 weeks ' gestation , eligible women were r and omized to a dietary intervention ( 4 tailored educational sessions at ≤28 weeks ' gestation by a community health worker trained in key aspects of pregnancy nutrition plus text messaging until birth ) or to routine dietary advice ; and to daily capsules containing either ( Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 , minimum 6.5 × 109 colony forming units ) , or placebo , until birth . Analysis was by intention to treat with adjustment for maternal baseline body mass index . Infant outcomes were additionally adjusted for ethnicity , sex , and gestational age at birth . RESULTS In total , 230 women were recruited between April 2015 and June 2017 ( dietary intervention N = 116 vs routine dietary advice N = 114 ; probiotics N = 115 vs placebo N = 115 ) . Baseline characteristics and demographic variables were similar across all groups . There was no significant difference between intervention groups , for the co- primary outcomes of ( 1 ) proportion of women with excessive gestational weight gain ( dietary intervention vs routine advice : 79/107 [ 73.8 % ] vs 90/110 [ 81.8 % ] , adjusted relative risk [ relative risk , 0.92 ; 95 % confidence interval , 0.80 - 1.05 ] ; probiotics versus placebo : 89/108 [ 82.4 % ] and 80/109 [ 73.4 % ] , relative risk , 1.14 , 95 % confidence interval , 0.99 - 1.31 ) or ( 2 ) birthweight ( dietary intervention vs routine advice : 3575 vs 3612 g , adjusted mean difference , -24 g , 95 % confidence interval , -146 to 97 ; probiotics vs placebo : 3685 vs 3504 g , adjusted mean difference , 107 g , 95 % confidence interval , -14 to 228 ) . Total maternal weight gain , a secondary outcome , was lower with dietary intervention compared with routine dietary advice ( 9.7 vs 11.4 kg , adjusted mean difference , -1.76 , 95 % confidence interval , -3.55 to 0.03 ) . There were no significant differences between intervention groups in other secondary maternal or neonatal outcomes . CONCLUSION Although dietary education and or probiotics did not alter rates of excessive gestational weight gain or birthweight in this multiethnic , high-deprivation population of pregnant women with obesity , dietary education was associated with a modest reduction in total weight gain with potential future benefit for the health of mothers and their offspring if sustained",
"Introduction There is only some evidence about effectiveness of probiotics for preventing gestational hyperglycaemia . This trial examined the effects of probiotic yoghurts containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 on maternal plasma glucose ( primary outcome ) and on some maternal and infant complications ( secondary outcomes ) in overweight and obese women with no diabetes in pregnancy . Methods Using stratified block r and omization , women with pre- or early-pregnancy BMI ≥ 25 and fasting plasma glucose were assigned into probiotic or conventional yoghurt group , consuming 100 g/day from 24 weeks of gestation until delivery . The women and their infants were followed up until 1 month after birth . Results In each group , one out of 65 women had intra-uterine foetal death and were not analysed for other outcomes . The mean BMI was 29.2 ( SD 3.3 ) in probiotic and 30.3 ( SD 4.1 ) in conventional yoghurt group . Four weeks after initiation of the treatment , plasma glucose levels were significantly lower in the probiotic than in conventional yoghurt group at fasting ( mean difference adjusted for the BMI category ) and baseline FPG ( − 4.0 mg/dl ; 95 % confidence interval − 6.9 , − 1.1 ) and 2-h OGTT ( − 13.9 ; − 22.8 , − 5.0 ) . At the 1-h OGTT , however , the difference was not statistically significant ( − 9.8 ; − 20.6 , 0.9 ) . Further , there was a significantly lower infant bilirubin level in the probiotic group on days 3–5 after birth ( − 2.2 mg/dl ; − 3.3 , − 1.2 ) . There were not statistically significant differences between the groups regarding the risk of gestational diabetes ( 6 vs 11 ; odds ratio 0.5 ; 0.2 , 1.5 ) , preterm delivery ( 3 vs 8 ; 0.3 ; 0.1 , 1.2 ) , and other maternal and infant outcomes . Conclusion The probiotics supplementation has some beneficial effects on glucose metabolism of overweight and obese pregnant women . Nevertheless , further studies are required to judge the clinical significance of such effects"
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The incorporation of functional monomers in dental adhesive systems promotes chemical interaction with dental substrates , result ing in higher adhesion forces when compared to micromechanical adhesion only . The 10-MDP monomer , whose chemical structure allows for a polar behavior which is favorable to adhesion , also promotes the protection of collagen fibers through the formation of MDP-calcium salts . This systematic review aim ed to characterize the interface created by 10-MDP containing adhesive systems through an evaluation of the following parameters : Formation of nano-layered structures , capacity to produce an acid-base resistant zone , and adhesion stability . The research was conducted using PubMed , Cochrane Library , Web of Science and Embase , limited to English , Spanish , and Portuguese articles . The research was done according to the PICO strategy . The 10-MDP monomer has the capacity to produce an acid-base resistant zone on the adhesive interface , which increases the response to acid-base challenges . The adhesion established by these systems is stable over time . To have the best of these adhesive solutions , a scrubbing technique must be used to apply the adhesive system on dental substrates , in order to improve monomers infiltration and to create a stable bond . Time must be given for the solution to infiltrate , hybridize and form the MDP-Ca , improving adhesive stability | [
"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",
"Self-assembled nanolayering structures have been reported in resin-dentin interfaces created by adhesives that contain 10-methacryloyloxydecyl dihydrogen phosphate ( 10-MDP ) . These structures have been hypothesized to contribute to bond durability . The objective of the present study was to determine the extent of nanolayering in resin-dentin interfaces after application of commercialized 10-MDP-containing self-etch and universal adhesives to human dentin . Seven commercialized adhesives were examined : Adhese Universal ( Ivoclar-Vivadent ) , All-Bond Universal ( Bisco , Inc. ) , Clearfil SE Bond 2 , Clearfil S3 Bond Plus , Clearfil Universal Bond ( all from Kuraray Noritake Dental Inc. ) , G-Premio Bond ( GC Corp. ) , and Scotchbond Universal ( 3 M ESPE ) . Each adhesive was applied in the self-etch mode on midcoronal dentin according to the respective manufacturer ’s instructions . Bonded specimens ( n = 6 ) were covered with flowable resin composite , processed for transmission electron microscopy , and examined at 30 r and om sites without staining . Thin-film glancing angle X-ray diffraction ( XRD ) was used to detect the characteristic peaks exhibited by nanolayering ( n = 4 ) . The control consisted of 15%wt , 10%wt , and 5%wt 10-MDP ( DM Healthcare Products , Inc. ) dissolved in a mixed solvent ( ethanol and water weight ratio 9:8 , with photoinitiators ) . Experimental primers were applied to dentin for 20 s , covered with hydrophobic resin layer , and examined in the same manner . Profuse nanolayering with highly ordered periodicity ( ~3.7 nm wide ) was observed adjacent to partially dissolved apatite crystallites in dentin treated with the 15 % 10-MDP primer . Three peaks in the 2θ range of 2.40 ° ( 3.68 nm ) , 4.78 ° ( 1.85 nm ) , and 7.18 ° ( 1.23 nm ) were identified from thin-film XRD . Reduction in the extent of nanolayering was observed in the 10 % and 5 % 10-MDP experimental primer-dentin interface along with lower intensity XRD peaks . Nanolayering and characteristic XRD peaks were rarely observed in specimens prepared from the commercialized adhesives . The sparsity of nanolayering in resin-dentin interfaces created by commercialized adhesives challenges its clinical effectiveness as a mechanism for improving bond longevity in dentin bonding"
] | 411670e0-06ff-11f0-808a-c43d1ab1c353 |
Background . Several factors influence the risk of recurrence after inguinal hernia surgery ; however , a systematic review and meta- analysis of patient-related risk factors for recurrence after inguinal hernia surgery has not been performed earlier . Methods . MEDLINE , Embase , and Cochrane data bases were search ed in June 2013 for studies evaluating patient-related risk factors for recurrence after inguinal hernia operation . Observational studies evaluating nontechnical patient-related risk factors for recurrence after inguinal hernia surgery were included . Outcome variables were grouped under patient demographics , hernia characteristics , connective tissue composition and degradation , habits and social relations , and conditions related to inguinal hernia recurrence . Results . From a total of 5061 records screened , we included 40 observational studies enrolling 720 651 inguinal hernia procedures in 714 917 patients in the systematic review . Of the 40 studies , 14 studies were included in 8 meta-analyses evaluating sex , hernia type , hernia size , re-recurrence , bilaterality , mode of admission , age , and smoking as risk factors for recurrence after inguinal hernia surgery in a total of 378 824 procedures in 375 620 patients . Conclusions . We found that female sex , direct inguinal hernias at the primary procedure , operation for a recurrent inguinal hernia , and smoking were significant risk factors for recurrence after inguinal hernia surgery . This knowledge of patient-related risk factors for recurrence after inguinal hernia surgery could be implemented in clinical practice | [
"Inguinal hernias in women are relatively rare , and an outcome in this specific subgroup of hernias has not been documented in the literature . An analysis was performed using data from the prospect i ve recording of 3,696 female inguinal hernia repairs in the national Danish hernia data base , in the 5.5 year period from January 1 , 1998 to June 30 , 2003 , where observation time specific reoperation rates were used as a proxy for recurrence . In the 3,696 female inguinal herniorrhaphies recorded , the overall reoperation rate was 4.3 % , which is slightly higher compared to male inguinal herniorrhaphies ( 3.1 % ) ( P=0.001 ) . The reoperation rate was independent of the type of surgical repair . In 41.5 % of the reoperations a femoral hernia was found , compared to 5.4 % in males . Female inguinal herniorrhaphy is followed by a higher reoperation rate than in males , and is unrelated to the type of repair . The frequent finding of a femoral hernia at reoperation suggests the need for the exploration of the femoral canal at the primary operation",
"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 An association between smoking and impaired wound healing has been reported in retrospective studies . The smoking status of a surgical patient may be confounded by social and medical parameters . We have evaluated the effect of smoking in a test wound in volunteers , with special reference to a reliable scientific match between smokers and nonsmokers . METHODS In a prospect i ve open study with blinded assessment , 19 smoking ( 20 cigarettes/day ) and 18 nonsmoking healthy volunteers were matched with respect to baseline characteristics . The deposition of total protein and mature collagen ( expressed as hydroxyproline ) was assessed in an exp and ed polytetrafluoroethylene wound healing model implanted subcutaneously for 10 days . RESULTS The nonsmokers had a 1.8 times higher median amount of hydroxyproline than the smokers ( p deposition of hydroxyproline was negatively correlated with the consumption of tobacco both before ( r = -0.44 ; p < 0.01 ) and during the study ( r = -0.48 ; p < 0.005 ) . The impairment was specific for the production of collagenous proteins and not other proteins . CONCLUSIONS The synthesis of subcutaneous collagen in smokers is specifically impeded , indicating an impaired wound-healing process . Because mature collagen is the main determinator of strength of an operative wound , the results support the view that patients should be advised to stop smoking before an operation",
"Background Large-scale data for the optimal inguinal hernia repair in younger men with an indirect hernia is not available . We analysed nationwide data for risk of reoperation in younger men after a primary repair using a Lichtenstein operation or a conventional non-mesh hernia repair . Methods Prospect i ve recording of all inguinal hernia repairs from 1 January 1998 to 31 December 2005 in the national Danish Hernia Data base , using reoperation rate as a proxy for recurrence . We included only men between the age of 18 and 30 years with a primary repair of a primary indirect inguinal hernia . Results A primary sutured repair was performed in 1,120 men ( median age 23 years , range 18–30 ) and a Lichtenstein mesh repair in 2,061 young men ( 24 years , range 18–30 ) ( total 3,181 patients ) . The observation time after conventional hernia repair was median 62 months ( range 0–96 ) and 41 months ( range 0–96 ) after a Lichtenstein repair . The cumulative incidence of reoperation at 5 years was 1.6 % ( Lichtenstein ) versus 3.9 % ( sutured repair ) , while overall reoperation rates were almost three-fold as high after a sutured repair ( 39 reoperations , overall reoperation rate = 3.5 % ) compared to a Lichtenstein repair ( 24 reoperations , overall reoperation rate = 1.2 % ; P = 0.0003 ) . Conclusions Lichtenstein repair for an indirect inguinal hernia reduces the risk of recurrence in young men between the age of 18 and 30 years compared with a sutured repair . The use of a Lichtenstein mesh repair in young males must be balanced against the risk of chronic pain",
"Laparoscopic transperitoneal hernioplasty ( TAPP ) repair of inguinal hernias is thought to be a difficult surgical technique with high complication rates . The present study evaluated TAPP based on prospect i ve documentation",
"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",
"Cigarette smokers deposit less collagen , expressed as hydroxyproline , in granulation tissue than nonsmokers . We studied the effect of abstinence from smoking and transdermal nicotine patches on deposition of hydroxyproline , proline , type I procollagen , and total proteins . Fifty-four healthy smokers were studied during 10 days of smoking and again from days 10 to 20 following smoking cessation . After the first 10 days of abstinence they were r and omized to double-blind treatment with transdermal nicotine patches of 25 mg/day or placebo for a period of 10 days . During this period and during smoking , an exp and ed polytetrafluoroethylene tube was implanted into the subcutis . Following removal of the implant , total amino acids and peptides were extracted . Hydroxyproline and proline were analyzed by high-pressure liquid chromatography , type I procollagen was analyzed by enzyme-linked immunoassay , and total proteins were determined colorimetrically . In the 39 subjects who complied with the study protocol , abstinence from smoking did not affect the deposition of hydroxyproline , proline , type I procollagen , or total protein in the implants . During abstinence , the type I procollagen level increased by 18 % in the transdermal nicotine patches group and decreased by 10 % in the placebo group ( p collagen deposition in granulation tissue . However , in abstinent smokers , transdermal nicotine patches appears to increase type I collagen synthesis",
"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",
"Background During totally extraperitoneal ( TEP ) endoscopic repair of inguinal hernias , it is possible to see the internal opening of the femoral canal . The aim of our study was to determine the incidence of synchronous femoral hernias found in patients undergoing TEP endoscopic inguinal hernia repair . Method This was a retrospective review of prospect ively collected data on 362 consecutive patients who underwent 484 TEP endoscopic inguinal hernia repairs during a 5-year period , May 2005 to May 2010 . During surgery , both inguinal and femoral canal orifices were routinely inspected . The presence of unilateral or bilateral inguinal and femoral hernias was recorded and repaired accordingly . Results There were a total of 362 patients . More males ( 343 , 95 % ) underwent a TEP hernia repair than females ( 19 , 5 % ) . There were more cases of unilateral ( 240/362 , 66 % ) than bilateral ( 122/362 , 34 % ) inguinal hernias . A total of 18 cases of synchronous femoral hernias were found during operation . There was a higher incidence of femoral hernia in females ( 7/19 , 37 % ) compared to males ( 11/343 , 3 % ) ( P femoral hernias were clinical ly detectable preoperatively . Conclusion Females undergoing elective inguinal hernia repair are more likely to have a synchronous femoral hernia than males . We suggest that all women presenting with an inguinal hernia also have a formal assessment of the femoral canal . TEP endoscopic inguinal hernia repair is an ideal approach as both inguinal and femoral orifices can be assessed and hernias repaired simultaneously during surgery",
"Objective To analyze reoperation rates for recurrent and primary groin hernia repair documented in the Swedish Hernia Register from 1996 to 1998 , and to study variables associated with increased or decreased relative risks for reoperation after recurrent hernia . Methods Data were retrieved for all groin hernia repairs prospect ively recorded in the Swedish Hernia register from 1996 to 1998 . Actuarial analysis adjusted for patients ’ death was used for calculating the cumulative incidence of reoperation . Relative risk for reoperation was estimated using the Cox proportional hazards model . Results From 1996 to 1998 , 17,985 groin hernia operations were recorded in the Swedish Hernia Register , 15 % for recurrent hernia and 85 % for primary hernia . At 24 months the risk for having had a reoperation was 4.6 % after recurrent hernia repair and 1.7 % after primary hernia repair . The relative risk for reoperation was significantly lower for laparoscopic methods and for anterior tension-free repair than for other techniques . Postoperative complications and direct hernia were associated with an increased relative risk for reoperation . Day-case surgery and local infiltration anesthesia were used less frequently for recurrent hernia than for primary hernia . Conclusions Recurrent groin hernia still constitutes a significant quantitative problem for the surgical community . This study supports the use of mesh by laparoscopy or anterior tension-free repair for recurrent hernia operations",
"OBJECTIVE To find out whether simultaneous repair of bilateral hernias increases the risk of recurrence compared with unilateral repair . DESIGN Prospect i ve study . SETTING Swedish hospitals participating in the Swedish Hernia Register ( SHR ) . INTERVENTIONS Prospect i ve collection of data from the SHR , 1992 - 1999 inclusive . The Cox proportional hazard test was used for calculating odds ratio ( OR ) . MAIN OUTCOME MEASURES Hernia repairs were followed up in a life table fashion until re-operation for recurrence or death of the patient . RESULTS 33416 unilateral and 1487 bilateral operations on 2974 groin hernias were found . Direct hernias were more common in the bilateral than in the unilateral group , 1,825 , 61 % compared with 13,336 , 40 % , ( p cumulative incidence of reoperation at three years for groin hernias after bilateral and unilateral repair was 4.1 % ( 95 % confidence interval 3.1 % to 5.1 % ) and 3.4 % ( 95 % Cl 3.1 % to 3.7 % , respectively . After adjustment for other risk factors , the OR for reoperation for recurrence after bilateral repair was 1.2 ( 95 % CI 0.9 to 1.5 ) with unilateral repair as reference . The OR for reoperation after laparoscopic bilateral repair compared with open bilateral repair was 0.9 ( 95 % CI 0.6 to 1.4 ) . CONCLUSIONS Simultaneous repair of bilateral hernias does not increase the risk of reoperation for recurrence and there is no significant difference in the risk of reoperation after bilateral repair using open or laparoscopic techniques",
"BACKGROUND We compare the use of unilateral and simultaneous bilateral laparoscopic hernioplasty [ transabdominal preperitoneal patch ( TAPP ) ] METHOD We employed a prospect i ve consecutive single-center trial lasting from April 1993 to December 2000 . RESULTS In our study , 5524 consecutive patients underwent 6860 laparoscopic hernia repairs . The median age in group A ( unilateral repair , n = 4188 ) was 58 years ( 16 - 94 years ) , and that in group B ( simultaneous bilateral repair , n = 1336 ) was 60 years ( 19 - 97 years ) in ( simultaneous bilateral repair , n = 1336 ) . Morbidity in group A was 3.2 % ( 135/4188 ) with a 0.6 % reoperation rate ( 24/4188 ) ; in group B morbidity was 5.0 % ( 67/1336 ) with a 1.4 % reoperation rate . ( 19/1336 ) . Morbidity and reoperation rates showed no statistically significant difference between the two groups in relation to number of repairs in group B. After a median 24-month clinical follow-up period ( 1 - 84 months ) ( follow-up rate 93.1 % ) 38 recurrences were observed in group A ( 0.9 % ) and 17 in group B ( 0.6 % ; 17/2672 ) ( p = 0.2668 ) . Median time off work was 14 days after unilateral ( 2 - 63 days ) and 17 days after bilateral repair ( 3 - 100 days ) ( p = 0.1359 ) . Pain levels ( numerical analogue scale ) and incidence of persistent inguinal and scrotal pain are not higher after bilateral repair . CONCLUSION Compared to unilateral repair , bilateral simultaneous laparoscopic hernia repair ( TAPP ) is safe , comfortable for patients , and cost-effective , without increased morbidity or recurrence risk . Bilateral inguinal hernia is an ideal indication for endoscopic transabdominal repair",
"OBJECTIVES To examine the relationship between operating time and reoperation for recurrence and other complications in groin hernia repairs . DESIGN Observational population -based register study . SETTING Data from the nationwide Swedish Hernia Register , which prospect ively collects data from almost all groin hernia repairs performed in Sweden . PATIENTS There were 123,917 primary groin hernia repairs recorded in the Swedish Hernia Register from January 1 , 1998 , through December 31 , 2007 . MAIN OUTCOME MEASURES Relative risk of reoperation for recurrence and odds ratios for postoperative complications in 4 operating time groups . RESULTS The relative risk of reoperation for recurrence of all patients operated on in less than 36 minutes was 26 % higher than that of all patients with an operating time of more than 66 minutes ( 1.26 ; 95 % CI , 1.11 - 1.43 ) . Because the Lichtenstein procedure is the st and ard procedure in Sweden today , its results were also analyzed separately . In this homogeneous group , the difference was even more striking with an increased relative risk of 45 % ( 1.45 ; 95 % CI , 1.21 - 1.75 ) . The odds ratio for infection and other postoperative complications increased with increasing operating time . CONCLUSION A significant decrease in reoperation for recurrence with increasing operating time exhorts the hernia surgeon to avoid speed and to maintain thoroughness throughout the procedure",
"Objective : To describe the characteristics of patients undergoing multiple groin hernia repairs and to identify strategies that prevent further recurrence . Summary Background Data : Although relatively infrequent , recurrent groin hernias where several repairs have previously been undertaken constitutes a major problem in hernia surgery . Low numbers and heterogeneity have made it difficult to perform large prospect i ve studies on this group . Methods : The study was design ed as an observational population -based register study . All repairs for recurrent hernia recorded in the Swedish Hernia Register ( SHR ) 1992–2006 were identified . Risk for reoperation by number of previous repairs , with adjustment for gender and age , and risk for reoperation by unit responsible for previous repair were determined using Cox proportional hazard analysis . Results : There were 12,104 cases of hernia repaired once , 2 repairs in 4199 cases , 3 repairs in 310 cases , 4 repairs in 32 cases , and 5 repairs in 3 cases . The risk for further reoperation increased with the number of previous repairs ( P The hazard ratios for reoperation following open preperitoneal mesh repair and laparoscopic repair decreased ; whereas , the hazard ratio for sutured repair increased with the number of previous repairs . The difference between Lichtenstein repair and laparoscopic repair was significant for the first 2 repairs ( P groin hernia recurrence ",
"Objectives : We examined the influence of surgeon age and other factors on proficiency in laparoscopic or open hernia repair . Summary Background Data : In a multicenter , r and omized trial comparing open and laparoscopic herniorrhaphies , conducted in Veterans Administration hospitals ( CSP 456 ) , we reported significant differences in recurrence rates ( RR ) for the laparoscopic procedure as a result of surgeons ’ experience . We have also reported significant differences in RR for the open procedure related to resident postgraduate year ( PGY ) level . Methods : We analyzed data from unilateral laparoscopic and open herniorrhaphies from CSP 456 ( n = 1629 ) . Surgeon 's experience ( experienced ≥250 procedures ; inexperienced older ( ≥45 years ) and younger ( . Surgeon 's inexperience and older age were significant predictors of recurrence in laparoscopic herniorrhaphy . The odds of recurrence for an inexperienced surgeon aged 45 years or older was 1.72 times that of a younger inexperienced surgeon . For open repairs , although surgeon 's age and operation time appeared to be related to recurrence , only median PGY level of surgeon 's age of 45 years and older , when combined with inexperience in laparoscopic inguinal herniorrhaphies , increases risk of recurrence . For open repairs , only a median PGY level of <3 was a significant risk factor",
"OBJECTIVE Analysis of reoperation and recurrence rates three years after repair of groin hernias . DESIGN Prospect i ve audit by question naire and selective follow-up . SETTING Eight Swedish hospitals . SUBJECTS All groin hernia operations done during 1992 on patients between the ages of 15 and 80 years . MAIN OUTCOME MEASURES Postoperative complications , reoperation for recurrence , and recurrence . RESULTS During 1992 , 1565 hernia operations were done . The postoperative complication rate was 8 % ( 125/1565 ) . At 36 months postoperatively 108 recurrences had already been reoperated on , six patients with recurrences were on the waiting list for reoperation and a further 36 recurrences had been detected at follow-up . The interhospital variation in recurrence rate ranged from 3 % to 20 % . Postoperative complications , recurrent hernia , direct hernia and hospital catchment area over 100000 inhabitants were all factors associated with an increased relative risk of recurrence . CONCLUSIONS The recurrence rate exceeded the reoperation rate for recurrence by almost 40 % which should be taken into account if the reoperation rate is used as the endpoint after repairs of groin hernia . An audit scheme , based on prospect i ve recording , reoperation rate , and ( periodic ) calculation of the recurrence rate may be used to identify risk factors for recurrence and areas in need of improvement",
"BACKGROUND More than sixty thous and inguinal hernia operations are performed every year in Pol and . Despite many years of related research , the exact pathologic mechanism of this condition is still not fully understood . Recent studies suggested a pronounced relationship between the molecular structure of collagen fibers and the activity of metalloproteinases , the enzymes taking part in the degradation of collagen , as well as their tissue inhibitors . MATERIAL S AND METHODS A prospect i ve study has been established to measure serum levels of the matrix metalloproteinase 2 ( MMP-2 ) and Matrix metalloproteinase tissue inhibitor 2 ( TIMP-2 ) in 150 males between the ages of 26 and 70 . The control group ( CG ) consisted of thirty healthy male volunteers of a similar age distribution . RESULTS Our results indicate that MMP-2 was highest in the direct hernia group , a statistically very significant elevation ( P MMP-2 and TIMP-2 levels were concurrently elevated only in the recurrent hernia group . CONCLUSIONS The patients with inguinal hernia have a statistically significant increase in serum levels of MMP-2 . Our finding of the MMP-2 and TIMP-2 distinctly higher in the patients suffering from recurrence of direct inguinal hernia ( reflecting a previous surgical failure ) may suggest the theory that the extracellular matrix defect lies at the basis of this disorder"
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BACKGROUND Coronary heart disease is the leading cause of death in adults . Screening for abnormalities by using resting or exercise electrocardiography ( ECG ) might help identify persons who would benefit from interventions to reduce cardiovascular risk . PURPOSE To up date the 2004 U.S. Preventive Services Task Force evidence review on screening for resting or exercise ECG abnormalities in asymptomatic adults . DATA SOURCES MEDLINE ( 2002 through January 2011 ) , the Cochrane Library data base ( through the fourth quarter of 2010 ) , and reference lists . STUDY SELECTION R and omized , controlled trials and prospect i ve cohort studies . DATA EXTRACTION Investigators abstract ed details about the study population , study design , data analysis , follow-up , and results and assessed quality by using predefined criteria . DATA SYNTHESIS No study evaluated clinical outcomes or use of risk-reducing therapies after screening versus no screening . No study estimated how accurately resting or exercise electrocardiography classified participants into high- , intermediate- , or low-risk groups , compared with traditional risk factor assessment alone . Sixty-three prospect i ve cohort studies evaluated abnormalities on resting or exercise ECG as predictors of cardiovascular events after adjustment for traditional risk factors . Abnormalities on resting ECG ( ST-segment or T-wave abnormalities , left ventricular hypertrophy , bundle branch block , or left-axis deviation ) or exercise ECG ( ST-segment depression with exercise , chronotropic incompetence , abnormal heart rate recovery , or decreased exercise capacity ) were associated with increased risk ( pooled hazard ratio estimates , 1.4 to 2.1 ) . Evidence on harms was limited , but direct harms seemed minimal ( for resting ECG ) or small ( for exercise ECG ) . No study estimated harms from subsequent testing or interventions , although rates of angiography after exercise ECG ranged from 0.6 % to 2.9 % . LIMITATIONS Only English- language studies were included . Statistical heterogeneity was present in several of the pooled analyses . CONCLUSION Abnormalities on resting or exercise ECG are associated with an increased risk for subsequent cardiovascular events after adjustment for traditional risk factors , but the clinical implication s of these findings are unclear | [
"Risk prediction for electrocardiographic ( ECG ) left ventricular hypertrophy related criteria , used in clinical trials , and epidemiologic studies of clinical ly healthy people , has depended in the past on dichotomous classification of ECG LVH criteria . Recent analyses have shown that more sensitive methods of LVH ECG classification without loss of specificity are needed to improve on dichotomous classification . This was done by relating six year incident significant change in continuous score criteria of ECG LVH to the 16 year ( 10 year post trial ) coronary heart disease ( CHD ) and cardiovascular disease ( CVD ) mortality among 12,866 men , free of clinical disease , aged 35 to 57 years at baseline in the Multiple Risk Factor Intervention Trial . It was found that significant change in continuous ECG LVH criteria was a stronger independent predictor of future CHD and CVD mortality than was use of dichotomous classification of the same criteria . It was also demonstrated that increase in continuous ECG LVH indexes , below previous dichotomous thresholds independently ( of st and ard CVD risk factors , including increase in obesity-indicated by an increase in adult BMI ) predicted excess CHD and CVD mortality and that combinations of continuous indices increases the specificity and relative risk in clinical ly disease-free middle-aged men",
"1 . Frei B , Engl and L , Ames BN . Ascorbate is an outst and ing antioxidant in human blood plasma . Proc Natl Acad Sci U S A 1989;86:6377–6381 . 2 . Ting HH , Timimi FK , Boles KS , Creager SJ , Ganz P , Creager MA . Vitamin C improves endothelium-dependent vasodilation in patients with non-insulindependent diabetes mellitus . J Clin Invest 1996;97:22–28 . 3 . Heitzer T , Just H , Munzel T. Antioxidant vitamin C improves endothelial dysfunction in chronic smokers . Circulation 1996;94:6–9 . 4 . Slakey D , Roza A , Pieper G , Johnson C , Adams M. Delayed cardiac allograft rejection due to combined cyclosporine and antioxidant therapy . Transplantation 1993;56:1305–1309 . 5 . Fish RD , Nabel EG , Selwyn AP , Ludmer PL , Mudge GH , Kirshenbaum JM , Schoen FJ , Alex and er RW , Ganz P. Responses of coronary arteries of cardiac transplant patients to acetylcholine . J Clin Invest 1988;81:21–31 . 6 . Davis SF , Yeung AC , Meredith IT , Charbonneau F , Ganz P , Selwyn AP , And erson TJ . Early endothelial dysfunction predicts the development of transplant coronary artery disease at 1 year posttransplant . Circulation 1996;93:457– 462 . 7 . Morrow JD , Roberts LJ II . Mass spectrometric quantification of F2-isoprostanes in biological fluids and tissues as measure of oxidant stress . Methods Enzymol 1999;300:3–12 . 8 . Watanabe H , Kakihana M , Ohtsuka S , Sugishita Y. R and omized , double-blind , placebo-controlled study of ascorbate on the preventive effect of nitrate tolerance in patients with congestive heart failure . Circulation 1998;97:886–891",
"Key Summary Points Risk prediction models are statistical models used to predict the probability of an outcome on the basis of the values of 1 or more risk factors ( markers ) . The accuracy of the model 's predictions is typically summarized with statistics that describe the model 's discrimination and calibration . Risk stratification tables are a more informative way to assess and compare the models . The tables illustrate the distribution of predictions across risk categories . That illustration allows users to assess 3 key measures of the models ' value for guiding medical decisions : the models ' calibration , ability to stratify people into clinical ly relevant risk categories , and accuracy at classifying patients into higher- and lower-risk categories . This information is contained in the margins of the risk stratification table rather than in its cells . The tables should only be used to compare risk prediction models when one of the models contains all of the markers that are contained in the other ( nested models ) ; they should not be used to compare models with different sets of markers ( nonnested models ) . The table predictions require corrections when casecontrol data are used . The recent epidemiologic and clinical literature is filled with studies evaluating statistical models that predict risk for disease or some other adverse event ( 15 ) . Because risk prediction models are intended to help patients and clinicians make decisions , evaluation of these models requires methods that differ from those used to assess models describing disease etiology . This is because the characteristics of the models are less important than their value for guiding decisions . Cook and colleagues ( 1 , 6 ) recently proposed a new approach to evaluate risk prediction models : a risk stratification table . This methodology appropriately focuses on the key purpose of a risk prediction model , which is to classify individuals into clinical ly relevant risk categories , and it has therefore been widely adopted in the literature ( 24 ) . We examine the risk stratification approach in detail in this article , identifying the relevant information that can be abstract ed from a risk stratification table and caution ing against misuses of the method that frequently occur in practice . We use a recently published study of a breast cancer risk prediction model by Tice and colleagues ( 2 ) to illustrate the concepts . Background A risk prediction marker is any measure that is used to predict a person 's risk for an event . It may be a quantitative measure , such as high-density lipoprotein cholesterol level , or a qualitative measure , such as family history of disease . Risk predictors are also risk factors , in the sense that they will necessarily be strongly associated with the risk for disease . But a large , significant association does not assure that the marker has value in predicting risk for many people . A risk prediction model is a statistical model that combines information from several markers . Common types include logistic regression models , Cox proportional hazard models , and classification trees . Each type of model produces a predicted risk for each person by using information in the model . Consider , for example , a model predicting breast cancer risk that includes age as the only predictor . The result ing risk prediction for a woman of a given age is simply the proportion of women her age who develop breast cancer . The woman 's predicted risk will change if more information is included in the model . For instance , if family history information is added , her predicted risk will be the proportion of women her age and with her family history who develop breast cancer . The purpose of a risk prediction model is to accurately stratify individuals into clinical ly relevant risk categories . This risk information can be used to guide clinical or policy decisions , for example , about preventive interventions for persons or disease screening for sub population s identified as high risk , or to select persons for inclusion in clinical trials . The value of a risk prediction model for guiding these kinds of decisions can be judged by the extent to which the risk calculated from the model reflects the fraction of persons in the population with actual events ( its calibration ) ; the proportions in which the population is stratified into clinical ly relevant risk categories ( its stratification capacity ) ; and the extent to which participants with events are assigned to high-risk categories and those without events are assigned to low-risk categories ( its classification accuracy ) . Risk prediction models are commonly evaluated by using the receiver-operating characteristic ( ROC ) curve ( 4 , 7 ) , which is a st and ard tool for evaluating the discriminatory accuracy of diagnostic or screening markers . This curve shows the true-positive rate plotted against the false-positive rate for rules that classify persons by using risk thresholds that vary over allpossible values . Receiver-operating characteristic curves are generally not helpful for evaluating risk prediction models because they do not provide information about the actual risks that the models predict or about the proportion of participants who have high or low risk values . Moreover , when comparing ROC curves for 2 risk prediction models , the models are aligned according to their false-positive rates ( that is , different risk thresholds are applied to the 2 models to achieve the same false-positive rate ) . This is clearly inappropriate . In addition , the area under the ROC curve or c-statistic , a commonly reported summary measure that can be interpreted as the probability that the predicted risk for a participant with an event is higher than that for a participant without an event , has little direct clinical relevance . Clinicians are never asked to compare risks for a pair of patients one who will eventually have the event and one who will not . Neither the ROC curve nor the c-statistic relates to the practical task of predicting risks for clinical decision making . Cook and colleagues ( 1 , 6 ) propose using risk stratification tables to evaluate the incremental value of a new marker , or the benefit of adding a new marker ( for example , C-reactive protein ) , to an established set of risk predictors ( for example , Framingham risk predictors , such as age , diabetes , cholesterol level , smoking , and low-density lipoprotein cholesterol levels ) . In these stratification tables , risks calculated from models with and without the new marker are cross-tabulated . This approach represents a substantial improvement over the use of ROC methodology because it displays the risks calculated by use of the model and the proportions of individuals in the population who are stratified into the risk groups . We will provide an example of this approach and show how information about model calibration , stratification capacity , and classification accuracy can be derived from a risk stratification table and used to assess the added value of a marker for clinical and health care policy decisions . Example Tice and colleagues ( 2 ) published a study that builds and evaluates a model for predicting breast cancer risk by using data from 1095484 women in a prospect i ve cohort and incidence data from the Surveillance , Epidemiology , and End Results data base . Age , race or ethnicity , family history , and history of breast biopsy were used to model risk with a Cox proportional hazard model . The study focused on the benefit of adding breast density information to the model . The hazard ratio for breast density in the multivariate model ( extremely dense vs. almost entirely fat ) was estimated as 4.2 for women younger than age 65 years and 2.2 for women age 65 years or older . This suggests that breast density is strongly associated with disease riskthat is , that breast cancer rates are higher among women with higher breast density . However , it does not describe the value of breast density for helping women make informed clinical decisions , which requires knowledge of the frequency distribution of breast density in the population . To evaluate the added value of breast density , Tice and colleagues defined 5-year breast cancer risk categories as low ( # # lt##1 % ) , low to intermediate ( 1 % to 1.66 % ) , intermediate to high ( 1.67 % to 2.5 % ) , and high ( # # gt##2.5 % ) . The 1.67 % cutoff for intermediate risk was presumably chosen on the basis of recommendations by the American Society of Clinical Oncology ( 8) and the Canadian Task Force on Preventive Health Care ( 9 ) to counsel women with 5-year risks greater than this threshold about considering tamoxifen for breast cancer prevention . Tice and colleagues used a risk stratification table ( Table 1 ) to compare risk prediction models with and without breast density . Table 1 . Five-Year Risks for Breast Cancer as Predicted by Models That Do and Do Not Include Breast Density Calibration Assessing model calibration is an important first step in evaluating any risk prediction model . Good calibration is essential ; it means that the model-predicted probability of an event for a person with specified predictor values is the same as or very close to the proportion of all persons in the population with those same predictor values who experience the event ( 10 ) . With many predictors , and especially with continuous predictors , we can not evaluate calibration at each possible predictor value because there are too few participants with exactly those values . Instead , the st and ard approach is to place persons within categories of predicted risk and to compare the category values with the observed event rates for participants in each category . The calibration of the risk prediction models for breast cancer can be assessed by comparing the proportions of events in the margins of Table 1 with the corresponding row and column labels . For the model without breast density , the proportions of observed events within each risk category are in the far-right Total column and they generally agree",
"OBJECTIVE We investigated the prognostic significance of risk scores and exercise workload with respect to stroke . Background . There are no data on exercise workload combined with European Systematic Coronary Risk Evaluation ( SCORE ) in the prediction of stroke . METHODS Exercise workload was measured by exercise test with an electrically braked cycle ergometer performed at baseline . The study is based on a r and om population -based sample of 1639 men ( 42 - 60 years ) without history of type 2 diabetes or atherosclerotic cardiovascular disease including coronary heart disease , stroke or claudication . RESULTS During an average follow-up of 16 years , a total of 97 strokes occurred , of which 71 were ischaemic strokes . Independent predictors for all strokes were European SCORE [ for 1 % increment , relative risk ( RR ) : 1.12 , 95 % CI : 1.02 to 1.22 , P=0.017 ) , maximal workload ( for 20 W increment , RR : 0.87 , 95 % CI : 0.80 to 0.95 , P=0.003 ) and body mass index ( for 5 kg m(-2 ) increment , RR : 1.08 , 95 % CI : 1.03 to 1.14 , P=0.004 ) , when adjusted for serum HDL , alcohol consumption , C-reactive protein , family history of coronary heart disease , exercise-induced ST changes and the use of medications for hypertension , dyslipidaemia or aspirin . The risk was 2.54-fold ( 95 % CI : 1.27 - 5.09 , P=0.008 ) for any strokes and 4.43-fold ( 95 % CI 1.69 - 11.78 , P=0.003 ) for ischaemic strokes amongst men with exercise capacity less than 162 W when compared with those with high exercise capacity over 230 W , after adjustment for risk factors . CONCLUSIONS Low exercise workload predicts an especially high risk for stroke in the presence of high risk SCORE",
"Background —National Cholesterol Education Program Adult Treatment Panel III ( ATP III ) guidelines recommend the use of Framingham risk scores ( FRS ) for cardiovascular assessment of asymptomatic individuals . We hypothesized that risk prediction could be improved with 2 non-ECG exercise test measures , exercise capacity ( metabolic equivalents , or METs ) and heart rate recovery ( HRR ) . Methods and Results —An asymptomatic cohort with baseline treadmill tests ( n=6126 ; 46 % women , FRS was followed up prospect ively for 20 years . Individuals with low ( median or less ) HRR or METs experienced 91 % of all cardiovascular disease ( CVD ) deaths ( 225/246 ) . After FRS adjustment , low HRR and METs individually were highly significant predictors of CVD death , but low HRR and METs together were associated with substantially higher risk ( adjusted hazard ratio compared with high HRR/high METs for women 8.51 , 95 % CI 3.65 to 19.84 ; for men , 3.53 , 95 % CI 2.03 to 6.15 ; P FRS-adjusted CVD death risk associated with low HRR/low METs was less than at 20 years but remained significant ( women 3.83 , 95 % CI 1.09 to 13.47 , and men 2.70 , 95 % CI 1.11 to 6.55 ) . The application of HRR/METs information to FRS assessment identified those at high risk ( > 0.5 % annual CVD mortality ) in half of women with FRS 6 % to 9 % and 10 % to 19 % and just under half of men with FRS 10 % to 19 % . Low HRR/low METs was also associated with an increased relative risk of CVD death in individuals with low-risk FRS ( FRS absolute CVD mortality rates were low in this subgroup . Conclusions —Exercise testing may be a useful adjunct for clinical risk assessment in asymptomatic women with FRS 6 % to 19 % and men with FRS 10 % to 19 % ",
"Background and Purpose — There are few if any data on the prognostic importance of silent myocardial ischemia during exercise with regard to the risk of stroke and cardiovascular diseases ( CVDs ) among asymptomatic men . In this prospect i ve study , we investigated the relation of silent myocardial ischemia and the risk of stroke and CVD death in men with and without conventional risk factors . Methods — The study sample included 1726 middle-aged men with no history of stroke , coronary heart disease , or atrial fibrillation at baseline . Silent myocardial ischemia was defined as a horizontal or downsloping ST-segment depression ( ⪖1 mm ) during exercise electrocardiography . A total of 86 CVD-related deaths and 78 strokes occurred during an average follow-up of 10 years . Results — Men with silent ischemia during exercise had a 3.5-fold increased risk of CVD death and a 2.2-fold increased risk of stroke compared with men without silent ischemia , after adjusting for conventional risk factors . Silent ischemia during exercise was associated with a 3.8-fold ( 95 % confidence interval [ CI ] , 1.5 to 9.5 ) increased risk for CVD in smokers , a 3.9-fold ( 95 % CI , 2.1 to 7.3 ) increased risk in hypercholesterolemic subjects , a 3.6-fold ( 95 % CI , 1.9 to 6.8 ) increased risk in the hypertensives , and 3.8-fold ( 95 % CI , 2.0 to 7.1 ) increased risk in overweight men . The respective relative risks for stroke were 3.8 ( 95 % CI , 1.1 to 12.5 ) , 3.5 ( 95 % CI , 1.7 to 7.4 ) , 3.4 ( 95 % CI , 1.6 to 7.1 ) , and 2.9 ( 95 % CI , 1.4 to 6.1 ) . Conclusions — Exercise-induced silent myocardial ischemia is an important indicator of increased risk of stroke and CVD in men with other risk factors , such as smoking , hypercholesterolemia , hypertension , and being overweight",
"OBJECTIVES This study was conducted to determine the incidence of physiologically significant coronary artery disease in a group of asymptomatic high risk men with essential hypertension and to assess the validity of noninvasive tests in a subset of these patients undergoing coronary arteriography . METHODS Two hundred twenty-six asymptomatic men ( mean age 61 + /- 8 years ) with essential hypertension and no clinical evidence of coronary artery disease but with at least one additional coronary risk factor were studied prospect ively . Fifty age- and risk factor-matched normotensive subjects were evaluated as a control group . After a minimum of 4 days without medication , subjects underwent stress thallium-201 scintigraphy , exercise and 48-h ambulatory electrocardiography , and echocardiography . Coronary angiography was performed in a subset of 34 ( 40 % ) of 84 patients with one or more positive test results . RESULTS A positive thallium-201 scintigram ( 18 % vs. 6 % ; odds ratio 3.4 , confidence interval 0.95 to 10.8 , p = 0.056 ) , exercise electrocardiograms ( ECGs ) ( 37 % vs. 13 % ; odds ratio 4.1 , confidence interval 1.5 to 11.2 , p ambulatory ECG ( 15 % vs. 0 % , p coronary angiography , thallium-201 scintigraphy was both sensitive and specific for epicardial atherosclerotic coronary disease ( 90 % and 79 % , respectively ) , but positive exercise and ambulatory ECGs occurred frequently in the absence of significant coronary stenoses . In the 39 % of hypertensive patients who had mild to moderate left ventricular hypertrophy , positive exercise and ambulatory ECGs occurred at a higher rate . CONCLUSIONS These findings suggest that physiologically significant coronary artery disease occurs more frequently in asymptomatic hypertensive men than in comparable normotensive control subjects . In the subgroup undergoing coronary arteriography , reversible scintigraphic defects were both sensitive and specific for diagnosing epicardial coronary artery disease , but exercise and ambulatory ECGs appeared to yield frequent false positive results , especially when left ventricular hypertrophy was present . These results indicate that patients with \" silent \" coronary artery disease can be identified among high risk hypertensive patients , but the appropriate application of such screening in clinical practice remains to be determined",
"BACKGROUND Previous reports have suggested that an attenuated exercise heart rate response may be associated with coronary heart disease risk and with mortality . These observations may parallel the association between reduced heart rate variability during normal activities and adverse outcome . This investigation was design ed to look at the prognostic implication s of exercise heart rate response in a population -based sample . METHODS AND RESULTS In this prospect i ve cohort investigation , 1575 male participants ( mean age , 43 years ) in the Framingham Offspring Study who were free of coronary heart disease , who were not taking beta-blockers , and who underwent submaximal treadmill exercise testing ( Bruce protocol ) were studied . Heart rate response was assessed in three ways : ( 1 ) failure to achieve 85 % of the age-predicted maximum heart rate , which has been the traditional definition of chronotropic incompetence ; ( 2 ) the actual increase in heart rate from rest to peak exercise ; and ( 3 ) the ratio of heart rate to metabolic reserve used by stage 2 of exercise ( \" chronotropic response index \" ) . Proportional hazards analyses were used to evaluate the associations of heart rate responses with all-cause mortality and with coronary heart disease incidence during 7.7 years of follow-up . Failure to achieve target heart rate occurred in 327 ( 21 % ) subjects . During follow-up there were 55 deaths ( 14 caused by coronary heart disease ) and 95 cases of incident coronary heart disease . Failure to achieve target heart rate , a smaller increase in heart rate with exercise , and the chronotropic response index were predictive of total mortality and incident coronary heart disease ( P achieve target heart rate remained predictive of incident coronary heart disease even after adjusting for age , ST-segment response , physical activity , and traditional coronary disease risk factors ( adjusted hazard ratio , 1.75 ; 95 % confidence interval , 1.11 to 2.74 ; P=.02 ) . After adjusting for the same factors , the increase in exercise heart rate remained inversely predictive of total mortality ( P=.04 ) and coronary heart disease incidence ( P=.0003 ) . The chronotropic response index also was predictive of total mortality ( P=.05 ) and incident coronary heart disease ( P=.001 ) after adjusting for age and other risk factors . CONCLUSIONS An attenuated heart rate response to exercise , a manifestation of chronotropic incompetence , is predictive of increased mortality and coronary heart disease incidence",
"CONTEXT The usefulness of exercise stress test results and global cardiovascular risk systems for predicting all-cause mortality in asymptomatic individuals seen in clinical setting s is unclear . OBJECTIVES To determine the validity for prediction of all-cause mortality of the Framingham Risk Score and of a recently described European global scoring system Systematic Coronary Risk Evaluation ( SCORE ) for cardiovascular mortality among asymptomatic individuals evaluated in a clinical setting and to determine the potential prognostic value of exercise stress testing once these baseline risks are known . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 3554 asymptomatic adults between the ages of 50 and 75 years who underwent exercise stress testing as part of an executive health program between October 1990 and December 2002 ; participants were followed up for a mean of 8 years . MAIN OUTCOME MEASURES Global risk based on the Framingham Risk Score and the European SCORE . Prospect ively recorded exercise stress test result abnormalities included impaired physical fitness , abnormal heart rate recovery , ventricular ectopy , and ST-segment abnormalities . The primary end point was all-cause mortality . RESULTS There were 114 deaths . The c-index , which corresponds to receiver operating characteristic curve values , and the Akaike Information Criteria found that the European SCORE was superior to the Framingham Risk Score in estimating global mortality risk . In a multivariable model , independent predictors of death were a higher SCORE ( for 1 % predicted increase in absolute risk , relative risk [ RR ] , 1.07 ; 95 % confidence interval [ CI ] , 1.04 - 1.09 ; P impaired functional capacity ( RR , 2.95 ; 95 % CI , 1.98 - 4.39 ; P abnormal heart rate recovery ( RR , 1.59 ; 95 % , 1.04 - 2.41 ; P = .03 ) . ST-segment depression did not predict mortality . Among patients in the highest tertile from the SCORE , an abnormal exercise stress test result , defined as either impaired functional capacity or an abnormal heart rate recovery , identified a mortality risk of more than 1 % per year . CONCLUSION Exercise stress testing when combined with the European global risk SCORE may be useful for stratifying risk in asymptomatic individuals in a comprehensive executive health screening program",
"CONTEXT A frequently cited concept is that individual major risk factors for coronary heart disease ( CHD ) are absent in many patients ( perhaps > 50 % ) with CHD . However , prior studies have not systematic ally evaluated the extent to which CHD patients have previous exposure to at least 1 risk factor , including diabetes , cigarette smoking , or clinical ly elevated levels of cholesterol or blood pressure . OBJECTIVE To determine the frequency of exposure to major CHD risk factors . DESIGN , SETTING , AND PARTICIPANTS Three prospect i ve cohort studies were included : the Chicago Heart Association Detection Project in Industry , with a population sample of 35 642 employed men and women aged 18 to 59 years ; screenees for the Multiple Risk Factor Intervention Trial , including 347 978 men aged 35 to 57 years ; and a population -based sample of 3295 men and women aged 34 to 59 years from the Framingham Heart Study ( FHS ) . Follow-up lasted 21 to 30 years across the studies . MAIN OUTCOME MEASURES Fatal CHD in all cohorts and nonfatal myocardial infa rct ion ( MI ) in the FHS , compared by exposure to major CHD risk factors , defined as total cholesterol of at least 240 mg/dL ( > or = 6.22 mmol/L ) , systolic blood pressure of at least 140 mm Hg , diastolic blood pressure of at least 90 mm Hg , cigarette smoking , and diabetes . Participants were stratified by sex and age ( 18 - 39 vs 40 - 59 years ) . RESULTS For fatal CHD ( n = 20 995 ) , exposure to at least 1 clinical ly elevated major risk factor ranged from 87 % to 100 % . Among those aged 40 to 59 years at baseline with fatal CHD ( n = 19 263 ) , exposure to at least 1 major risk factor ranged from 87 % to 94 % . For nonfatal MI , prior exposure was documented in 92 % ( 95 % CI , 87%-96 % ) ( n = 167 ) of men aged 40 to 59 years at baseline and in 87 % ( 95 % CI , 80%-94 % ) ( n = 94 ) of women in this age group . CONCLUSIONS Antecedent major CHD risk factor exposures were very common among those who developed CHD , emphasizing the importance of considering all major risk factors in determining CHD risk estimation and in attempting to prevent clinical CHD . These results challenge cl aims that CHD events commonly occur in persons without exposure to at least 1 major CHD risk factor",
"Background —Exercise stress testing alone or with perfusion imaging is the st and ard screening method to determine the presence of obstructive coronary artery disease ( CAD ) in people with chest pain . In asymptomatic individuals with a family history of premature CAD , it is unclear whether abnormalities on these functional exercise tests represent significant coronary disease . Methods and Results —An abnormal exercise test , thallium scan , or both occurred in 153 ( 21 % ) of 734 asymptomatic siblings of persons with documented CAD , of whom 105 underwent coronary angiography with quantitative analysis of stenosis severity . Overall , 95 % had coronary atherosclerosis , but only 39 % had 1 or more stenoses with ≥50 % narrowing . Of 30 siblings in whom the exercise test and perfusion scan were both abnormal , 70 % had ≥50 % stenoses . The mean stenosis in arteries that fed perfusion defects was only 43±31 % , and 68 % of such stenoses were asymptomatic persons with a family history of CAD , abnormal exercise scintigraphy identifies predominantly mild coronary atherosclerosis . Perfusion defects may be caused by coronary vasomotor dysfunction in addition to atherosclerotic plaque",
"Prospect i ve data relating cardiorespiratory fitness ( CRF ) with nonfatal cardiovascular disease ( CVD ) events are limited to studies in men or studies of combined fatal and nonfatal CVD endpoints . The authors examined the association between CRF and nonfatal CVD events in 20,728 men and 5,909 women without CVD at baseline . All participants performed a maximal treadmill exercise test and completed a follow-up health survey in the Aerobics Center Longitudinal Study ( Dallas , Texas ) between 1971 and 2004 . There were 1,512 events in men and 159 events in women during an average follow-up of 10 years . Across incremental CRF groups , age- and examination year-adjusted event rates per 10,000 person-years were 107.9 , 75.2 , and 50.3 in men ( p(trend ) smoking , alcohol intake , family history of CVD , and abnormal exercise electrocardiogram responses , hazard ratios were 1.00 ( referent ) , 0.82 ( 95 % confidence interval ( CI ) : 0.72 , 0.94 ) , and 0.61 ( 95 % CI : 0.53 , 0.71 ) in men , p(trend ) < 0.001 , and were 1.00 ( referent ) , 0.74 ( 95 % CI : 0.49 , 1.13 ) , and 0.63 ( 95 % CI : 0.40 , 0.98 ) in women , p(trend ) = 0.05 . After adjustment for other CVD predictors , the association remained significant in men but not in women",
"Objective To study abnormalities in the resting ECG as independent predictors for all cause , cardiovascular disease ( CVD ) , and coronary heart disease ( CHD ) mortality in a population based r and om sample of men and women , and to explore whether their prognostic value is different between sexes . Design and subjects An age and sex stratified r and om sample was selected from the total Belgian population aged 25 to 74 years . Baseline data were gathered and resting ECGs were classified according to Minnesota code criteria . The sample was then followed for at least 10 years with respect to cause specific death . Results are based on observations from 5208 men and 4746 women free from prevalent CHD at the start of the follow up period . Results Although the prevalence of major abnormalities in general was comparable between sexes , women had more ischaemic findings , ST segment changes , and abnormal T waves on their baseline ECG , while men showed more arrhythmias , bundle branch blocks , and left ventricular hypertrophy . Fitting the multiplicative effect on subsequent mortality between all ECG classifications under study and sex indicated that the prognostic value of ECG changes was equal in women and men . Independently of other risk factors and other major ECG changes , almost all ECG classifications were significantly related to all cause , CVD , and CHD mortality . The most predictive ECG findings for CVD death were ST segment depression ( risk ratio ( RR ) 4.71 ) , major ECG findings ( RR 3.26 ) , left ventricular hypertrophy ( RR 2.79 ) , bundle branch blocks ( RR 2.58 ) , T wave flattening ( RR 2.47 ) , ischaemic ECG findings ( RR 2.35 ) , and arrhythmias ( RR 2.15 ) . The prognostic value of major ECG findings for CVD and CHD death was more powerful than well established cardiovascular risk factors . Conclusions Abnormalities in the baseline ECG are strongly associated with subsequent all cause , CVD , and CHD mortality . Their predictive value was similar for men and women",
"We prospect ively studied 135 asymptomatic normotensive subjects with exercise-induced ST ischemic depression of 1 mm or more and compared them with 379 controls . At least two controls with negative responses on the exercise electrocardiographic ( EKG ) test were selected for each case and were matched for age , sex , work , community , and coronary-risk-factors index . The end points considered were the following coronary events : angina pectoris , myocardial infa rct ion , and sudden death . After a median follow-up period of 6.0 years for the cases and 6.4 years for the controls , the relative risk was 5.55 ( 95 per cent confidence limits , 2.75 to 11.22 ) . Coronary events occurred significantly earlier in the cases than in the controls . Our data also suggest that the exercise EKG response is a particularly good prognostic indicator for myocardial infa rct ion . In addition , our analysis has confirmed the predictive roles of age , smoking , blood pressure , and the coronary-risk-factors index and suggests that the exercise EKG response is an additional independent risk indicator for coronary events",
"A positive exercise electrocardiogram ( ECG ) has been proved to predict cardiovascular events in asymptomatic normolipidemic men . To study whether it is also predictive for hypercholesterolemic men , data from 3,806 asymptomatic hypercholesterolemic men in the Lipid Research Clinics Coronary Primary Prevention Trial were analyzed . All the men had performed a submaximal treadmill exercise test at baseline , before they were assigned to the cholestyramine or placebo treatment group . Because of missing or inconclusive data , 31 men were excluded from the analyses . A test was positive if the ST segment was displaced by greater than or equal to 1 mm ( visual code ) or there was greater than or equal to 10 microV-s change in the ST integral ( computer code ) , or both . The prevalence of a positive test was 8.3 % . During the 7 to 10 year ( mean 7.4 ) follow-up period , the mortality rate from coronary heart disease was 6.7 % ( 21 of 315 ) in men with a positive test and 1.3 % ( 46 of 3,460 ) in men with a negative test ( placebo and cholestyramine groups combined ) . The age-adjusted rate ratio for a positive test , compared with a negative test , was 6.7 in the placebo group and 4.8 in the cholestyramine group . With use of Cox 's proportional hazards models , it was found that the risk of death from coronary heart disease associated with a positive test was 5.7 times higher in the placebo group and 4.9 times higher in the cholestyramine group after adjustment for age , smoking history , systolic blood pressure , high density lipoprotein cholesterol and low density lipoprotein cholesterol . A positive test was not significantly associated with nonfatal myocardial infa rct ion . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Background Previous studies have shown that ST depressions ≤ 1.0 mm during or post-exercise increase long-term risk of dying from coronary heart disease ( CHD ) , the need for coronary artery bypass grafting ( CABG ) or the development of acute myocardial infa rct ion ( AMI ) in healthy men . In the present prospect i ve cohort study we investigate whether less marked ST depressions may influence CHD mortality , incidence of AMI , the need for a CABG or having a non-fatal stroke . Methods During 1972–75 , 2014 men aged 40–59 years , free from somatic diseases and not using any drugs , underwent an examination programme including case history , clinical examination , various blood tests and a symptom-limited exercise ECG-test . ECG was registered during exercise and at 30 s , 1 , 2 , 3 and 5 min post-exercise . The possible prognostic impact of ST-changes of 0.50–0.99 mm and ≤ 1.00 mm compared with normal ST-segments were studied separately and combined . Horizontal , down-sloping and slowly up-sloping ST-segment patterns were combined . Results After adjustment for age , smoking , blood pressure , cholesterol , maximal heart rate , left ventricular hypertrophy and physical fitness ST depressions ≤ 0.50 mm - during and /or post-exercise - were associated with a 1.47-fold [ 95 % confidence interval ( CI ) 1.10–1.95 ] , and 1.54-fold ( 95 % CI of 1.17–2.04 ) increased 26 years risk of CHD-mortality , respectively . The same ST-changes also increased 22 years risk of developing non-fatal AMI or needing CABG but not developing non-fatal stroke . Conclusions Even an ST depression ≤ 0.50 mm during and /or after exercise increases the long-term risk of CHD-death , developing an AMI or needing CABG . No association was found between ST-changes and incidence of non-fatal strokes ",
"Minor ST-T abnormalities are common on the resting electrocardiogram of otherwise healthy persons , but the long-term importance of these findings has not been extensively evaluated , especially in women . In a prospect i ve study , 7,985 women and 9,630 men ( aged 40 to 64 years at baseline ) without other electrocardiographic abnormalities and free of previous coronary heart disease ( CHD ) were studied using Cox regression for 22-years of follow-up . Primary outcomes were death from CHD and total cardiovascular disease ( CVD ) ; total mortality was a secondary outcome . Minnesota Code was employed to assess the presence or absence of electrocardiographic abnormalities . Analyses compared persons with minor Minnesota Code ST-segment ( codes 4 - 3 or 4 - 4 ) or T-wave findings ( codes 5 - 3 or 5 - 4 ) to those with normal electrocardiographic findings . In combined analyses of men and women adjusted for age , isolated minor T-wave abnormality , minor ST-segment depression , or a combination of minor ST-segment and T-wave abnormalities were each associated with increased mortality risks . For CHD mortality , hazard ratios ( HRs ) ranged from 1.60 to 2.10 ; for CVD mortality , HRs ranged from 1.50 to 1.95 ; and for total mortality , HRs ranged from 1.31 to 1.50 ( p combined ST-T-wave abnormalities in both genders for CHD and CVD mortality ( HR 1.72 to 1.75 for men , p death in middle-aged women and men and can be considered markers of heightened CHD and CVD risk",
"In Leeds in hospital population s of patients with angina the maximal ST/HR slope was found to be a reliable index of myocardial ischemia as assessed by coronary angiography . Subsequent studies in Leeds and elsewhere in population s of patients with cardiac enlargement or following myocardial infa rct ion have shown that the slope is affected by myocardial scarring , ventricular enlargement and aneurysm . These findings implied that the slope had features in common with other usual exercise tests ; studies in Leeds and elsewhere , however , have shown a superior diagnostic reliability using the maximal ST/HR slope in patients with angina . The present report involves the use of the slope in asymptomatic population s. Trials are being undertaken in two factory population s , which respectively comprised all volunteers or asymptomatic men over the age of 30 who were r and omly chosen by computer . Subjects with slope values indicating , according to previous experience , myocardial ischemia equivalent to coronary heart disease were referred for cardiological investigations which included angiocardiography ; blind comparisons were performed between results of investigations and the slope . So far 1194 subjects have been examined . In 68 subjects the maximal ST/HR slope indicated myocardial ischemia , and in 24 of these cardiological investigations were completed . In nine of the 24 subjects the slope corresponded to the number of significantly narrowed coronary arteries ( greater than 75 % reduction in luminal diameter ) ; in 12 of the remaining 15 subjects who had no coronary narrowing , there were cardiac lesions which included cardiac enlargement , aortic valve disease , myocarditis , pericarditis , myocardial bridging and conduction defects . ( ABSTRACT TRUNCATED AT 250 WORDS",
"CONTEXT Data are sparse regarding the prevalence , incidence , and independent prognostic value of minor and /or major electrocardiographic ( ECG ) abnormalities in asymptomatic postmenopausal women . There is no information on the effect , if any , of hormonal treatment on the prognostic value of the ECG . OBJECTIVE To examine association of minor and major baseline and incident ECG abnormalities with long-term cardiovascular morbidity and mortality . DESIGN , SETTING , AND PARTICIPANTS Post-hoc analysis of the estrogen plus progestin component of the Women 's Health Initiative study , a r and omized controlled primary prevention trial of 14 749 postmenopausal asymptomatic women with intact uterus who received 1 daily tablet containing 0.625 mg of oral conjugated equine estrogen and 2.5 mg of medroxyprogesterone acetate or a matching placebo . Participants were enrolled from 1993 to 1998 , and the estrogen plus progestin trial was stopped on July 7 , 2002 . MAIN OUTCOME MEASURES The Novacode criteria were used to define minor , major , and incident ECG abnormalities . Cardiovascular end points included incident coronary heart disease ( CHD ) and cardiovascular disease ( CVD ) events . RESULTS Among women with absent ( n = 9744 ) , minor ( n = 4095 ) , and major ( n = 910 ) ECG abnormalities , there were 118 , 91 , and 37 incident CHD events , respectively . The incident annual CHD event rates per 10 000 women with absent , minor , or major ECG abnormalities were 21 ( 95 % confidence interval [ CI ] , 18 - 26 ) , 40 ( 95 % CI , 32 - 49 ) , and 75 ( 95 % CI , 54 - 104 ) , respectively . After 3 years of follow-up , 5 % of women who had normal ECG at baseline developed new ECG abnormalities with an annual CHD event rate of 85 ( 95 % CI , 44 - 164 ) per 10 000 women . The adjusted hazard ratios for CHD events were 1.55 ( 95 % CI , 1.14 - 2.11 ) for minor baseline , 3.01 ( 95 % CI , 2.03 - 4.46 ) for major baseline , and 2.60 ( 95 % CI , 1.08 - 6.27 ) for incident ECG abnormalities . There were no significant interactions between hormone treatment assignment and ECG abnormalities for risk prediction of cardiovascular end points . For prediction of CHD events , the addition of ECG findings to the Framingham risk score increased from 0.69 to 0.74 the area under the receiver operating characteristic curve . Similar findings were found for incident CVD events . CONCLUSIONS Among asymptomatic postmenopausal women , clinical ly relevant baseline and incident ECG abnormalities are independently associated with increased risk of cardiovascular events and mortality , and the information is incremental to the established method of risk stratification . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00000611",
"Objective The value of exercise testing ( ET ) in asymptomatic subjects remains controversial and is unknown in countries with a low coronary heart disease ( CHD ) incidence . The aim of this study was to investigate the ability of ET to improve the prediction of a first coronary event in such a population . Methods Using a prospect i ve cohort study , 1051 consecutive healthy asymptomatic adults were enrolled in a cardiovascular screening program including ET . The pre-test risk of CHD was evaluated by the 10-year Framingham risk function . Positive ET was defined as a horizontal or downsloping ST-segment depression ≥ 1.0 mm . The primary outcome was total coronary events ( CE ) occurrence , including cardiac deaths , acute myocardial infa rct ion and stable or unstable angina . The mean follow-up period was 6 years . Results Subjects were aged 18 - 79 years and 36 % were women . A total of 89 subjects ( 8.5 % ) had a positive ET . Positive exercise testing was associated with CE occurrence in a univariate analysis only in subjects with higher pre-test risk , defined by a 10-year Framingham risk > 10.4 % [ hazards ratio ( HR ) = 2.61 ; 95 % confidence interval ( CI ) ( 1.07 - 6.40 ) ] . In this risk category , ET was able to provide incremental information over the major risk factors in both men and women [ risk factor-adjusted HR for positive ET = 2.86 ; 95 % CI ( 1.14 - 7.20 ) ] . This risk excess in subjects with positive ET persisted even when a coronary revascularization was performed . Subjects with intermediate pre-test probability ( 10 - 15 % ) and positive ET had a post-test probability of CE largely equivalent to the probability in subjects with known CHD . Conclusion Additional informátion provided by ET in subjects with a pre-test risk at 10-years > 10 % should lead to a more efficient use of risk-reducing therapies than it would be the case in this risk category with the analysis of traditional risk factors only",
"1996;3:213–219 . 5 . Rubins HB , Robins SJ , Collins D , Fye CL , And erson JW , Elam MB , Faas FH , Linares E , Schaefer EJ , Schectman G , Wilt TJ , Wittes J. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol . Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group . N Engl J Med 1999;341 : 410 –418 . 6 . Bloomfield Rubins H , Davenport J , Babikian V , Brass LM , Collins D , Wexler L , Wagner S , Papademetriou V , Rutan G , Robins SJ . Reduction in stroke with gemfibrozil in men with coronary heart disease and low HDL cholesterol : the Veterans Affairs HDL Intervention Trial ( VA-HIT ) . Circulation 2001;103:2828– 2833 . 7 . Frick MH , Elo O , Haapa K , Heinonen OP , Heinsalmi P , Helo P , Huttunen JK , Kaitaniemi P , Koskinen P , Manninen V , et al. Helsinki Heart Study : primary prevention trial with gemfibrozil in middle-aged men with dyslipidemia . Safety of treatment , changes in risk factors , and incidence of coronary heart disease . N Engl J Med 1987;317:1237–1245",
"We determined whether the exercise electrocardiogram predicted acute cardiac events during moderate or strenuous physical activity among 3617 asymptomatic , hypercholesterolemic men ( age range , 35 to 59 years ) who were followed up in the Coronary Primary Prevention Trial . Submaximal exercise test results were obtained at entry and at annual follow-up visits in years 2 through 7 . ST-segment depression or elevation ( greater than or equal to 1 mm or 10 microV-sec ) was considered to be a positive test result . The circumstances that surrounded each nonfatal myocardial infa rct ion and coronary heart disease death were determined through a record review . The cumulative incidence of activity-related acute cardiac events was 2 % during a mean follow-up period of 7.4 years . The risk was increased 2.6-fold in the presence of clinical ly silent , exercise-induced , ST-segment changes at entry ( 95 % confidence interval [ Cl ] , 1.3 to 5.2 ) after adjustment for 11 other potential risk factors . Of 62 men who experienced an activity-related event , 11 had a positive test result at entry ( sensitivity , 18 % ; 95 % Cl , 8 to 27 ) . The specificity of the entry exercise test was 92 % ( 95 % Cl , 91 to 93 ) . The sensitivity and specificity were similar when the length of follow-up was restricted to 1 year after testing . For a newly positive test result on a follow-up visit , the sensitivity was 24 % ( 95 % Cl , 12 to 36 ) , and the specificity was 85 % ( 95 % Cl , 84 to 86 ) ; for any positive test result during the study ( mean number of tests per subject , 6.2 ) , the sensitivity was 37 % ( 95 % Cl , 25 to 49 ) , and the specificity was 79 % ( 95 % Cl , 77 to 80 ) . Our findings suggested that the presence of clinical ly silent , exercise-induced , ischemic ST-segment changes on a submaximal test was associated with an increased risk of activity-related acute cardiac events . However , this test was not sensitive when used to predict the occurrence of activity-related events among asymptomatic , hypercholesterolemic men . For this reason , the utility of the submaximal exercise test to assess the safety of physical activity among asymptomatic men at risk of coronary heart disease is likely to be limited",
"OBJECTIVES We sought to characterize the predictors of incident congestive heart failure ( CHF ) , as determined by central adjudication , in a community-based elderly population . BACKGROUND The elderly constitute a growing proportion of patients admitted to the hospital with CHF , and CHF is a leading source of morbidity and mortality in this group . Elderly patients differ from younger individuals diagnosed with CHF in terms of biologic characteristics . METHODS We analyzed data from the Cardiovascular Health Study , a prospect i ve population -based study of 5,888 elderly people > 65 years old ( average 73 + /- 5 , range 65 to 100 ) at four locations . Multiple laboratory measures of cardiovascular structure and function , blood chemistries and functional assessment s were obtained . RESULTS During an average follow-up of 5.5 years ( median 6.3 ) , 597 participants developed incident CHF ( rate 19.3/1,000 person-years ) . The incidence of CHF increased progressively across age groups and was greater in men than in women . On multivariate analysis , other independent predictors included prevalent coronary heart disease , stroke or transient ischemic attack at baseline , diabetes , systolic blood pressure ( BP ) , forced expiratory volume 1 s , creatinine > 1.4 mg/dl , C-reactive protein , ankle-arm index atrial fibrillation , electrocardiographic ( ECG ) left ventricular ( LV ) mass , ECG ST-T segment abnormality , internal carotid artery wall thickness and decreased LV systolic function . Population -attributable risk , determined from predictors of risk and prevalence , was relatively high for prevalent coronary heart disease ( 13.1 % ) , systolic BP > or = 140 mm Hg ( 12.8 % ) and a high level of C-reactive protein ( 9.7 % ) , but was low for subnormal LV function ( 4.1 % ) and atrial fibrillation ( 2.2 % ) . CONCLUSIONS The incidence of CHF is high in the elderly and is related mainly to age , gender , clinical and sub clinical coronary heart disease , systolic BP and inflammation . Despite the high relative risk of subnormal systolic LV function and atrial fibrillation , the actual population risk of these for CHF is small because of their relatively low prevalence in community-dwelling elderly people",
"Aim of the study was to analyze the predictive power on short term mortality of electrocardiographic findings in asymptomatic subjects belonging to sample s of the general population . In the Italian RIFLE Pooling Project ( Risk Factors and Life Expectancy ) 12 180 men and 10 373 women aged 30 to 69 years had a resting electrocardiogram ( ECG ) recorded at baseline examination . All of them were free from clinical ly symptomatic heart disease and represented 23 cohorts spread all over Italy . ECGs were read by the Minnesota Code using 5 large categories of abnormalities , i.e. Q-QS abnormalities , ST-T abnormalities , high R. waves , major arrhythmias , and blocks . Some clinical ly relevant ECG combination of abnormalities were also analyzed . Six-year mortality from coronary heart disease ( CHD ) , cardiovascular diseases ( CVD ) and all-cause mortality ( ALL ) were the end-point . Those ECG findings were relatively common and covered the majority ( 80 to 90 % ) of all abnormalities found in the general population before excluding subjects with symptomatic heart disease . Most ECG findings on most occasions were associated with an excess mortality from the three end-points in both men and women and among relatively young ( age 30 - 49 ) and mature ( age 50 - 69 ) adults . The strongest predictor of fatal events were Q-QS items and blocks . The most consistent predictors were ST-T findings , although this was true for men and not for women . Relative risk against the absence of abnormalities ( one by one and all together ) were adjusted by multivariate analysis feeding in the models some possible confounders , i.e. age , systolic blood pressure , serum cholesterol , cigarette consumption and body mass index . Relative risks in cells with more than 20 events ( cells being separately made by men , women , the 5 ECG findings categories and the 3 end-points ) were ranging 1.00 to 9.88 for Q-QS abnormalities , 1.03 to 3.76 for ST-T abnormalities , 1.28 to 5.14 for high R waves , 0.81 to 2.28 for arrhythmias and 0.79 to 3.59 for blocks . Most of these relative risks were statistically significant . Combinations of clinical ly relevant ECG findings in the same individual ( LVH , possible and definite myocardial infa rct ion ) were rare but carried a severe prognosis with high and statistically significant relative risks among men ( ranging between 3.19 and 7.24 ) while they could not be properly tested in most cells for women due to the small numbers involved . It is concluded that in the general population high rates of prevalent ignored ECG abnormalities in asymptomatic subjects are associated with significant excess mortality from CHD , CVD and all-cause mortality , suggesting a high prevalence of silent heart disease",
"We previously reported on the prognostic importance of heart rate recovery after symptom-limited exercise in an intermediate-risk group of patients who were referred for exercise testing with thallium single-photon emission computed tomography in a tertiary-care center ( 1 ) . It is unknown , however , whether these findings can be generalized to healthy adults undergoing submaximal exercise . Our goal was to examine heart rate recovery as a predictor of long-term mortality in a population -based cohort of adults without evidence of cardiovascular disease who underwent submaximal exercise testing . All-cause mortality was the outcome of interest because of its relevance and its objective and unbiased nature ( 2 ) . Methods The study cohort was derived from the Lipid Research Clinics Prevalence Study , the selection of which has been described in detail elsewhere ( 3 - 6 ) . Briefly , that study was design ed to determine the prevalence of lipid abnormalities among North Americans . Of the 68 317 population -based persons recruited from 10 primary care centers , those with lipid abnormalities ( approximately 10 % of the population ) and an additional r and omly selected 15 % were invited to undergo more extensive investigation ( 3 ) . Of the 13 852 who appeared for this second visit , 8681 underwent exercise testing . Reasons for exclusion from exercise testing included resting systolic blood pressure less than 90 or greater than 200 mm Hg , resting diastolic blood pressure greater than 120 mm Hg , inability to complete a treadmill test on the basis of physician examination , or participant request ( 5 , 6 ) . To assure selection of a cardiovascularly healthy asymptomatic cohort similar to that in previous population -based studies ( 7 ) , persons were excluded if they were younger than 30 years of age ( n=131 [ 2 % ] ) ; were taking -blockers , digoxin , antiarrhythmic agents , or nitrates ( n=356 [ 4 % ] ) ; had a history of cardiovascular disease ( defined as previous heart surgery or history of angina , myocardial infa rct ion , claudication , stroke , previous vascular surgery , congenital disease , or arrhythmia ) ( n=2413 [ 28 % ] ) ; or were unable to reach stage 2 of exercise ( n=1620 [ 19 % ] ) . Before testing , participants underwent a detailed medical and family history that elicited information about medical conditions , alcohol use , smoking , education level , socioeconomic status , exercise habits , and medications . Lipid profiles were obtained in all patients . The treadmill exercise protocol used was the Bruce or modified Bruce protocol ( 5 , 6 ) . Participants exercised until they attained at least 85 % to 90 % of their age- and fitness-predicted maximum heart rate for 1 minute or until fatigue or medical contraindications to continued exercise were observed . Data on symptoms , heart rate , and blood pressure were collected and electrocardiography was done before exercise , at the end of each stage , immediately after exercise , and 2 minutes into recovery . Estimated workload , expressed in metabolic equivalents , was based on total treadmill time . Chronotropic response during exercise was assessed by using the chronotropic indexthe ratio of heart rate to metabolic reserve usedduring stage 2 of exercise ( 8 , 9 ) . We used a cutoff value ( 0.86 ) that maximized the log-rank chi-square statistic ( 10 ) . Immediately after exercise , participants were helped to chairs , and recovery data were obtained . Heart rate recovery was defined as the change from peak heart rate to that measured after 2 minutes of recovery ( that is , heart rate recovery = heart ratepeak heart rate2-min recovery ) . An abnormal value for heart rate recovery was determined by finding the maximum value for the log-rank chi-square test statistic for all possible cutoff points between the 10th and 90th percentiles ( 10 ) ; this turned out to be 42 beats/min or less . This cutoff value differed from and could not be validly compared to that of our previous study ( 1 ) because 2-minute values ( rather than 1-minute values ) were used and because exercise was submaximal , not symptom-limited . We also considered indexing the 2-minute heart rate recovery by the maximum heart rate , but this result ed in a substantially lower maximum log-rank chi-square value ( 44 compared with 77 ) . Mean follow-up time was 12 years . The primary end point was all-cause mortality , which was determined through annual telephone interviews with study participants or their families or employers . Cause of death was assessed by review of death certificates and interviews of physicians or next of kin ( 6 ) . If the patient could not be contacted , registries were search ed for mortality information . For assessment of vital status , follow-up was 100 % complete . All analyses were performed by using version 6.12 of the SAS statistical package ( SAS Institute , Inc. , Cary , North Carolina ) . For descriptive purpose s , patients were divided into two groups based on heart rate recovery . Continuous variables are presented as the mean SD . Differences between groups were compared by using the Student t-test , Wilcoxon rank-sum test , and chi-square test , as appropriate . Heart rate recovery was related to all-cause mortality by using univariable and multivariable Cox regression analyses . Stratified analyses were performed on prespecified subgroups according to age , sex , exercise patterns , smoking , cholesterol level , resting blood pressure and heart rate , chronotropic response to exercise , and medication use . Logarithmic and quadratic transformations and potential interactions were assessed for improvement of fit ; the strata option of PROC PHREG was used to allow for accurate estimation of main effects relative risks . The Cox proportional-hazards assumption was confirmed by inspection of log ( log [ survival ] ) curves . Attributable risk was calculated as P ( RR 1)/[P ( RR 1 ) + 1 ] , where P is prevalence and RR is relative risk . The estimated actuarial survival rate for the population was estimated on the basis of data from 1985 U.S. life tables ( 11 ) . According to the policy at our institution , this research was considered exempt from institutional review board approval because it used existing , publically available data . In addition , the data were recorded in such a manner that participants could not be identified directly or through identifiers linked to them . Results Baseline and Exercise Characteristics A total of 5234 adults met all inclusion criteria . The median value for heart rate recovery was 49 beats/min ( 25th and 75th percentiles , 39 and 59 beats/min ) . An abnormal heart rate recovery of 42 beats/min or less was seen in 1715 participants ( 33 % ) . Baseline and exercise characteristics of the study participants according to heart rate recovery are summarized in Table 1 . Table 1 . Baseline and Exercise Characteristics according to Heart Rate Recovery after Exercise Heart Rate Recovery and Mortality During 12 years of follow-up , 325 patients ( 6.2 % ) died . According to U.S. life tables , the actuarial predicted death rate was 7 % . Abnormal heart rate recovery was strongly predictive of death ( 10 % compared with 4 % among participants with normal heart rate recovery ; relative risk , 2.58 [ 95 % CI , 2.06 to 3.20 ] ) ( P sensitivity , specificity , and positive and negative predictive values of an abnormal heart rate recovery for prediction of death over 12 years were 54 % , 69 % , 10 % , and 96 % , respectively . Of the participants who died , 116 ( 36 % ) were thought to have died of cardiovascular causes . An abnormal heart rate recovery was even more strongly predictive of cardiovascular death than of death in general ( 4 % compared with 1 % ; relative risk , 3.06 [ CI , 2.10 to 4.44 ] ) ( P rate recovery was predictive of death in all subgroups except participants taking vasodilators . Table 2 . Association of Abnormal Heart Rate Recovery with Mortality according to Prespecified Subgroups Multivariable Cox Regression Analyses After adjustment for age , sex , body mass index , ethnicity , resting systolic blood pressure , use of vasodilators , exercise habits , physical fitness , smoking , diabetes , lipid profiles , ST-segment response , resting heart rate , chronotropic index , and educational and socioeconomic status and after consideration of interaction terms , a slower decrease in heart rate remained predictive of death ( adjusted relative risk , 1.55 [ CI , 1.22 to 1.98 ] ) ( P death related to abnormal heart rate recovery was 15 % ( CI , 7 % to 24 % ) . Abnormal heart rate recovery was also predictive of cardiovascular death after adjustment for potential confounders and interactions ( adjusted relative risk , 1.95 [ CI , 1.11 to 3.42 ] ) ( P=0.02 ) . Discussion Heart rate recovery after submaximal exercise was a powerful predictor of mortality in a population -based cohort of adults without clinical ly evident cardiovascular disease , even after we adjusted for multiple , potentially confounding factors . These findings confirm the results of our previous study ( 1 ) and exp and them by demonstrating the prognostic importance of heart rate recovery in healthy persons undergoing submaximal , as opposed to symptom-limited , exercise testing . Heart rate recovery may therefore be a clinical ly relevant predictor of risk among patients undergoing screening exercise testing . Furthermore , because an abnormal heart rate recovery accounted for 15 % of deaths , this measure may be useful for insurance underwriting assessment s. It has been suggested that the link between heart rate recovery and mortality may be related to vagal tone and physical fitness ( 12 ) . We also noted an association between fitness levels and recovery heart rate ; participants with abnormal heart rate recovery were less likely to exercise regularly and to participate in strenuous exercise ( Table 1 ) . It should be noted that heart rates",
"The clinical relevance of ventricular premature complexes ( VPCs ) in apparently healthy patients is not clear and is typically not considered when evaluating risk . We conducted a prospect i ve longitudinal study of the population -based Atherosclerosis Risk In Communities ( ARIC ) study of 15,070 Caucasians and African-Americans , 45 to 64 years of age , to assess the risks of coronary heart disease ( CHD ) events and mortality associated with VPCs among participants with and without prevalent CHD at baseline . VPCs on a single 2-minute electrocardiogram were identified in 940 participants ( 6.2 % ) . After a follow-up of > 10 years , 1,762 participants died , with 366 deaths related to CHD , and 1,736 had cardiac events . The percentage of participants with CHD mortality was > 3 times greater for those with VPCs compared with those without VPCs . After controlling for cardiovascular risk factors and therapy with proportional hazards regression , participants with VPCs were > 2 times as likely to die due to CHD than were those without VPCs . Increased risk was found for participants with and without baseline CHD . In conclusion , a clinical finding of VPCs on electrocardiography of even apparently healthy patients may warrant a heightened awareness of and attention to cardiovascular risk assessment and management",
"The Duke Treadmill Score ( DTS ) has been shown to predict mortality in women who have symptomatic heart disease , but its ability to do so in asymptomatic women is unknown , as is its comparative advantage to exercise capacity . We investigated whether a decreased DTS is associated with increased mortality in a prospect i ve cohort of 5,636 asymptomatic women . A symptom-limited exercise treadmill test using Bruce 's protocol was performed at baseline . DTS was calculated using exercise time , exercise-induced angina , and ST-segment depression . Exercise capacity was measured in METs . Deaths and cause of death were identified from 1992 to 2000 . After adjusting for the Framingham Risk Score , the risk of death decreased by 9 % for each unit increase in DTS and by 17 % for every 1-MET increase ( p hazard ratios for death and cardiac death that were 2.2 and 2.5 times greater , respectively , than did those who had a DTS > or = 5 ( low risk ) , after adjusting for Framingham Risk Score ( p mortality and cardiac mortality in asymptomatic women , it does not appear to be a better predictor than exercise capacity alone . The role of ST-segment changes and symptoms with stress testing in asymptomatic women does not provide additional prognostic information",
"Background No data exist on exercise workload combined with European Systematic Coronary Risk Evaluation ( SCORE ) with respect to death from cardiovascular diseases and other causes . We therefore investigated the prognostic significance of risk scores and exercise capacity with respect to cardiovascular diseases . Design A population -based follow-up study . Methods Exercise workload was measured by exercise test with an electrically braked cycle ergometer . The study is based on a r and om population -based sample of 1639 men ( 42–60 years ) without history of type II diabetes or atherosclerotic cardiovascular disease including coronary heart disease , stroke or claudication . Results During an average follow-up of 16 years , a total of 304 overall deaths and 116 cardiovascular deaths occurred . Relative risk ( RR ) was 2.50 [ 95 % confidence intervals ( CI ) : 1.71–3.68 , P all-cause death and 2.04 ( 95 % CI : 1.14–3.65 , P = 0.016 ) for cardiovascular death among men with exercise capacity less than 162W as compared with those with exercise capacity over 230 W , after adjustment for risk factors . Independent predictors for all-cause death were European SCORE ( for 1 % increment , RR : 1.15 , 95 % CI : 1.10–1.20 , P , exercise workload ( for 20W increment , RR : 0.86 , 95 % CI : 0.82–0.91 , P ) , C-reactive protein and alcohol consumption , when adjusted for serum high-density lipoprotein , body mass index , family history of coronary heart disease , exercise-induced ST changes and the use of medications for hypertension , dyslipidemia or aspirin . Conclusion Low exercise workload predicts an especially high risk for death from cardiovascular and any other cause when combined with high risk SCORE",
"OBJECTIVE The objective of this study was to report on the prevalence , incidence and prognosis of left ventricular hypertrophy ( LVH ) on the electrocardiogram ( ECG ) in a cohort of ambulatory older men and women . DESIGN A prospect i ve , longitudinal study of 10 years duration with ECGs obtained at baseline and on an annual basis . SETTING AND PATIENTS A community-based cohort study consisting of 459 subjects ( aged 75 - 85 , mean age 79 years ) . MEASUREMENTS Baseline and follow up ECGs were interpreted using the Minnesota Code . Prevalence and incidence of LVH and ECG were determined as well as regression of ECG LVH . Clinical event rates measured were incidence of total mortality , myocardial infa rct ion ( MI , fatal and non-fatal ) , cardiovascular mortality , cardiovascular disease ( fatal and non-fatal ) , stroke ( fatal and non-fatal ) , all-cause dementia , and multi-infa rct dementia . Differences in event rates between groups ( those subjects with and without LVH ) were compared as tests between proportions . A Cox Proportional Hazards Regression Analysis was performed to compare the relative independent predictive values of different competing factors , including age , gender , serum cholesterol , digitalis use , body mass , index , Blessed Dementia Scale , cigarette smoking , LVH at baseline , LVH ar baseline ( persisting ) , new LVH , new LVH ( persisting ) , new LVH ( regressed ) , previous MI by history of ECG , hypertension by history , and cardiomegaly by X-ray ( cardiothoracic ratio > or = 50 % ) . RESULTS At baseline , 9.2 % of subjects ( n = 42 ) had LVH on ECG and a mortality rate of 11.7/100 persons years versus 4.9/100 persons years for subjects without baseline LVH ( P MI rate of 7.5/100 persons years with LVH versus 2.6/100 persons years without LVH ( P cardiovascular mortality rate of 7.2/100 persons years without LVH versus 2.7/100 person years without LVH . Subjects who developed new LVH on ECG ( n = 39 ) had a mortality rate of 14.4/100 person-years compared with 4.4/100 person-years for those without LVH ( P cardiovascular mortality rate of 11.1/100 person years versus 2.0/100 person years without LVH ( P MI rate of 6.1/100 person years versus 2.0/100 person years without LVH ( P cardiovascular mortal and morbid events than those with persistent LVH . According to the regression analyses , persistent LVH from baseline was an independent predictor of MI , overall cardiovascular disease , and total mortality . Newly developing LVH with subsequent regression was an independent predictor of overall cardiovascular disease and death . CONCLUSIONS An increased prevalence and incidence of LVH on ECG , irrespective cause , is associated with a poor prognosis in very old men and women . Regression of ECG LVH in older people , irrespective of cause , may confer improvement in risk for cardiovascular disease ",
"The associations of many electrocardiographic ( ECG ) abnormalities at rest with incident coronary heart disease ( CHD ) are not completely established , and whether individual ECG abnormalities convey similar risk across gender and race is uncertain . We studied the independent association of several ECG findings with incident CHD , testing for effect modification by gender and race , in a large , population -based , prospect i ve cohort study . Findings from the baseline 12-lead electrocardiograms in 1987 to 1989 were classified according to the Minnesota Code in 12,987 black and white men and women , aged 45 to 64 years , who were initially free of CHD and the use of specific cardiac medications . The incidence of CHD was ascertained through 2000 . After adjustment for multiple cardiovascular risk factors , the ECG findings that had the highest hazard rate ratios ( HRRs ) for incident CHD , when considered singly , were left ventricular hypertrophy with ST-T strain pattern in white men ( HRR 6.50 ) and in black women ( HRR 2.31 ) and , in the whole cohort , major ( HRR 2.27 ) and minor ( HRR 2.47 ) ST depression and major T-wave abnormalities ( HRR 2.12 ) . Statistically significant associations were also found in the whole cohort for minor Q waves and left ventricular hypertrophy by the Cornell definition , but not for a prolonged QTc interval , major ventricular conduction defects , or ST elevation . In conclusion , several 12-lead ECG findings were independently associated with incident CHD in middle-aged adults . With only a few exceptions , the associations were similar for blacks and whites",
"PURPOSE As the first and only manifestation of ischemic heart disease , sudden unexpected cardiac death ( SUCD ) is a serious clinical and epidemiological concern . Prospect i ve population studies permit the identification of risk factors for SUCD . Knowledge of the short- and long-term risks for SUCD are key to underst and ing the basis of any intervention . The present paper explores the effect of time since the detection of factors on the risk for SUCD . SUBJECTS AND METHODS The Manitoba Follow-Up Study is a longitudinal , prospect i ve study of 3983 originally healthy young men who have been followed with routine medical examinations since 1948 . During 56 years of follow-up , SUCD occurred in 171 men . This analysis examined 21 possible risk factors for SUCD , including clinical findings , social variables and electrocardiographic abnormalities . Time-dependent covariate Cox proportional hazard models were used to estimate age-adjusted relative risks for SUCD . In multivariate models , the relative risk of SUCD was estimated as a function of time since the documentation of each risk factor . RESULTS Excess alcohol consumption and T wave changes were associated with a high short-term risk for SUCD . Arterial hypertension and ST/T changes had sustained excess risk over both the short and long term . Newly developed left bundle branch block was a highly significant short-term risk that diminished with time . CONCLUSION These findings add new information for the clinical management of risk factors . The identification of time since the detection of these risk factors is an important consideration to reduce SUCD"
] | 41167158-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Although evidence from cohort studies has suggested that trans fatty acid ( TFA ) consumption may be associated with insulin resistance and diabetes , r and omized placebo-controlled trials ( RCTs ) have yielded conflicting results . OBJECTIVE In a meta- analysis , we combined all available RCTs that examined the role of TFA intake on glucose homeostasis . DESIGN A systematic review of PubMed was performed , and a total of 7 RCTs were included in the meta- analysis . Primary outcomes were glucose and insulin concentrations . Secondary outcomes were total , LDL- , and HDL-cholesterol and triglyceride concentrations . The pooled effect size ( ES ) was calculated through fixed- and r and om-effects meta-analyses . The potential existence of publication bias was evaluated by using funnel-plot analysis . Metaregression analysis was performed to evaluate for potential dose-response relations between the ES of outcomes and TFA intake . RESULTS Increased TFA intake did not result in significant changes in glucose or insulin concentrations . Increased TFA intake led to a significant increase in total and LDL-cholesterol [ ES ( 95 % CI ) : 0.28 ( 0.04 , 0.51 ) and 0.36 ( 0.13 , 0.60 ) , respectively ] and a significant decrease in HDL-cholesterol concentrations [ ES ( 95 % CI ) : -0.25 ( -0.48 , -0.01 ) ] . Our analysis also showed the absence of publication bias and any dose-response relations between the ES and TFA intake . CONCLUSIONS Increased TFA intake does not result in changes in glucose , insulin , or triglyceride concentrations but leads to an increase in total and LDL-cholesterol and a decrease in HDL-cholesterol concentrations . There is no evidence to support a potential benefit of the reduction of dietary TFA intake on glucose homeostasis | [
"OBJECTIVE High intake of trans fatty acids and saturated fatty acids ( SFAs ) is known to increase the risk of coronary heart disease . We studied the effects of diets enriched in various fatty acids on postpr and ial insulinemia and fasting serum levels of lipids and lipoproteins in obese patients with NIDDM . RESEARCH DESIGN AND METHODS Sixteen obese NIDDM patients were studied in a free-living outpatient regimen . After a run-in period , the patients received three different isocaloric diets for 6 weeks using a r and omized crossover design . The patients were instructed to keep the energy intake from carbohydrate and protein constant at 50 and 20 E% ( percent of energy intake ) , respectively , on all three diets . The fat composition of the diets differed : saturated fat ( SAT ) diet ( 20 E% SFAs , 5 E% polyunsaturated fatty acids [ PUFAs ] , and 5 E% monounsaturated fatty acids [ MUFAs ] ) versus cis monounsaturated fatty acid ( CMUFA ) diet ( 20 E% cis-MUFAs , 5 E% PUFAs , and 5 E% SFAs ) versus trans monounsaturated fatty acid ( TMUFA ) diet ( 20 E% trans-MUFAs , 5 E% PUFAs , and 5 E% SFAs ) . Fasting serum levels of lipids and lipoproteins were measured at baseline and in the fasting state before meal tolerance tests at the end of each study period . Insulin secretion was assessed from incremental serum insulin and C-peptide responses during the meal tests . RESULTS BMI , waist-to-hip ratio , and glycemic control remained stable throughout the study . After meal stimulation , postpr and ial glycemic responses were similar on all diets ; however , serum insulin and C-peptide responses were greater following the TMUFA and SAT diets than following the baseline or CMUFA diets ( P fasting levels of serum lipids ( total cholesterol , triglyceride , phospholipid , and nonesterified fatty acids ) or lipoproteins of HDL cholesterol , VLDL cholesterol , LDL cholesterol , and apolipoprotein B between diets . CONCLUSIONS In the presence of unchanged glycemia , both dietary trans fatty acids and SFAs induce an increase in postpr and ial insulinemia in obese patients with NIDDM",
"BACKGROUND Dietary trans fatty acids ( FAs ) , which are formed during the process of hydrogenating vegetable oil , are known to increase plasma LDL-cholesterol concentrations . However , their effect on LDL particle size has yet to be investigated . OBJECTIVE We investigated the effect of trans FA consumption on the electrophoretic characteristics of LDL particles . DESIGN Eighteen women and 18 men each consumed 5 experimental diets in r and om order for 35-d periods . Fat represented 30 % of total energy intake in each diet , with two-thirds of the fat in the form of semiliquid margarine ( 0.6 g trans FAs/100 g fat ) , soft margarine ( 9.4 g trans FAs/100 g fat ) , shortening ( 13.6 g trans FAs/100 g fat ) , stick margarine ( 26.1 g trans FAs/100 g fat ) , or butter , which was low in trans FAs ( 2.6 g trans FAs/100 g fat ) but rich in saturated fat . LDL particle size and distribution were characterized by nondenaturing , 2 - 16 % polyacrylamide gradient gel electrophoresis . RESULTS Relative to the LDL particle size observed after consumption of the butter-enriched diet , LDL particle size decreased significantly and in a dose-dependent fashion with increasing amounts of dietary trans FAs ( P Cholesterol concentrations in large ( > 260 A ) and medium-sized ( 255 - 260 A ) LDL particles also increased proportionately to the amount of trans FAs in the diet . CONCLUSION Consumption of dietary trans FAs is associated with a deleterious increase in small , dense LDL , which further reinforces the importance of promoting diets low in trans FAs to favorably affect the lipoprotein profile",
"BACKGROUND The effect of individual dietary fatty acids on emerging risk factors for cardiovascular disease that are associated with sub clinical inflammation is unknown . OBJECTIVE The goal was to evaluate the role of dietary fat and specific fatty acids , especially trans fatty acids , in altering concentrations of markers of inflammation in humans fed controlled diets . DESIGN In a r and omized crossover design , 50 men consumed controlled diets for 5 wk that provided 15 % of energy from protein , 39 % of energy from fat , and 46 % of energy from carbohydrate . Eight percent of fat or fatty acids was replaced across diets with the following : cholesterol , oleic acid , trans fatty acids ( TFAs ) , stearic acid ( STE ) , TFA+STE ( 4 % of energy each ) , and 12:0 - 16:0 saturated fatty acids ( LMP ) . RESULTS Fibrinogen concentrations were higher after consumption of the diet enriched in stearic acid than after consumption of the carbohydrate diet . C-reactive protein concentrations were higher after consumption of the TFA diet than after consumption of the carbohydrate diet , but were not significantly different after consumption of the TFA and TFA+STE diets than after consumption of the LMP diet . Interleukin 6 concentrations were lower after consumption of the oleic acid diet than after consumption of the LMP , TFA , and STE diets . E-selectin concentrations were higher after consumption of the TFA diet than after consumption of the carbohydrate diet . Consumption of the TFA but not the TFA+STE diet result ed in higher E-selectin concentrations than did the LMP diet . CONCLUSIONS These data provide evidence that dietary fatty acids can modulate markers of inflammation . Although stearic acid minimally affects LDL cholesterol , it does appear to increase fibrinogen concentrations",
"Epidemiological and experimental studies suggest that a diet rich in saturated fat affects insulin sensitivity . Monoenes and dienes that have an usaturated bond with the trans configuration ( trans fatty acids ) resemble saturated fatty acids with respect to structure , but no published data are available on the effect of trans fatty acids on insulin sensitivity . Therefore , the effects of diets high in trans fatty acids ( TFA diet ) and oleic acid ( monounsaturated fat [ MUFA ] diet ) on glucose and lipid metabolism were studied in 14 healthy women . Subjects consumed both experimental diets for 4 weeks according to a r and omized crossover study design . Both experimental diet periods were preceded by consumption of a st and ardized baseline diet for 2 weeks . The diets provided 36.6 % to 37.9 % of energy ( E% ) as fat . In the TFA diet , there was 5.1 E% trans fatty acids , and in the MUFA diet , 5.2 E% oleic acid , substituted for saturated fatty acids in the baseline diet . A frequently sample d intravenous glucose tolerance test ( FSIGT ) was performed at the end of the experimental diet periods . Glucose effectiveness ( S(G ) ) and the insulin sensitivity index ( S(I ) ) did not differ after the two experimental diet periods . There was also no difference in the acute insulin response between the diets . The total cholesterol to high-density lipoprotein ( HDL ) cholesterol ratio and serum total triglyceride , HDL , and low-density lipoprotein ( LDL ) triglyceride and apolipoprotein B ( apoB ) concentrations were higher ( P TFA diet . In conclusion , in young healthy women , the TFA diet result ed in a higher total/HDL cholesterol ratio and an elevation in triglyceride and apo B concentrations but had no effect on glucose and insulin metabolism compared with the MUFA diet",
"The objective of this study was to compare the effects of linoleic acid ( cis , cis-C18:2(n-6 ) ) and its hydrogenation products elaidic ( trans-C18:1(n-9 ) ) and stearic acid ( C18:0 ) on serum lipoprotein levels in humans . Twenty-six men and 30 women , all normolipemic and apparently healthy , completed the trial . Three experimental diets were supplied to every subject for 3 weeks each , in r and om order ( multiple cross-over ) . The Linoleate-diet provided 12.0 % of total energy intake as linoleic acid , 2.8 % as stearic acid , and 0.1 % as trans fatty acids . The Stearate-diet supplied 3.9 energy % as linoleic acid , 11.8 % stearic acid , and 0.3 % trans fatty acids . The Trans-diet provided 3.8 energy % as linoleic acid , 3.0 % stearic acid , and 7.7 % as monounsaturated trans fatty acids , largely elaidic acid ( trans-C18:1(n-9 ) ) . Other nutrients were constant . Fasting blood was sample d at the end of each dietary period . Mean ( + /- SD ) serum LDL cholesterol was 109 + /- 24 mg/dl ( 2.83 + /- 0.63 mmol/l ) on the Linoleate-diet . It rose to 116 + /- 27 mg/dl ( 3.00 + /- 0.71 mmol/l ) on the Stearate-diet ( change , 7 mg/dl or 0.17 mmol/l , P = 0.0008 ) and to 119 + /- 25 mg/dl ( 3.07 + /- 0.65 mmol/l ) on the Trans-diet ( change , 9 mg/dl or 0.24 mmol/l , P less than 0.0001 ) . High density lipoprotein ( HDL ) cholesterol decreased by 2 mg/dl ( 0.06 mmol/l , P less than 0.0001 ) on the Stearate-diet and by 4 mg/dl ( 0.10 mmol/l , P less than 0.0001 ) on the Trans-diet , both relative to linoleic acid . Our findings show that 7.7 % of energy ( mean , 24 g/day ) of trans fatty acids in the diet significantly lowered HDL cholesterol and raised LDL cholesterol relative to linoleic acid . Combination with earlier results ( Mensink , R. P. , and M. B. Katan . 1990 . N. Engl . J. Med . 323 : 439 - 445 ) suggests a linear dose-response relation . Replacement of linoleic acid by stearic acid also caused somewhat lower HDL cholesterol and higher LDL cholesterol levels . Hydrogenation of linoleic acid to either stearic or trans fatty acids produces fatty acids that may increase LDL and decrease HDL cholesterol relative to linoleic acid itself",
"The authors investigated the association of dietary patterns and type 2 diabetes in a 4-year prospect i ve study of 36,787 adults in the Melbourne Collaborative Cohort Study ( 1990 - 1994 ) . A total of 31,641 ( 86 % ) participants completed follow-up , and 365 cases were identified . Four factors with eigenvalues of greater than 2 were identified using the principal factor method with 124 foods/beverages , followed by orthogonal rotation . Variables with factor loadings having absolute values of 0.3 or greater were used in interpreting the factors . Odds ratios for diabetes incidence across quintiles of factor scores were computed by use of logistic regression , adjusting for age , energy intake , family history of diabetes , country of birth , and other factor scores . Factor 1 , characterized by olive oil , salad vegetables , and legumes and by avoidance of sweet bakery items , margarine , and tea , was associated with country of birth but not with diabetes . Factor 2 , characterized by salad and cooked vegetables , was inversely associated with diabetes . Factor 3 , characterized by meats and fatty foods , was associated with increased diabetes risk . A range of fruits loaded strongly on factor 4 , which showed little association with diabetes . Avoidance of a dietary pattern including meats and fatty foods , as well as adherence to a pattern including salad and cooked vegetables , is recommended",
"Background Dietary trans-rich and interesterified fats were compared to an unmodified saturated fat for their relative impact on blood lipids and plasma glucose . Each fat had melting characteristics , plasticity and solids fat content suitable for use as hardstock in margarine and other solid fat formulations . Methods Thirty human volunteers were fed complete , whole food diets during 4 wk periods , where total fat ( ~31 % daily energy , > 70 % from the test fats ) and fatty acid composition were tightly controlled . A crossover design was used with 3 r and omly-assigned diet rotations and repeated- measures analysis . One test fat rotation was based on palm olein ( POL ) and provided 12.0 percent of energy ( % en ) as palmitic acid ( 16:0 ) ; a second contained trans-rich partially hydrogenated soybean oil ( PHSO ) and provided 3.2 % en as trans fatty acids plus 6.5 % en as 16:0 , while the third used an interesterified fat ( IE ) and provided 12.5 % en as stearic acid ( 18:0 ) . After 4 wk the plasma lipoproteins , fatty acid profile , as well as fasting glucose and insulin were assessed . In addition , after 2 wk into each period an 8 h postpr and ial challenge was initiated in a subset of 19 subjects who consumed a meal containing 53 g of test fat . Results After 4 wk , both PHSO and IE fats significantly elevated both the LDL/HDL ratio and fasting blood glucose , the latter almost 20 % in the IE group relative to POL . Fasting 4 wk insulin was 10 % lower after PHSO ( p > 0.05 ) and 22 % lower after IE ( p the glucose incremental area under the curve ( IAUC ) following the IE meal was 40 % greater than after either other meal ( p depressed insulin and C-peptide ( p PHSO and IE fats altered the metabolism of lipoproteins and glucose relative to an unmodified saturated fat when fed to humans under identical circumstances",
"OBJECTIVE To examine the associations between reported intakes of dietary fat and incident type 2 diabetes . RESEARCH DESIGN AND METHODS We studied the relation between dietary fatty acids and diabetes in a prospect i ve cohort study of 35,988 older women who initially did not have diabetes . Diet was assessed with a food frequency question naire at baseline , and 1,890 incident cases of diabetes occurred during 11 years of follow-up . RESULTS After adjusting for age , smoking , alcohol consumption , BMI , waist-to-hip ratio , physical activity , demographic factors , and dietary magnesium and cereal fiber , diabetes incidence was negatively associated with dietary polyunsaturated fatty acids , vegetable fat , and trans fatty acids and positively associated with omega-3 fatty acids , cholesterol , and the Keys score . After simultaneous adjustment for other dietary fat , only vegetable fat remained clearly related to diabetes risk . Relative risks across quintiles of vegetable fat intake were 1.00 , 0.90 , 0.87 , 0.84 , and 0.82 ( P = 0.02 ) . Diabetes risk was also inversely related to substituting polyunsaturated fatty acids for saturated fatty acids and positively correlated to the Keys dietary score . CONCLUSIONS These data support an inverse relation between incident type 2 diabetes and vegetable fat and substituting polyunsaturated fatty acids for saturated fatty acids and cholesterol",
"OBJECTIVE To examine dietary fat and meat intake in relation to risk of type 2 diabetes . RESEARCH DESIGN AND METHODS We prospect ively followed 42,504 male participants of the Health Professionals Follow-Up Study who were aged 40 - 75 years and free of diagnosed diabetes , cardiovascular disease , and cancer in 1986 . Diet was assessed by a vali date d food frequency question naire and up date d in 1990 and 1994 . During 12 years of follow-up , we ascertained 1,321 incident cases of type 2 diabetes . RESULTS Intakes of total fat ( multivariate RR for extreme quintiles 1.27 , CI 1.04 - 1.55 , P for trend=0.02 ) and saturated fat ( 1.34 , 1.09 - 1.66 , P for trend=0.01 ) were associated with a higher risk of type 2 diabetes . However , these associations disappeared after additional adjustment for BMI ( total fat RR 0.97 , CI 0.79 - 1.18 ; saturated fat 0.97 , 0.79 - 1.20 ) . Intakes of oleic acid , trans-fat , long-chain n-3 fat , and alpha-linolenic acid were not associated with diabetes risk after multivariate adjustment . Linoleic acid was associated with a lower risk of type 2 diabetes in men older and obese men . Frequent consumption of processed meat was associated with a higher risk for type 2 diabetes ( RR 1.46 , CI 1.14 - 1.86 for > or = 5/week vs. saturated fat intake were associated with a higher risk of type 2 diabetes , but these associations were not independent of BMI . Frequent consumption of processed meats may increase risk of type 2 diabetes",
"Intake of industrially produced trans-fatty acids ( TFA ) has been linked to increased risk of type 2 diabetes mellitus in observational studies . We investigated the causality of this association by examining if a high intake of TFA impairs measures of glucose homeostasis and induces intramuscular lipid deposition in abdominally obese women . In a double-blind , parallel dietary intervention study , 52 healthy but overweight postmenopausal women were r and omized to receive either partially hydrogenated soybean oil ( 15 g/d TFA ) or a control oil ( mainly oleic and palmitic acid ) for 16 weeks . Three markers of glucose homeostasis and 4 markers of lipolysis were derived from glucose , insulin , C-peptide , nonesterified fatty acid , and glycerol concentrations during a 3-hour frequent sampling oral glucose tolerance test . Intramuscular lipids were assessed by magnetic resonance spectroscopy . Forty-nine women completed the study . Insulin sensitivity ( assessed by ISI(composite ) ) , β-cell function ( the disposition index ) , and the metabolic clearance rate of insulin were not significantly affected by the dietary intervention . Neither was the ability of insulin to suppress plasma nonesterified fatty acid and glycerol during oral glucose ingestion nor the intramuscular lipid deposition . In conclusion , high TFA intake did not affect glucose metabolism over 16 weeks in postmenopausal overweight women . A study population with a stronger predisposition to insulin resistance and /or a longer duration of exposure may be required for insulin sensitivity to be affected by intake of industrial TFA ",
"Dietary trans fatty acids/partially-hydrogenated fat has been associated with increased risk of developing cardiovascular disease ( CVD ) , possibly greater than predicted from changes in lipoprotein levels . To explore this issue further potential risk factors were assessed in subjects provided with each of six diets in r and omized order containing as the major source of fat : soybean oil , semi-liquid margarine , soft margarine , shortening , traditional stick margarine or butter . Plasma fatty acid profiles reflected diet , with triglyceride and phospholipid subfractions affected to a greater extent than cholesteryl ester . Non-fasting LDL-cholesterol levels were 144+/-27 , 141+/-27 , 146+/-26 , 148+/-30 , 151+/-29 and 165+/-31 mg/dl ( P total cholesterol/HDL-cholesterol ratios were 5.50+/-1.25 , 5.54+/-1.50 , 5.69+/-1.29 , 5.82+/-1.40 , 6.11+/-1.30 and 5.94+/-1.43 ( P=0.011 ) , respectively , whereas other lipoprotein levels were not significantly different . Remnant-like particles levels were unaffected by dietary fat , either in the fasting or non-fasting state . Differences in fasting insulin and glucose levels were small and would not be predicted to have a large impact on glucose homeostasis . There was no significant effect of dietary fat type on C-reactive protein levels or blood pressure . These data suggest that , as previously demonstrated , the major CVD risk factor adversely affected by dietary trans fatty acids/partially-hydrogenated fat is LDL-cholesterol levels and total cholesterol/HDL-cholesterol ratios",
"OBJECTIVE Diets high in total and saturated fat are associated with insulin resistance . This study examined the effects of feeding monounsaturated , saturated , and trans fatty acids on insulin action in healthy adults . RESEARCH DESIGN AND METHODS A r and omized , double-blind , crossover study was conducted comparing three controlled 4-week diets ( 57 % carbohydrate , 28 % fat , and 15 % protein ) enriched with different fatty acids in 25 healthy men and women . The monounsaturated fat diet ( M ) had 9 % of energy as C18:1cis ( oleic acid ) . The saturated fat diet ( S ) had 9 % of energy as palmitic acid , and the trans fatty acid diet ( T ) had 9 % as C18:1trans . Body weight was kept constant throughout the study . After each diet period , insulin pulsatile secretion , insulin sensitivity index ( S(I ) ) by the minimal model method , serum lipids , and fat oxidation by indirect calorimetry were measured . RESULTS Mean S(I ) for the M , S , and T diets was 3.44 + /- 0.26 , 3.20 + /- 0.26 , and 3.40 + /- 0.26 x 10(-4 ) min(-1 ) . microU(-1 ) . ml(-1 ) , respectively ( NS ) . S(I ) decreased by 24 % on the S versus M diet in overweight subjects but was unchanged in lean subjects ( NS ) . Insulin secretion was unaffected by diet , whereas total and HDL cholesterol increased significantly on the S diet . Subjects oxidized the least fat on the M diet ( 26.0 + /- 1.5 g/day ) and the most fat on the T diet ( 31.4 + /- 1.5 g/day ) ( P = 0.02 ) . CONCLUSIONS Dietary fatty acid composition significantly influenced fat oxidation but did not impact insulin sensitivity or secretion in lean individuals . Overweight individuals were more susceptible to developing insulin resistance on high-saturated fat diets",
"In a retrospective survey , 487 research projects approved by the Central Oxford Research Ethics Committee between 1984 and 1987 , were studied for evidence of publication bias . As of May , 1990 , 285 of the studies had been analysed by the investigators , and 52 % of these had been published . Studies with statistically significant results were more likely to be published than those finding no difference between the study groups ( adjusted odds ratio [ OR ] 2.32 ; 95 % confidence interval [ Cl ] 1.25 - 4.28 ) . Studies with significant results were also more likely to lead to a greater number of publications and presentations and to be published in journals with a high citation impact factor . An increased likelihood of publication was also associated with a high rating by the investigator of the importance of the study results , and with increasing sample size . The tendency towards publication bias was greater with observational and laboratory-based experimental studies ( OR = 3.79 ; 95 % Cl = 1.47 - 9.76 ) than with r and omised clinical trials ( OR = 0.84 ; 95 % Cl = 0.34 - 2.09 ) . We have confirmed the presence of publication bias in a cohort of clinical research studies . These findings suggest that conclusions based only on a review of published data should be interpreted cautiously , especially for observational studies . Improved strategies are needed to identify the results of unpublished as well as published studies",
"BACKGROUND The 2 major dietary sources of trans fatty acids ( TFAs ) are partially hydrogenated oils and ruminant-derived products . Epidemiologic data suggest that chronic consumption of industrial sources of TFAs could be damaging to insulin sensitivity , but intervention studies on this issue have remained inconclusive . OBJECTIVE The trial was design ed to compare the effects of dairy compared with industrial sources of TFAs on insulin sensitivity in overweight women . DESIGN Sixty-three healthy women with abdominal obesity [ waist circumference > 88 cm and a body mass index ( in kg/m(2 ) ) > 28 ] were recruited . After a run-in period , the volunteers were r and omly assigned to consume 1 of 3 four-week diets : 60 g low-TFA lipids/d ( 0.54 g/d ; n = 21 ) , ruminant TFA-rich lipids ( 4.86 g/d ; n = 21 ) , or industrial TFA-rich lipids ( 5.58 g/d ; n = 21 ) . Changes in peripheral insulin sensitivity were assessed by using hyperinsulinemic-euglycemic clamps . RESULTS After the intervention period , fasting glycemia and insulinemia and insulin sensitivity were not significantly modified in either group ( P > 0.05 ) . CONCLUSIONS These data indicate that consumption of dairy- and industrial- source TFAs for 4 wk at nutritional levels do not impair peripheral insulin sensitivity in insulin-resistant women . Our study may not preassess the effects of TFAs in normal insulin-sensitive individuals . This trial was registered at Clinical Trials.gov as NCT00617435"
] | 41167194-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE To up date the available evidence about zinc use for treating diarrhea in children and to assess its effect on the malnourished population , a subgroup that has not been fully explored in previous analyses . METHODS A systematic review was performed of r and omized clinical trials that assessed children up to 5 years old with acute diarrhea who received zinc supplementation . Controls received a placebo or oral rehydration therapy . After search ing the main data bases , without language restrictions , two independent review ers selected eligible studies , extracted the data , and assessed the risk of bias of included studies . Meta-analyses were calculated using Mantel-Haenszel or inverse variance r and om effects . RESULTS Eighteen of 1 041 studies retrieved were included in the review ( n = 7 314 children ) . Zinc was beneficial for reducing the duration of diarrhea in hours ( mean difference [ MD ] = -20.12 , 95 % confidence interval [ CI ] = -29.15 to -11.09 , I² = 91 % ) . The effect was greater in malnourished children ( MD = -33.17 , 95 % CI = -33.55 to -27.79 , I² = 0 % ) . Diarrhea prevalence on days 3 , 5 , and 7 was lower in the zinc group . The incidence of vomiting was significantly greater in the group that received zinc than in the control group . Included r and omized controlled trials were of low risk of bias in most domains assessed . CONCLUSIONS Oral zinc supplementation significantly decreases diarrhea duration and has a greater effect on malnourished children . Zinc supplementation seems to be an appropriate public health strategy , mainly in areas of endemic deficiencies | [
"Objective To investigate the impact of zinc supplementation in children with cholera . Design Double blind , r and omised , placebo controlled trial . Setting Dhaka Hospital , Bangladesh . Participants 179 children aged 3 - 14 years with watery diarrhoea and stool dark field examination positive for Vibrio cholerae and confirmed by stool culture . Intervention Children were r and omised to receive 30 mg elemental zinc per day ( n=90 ) or placebo ( n=89 ) until recovery . All children received erythromycin suspension orally in a dose of 12.5 mg/kg every six hours for three days . Main outcome measures Duration of diarrhoea and stool output . Results 82 children in each group completed the study . More patients in the zinc group than in the control group recovered by two days ( 49 % v 32 % , P=0.032 ) and by three days ( 81 % v 68 % , P=0.03 ) . Zinc supplemented patients had 12 % shorter duration of diarrhoea than control patients ( 64.1 v 72.8 h , P=0.028 ) and 11 % less stool output ( 1.6 v 1.8 kg/day , P=0.039 ) . Conclusion Zinc supplementation significantly reduced the duration of diarrhoea and stool output in children with cholera . Children with cholera should be supplemented with zinc to reduce its duration and severity . Trial registration Clinical trials NCT00226616",
"OBJECTIVE To evaluate the efficacy and safety of zinc in the treatment of acute gastroenteritis ( AGE ) in children in Pol and . STUDY DESIGN Children aged 3 to 48 months with AGE were enrolled in a r and omized , double-blind , placebo-controlled trial in which they received zinc sulfate ( 10 or 20 mg/day depending on age ) or placebo for 10 days . A total of 141 of 160 children recruited were available for intention-to-treat analysis . The primary outcome was the duration of diarrhea . RESULTS In the experimental group ( n = 69 ) compared with the control group ( n = 72 ) , there was no significant difference in the duration of diarrhea ( P > .05 ) . Similarly , there was no significant difference in the groups in secondary outcome measures such as stool frequency on days 1 , 2 , and 3 , vomiting frequency , intravenous fluid intake , and the number of children with diarrhea lasting > 7 days . CONCLUSION Children living in a country where zinc deficiency is rare do not appear to benefit from the use of zinc in the treatment of AGE",
"OBJECTIVE To compare the clinical efficacy of supplementation of zinc , zinc plus vitamin A , and zinc plus combination of micronutrients and vitamins ( iron , copper , selenium , vitamin B(12 ) , folate , and vitamin A ) on acute diarrhea in children . STUDY DESIGN This was a double-blind , r and omized , placebo-controlled trial . Children aged 6 to 24 months with diarrhea and moderate dehydration were r and omized to receive zinc plus placebo vitamin A ( group 1 ) , zinc plus other micronutrients plus vitamin A ( group 2 ) , zinc plus vitamin A ( group 3 ) , or placebo ( group 4 ) as an adjunct to oral rehydration solution . Duration , volume of diarrhea , and consumption of oral rehydration solution were compared as outcome variables within the supplemented groups and with the placebo group . RESULTS The 167 study subjects included 41 in group 1 , 39 in group 2 , 44 in group 3 , and 43 in group 4 . All 3 supplemented groups demonstrated a significant reduction in outcome variables ( P speedy recovery , but differences among the supplemented groups were not statistically significant . CONCLUSIONS Supplementation with a combination of micronutrients and vitamins was not superior to zinc alone , confirming the clinical benefit of zinc in children with diarrhea",
"Background Diarrhea causes an estimated 2.5 million child deaths in developing countries each year , 35 % of which are due to acute diarrhea . Zinc and copper stores in the body are known to be depleted during acute diarrhea . Our objectives were to evaluate the efficacy of zinc and copper supplementation when given with st and ard treatment to children with acute watery or bloody diarrhea . Methods We conducted a double-blind r and omized controlled clinical trial in the Department of Pediatrics at Indira G and hi Government Medical College Nagpur , India . Eight hundred and eight children aged 6 months to 59 months with acute diarrhea were individually r and omized to placebo ( Pl ) , zinc ( Zn ) only , and zinc and copper ( Zn+Cu ) together with st and ard treatment for acute diarrhea . Results The mean duration of diarrhea from enrolment and the mean stool weight during hospital stay were 63.7 hours and 940 grams , respectively , and there were no significant differences in the adjusted means across treatment groups . Similarly , the adjusted means of the amount of oral rehydration solution or intravenous fluids used , the proportion of participants with diarrhea more than 7 days from onset , and the severity of diarrhea indicated by more than three episodes of some dehydration or any episode of severe dehydration after enrolment , did not differ across the three groups . Conclusion The expected beneficial effects of zinc supplementation for acute diarrhea were not observed . Therapeutic Zn or Zn and Cu supplementation may not have a universal beneficial impact on the duration of acute diarrhea in children . Trial registration The study was registered as an International St and ard R and omized Controlled Trial ( IS RCT N85071383 )",
"OBJECTIVE To evaluate the impact of zinc supplementation on the clinical course , stool weight , duration of diarrhoea , changes in serum zinc , and body weight gain of children with acute diarrhoea . DESIGN R and omised double blind controlled trial . Children were assigned to receive zinc ( 20 mg elemental zinc per day ) containing multivitamins or control group ( zinc-free multivitamins ) daily in three divided doses for two weeks . SETTING A diarrhoeal disease hospital in Dhaka , Bangladesh . PATIENTS 111 children , 3 to 24 months old , below 76 % median weight for age of the National Center for Health Statistics st and ard with acute diarrhoea . Children with severe infection and /or oedema were excluded . MAIN OUTCOME MEASURES Total diarrhoeal stool output , duration of diarrhoea , rate of weight gain , and changes in serum zinc levels after supplementation . RESULTS Stool output was 28 % less and duration 14 % shorter in the zinc supplemented group than placebo ( p = 0.06 ) . There were reductions in median total diarrhoeal stool output among zinc supplemented subjects who were shorter ( less than 95 % height for age ) , 239 v 326 g/kg ( p mean time to recovery occurred ( 4.7v 6.2 days , p mean serum zinc in the zinc supplemented group ( + 2.4 v −0.3 μmol/l , p better mean weight gain ( 120 v 30 g , p CONCLUSIONS Zinc supplementation is a simple , acceptable , and affordable strategy which should be considered in the management of acute diarrhoea and in prevention of growth faltering in children specially those who are malnourished . Key messages 20 mg of daily zinc supplementation reduced diarrhoeal stool in shorter children Zinc reduced diarrhoeal stool in those with low serum zinc Zinc reduced duration of diarrhoea in children with low serum zinc Zinc increased body weight of children during acute diarrhoeal episode Malnourished children are likely to benefit more from zinc ",
"Background and Aim : The World Health Organization recommends oral zinc ( tablets or syrups ) as adjunct therapy with oral rehydration solution ( ORS ) for acute childhood diarrhea . Mixing zinc with ORS can be an attractive approach for simultaneous provision of these 2 effective interventions . This double-masked r and omized controlled trial evaluated the efficacy of ORS containing 40 mg/L elemental zinc per liter ( zinc-ORS ) in reducing stool weight and duration of diarrhea . Patients and Methods : Five hundred northern Indian children ages 1 to 35 months with diarrhea were r and omized to zinc-ORS or ORS . The primary outcomes were total stool output and time to recovery . Results : The median total stool output was 2.12 g · kg−1 · h−1 ( interquartile range [ IQR ] 0.9–3.76 ) in the zinc-ORS group compared with 1.78 g · kg−1 · h−1 ( IQR 0.83–3.45 ) in the ORS group . The time to recovery was also similar in the 2 groups ( hazard ratio 1.06 [ 95 % confidence interval 0.88–1.27 ] ) . In subjects who received zinc-ORS , the median ( IQR ) zinc intakes were 27 ( 16–46 ) mg on day 1 , 15 ( 6–27 ) mg on day 2 , and negligible thereafter . Conclusions : The World Health Organization – recommended daily dose of zinc for diarrhea was not achieved in most children beyond the first day of treatment . This is the likely explanation for the lack of improvement in outcomes from zinc-ORS when compared with ORS alone . Our findings do not support a change from using zinc syrup or dispersible tablets for treatment of acute diarrhea in children",
"In a community-based double-blind r and omized trial in children aged 6–35 months , both intervention and control groups received a multi-vitamin syrup containing vitamin A , while the intervention group had zinc gluconate ( equivalent to 10 mg of elemental zinc ) additional in the syrup . There was a significant decrease in diarrhoea and pneumonia in the intervention group . This study was undertaken to investigate if addition of zinc to vitamin A had improved plasma retinol levels , which , in turn , was responsible for the effects observed in the intervention group . In a r and omly-selected sub sample of 200 children—100 each from the intervention and the control group , plasma retinol levels after 120 days of supplementation were measured . There was no difference in the mean plasma retinol levels [ the difference in the mean 0.46 μg/dL ( 95 % confidence interval -1.42–2.36 ) ] between the two groups following supplementation . No difference in plasma retinol levels was observed in the subgroups based on baseline nutritional status and plasma zinc levels . Addition of zinc to low-dose vitamin A in this study did not improve the vitamin A status of children and can not explain morbidity effects of the intervention",
"Objective . To evaluate the potential benefit of dietary supplementation of a rice-lentil ( Khitchri ) and yogurt diet with 3 mg/kg/d of elemental zinc ( as zinc sulfate ) in hospitalized malnourished children ( age 6–36 months ) with persistent diarrhea for 14 days . Methodology . R and omized , double-blind placebo-controlled trial . Setting . Nutrition Research Ward at the National Institute of Child Health , Karachi , Pakistan , where children were admitted for 14 days of inpatient supervised rehabilitation . Main Outcome Measures . Primary outcome : overall weight gain by day 14 . Secondary outcomes : overall energy intake , stool output , time to diarrheal recovery and weight gain ( ≥3 days ) , plasma zinc , copper , prealbumin , and insulin-like growth factor-1 . Results . Of 87 children r and omized for supplementation with either zinc or placebo , the two groups were comparable at admission in terms of severity and duration of diarrhea , as well as nutritional and anthropometric parameters . The overall weight gain , stool volume , stool frequency , as well as the time taken for diarrheal recovery or steady weight gain , were comparable for both supplemented children and controls . Supplemented children had a significant improvement in plasma zinc levels and serum alkaline phosphatase by day 14 of therapy in comparison with controls . Plasma copper levels were low in both groups at admission and although an increase was seen in control children , levels decreased further after zinc supplementation . There was no significant difference between the two groups for hemoglobin , serum albumin , prealbumin , and plasma insulin-like growth factor-1 increments during the course of therapy . Evaluation of primary and secondary outcome criteria among the subset of children with plasma zinc levels children with persistent diarrhea receiving the Khitchri-yogurt diet , there was no evidence of improved weight gain or acceleration of recovery from diarrhea with zinc supplementation . In contrast , the reduction in plasma copper levels in zinc-supplemented malnourished children suggests that caution should be exercised in supplementing severely malnourished children with zinc alone",
"Background / Objective : The efficacy of zinc combined with vitamin A or multiple micronutrients in preventing diarrhoea is unclear in African countries with high prevalence of human immunodeficiency virus (HIV)-exposed children . Potential modifying factors , such as stunting , need to be addressed . The objective of this study was to determine whether adding zinc or zinc plus multiple micronutrients to vitamin A reduces diarrhoea incidence , and whether this differs between the strata of stunted or HIV-infected children . Methods : We analyzed data from a r and omized , controlled , double-blinded trial ( Clinical Trials.gov NCT00156832 ) of prophylactic micronutrient supplementation to children aged 6–24 months . Three cohorts of children : 32 HIV-infected children , 154 HIV-uninfected children born to HIV-infected mothers and 187 uninfected children born to HIV-uninfected mothers , received vitamin A , vitamin A plus zinc or multiple micronutrients , which included vitamin A and zinc . The main outcome was incidence of diarrhoea . Poisson regression was used in intent-to-treat analyses . Stratified analyses followed testing for statistical interaction between intervention and stunting . Results : We observed no significant differences in overall diarrhoea incidence among treatment arms . Stunting modified this effect with stunted HIV-uninfected children having significantly lower diarrhoea incidence when supplemented with zinc or multiple micronutrients compared with vitamin A alone ( 2.04 and 2.23 vs 3.92 episodes/year , respectively , P=0.024 ) . No meaningful subgroup analyses could be done in the cohort of HIV-infected children . Conclusions : Compared with vitamin A alone , supplementation with zinc and with zinc and multiple micronutrients , reduced diarrhoea morbidity in stunted rural South African children . Efficacy of zinc supplementation in HIV-infected children needs confirmation in studies that represent the spectrum of disease severity and age groups",
"BACKGROUND Intervention trials have shown that zinc may be efficacious in treating acute diarrhea in children of developing countries . A double-blind placebo-controlled study was design ed to evaluate the effects of zinc supplementation on the clinical course and duration of diarrhea in malnourished Turkish children . METHODS The study group comprised 40 subjects with low zinc levels ( Group 1a ) and 52 subjects with normal zinc levels ( Group 1b ) . The control group was also comprised of two subgroups : 36 subjects with low zinc levels ( Group 2a ) and 54 subject with normal zinc levels ( Group 2b ) . Forty-three percent of children in the study group and 40 % of controls had low serum zinc levels ( mg zinc per day for 10 days and the control group were given 750 mg glucose per day as a placebo for 10 days . RESULTS The mean duration of diarrhea was shorter and the percentage of children with consistent diarrhea for more than 3 - 7 days was lower in the study subgroups than in the control subgroups . Prolonged diarrhea was present in 12 % of children in the study group , and in 44 % and 37 % of children in the hypozincemic and normozincemic control subgroups , respectively . The was no significant difference among the four subgroups of children in the number of cases with post-enrollment diarrhea of a duration of>14 days . Stool frequency over the first 4 days after enrollment was lower in children in the study group . CONCLUSION It was concluded that zinc supplementation in malnourished children with acute diarrhea may reduce the severity and duration of diarrhea , especially in children with low zinc levels",
"Objective : To assess the impact of zinc supplementation on clinical recovery , weight gain and subsequent growth and morbidity in moderately malnourished children with shigellosis . Design : A r and omized , double-blind , controlled trial . Setting : Dhaka hospital of ICDDR , B : Centre for Health and Population Research , Dhaka , Bangladesh . Subjects : Fifty-six moderately malnourished children , aged 12–59 months with culture-proven shigellosis . Methods : Subjects were r and omly allocated to receive zinc ( 20 mg/day elemental ) in multivitamin syrup ( intervention ) or multivitamin syrup without zinc ( control ) in two equally divided doses daily for 2 weeks . All children received pivmecillinam in a dose of 15 mg/kg every 6 h for 5 days . After supplementation , children were followed in their respective homes every 2 weeks for 6 months . Results : Children receiving zinc recovered from acute illness significantly faster than the control children ( P The medians time ( days ) to recovery and disappearances of blood and mucous were significantly 50 % shorter in the zinc-supplemented group compared to the control group . The mean body weight of zinc supplemented children increased significantly from 8.8 kg on admission to 9.2 kg ( P mean episodes of diarrhoea compared to the control children ( 2.2 vs 3.3 ; P=0.03 ) . Conclusion : Zinc supplementation significantly shortens the duration of acute shigellosis , promotes better weight gain during recovery and reduces diarrhoeal morbidity during the subsequent 6 months",
"BACKGROUND In developing countries the duration and severity of diarrheal illnesses are greatest among infants and young children with malnutrition and impaired immune status , both factors that may be associated with zinc deficiency . In children with severe zinc deficiency , diarrhea is common and responds quickly to zinc supplementation . METHODS To evaluate the effects of daily supplementation with 20 mg of elemental zinc on the duration and severity of acute diarrhea , we conducted a double-blind , r and omized , controlled trial involving 937 children , 6 to 35 months of age , in New Delhi , India . All the children also received oral rehydration therapy and vitamin supplements . RESULTS Among the children who received zinc supplementation , there was a 23 percent reduction ( 95 percent confidence interval , 12 percent to 32 percent ) in the risk of continued diarrhea . Estimates of the likelihood of recovery according to the day of zinc supplementation revealed a reduction of 7 percent ( 95 percent confidence interval , -9 percent to + 22 percent ) in the risk of continued diarrhea during days 1 through 3 and a reduction of 38 percent ( 95 percent confidence interval , 27 percent to 48 percent ) after day 3 . When zinc supplementation was initiated within three days of the onset of diarrhea , there was a 39 percent reduction ( 95 percent confidence interval , 7 percent to 61 percent ) in the proportion of episodes lasting more than seven days . In the zinc-supplementation group there was a decrease of 39 percent ( 95 percent confidence interval , 6 percent to 70 percent ) in the mean number of watery stools per day ( P = 0.02 ) and a decrease of 21 percent ( 95 percent confidence interval , 10 percent to 31 percent ) in the number of days with watery diarrhea . The reductions in the duration and severity of diarrhea were greater in children with stunted growth than in those with normal growth . CONCLUSION For infants and young children with acute diarrhea , zinc supplementation results in clinical ly important reductions in the duration and severity of diarrhea",
"The childhood diarrhoea-management guidelines of the World Health Organization/United Nations Children 's Fund ( WHO/UNICEF ) now include zinc treatment , 20 mg per day for 10 days . To determine if a dispersible zinc sulphate tablet formulation is associated with increased risk of vomiting or regurgitation following the initial , first treatment dose , a double-blind , placebo-controlled r and omized clinical trial was carried out in the Dhaka hospital of ICDDR , B : Centre for Health and Population Research ( n=800 ) and in an adjacent NGO outpatient clinic ( n=800 ) . Children were r and omized to one of three groups : no treatment , placebo , or zinc sulphate tablet ( 20 mg ) . They were then observed for 60 minutes , and all vomiting or regurgitation episodes were recorded . When compared with placebo , zinc treatment result ed in an attributable risk increase of 14 % for vomiting and 5.2 % for regurgitation . The median time to vomiting among those receiving zinc was 9.6 minutes and was limited to one episode in 91.2 % of the cases . Overall , the proportion of 60-minute post-treatment vomiting attributable to zinc , placebo , and the illness episode was estimated to be 40 % , 26 % , and 34 % respectively . The dispersible zinc sulphate tablet formulation at a dose of 20 mg is associated with increased risks of vomiting and regurgitation . Both are transient side-effects",
"BACKGROUND Diarrhea is one of the principal causes of morbidity and mortality among children in the developing world . Cumulative costs of treating diarrhea would be high and would further increase if zinc was used as an adjunct to treatment of acute diarrhea . OBJECTIVE To determine the impact of zinc supplementation on the mean predicted costs of treating acute diarrhea and the incremental cost-effectiveness ( CE ) as compared with placebo , from the provider 's ( government ) and patient 's perspective . STUDY DESIGN AND SETTING In a r and omized , double-blind , placebo-controlled clinical trial , 808 children aged 6 - 59 months with acute diarrhea were individually r and omized to placebo ( Pl ) , zinc ( Zn ) only , and zinc and copper ( Zn + Cu ) together with st and ard treatment of acute diarrhea . The actual re source utilization and cost data were collected for all participants . The incremental CE ratio and its 95 % confidence interval ( 95 % CI ) were assessed . RESULTS The relative CE for treating acute diarrhea was 1.5 ( 95 % CI : 1.50 , 1.52 ) times more when supplemented with zinc and 1.7 ( 95 % CI : 1.69 , 1.71 ) times more when supplemented with Zn + Cu with no additional beneficial effect . CONCLUSION This study showed that zinc or zinc with copper supplementation were not cost-effective in the treatment of acute diarrhea in this study population",
"Objective : Assess the impact of zinc supplementation with locally developed culturally specific educational statements ( messages ) on oral rehydration solution ( ORS ) and antibiotics or antidiarrheal use in children with acute watery diarrhea as well as to assess adherence and side effects of zinc . Methods : This was a r and omized effectiveness trial conducted in outpatient health facilities of six sites in five countries , namely , Fortaleza ( Brazil ) , Addis Adaba ( Ethiopia ) , Cairo ( Egypt ) , Lucknow and Nagpur ( India ) , and Manila ( Philippines ) . Participants were 2,002 children aged 2 to 59 months . Intervention was zinc ( 20 mg orally , once daily for 14 days ) with ORS ( zinc group ) compared with ORS alone ( control group ) . Primary outcomes were ORS use on day 3 to 5 ; adherence to zinc ; and any use of an antibacterial/antidiarrheal up to day 14 . Results : One thous and ten and 992 children enrolled in zinc and control groups , respectively . Loss to follow-up on days 3 to 5 and 15 to 17 was 1.2 % and 2.8 % in the zinc group and 0.8 % and 1.7 % in the control group . In five of six sites , ORS use in cases with continued diarrhea on days 3 to 5 was the same in the two groups or higher in zinc group . Overall adherence to zinc supplementation was 83.8 % ( 95 % confidence interval [ CI ] 81 - 86 ) . There was no difference in vomiting by group . In consideration of the six countries overall , less antibiotic/antidiarrheal use occurred in the zinc group ( absolute difference , 3.8 % [ 95 % CI 1.7 - 5.9 ] ) . Conclusions : In the management of acute watery diarrhea , zinc plus ORS along with culturally appropriate , site-specific messages in local language does not affect overall ORS use generally and decreases antibiotic/antidiarrheal use ; children had good adherence without side effects",
"In a double‐blind , controlled trial with a factorial design , 684 patients ( aged 6 months to 2 y ; excludes 6 early dropouts ) with acute watery diarrhoea of 3 d or less and some dehydration , who were attending a hospital , were r and omly assigned to 4 groups to receive : ( a ) vitamin A 4500 μg retinol equivalent daily for 15 d ; ( b ) 14.2 mg elemental zinc as acetate for the first 417 patients and 40 mg of the remaining 273 patients r and omized to this group for 15 d ; ( c ) both vitamin A 4500 μg retinol equivalent and zinc at the above doses daily for 15 d ; or ( d ) placebo mixtures for 15 d. Patients were observed in the hospital for 24 h and followed up at home for 15 d. All received ascorbic acid 30 mg with each dose of medicine or placebo . Zinc supplementation was associated with a reduced duration of diarrhoea ( 13 % , p= 0.03 ) and markedly reduced rate ( 43 % , p= 0.017 ) of prolonged diarrhoea ( 7 d ) . Vitamin A supplementation was associated with a nonsignificant trend for reduced rate of prolonged diarrhoea ( p= 0.089 ) . In conclusion , zinc supplementation as adjunct therapy had a substantial impact on the rate of prolonged diarrhoea and some impact on duration and may be beneficial in children with diarrhoea in developing countries",
"Objective : Zinc deficiency is prevalent in children in developing countries . Supplemental zinc provides therapeutic benefits in diarrhoea . Our aim was to evaluate the effect of daily zinc supplementation for 14 days on diarrhoea duration , severity , and morbidity in children . Methods : In a r and omised , open label non-placebo controlled trial , we assessed the efficacy of providing zinc sulfate to 6–60 month old children with acute diarrhoea for 2 weeks followed by 3 months of morbidity surveillance . Children were r and omly assigned to zinc ( n = 150 ) and control ( n = 130 ) groups and received 15–30 mg elemental zinc daily . Results : Supplemented children had significantly improved plasma zinc levels by day 14 of therapy . Zinc deficiency was observed in 2.6 % of the treatment and 3.3 % of the control group . The mean duration of diarrhoea after starting supplementation was 3.02±2 days in the zinc group and 3.67±3.2 days in the control group . There was no significant difference in diarrhoea duration by treatment group ( p>0.05 ) . The number of stools after starting supplementation was 5.8±3.7 and 5.1±3.9 on day 1 , 2.9±1.6 and 3.0±2.2 on day 2 , and 1.8±1.1 and 1.6±0.9 on day 3 in the zinc and control groups , respectively . There was no significant difference in diarrhoea severity by treatment group ( p>0.05 ) . No significant effect was found on the incidence and prevalence of diarrhoea in the zinc compared with the control group . Conclusion : Our data indicate that supplementing children with acute diarrhoea in Turkey with 3 RDA of elemental zinc for 14 days improved neither diarrhoea duration nor severity despite significant increments in plasma zinc",
"OBJECTIVE To determine whether zinc with oral rehydration solution ( ORS ) is more cost effective than ORS alone in the treatment of acute diarrhea . STUDY DESIGN AND SETTING Cost-effectiveness analysis among patients consulting the emergency room of a government institution . METHOD Cost of treatment and outcome of participants of a r and omized trial of zinc+ORS vs. ORS alone for acute diarrhea were investigated . Included were subjects 2 - 59 months with diarrhea The direct medical , nonmedical and indirect costs were obtained , using the societal perspective . The incremental cost-effectiveness ratio ( ICER ) was calculated . RESULTS Sixty patients were given zinc+ORS and 57 were given ORS alone . Mean duration of diarrhea was 17 hours shorter and mean total cost of treatment was 5 % cheaper in the zinc than ORS group . The ICER showed that with use of zinc , the society saves $ 2.4 per day of diarrhea zinc with ORS reduced the total cost and duration of acute diarrhea . The ICER suggests cost effectiveness of zinc supplementation but there is a need to further assess the role of zinc supplementation in a larger population",
"A double-blind , r and omized , controlled clinical trial was conducted on 80 malnourished children with acute dehydrating diarrhoea to evaluate the efficacy of oral supplementation of zinc as an adjunct therapy to oral rehydration solution ( ORS ) . After decoding it was observed that 44 children received zinc sulphate ( 177 mg/kg/day in three divided doses equivalent to 40 mg elemental zinc ) in a syrup form and 36 children received only syrup placebo . Clinical parameters and microbiological findings of stool sample s were comparable in the two groups at the time of enrollment . All the children ( 100 per cent ) in the zinc supplemented group and 32 ( 89 per cent ) children in the placebo group recovered within 5 days of hospitalization ( p = 0.04 ) . The zinc supplemented group had a significantly shorter duration of diarrhoea ( 70.4 + /- 10.0 vs. 103.4 + /- 17.1 h ; p = 0.0001 ) , passed less liquid stool ( 1.5 + /- 0.7 vs. 2.4 + /- 0.7 kg ; p=0.0001 ) , consumed less oral rehydration solution ( 2.5 + /- 1.0 vs. 3.6 + /- 0.8 litre ; p = 0.0001 ) and other liquids ( 867.0 + /- 466.1 vs. 1354.7 + /- 675.6 ml ; p = 0.0001 ) as compared to the placebo group . Our findings suggest that zinc supplementation as an adjunct therapy to ORS has beneficial effects on the clinical course of dehydrating acute diarrhoea",
"Objectives The authors evaluated the effect of zinc treatment as an adjunct to oral rehydration therapy on stool output and diarrheal duration in children with acute noncholera diarrhea with dehydration . Methods This double-blind , r and omized , controlled trial was conducted at two urban hospitals in New Delhi . A total of 287 dehydrated male patients , ages 3 to 36 months , with diarrhea for ≤ 72 hours were enrolled . They were assigned to zinc or placebo by a r and omization scheme stratified by age ( ≤ or > 12 months ) and weight for height ( 65%–80 % or > 80 % National Centre for Health Statistics median ) . Participants in the zinc group received 15 mg ( ≤12 months ) or 30 mg ( > 12 months ) elemental zinc daily in three divided doses for 14 days . The main outcome measures were stool output and diarrheal duration . Results Zinc treatment reduced total stool output ( ratio of geometric means , 0.69 ; 95 % confidence interval [ CI ] : 0.48 , 0.99 ) and stool output per day of diarrhea ( ratio of geometric means , 0.76 ; 95 % CI : 0.59 , 0.98 ) . The risk of continued diarrhea was lower ( relative hazards , 0.76 ; 95 % CI : 0.59 , 0.97 ) and the proportion of diarrheal episodes lasting ≥ 5 days ( odds ratio , 0.49 ; 95 % CI : 0.25 , 0.97 ) or ≥ 7 days was less ( odds ratio , 0.09 ; 95 % CI : 0.01 , 0.73 ) in the zinc group . Conclusions This study demonstrates a beneficial effect of zinc administered during acute diarrhea on stool output , diarrheal duration , and proportion of episodes lasting more than 7 days . The effects are large enough to merit routine use of zinc during acute diarrhea in developing countries",
" Our objective was to evaluate the effect of zinc and copper supplementation in acute diarrhea on morbidity and growth during 12 weeks of follow-up . In a double-blind r and omized controlled clinical trial of 724 children aged 6–59 months , none of the 11 evaluated outcomes showed significant association with zinc or zinc and copper supplementation . Thus , therapeutic zinc supplementation may not always yield short-term benefits",
"Objectives : We assessed the effect of zinc for the treatment of diarrhoea implemented at the community level on physical growth among children 6 to 35 months of age . Methods : The service areas of 30 community health workers in the Matlab field site of International Centre for Diarrhoeal Disease Research , Bangladesh , were r and omly allocated to the intervention or comparison study arm . Between November 1998 and October 2000 , caretakers of 3- to 59-month-old children with diarrhoea in both intervention and comparison areas were offered oral rehydration solution and feeding advice , and severe episodes were referred for facility-based care . The caretakers of the children in the intervention area were additionally offered 20 mg/day elemental zinc for 14 days as adjunct treatment for each diarrhoea episode . Weight and length of children who were 6 to 11 months of age at the beginning of the study were measured every 2 months for 2 years . Rates of length and weight gains were compared between children living in intervention and control arms using a latent growth model . Results : Characteristics of children living in control and intervention areas were similar , except that more children living in intervention areas were underweight at baseline ( 44 vs 35 % ; P = 0.02 ) . Children living in intervention clusters gained slightly more weight and length than children in the control clusters ( 86.4 g/year and 2.8 mm/year , respectively ) . Conclusions : The therapeutic use of zinc along with oral rehydration solution for community-based diarrhoea management may have a small positive benefit on the rates of growth among children younger than 3 years of age "
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BACKGROUND Patients with chronic heart failure ( heart failure ) are at risk of thromboembolic events , and coronary ischaemic events also contribute to the progression of heart failure . Long-term oral anticoagulation is established in certain groups , including patients with heart failure and atrial fibrillation , but there is wide variation in the use of oral anticoagulation in the broader heart failure population . OBJECTIVE To determine whether long-term oral anticoagulation reduces total deaths and /or major thromboembolic events in patients with heart failure . DESIGN Systematic review . DATA SOURCES Reference lists of papers result ing from this search , electronic data base search ing ( MEDLINE , EMBASE , DARE ) , and abstract s from national and international cardiovascular meetings were studied to identify unpublished studies . Relevant authors of these studies were contacted to obtain further data . SELECTION CRITERIA R and omized controlled trials ( RCTs ) comparing oral anticoagulants with control or placebo . Non-r and omized studies were included , as they may help in assessing side-effects . Other inclusion criteria included duration of treatment > or = 1 month , and adults with heart failure due to any underlying cause . Inclusion decisions were duplicated , and disagreement resolved by discussion or a third party . RESULTS One recent pilot RCT compared warfarin , aspirin and no antithrombotic therapy , but no definitive data have yet been published . Three small prospect i ve studies of warfarin in heart failure were also identified , but were over 50 years old , with methods considered unreliable today : in these , anticoagulation was more efficacious than control in reducing all-cause death ( OR 0.64 ; 95%CI 0.45 - 0.90 ) and cardiovascular events ( OR 0.26 ; 95%CI 0.16 - 0.43 ) . Four retrospective non-r and omized cohort analyses and three small observational studies of oral anticoagulation in heart failure included differing population s of heart failure patients , and reported contradictory results . CONCLUSIONS Limited evidence from r and omized trials and observational studies found a reduction in mortality and cardiovascular events with anticoagulants compared to controls . This evidence should be interpreted with caution . Although oral anticoagulation is indicated in certain groups of patients with heart failure ( e.g. atrial fibrillation ) , the available data do not support its routine use in heart failure patients who remain in sinus rhythm | [
"PURPOSE To determine the incidence of major bleeding in out patients treated with warfarin and to identify predictive factors known at the start of therapy . PATIENTS AND METHODS The records of 565 patients starting outpatient therapy with warfarin upon discharge from a university hospital were review ed . Follow-up information was obtained for 562 patients ( 99.5 % ) . Bleeding was classified as major or minor using explicit criteria . The cumulative incidence of bleeding was estimated by means of survival analysis . Independent risk factors for major bleeding were identified using Cox regression analysis in 375 r and omly chosen patients ; they were tested in the remaining 187 patients . RESULTS Major bleeding occurred in 65 patients ( 12 % ) and was fatal in 10 patients ( 2 % ) . The cumulative incidences of major bleeding at one , 12 , and 48 months were 3 % , 11 % , and 22 % , respectively . The monthly risk of major bleeding decreased over time , from 3 % during the first month of outpatient therapy to 0.3 % per month after the first year of therapy . Five independent risk factors for major bleeding -- age 65 years or greater , history of stroke , history of gastrointestinal bleeding , a serious comorbid condition ( recent myocardial infa rct ion , renal insufficiency , or severe anemia ) , atrial fibrillation -- predicted major bleeding in the testing group ; the cumulative incidence of major bleeding at 48 months was 2 % in 57 low-risk patients , 17 % in 110 middle-risk patients , and 63 % in 20 high-risk patients . CONCLUSION These findings provide a quantitative basis for evaluating the risk of major bleeding in individual patients at the start of outpatient therapy with warfarin . Whether the risk of bleeding can be reduced in high-risk patients without reducing the benefit of therapy remains to be determined",
"OBJECTIVES We sought to evaluate the relation between warfarin anticoagulation and survival and morbidity from cardiac disease in patients with left ventricular ( LV ) dysfunction . BACKGROUND Warfarin anticoagulation plays a major role in the management of patients who have had a large myocardial infa rct ion and in those with atrial fibrillation . However , its use in patients with LV systolic dysfunction has been controversial . METHODS We review ed data on warfarin use in 6,797 patients enrolled in the Studies of Left Ventricular Dysfunction ( SOLVD ) trial and analyzed the relation between warfarin use and all-cause mortality , as well as the combined end point of death or hospital admission for heart failure . We used Cox regression to adjust for differences in baseline characteristics and to test for the interaction between warfarin use and selected patient variables in relation to outcome . RESULTS On multivariate analysis , use of warfarin was associated with a significant reduction in all-cause mortality ( adjusted hazard ratio [ HR ] 0.76 , 95 % confidence interval [ CI ] 0.65 to 0.89 , p = 0.0006 ) and in the risk of death or hospital admission for heart failure ( HR 0.82 , 95 % CI 0.72 to 0.93 , p = 0.0002 ) . Risk reduction was observed when each trial or r and omization arm was analyzed separately , as well as in both genders . It was not significantly influenced by the presence of atrial fibrillation , age , ejection fraction , New York Heart Association functional class or etiology . CONCLUSIONS In patients with LV systolic dysfunction , warfarin use is associated with improved survival and reduced morbidity . This association is primarily due to a reduction in cardiac events and does not appear to be limited to any particular subgroup",
"BACKGROUND In patients who have had a myocardial infa rct ion , the long-term risk of stroke and its relation to the extent of left ventricular dysfunction have not been determined . We studied whether a reduced left ventricular ejection fraction is associated with an increased risk of stroke after myocardial infa rct ion and whether other factors such as older age and therapy with anticoagulants , thrombolytic agents , or captopril affect long-term rates of stroke . METHODS We performed an observational analysis of prospect ively collected data on 2231 patients who had left ventricular dysfunction after acute myocardial infa rct ion who were enrolled in the Survival and Ventricular Enlargement trial . The mean follow-up was 42 months . Risk factors for stroke were assessed by both univariate and multivariate Cox proportional-hazards analysis . RESULTS Among these patients , 103 ( 4.6 percent ) had fatal or nonfatal strokes during the study ( rate of stroke per year of follow-up , 1.5 percent ) . The estimated five-year rate of stroke in all the patients was 8.1 percent . As compared with patients without stroke , patients with stroke were older ( mean [ + /-SD ] age , 63+/-9 years vs. 59+/-11 years ; P ejection fraction ( for every decrease of 5 percentage points in the ejection fraction there was an 18 percent increase in the risk of stroke ) , older age , and the absence of aspirin or anticoagulant therapy . Patients with ejection fractions of relative risk of stroke of 1.86 , as compared with patients with ejection fractions of more than 35 percent ( P=0.01 ) . The use of thrombolytic agents and captopril had no significant effect on the risk of stroke . CONCLUSIONS During the five years after myocardial infa rct ion , patients have a substantial risk of stroke . A decreased ejection fraction and older age are both independent predictors of an increased risk of stroke . Anticoagulant therapy appears to have a protective effect against stroke after myocardial infa rct ion",
"Background The incidence of thromboembolism and the benefit of anticoagulation in congestive heart failure are controversial . Methods and Results The data base provided by the Veterans Affairs Vasodilator-Heart Failure Trials ( V-HeFT I and II ) was examined retrospectively to address these issues . In V-HeFT I , 642 men with heart failure were followed an average of 2.28 years , providing 1,464 patient-years of follow-up . In V-HeFT II , 804 men were followed an average of 2.56 years , with 2,061 patient-years of follow-up . Mean left ventricular ejection fraction was 30%o in V-HeFT I and 29 % in V-HeFT II . Functional capacity was at the interface of classes II and III with a peak exercise oxygen consumption of 14.7 mL. kg -1 . min-1 in V-HeFT I and 13.7 mL- kg-1 min-1 in V-HeFT II . Warfarin and antiplatelet agents were administered at the discretion of individual investigators . The incidence of all thromboembolic events during 1,068 patient-years without warfarin in V-HeFIT I was 2.7/100 patient-years and during 1,188 patient-years in V-HeFT II was 2.1/100 patient-years and was not reduced in patients treated with warfarin . Patients experiencing events had a lower peak exercise oxygen consumption ( P mean ejection fraction ( P=0.10 in V-HeFT I and P=0.07 in V-HeFT II ) . Atrial fibrillation was not associated with an increased risk of thromboembolic events . Conclusions The incidence of thromboembolism and stroke in class II or III congestive heart failure is not high and may not be significantly reduced with warfarin treatment . Routine use of anticoagulants in patients with heart failure may not be justified",
"To evaluate the influence of the angiotensin-converting-enzyme inhibitor enalapril ( 2.5 to 40 mg per day ) on the prognosis of severe congestive heart failure ( New York Heart Association [ NYHA ] functional class IV ) , we r and omly assigned 253 patients in a double-blind study to receive either placebo ( n = 126 ) or enalapril ( n = 127 ) . Conventional treatment for heart failure , including the use of other vasodilators , was continued in both groups . Follow-up averaged 188 days ( range , 1 day to 20 months ) . The crude mortality at the end of six months ( primary end point ) was 26 percent in the enalapril group and 44 percent in the placebo group -- a reduction of 40 percent ( P = 0.002 ) . Mortality was reduced by 31 percent at one year ( P = 0.001 ) . By the end of the study , there had been 68 deaths in the placebo group and 50 in the enalapril group -- a reduction of 27 percent ( P = 0.003 ) . The entire reduction in total mortality was found to be among patients with progressive heart failure ( a reduction of 50 percent ) , whereas no difference was seen in the incidence of sudden cardiac death . A significant improvement in NYHA classification was observed in the enalapril group , together with a reduction in heart size and a reduced requirement for other medication for heart failure . The overall withdrawal rate was similar in both groups , but hypotension requiring withdrawal occurred in seven patients in the enalapril group and in no patients in the placebo group . After the initial dose of enalapril was reduced to 2.5 mg daily in high-risk patients , this side effect was less frequent . We conclude that the addition of enalapril to conventional therapy in patients with severe congestive heart failure can reduce mortality and improve symptoms . The beneficial effect on mortality is due to a reduction in death from the progression of heart failure"
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Research ers have generally considered autistic individuals to have difficulties generalising learned skills across novel context s. Successful generalisation is necessary for an intervention to have benefits in everyday life beyond the original learning environment . We conducted a systematic review of r and omised controlled trials of early social communication interventions for children with autism in order to explore generalisation and its measurement . We identified nine RCTs that provided evidence of initial target learning and measured generalisation , of which eight demonstrated at least some successful generalisation across people , setting s , and /or activities . The findings did not support the widely reported generalisation ' difficulties ' associated with autism . However , generalisation was not consistent across all skills within studies , and one study found no generalisation despite evidence for initial target learning within the intervention context . In general , there are few method ologically sound social communication intervention studies exploring generalisation in autism and no consensus on how it should be measured . In particular , failure to demonstrate initial learning of target skills within the intervention setting and an absence of formal mediation analyses of the hypothesised mechanisms limit current research . We outline a framework within which measurement of generalisation can be considered for use in future trials . To maximise the effectiveness of interventions , the field needs to gain a better underst and ing of the nature of generalisation among autistic individuals and what additional strategies may further enhance learning . Autism Res 2019 , 00 : 1 - 17 . © 2019 International Society for Autism Research , Wiley Periodicals , Inc. LAY SUMMARY : It is generally considered that autistic individuals experience difficulties applying things they have learned in one context into different setting s ( e.g. from school to home ) . This is important to consider for intervention studies . Our review does not support a complete lack of generalisation but instead suggests that after early social communication intervention , autistic children can transfer some skills to new context s. Overall , there is limited research in this area and further work is needed | [
"BACKGROUND Delays and deficits in joint attention and symbolic play constitute two important developmental problems in young children with autism . These areas of deficit have been well studied in autism but have rarely been the focus of treatment efforts ( see Kasari , Freeman , & Paparella , 2001 ) . In this study , we examine the efficacy of targeted interventions of joint attention and symbolic play . METHODS Participants were 58 children with autism aged 3 and 4 years ( 46 boys ) . Children were r and omized to a joint attention intervention , a symbolic play intervention , or control group . Interventions were conducted 30 minutes daily for 5 - 6 weeks . Both structured assessment s of joint attention and play skills and mother-child interactions were collected pre and post intervention by independent assessors . RESULTS Results indicate that both intervention groups improved significantly over the control group on certain behaviors . Children in the joint attention intervention initiated significantly more showing and responsiveness to joint attention on the structured joint attention assessment and more child-initiated joint attention in the mother-child interaction . The children in the play group showed more diverse types of symbolic play in interaction with their mothers and higher play levels on both the play assessment and in interaction with their mothers . CONCLUSIONS This r and omized controlled trial provides promising data on the specificity and generalizability of joint attention and play interventions for young children with autism . Future studies need to examine the long-term effects of these early interventions on children 's development",
"Abstract The study of mediation of treatment effects , or how treatments work , is important to underst and ing and improving psychological and behavioral treatments , but applications often focus on mediators and outcomes measured at a single time point . Such cross-sectional analyses do not respect the implied temporal ordering that mediation suggests . Clinical trials of treatments often provide repeated measures of outcomes and , increasingly , of mediators as well . Repeated measurements allow the application of various types of longitudinal structural equation mediation models . These provide flexibility in modeling , including the ability to incorporate some types of measurement error and unmeasured confounding that can strengthen the robustness of findings . The usual approach is to identify the most theoretically plausible model and apply that model . In the absence of clear theory , we put forward the option of fitting a few theoretically plausible models , providing a type of sensitivity analysis for the mediation hypothesis . In this tutorial , we outline how to fit several longitudinal mediation models , including simplex , latent growth and latent change models . This will allow readers to learn about one type of model that is of interest , or about several alternative models , so that they can take this sensitivity approach . We use the Pacing , Grade d Activity , and Cognitive Behavioral Therapy : A R and omized Evaluation ( PACE ) trial of rehabilitative treatments for chronic fatigue syndrome ( IS RCT N 54285094 ) as a motivating example and describe how to fit and interpret various longitudinal mediation models using simulated data similar to those in the PACE trial . The simulated data set and Mplus code and output are provided",
"This study aim ed to determine if a joint attention intervention would result in greater joint engagement between caregivers and toddlers with autism . The intervention consisted of 24 caregiver-mediated sessions with follow-up 1 year later . Compared to caregivers and toddlers r and omized to the waitlist control group the immediate treatment ( IT ) group made significant improvements in targeted areas of joint engagement . The IT group demonstrated significant improvements with medium to large effect sizes in their responsiveness to joint attention and their diversity of functional play acts after the intervention with maintenance of these skills 1 year post-intervention . These are among the first r and omized controlled data to suggest that short-term parent-mediated interventions can have important effects on core impairments in toddlers with autism . Clinical Trials # : NCT00065910",
"In 2002 , the National Institutes of Health sponsored a meeting concerning method ological challenges of research in psychosocial interventions in Autism Spectrum Disorders . This paper provides a summary of the presentations and the discussion s that occurred during this meeting . Recommendations to federal and private agencies included the need for r and omized clinical trials of comprehensive interventions for autism as the highest , but not the sole priority . Ongoing working groups were proposed to address psychosocial interventions with a focus on relevant statistics , st and ardized documentation and methods of diagnosis , development of outcome measures , establishment of st and ards in research ; and the need for innovative treatment design s , including application of design s from other research areas to the study of interventions in ASD",
"Objective : To evaluate the effectiveness of the Play and Language for Autistic Youngsters ( PLAY ) Project Home Consultation model , in combination with usual community services ( CS ) , to improve parent-child interaction , child development , and autism symptomatology in young children with autism spectrum disorders ( ASDs ) compared with CS only . Methods : Children ( N = 128 ) with autism or PDD-NOS ( DSM-4 criteria ) aged 2 years 8 months to 5 years 11 months and recruited from 5 disability agencies in 4 US states were r and omized in two 1-year cohorts . Using videotape and written feedback within a developmental framework , PLAY consultants coached caregivers monthly for 12 months to improve caregiver-child interaction . CS included speech/ language and occupational therapy and public education services . Primary outcomes included change in parent-child interactions , language and development , and autism-related diagnostic category/symptoms . Secondary outcomes included parent stress and depression and home consultant fidelity . Data were collected pre- and post-intervention . Results : Using intent-to-treat analysis ( ITT ) , large treatment effects were evident for parent and child interactional behaviors on the Maternal and Child Behavior Rating Scales . Child language and developmental quotient did not differ over time by group , although functional development improved significantly . PLAY children improved in diagnostic categories on the Autism Diagnostic Observation Schedule ( ADOS ) . PLAY caregivers ' stress did not increase , and depressive symptomatology decreased . Home consultants administered the intervention with fidelity . Conclusions : PLAY intervention demonstrated substantial changes in parent-child interaction without increasing parents ' stress/depression . ADOS findings must be interpreted cautiously because results do not align with clinical experience . PLAY offers communities a relatively inexpensive effective intervention for children with ASD and their parents",
"Abstract ‘ Everyday memory ’ is conceptualised as memory within the context of day-to-day life and , despite its functional relevance , has been little studied in individuals with autism spectrum disorders ( ASDs ) . In the first study of its kind , 94 adolescents with an ASD and 55 without an ASD completed measures of everyday memory from the Rivermead Behavioural Memory Test ( RBMT ) and a st and ard word recall task ( Children ’s Auditory Verbal Learning Test-2 : CAVLT-2 ) . The ASD group showed significant impairments on the RBMT , including in prospect i ve memory , alongside impaired performance on the CAVLT-2 . Social and communication ability was significantly associated with prospect i ve remembering in an everyday memory context but not with the CAVLT-2 . The complex nature of everyday memory and its relevance to ASD is discussed",
"Cognitive processing in autism has been characterized by a difficulty with the abstract ion of information across multiple stimuli or situations and subsequent generalization to new stimuli or situations . This apparent difficulty leads to the suggestion that prototype formation , a process of creating a mental summary representation of multiple experienced stimuli that go together in a category , may be impaired in autism . Adults with high functioning autism and a typically developing comparison group matched on age and IQ completed a r and om dot pattern categorization task . Participants with autism demonstrated intact prototype formation in all four ways it was operationally defined , and this performance was not significantly different from that of control participants . However , participants with autism categorized dot patterns that were more highly distorted from the category prototypes less accurately than did control participants . These findings suggest , at least within the constraints of the r and om dot pattern task , that although prototype formation may not be impaired in autism , difficulties may exist with the generalization of what has been learned about a category to novel stimuli , particularly as they become less similar to the category 's prototype",
"Summary Background Results of small trials suggest that early interventions for social communication are effective for the treatment of autism in children . We therefore investigated the efficacy of such an intervention in a larger trial . Methods Children with core autism ( aged 2 years to 4 years and 11 months ) were r and omly assigned in a one-to-one ratio to a parent-mediated communication-focused ( Preschool Autism Communication Trial [ PACT ] ) intervention or treatment as usual at three specialist centres in the UK . Those assigned to PACT were also given treatment as usual . R and omisation was by use of minimisation of probability in the marginal distribution of treatment centre , age ( ≤42 months or > 42 months ) , and autism severity ( Autism Diagnostic Observation Schedule-Generic [ ADOS-G ] algorithm score 12–17 or 18–24 ) . Primary outcome was severity of autism symptoms ( a total score of social communication algorithm items from ADOS-G , higher score indicating greater severity ) at 13 months . Complementary secondary outcomes were measures of parent-child interaction , child language , and adaptive functioning in school . Analysis was by intention to treat . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N58133827 . Results 152 children were recruited . 77 were assigned to PACT ( London [ n=26 ] , Manchester [ n=26 ] , and Newcastle [ n=25 ] ) ; and 75 to treatment as usual ( London [ n=26 ] , Manchester [ n=26 ] , and Newcastle [ n=23 ] ) . At the 13-month endpoint , the severity of symptoms was reduced by 3·9 points ( SD 4·7 ) on the ADOS-G algorithm in the group assigned to PACT , and 2·9 ( 3·9 ) in the group assigned to treatment as usual , representing a between-group effect size of −0·24 ( 95 % CI −0·59 to 0·11 ) , after adjustment for centre , sex , socioeconomic status , age , and verbal and non-verbal abilities . Treatment effect was positive for parental synchronous response to child ( 1·22 , 0·85 to 1·59 ) , child initiations with parent ( 0·41 , 0·08 to 0·74 ) , and for parent-child shared attention ( 0·33 , −0·02 to 0·68 ) . Effects on directly assessed language and adaptive functioning in school were small . Interpretation On the basis of our findings , we can not recommend the addition of the PACT intervention to treatment as usual for the reduction of autism symptoms ; however , a clear benefit was noted for parent-child dyadic social communication . Funding UK Medical Research Council , and UK Department for Children , Schools and Families",
"OBJECTIVES : To compare 2 short-term , community caregiver training interventions for preschool-aged children with Autism Spectrum Disorder who had low re sources . Low re source was defined by the US Department of Housing and Urban Development low-income index or 1 “ indicator , ” ( eg , Medicaid eligibility ) . Child outcomes focused on joint engagement , joint attention , and play . METHODS : Participants included 112 families of a child who had Autism Spectrum Disorder who met criteria for being low-re source d and who were r and omly assigned to 1 of 2 3-month interventions , group caregiver education or individualized caregiver-mediated intervention ( CMM ) . Children were assessed for social communication skills pre- and post-treatment , and followed up at 3 months . RESULTS : All children improved in joint engagement and initiating joint attention , with significantly greater improvement by the CMM group . Outcomes on play skills were mixed , with improvement of symbolic play for the CMM group and no change in functional play skills . Joint engagement maintained over time for the CMM group , and initiating joint attention maintained for both groups over time . CONCLUSIONS : This study is among the first r and omized trials comparing 2 active interventions with a large sample of low-re source d families . Results suggest improvements in core autism deficits of joint engagement , joint attention , and symbolic play with relatively brief , caregiver-mediated interventions , but additional support is necessary to maintain and generalize these gains over time",
"BACKGROUND Behavioral interventions are commonplace in the treatment of autism spectrum disorders , yet relatively little is known about how and why these interventions work . This study tests the relationship between isolated core components of a packaged social communication intervention and the primary outcome , joint engagement , to better underst and how the intervention is affecting change in individuals . METHODS A total of 86 toddlers and their parents were enrolled in the study and r and omized to one of two treatments , the joint attention , symbolic play , engagement , and regulation ( JASPER ) parent-mediated intervention or a psychoeducational intervention . Measures regarding the parent 's use of intervention strategies were collected before and after the 10-week intervention . Additional measures of child and parent joint engagement were also collected . RESULTS A significant effect of treatment was found for all four of the core strategies of the intervention , favoring a larger increase in the JASPER condition . A hierarchical linear regression revealed several individual predictors of joint engagement , including parent-rated buy-in , interventionist-rated parent involvement , and parental use of strategies . To complement the hierarchical analysis , we also tested the potential mediating effect the strategies may have on the relationship between treatment and joint engagement . Results showed that the strategy of mirrored pacing mediated the relationship between treatment and joint engagement in the positive direction . CONCLUSIONS These results strongly suggest that the mirrored pacing strategy is an active ingredient of the JASPER treatment",
"OBJECTIVE Previous research has demonstrated that peer rejection is a significant part of the clinical presentation of many children with attention-deficit hyperactivity disorder ( ADHD ) . Outcome studies of treatment interventions have typically failed to show generalization of treatment gains to the home and classroom . This has been especially true for children who have comorbid oppositional defiant disorder ( ODD ) . The present study was intended to demonstrate generalization of an outpatient social skills training program when parents were trained in skills relevant to their child 's social adjustment . METHOD Thirty-five children with ADHD and 14 children without ADHD were given 12 sessions of treatment ( treatment group ) . Outcome was compared with 12 children with ADHD and 12 children without ADHD who were on a waitlist for treatment ( waitlist group ) . Nineteen children with ODD were in the treatment group and five in the waitlist . Stimulant medication was prescribed for all children with ADHD . RESULTS Subjects with ADHD showed improvement comparable with that of subjects without ADHD on all teacher- and parent-reported measures of peer adjustment and social skills , except teacher-reported withdrawal . Children with ODD had outcome comparable with that of children without ODD . Effect sized ranged from 0.93 to 1.34 indicating that the average treatment group subject was better off than 83.4 % of waitlist subjects on outcome measures . CONCLUSIONS The present results suggest that children with ADHD are best heiped by a combination of social skills training for themselves , collateral training for their parents and stimulant medication",
"BACKGROUND The PACT r and omised-controlled trial evaluated a parent-mediated communication-focused treatment for children with autism , intended to reduce symptom severity as measured by a modified Autism Diagnostic Observation Schedule-Generic ( ADOS-G ) algorithm score . The therapy targeted parental behaviour , with no direct interaction between therapist and child . While nonsignificant group differences were found on ADOS-G score , significant group differences were found for both parent and child intermediate outcomes . This study aim ed to better underst and the mechanism by which the PACT treatment influenced changes in child behaviour though the targeted parent behaviour . METHODS Mediation analysis was used to assess the direct and indirect effects of treatment via parent behaviour on child behaviour and via child behaviour on ADOS-G score . Alternative mediation was explored to study whether the treatment effect acted as hypothesised or via another plausible pathway . Mediation models typically assume no unobserved confounding between mediator and outcome and no measurement error in the mediator . We show how to better exploit the information often available within a trial to begin to address these issues , examining scope for instrumental variable and measurement error models . RESULTS Estimates of mediation changed substantially when account was taken of the confounder effects of the baseline value of the mediator and of measurement error . Our best estimates that accounted for both suggested that the treatment effect on the ADOS-G score was very substantially mediated by parent synchrony and child initiations . CONCLUSIONS The results highlighted the value of repeated measurement of mediators during trials . The theoretical model underlying the PACT treatment was supported . However , the substantial fall-off in treatment effect highlighted both the need for additional data and for additional target behaviours for therapy",
"Few research -developed early intervention models have been deployed to and tested in real world preschool programs . In this study , teaching staff implemented a social communication modularized intervention , JASPER , in their daily program . Sixty-six preschool children with autism in twelve classrooms ( 12 teachers ) were r and omized to receive immediate JASPER training ( IT ) or were waitlisted ( WL ) for 3 months with a 1-month follow up . Measures of core deficits ( initiations of joint engagement , joint attention gestures and language , play skills ) and st and ardized cognitive measures were improved for IT over WL children . IT teachers achieved and maintained high fidelity . Teachers can implement evidence -based interventions with significant improvements in core deficits of their children with ASD",
"BACKGROUND Psychosocial treatments are the mainstay of management of autism in the UK but there is a notable lack of a systematic evidence base for their effectiveness . R and omised controlled trial ( RCT ) studies in this area have been rare but are essential because of the developmental heterogeneity of the disorder . We aim ed to test a new theoretically based social communication intervention targeting parental communication in a r and omised design against routine care alone . METHODS The intervention was given in addition to existing care and involved regular monthly therapist contact for 6 months with a further 6 months of 2-monthly consolidation sessions . It aim ed to educate parents and train them in adapted communication tailored to their child 's individual competencies . Twenty-eight children with autism were r and omised between this treatment and routine care alone , stratified for age and baseline severity . Outcome was measured at 12 months from commencement of intervention , using st and ardised instruments . RESULTS All cases studied met full Autism Diagnostic Interview ( ADI ) criteria for classical autism . Treatment and controls had similar routine care during the study period and there were no study dropouts after treatment had started . The active treatment group showed significant improvement compared with controls on the primary outcome measure -- Autism Diagnostic Observation Schedule ( ADOS ) total score , particularly in reciprocal social interaction-- and on secondary measures of expressive language , communicative initiation and parent-child interaction . Suggestive but non-significant results were found in Vinel and Adaptive Behaviour Scales ( Communication Sub-domain ) and ADOS stereotyped and restricted behaviour domain . CONCLUSIONS A R and omised Treatment Trial design of this kind in classical autism is feasible and acceptable to patients . This pilot study suggests significant additional treatment benefits following a targeted ( but relatively non-intensive ) dyadic social communication treatment , when compared with routine care . The study needs replication on larger and independent sample s. It should encourage further RCT design s in this area",
"Clinical trials are expensive and time-consuming and so should also be used to study how treatments work , allowing for the evaluation of theoretical treatment models and refinement and improvement of treatments . These treatment processes can be studied using mediation analysis . R and omised treatment makes some of the assumptions of mediation models plausible , but the mediator– outcome relationship could remain subject to bias . In addition , mediation is assumed to be a temporally ordered longitudinal process , but estimation in most mediation studies to date has been cross-sectional and unable to explore this assumption . This study used longitudinal structural equation modelling of mediator and outcome measurements from the PACE trial of rehabilitative treatments for chronic fatigue syndrome ( IS RCT N 54285094 ) to address these issues . In particular , autoregressive and simplex models were used to study measurement error in the mediator , different time lags in the mediator– outcome relationship , unmeasured confounding of the mediator and outcome , and the assumption of a constant mediator– outcome relationship over time . Results showed that allowing for measurement error and unmeasured confounding were important . Contemporaneous rather than lagged mediator– outcome effects were more consistent with the data , possibly due to the wide spacing of measurements . Assuming a constant mediator– outcome relationship over time increased precision",
"BACKGROUND Deficits in joint attention ( JA ) and joint engagement ( JE ) represent a core problem in young children with autism as these affect language and social development . Studies of parent-mediated and specialist-mediated JA-intervention suggest that such intervention may be effective . However , there is little knowledge about the success of the intervention when done in preschools . AIM Assess the effects of a preschool-based JA-intervention . METHODS 61 children ( 48 males ) with autistic disorder ( 29 - 60 months ) were r and omized to either 8 weeks of JA-intervention , in addition to their preschool programs ( n = 34 ) , or to preschool programs only ( n = 27 ) . The intervention was done by preschool teachers with weekly supervision by trained counselors from Child and Adolescent Mental Health Clinics ( CAMHC ) . Changes in JA and JE were measured by blinded independent testers using Early Social Communication Scale ( ESCS ) and video taped preschool teacher-child and mother-child play at baseline and post-intervention . CLINICAL TRIALS REGISTRATION Clinical trials.gov : NCT00378157 . RESULTS Intention-to-treat analysis showed significant difference between the intervention and the control group , with the intervention group yielding more JA initiation during interaction with the preschool teachers . The effect generalized to significantly longer duration of JE with the mothers . CONCLUSIONS This is the first r and omized study to show positive and generalized effects of preschool-based JA-intervention",
"Purpose This study examined the effects of incorporating a peer-mediated approach into a speech-generating device ( SGD ) intervention on communication of 45 nonverbal and minimally verbal preschoolers with autism spectrum disorder ( ASD ) and 95 peers without disabilities . The SGD was an iPad 2 ( Apple ) with voice output app . Method Effects were evaluated using a multivariate r and omized control trial design with repeated measures for 4 cohorts across baseline , intervention , generalization , and maintenance phases . Children were r and omly assigned to an experimental treatment that trained peers on use of the SGD or a business-as-usual comparison condition with untrained peers . Communication outcomes were measured for both children with ASD and peers . Results Children receiving the treatment demonstrated significant increases in rates of communication and more balanced responses and initiations ( a measure of reciprocity ) than children in the comparison group . They were able to generalize improvements and maintain communication gains . Treatment fidelity was high for school staff and peer implementation . Conclusions Results support positive effects on communication of teaching young children with ASD and peers without disabilities to use the same SGD system in typical preschool activities . SGD interventions that utilize peer-mediated approaches may improve core deficits in communication and reciprocity and allow for greater classroom social participation and interactions with peers",
"A major topic of debate is whether children with autism spectrum disorder should be educated in inclusive or specialized setting s. We examined the feasibility and preliminary effectiveness of delivering the Group-Early Start Denver Model to children with autism spectrum disorder in inclusive versus specialized classrooms . We r and omly assigned 44 preschoolers with autism spectrum disorder to receive the Group-Early Start Denver Model across one school calendar year in classrooms that included only children with autism spectrum disorder or mostly children who were typically developing . Blind-rated indicators of teaching quality showed similar results across setting s , which were above the local benchmark . Children showed improvements across blinded proximal measures of spontaneous vocalization , social interaction , and imitation and across distal measures of verbal cognition , adaptive behavior , and autism symptoms irrespective of intervention setting . Mothers of participants experienced a reduction in stress irrespective of child intervention setting . Across both setting s , age at intervention start was negatively associated with gains in verbal cognition . Delivery of Group-Early Start Denver Model in an inclusive setting appeared to be feasible , with no significant differences in teaching quality and child improvements when the program was implemented in inclusive versus specialized classrooms",
"Improving measurement of outcomes in r and omized controlled trials of early interventions for autism spectrum disorder ( ASD ) has been identified as a priority in the field . In addition , the importance of measurement across context s has been indicated by research ers and community stakeholders alike [ Lord et al. , ; McConachie et al. , ; Schreibman et al. , ] . The Brief Observation of Social Communication Change ( BOSCC ; Grzadzinski et al. , ) , an observational rating scheme of brief play interactions , was developed to address a need for measures that are reliable , sensitive to change , and valid for use in research setting s. The goal of this study was to examine the feasibility and utility of applying the BOSCC to a new context : a home snack routine . Results suggest that rating the BOSCC on home snack routines is feasible and psychometrically sound , and captures change in child social communication behaviors . However , the utility of the BOSCC for measuring restricted and repetitive behaviors ( RRBs ) is less clear . Nonetheless , differences in RRBs across play and snack lend support for the cl aim that measurement across context s is essential . Application of the BOSCC across context s may allow research ers to obtain a more accurate estimate of intervention response and help capture context ‐specific changes in social communication . It may also provide a method for research ers to evaluate the effect of context on child social communication more broadly . Autism Res 2019 , 12 : 636–644 . © 2019 International Society for Autism Research , Wiley Periodicals ,",
"The aim of this study was to pilot test a classroom-based intervention focused on facilitating play and joint attention for young children with autism in self-contained special education classrooms . Thirty-three children with autism between the ages of 3 and 6 years participated in the study with their classroom teachers ( n = 14 ) . The 14 preschool special education teachers were r and omly assigned to one of three groups : ( 1 ) symbolic play then joint attention intervention , ( 2 ) joint attention then symbolic intervention , and ( 3 ) wait-list control period then further r and omized to either group 1 or group 2 . In the intervention , teachers participated in eight weekly individualized 1-h sessions with a research er that emphasized embedding strategies targeting symbolic play and joint attention into their everyday classroom routines and activities . The main child outcome variables of interest were collected through direct classroom observations . Findings indicate that teachers can implement an intervention to significantly improve joint engagement of young children with autism in their classrooms . Furthermore , multilevel analyses showed significant increases in joint attention and symbolic play skills . Thus , these pilot data emphasize the need for further research and implementation of classroom-based interventions targeting play and joint attention skills for young children with autism",
"In a r and omized controlled trial , we evaluated the early intervention program Video-feedback Intervention to promote Positive Parenting adapted to Autism ( VIPP-AUTI ) with 78 primary caregivers and their child ( 16–61 months ) with Autism Spectrum Disorder . VIPP-AUTI is a brief attachment-based intervention program , focusing on improving parent – child interaction and reducing the child ’s individual Autism Spectrum Disorder – related symptomatology in five home visits . VIPP-AUTI , as compared with usual care , demonstrated efficacy in reducing parental intrusiveness . Moreover , parents who received VIPP-AUTI showed increased feelings of self-efficacy in child rearing . No significant group differences were found on other aspects of parent – child interaction or on child play behavior . At 3-months follow-up , intervention effects were found on child-initiated joint attention skills , not mediated by intervention effects on parenting . Implementation of VIPP-AUTI in clinical practice is facilitated by the use of a detailed manual and a relatively brief training of interveners",
"OBJECTIVE This study compared effects of two parent-mediated interventions on joint engagement outcomes as augmentations of an early intervention program for toddlers with autism spectrum disorder ( ASD ) . METHOD Participants included 86 toddlers ( range 22 - 36 months ) with ASD and their primary caregiver . Caregiver-child dyads were r and omized to receive 10 weeks of h and s-on parent training in a naturalistic , developmental behavioral intervention ( joint attention , symbolic play , engagement and regulation-JASPER ) or a parent-only psychoeducational intervention ( PEI ) . Dose was controlled in terms of research er-parent contact and early intervention services received by the child . RESULTS Results yielded significant effects of the JASPER intervention on the primary outcome of joint engagement . The treatment effect was large ( Cohen 's f² = .69 ) and maintained over the 6-month follow-up . JASPER effects were also found on secondary outcomes of play diversity , highest play level achieved , and generalization to the child 's classroom for child-initiated joint engagement . The PEI intervention was found to be effective in reducing parenting stress associated with child characteristics . All secondary effects were generally small to moderate . CONCLUSIONS These data highlight the benefit of a brief , targeted , parent-mediated intervention on child outcomes . Future studies may consider the combination of JASPER and PEI treatments for optimal parent and child outcomes . Trial registry no. NCT00999778"
] | 41167248-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Appendectomy , the surgical removal of the appendix , is performed primarily for acute appendicitis . Patients who undergo appendectomy for complicated appendicitis , defined as gangrenous or perforated appendicitis , are more likely to suffer from postoperative complications . The routine use of abdominal drainage to reduce postoperative complications after appendectomy for complicated appendicitis is controversial . OBJECTIVES To assess the safety and efficacy of abdominal drainage to prevent intra-peritoneal abscess after open appendectomy for complicated appendicitis . SEARCH METHODS We search ed The Cochrane Library ( Issue 1 , 2014 ) , MEDLINE ( 1950 to February 2014 ) , EMBASE ( 1974 to February 2014 ) , Science Citation Index Exp and ed ( 1900 to February 2014 ) , and Chinese Biomedical Literature Data base ( CBM ) ( 1978 to February 2014 ) . SELECTION CRITERIA We included all r and omised controlled trials ( RCTs ) that compared abdominal drainage and no drainage in patients undergoing emergency open appendectomy for complicated appendicitis . DATA COLLECTION AND ANALYSIS Two review authors identified the trials for inclusion , collected the data , and assessed the risk of bias independently . We performed the meta-analyses using Review Manager 5 . We calculated the risk ratio ( RR ) for dichotomous outcomes ( or a Peto odds ratio for very rare outcomes ) , and the mean difference ( MD ) for continuous outcomes with 95 % confidence intervals ( CI ) . MAIN RESULTS We included five trials involving 453 patients with complicated appendicitis who were r and omised to the drainage group ( n = 228 ) and the no drainage group ( n = 225 ) after emergency open appendectomies . All of the trials were at a high risk of bias . There were no significant differences between the two groups in the rates of intra-peritoneal abscess or wound infection . The hospital stay was longer in the drainage group than in the no drainage group ( MD 2.04 days ; 95 % CI 1.46 to 2.62 ) ( 34.4 % increase of an ' average ' hospital stay ) . AUTHORS ' CONCLUSIONS The quality of the current evidence is very low . It is not clear whether routine abdominal drainage has any effect on the prevention of intra-peritoneal abscess after open appendectomy for complicated appendicitis . Abdominal drainage after an emergency open appendectomy may be associated with delayed hospital discharge for patients with complicated appendicitis | [
" A total of 231 children with acute appendicitis were treated at our hospitals during the 10 years between 1984 and 1993 , 53 of whom had a perforated appendix . These 53 patients were r and omly assigned to two groups at the time of surgery according to the different procedures performed . Thus , 29 children were managed by appendectomy followed by peritoneal lavage using a large amount of saline , and intravenous antibiotic therapy consisting of aminoglycoside and cephem ( lavage group ) , while the other 24 children were treated by appendectomy with silicon tube drainage and the same systemic antibiotic therapy ( drainage group ) . The mean length of hospitalization , and the mean duration s of fever and the need for fasting after laparotomy in the lavage group were significantly less than those in the drainage group : 10.1 versus 18.8 days , 2.8 versus 7.7 days , and 1.8 versus 3.5 days , respectively . The operation wounds healed well in the lavage group due to the fact that there was no drain . Wound infections occurred in two children from the lavage group and six from the drainage group . Intra-abdominal abscesses occurred in two children from the drainage group . Accordingly , peritoneal lavage appears to be superior to intraperitoneal tube drainage for the management of perforated appendicitis in children",
"PURPOSE / BACKGROUND In this study , we aim ed to evaluate the effect of peritoneal drainage ( PD ) on postoperative infective complications in cases with perforated appendicitis . METHOD One hundred nine patients ( with PD ) were evaluated retrospectively and 117 cases ( with no drainage [ ND ] ) were evaluated prospect ively regarding complications like wound infection ( WI ) , intraabdominal abscess ( IAA ) , and small bowel obstruction caused by adhesions ( SBO ) in perforated appendicitis cases . The abdomen was irrigated with isotonic NaCl solution and the wounds were closed primarily in all patients . RESULTS The total number of patients was 226 ( male , 66.4 % ; female , 33.6 % ) , with a mean age of 8.6 + /- 3.4 years ( range , 1 - 15 years ) . The WI rates in PD and ND groups were 28.4 % to 16.2 % , respectively . The ratio of IAA in the PD group was 12.8 % which decreased to 3.4 % in the ND group . The difference was statistically significant ( P postoperative hospitalization period in the PD and ND groups were 10.2 + /- 6.5 and 8.3 + /- 3.3 days , duration s of antibiotic use were 9.5 + /- 5.5 and 7.7 + /- 2.7 days , duration s of NG tube usage were 3.2 + /- 1.5 and 2.2 + /- 1.2 days , time to oral feeding was 3.7 + /- 1.7 and 2.5 + /- 1.4 days , and time to normalization of the body temperatures was 3.7 + /- 2.3 vs 2.3 + /- 1.7 days . All differences were statistically significant ( P ratio of SBO increased from 2.8 % to 3.4 % in the ND group , but this result was not statistically significant . CONCLUSIONS As a result of this study , we recommend that peritoneal drainage should be ab and oned in childhood appendicitis",
"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",
"Abstract A prospect i ve , r and omised clinical trial has been carried out to determine the effects of peritoneal drainage or prophylactic systemic antibiotics on infection after emergency appendicectomy . 329 patients were included . Drainage increased the number of days of postoperative fever significantly (",
"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",
"BACKGROUND AND PURPOSE It is still a matter of debate whether delayed primary closure ( DPC ) of dirty abdominal incisions reduces surgical site infections ( SSIs ) compared with primary closure ( PC ) . Our objective was to determine whether DPC of dirty abdominal incisions reduces SSIs . METHOD A controlled r and omized study was conducted at an academic tertiary care 1,500-bed university hospital in Western India involving 81 consecutive patients with dirty abdominal incisions . Only 77 patients ( DPC = 37 , PC = 40 ) were evaluable because of the deaths of four patients . A total of 52 patients had peptic or typhoid perforations , whereas the rest had appendicular perforations/abscesses , penetrating or blunt abdominal injuries with gastrointestinal perforation , or intra-peritoneal abscesses . Patients were r and omized to have their surgical incisions ( skin and subcutaneous tissue ) either closed primarily ( PC ) or left open with saline-soaked gauze dressings for DPC on the 3(rd ) postoperative day or later if the incision conditions were inappropriate for closure . The main outcome measure was the incidence of postoperative SSI . RESULTS In the entire series , SSI developed after incision closure in 23 % of the patients . Infections were significantly more common in the PC group ( 42.5 % vs. 2.7 % for DPC ; p = 0.0000375 ) . There also were significantly more cases of abdominal dehiscence in the PC group ( DPC 1 [ 2.7 % ] vs. PC 10 [ 25 % ] ; p = 0.005 ) . The mean complete incision healing ( CIH ) time and length of hospital stay ( LOS ) were longer after PC ( 18.52 days ) than DPC ( 13.86 days ) , result ing in a significant difference in the end point of healing and LOS ( p = 0.0207 ) . Short-term cosmetic results for PC incisions were significantly inferior to those for DPC ( p = 0.03349 ) . CONCLUSIONS Delayed primary closure is a sound incision management technique that should be utilized for dirty abdominal incisions . It significantly lowers the rate of superficial SSI as well as fascial dehiscence and reduces the mean CIH time and hospitalization . The short-term cosmetic appearance is superior",
"Abstract . This prospect i ve study was performed to investigate epidemiological characteristics in terms of the age- and sex-specific incidence in patients with perforated and nonperforated appendicitis . The study population comprised 1486 consecutive patients who underwent appendectomy for suspected acute appendicitis between 1989 and 1993 . Two patient cohorts [ n = 544 ( 37 % ) ] were analyzed with regard to prehospitalization duration of symptoms and in-hospital observation time . The crude incidence of acute appendicitis was 86 per 100,000 per year . Although the incidence of nonperforated appendicitis was highest among adolescents and young adults ( 13–40 years of age ) , perforated appendicitis occurred at almost the same incidence in all sex and age groups . The diagnostic accuracy was 76 % . Perforated appendicitis occurred in 19 % , with higher rates in small children and the elderly , irrespective of gender . A high diagnostic accuracy was not associated with an increased rate of perforation . In small children and the elderly , the diagnostic accuracy was low and the perforation rate high . Patients with perforation had a significantly longer duration of symptoms as well as in-hospital observation time than did patients with nonperforated appendicitis . Perforated appendicitis showed a different incidence pattern than nonperforated appendicitis and was associated with a significantly longer duration of symptoms and in-hospital observation time , probably due to patient-related factors . We suggest this observation deserves attention regarding clinical diagnosis and treatment decision-making for patients with suspected acute appendicitis",
"The effectiveness of intraperitoneal drain was studied on patients undergoing appendicectomy for perforated appendicitis . R and omly 40 patients were allocated with drainage by corrugated rubber drains and 46 patients were without drainage . There were 5 deaths in the series , out of which 4 ( 10 % ) were in the drainage group and one ( 2.2 % ) in the group without drainage . The incidences of major wound sepsis , paralytic ileus , intraperitoneal abscess and urinary infection were observed in 55 % , 42.5 % , 12.5 % and 15 % respectively in drainage group and 50 % , 28.3 % , 21.7 % and 15.2 % respectively in non-drainage group . Occurrence of subphrenic abscess ( 7.5 % ) , burst abdomen ( 5 % ) and faecal fistula ( 5 % ) were confined to drainage group only",
"Peritoneal drainage in children with uncomplicated perforated appendicitis ( UPA ) is still controversial . Many pediatric surgeons prefer not to drain the peritoneal cavity in such cases . However , there is no r and omized controlled study performed in children . We aim ed to study the effects of peritoneal drainage in children with UPA in a r and omized prospect i ve trial . One hundred and forty consecutive patients with UPA were divided r and omly into 2 groups . Group I ( 70 patients ) consisted of cases with peritoneal drainage , and group II ( 70 patients ) without drainage . UPA is defined as perforated appendicitis with no more discoloration of peritoneal fluid after peritoneal wash out . Cases with localized abscess in the peritoneum were excluded from the study . In all patients , the ages , duration of symptoms , nasogastric drainage and hospitalization , and complications after surgery were recorded . The duration of hospitalization and nasogastric draining time were significantly lower in patients without peritoneal drainage . There was no difference in postoperative complications between the two groups . The onset of oral intake after surgery was significantly earlier in group II patients . Placing drains in the peritoneum does not improve outcome in UPA . Therefore , we do not recommend routine drainage of children with UPA",
"One hundred and three consecutive patients undergoing appendicectomy for perforated appendicitis were r and omly allocated either to have an intraperitoneal drain inserted or not . The results of this trial lend no support to the advocates of drainage",
"The value of extraperitoneal wound drainage and a 3‐day course of prophylactic systemic cephaloridine used both separately and together have been assessed in a prospect i ve controlled r and omized trial involving 246 patients undergoing appendicectomy at the Leicester Royal Infirmary . Extraperitoneal wound drainage was shown to reduce significantly the incidence of post‐operative wound infection in patients with a gangrenous or perforated appendix ( P ) . Prophylactic cephaloridine significantly reduced the overall incidence of wound infection ( P significant reduction in wound infection was achieved when the appendix was gangrenous or perforated by the addition of wound drainage to the antibiotic regimen ( P<0·001 )"
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The aim of the present study is to assess the comparative efficacy of different dietary approaches on glycaemic control in patients with type 2 diabetes mellitus using a systematic review of the literature . Electronic and h and search es were performed until July 2017 . The inclusion criteria were defined as follows : ( 1 ) r and omized trial with a dietary approach ; ( 2 ) adults with type 2 diabetes mellitus ; ( 3 ) outcome either HbA1c ( % ) and /or fasting glucose ( mmol/l ) ; ( 4 ) minimum intervention period of 12 weeks . For each outcome measure , r and om effects network meta- analysis was performed in order to determine the pooled effect of each intervention relative to each of the other interventions . A total of 56 trials comparing nine dietary approaches ( low-fat , Vegetarian , Mediterranean , high-protein , moderate-carbohydrate , low-carbohydrate , control , low GI/GL , Palaeolithic ) enrolling 4937 participants were included . For reducing HbA1c , the low-carbohydrate diet was ranked as the best dietary approach ( SUCRA : 84 % ) , followed by the Mediterranean diet ( 80 % ) and Palaeolithic diet ( 76 % ) compared to a control diet . For reducing fasting glucose , the Mediterranean diet ( 88 % ) was ranked as the best approach , followed by Palaeolithic diet ( 71 % ) and Vegetarian diet ( 63 % ) . The network analysis also revealed that all dietary approaches significantly reduce HbA1c ( − 0.82 to − 0.47 % reduction ) and fasting glucose ( − 1.61 to − 1.00 mmol/l reduction ) compared to a control diet . According to the network meta- analysis the Mediterranean diet is the most effective and efficacious dietary approach to improve glycaemic control in type 2 diabetes patients | [
"OBJECTIVE To test whether a weight loss program promotes greater weight loss , glycemic control , and improved cardiovascular disease risk factors compared with control conditions and whether there is a differential response to higher versus lower carbohydrate intake . RESEARCH DESIGN AND METHODS This r and omized controlled trial at two university medical centers enrolled 227 overweight or obese adults with type 2 diabetes and assigned them to parallel in-person diet and exercise counseling , with prepackaged foods in a planned menu during the initial phase , or to usual care ( UC ; two weight loss counseling sessions and monthly contacts ) . RESULTS Relative weight loss was 7.4 % ( 95 % CI 5.7–9.2 % ) , 9.0 % ( 7.1–10.9 % ) , and 2.5 % ( 1.3–3.8 % ) for the lower fat , lower carbohydrate , and UC groups ( P . Glycemic control markers and triglyceride levels were lower in the intervention groups compared with UC group at 1 year ( fasting glucose 141 [ 95 % CI 133–149 ] vs. 159 [ 144–174 ] mg/dL , P = 0.023 ; hemoglobin A1c 6.9 % [ 6.6–7.1 % ] vs. 7.5 % [ 7.1–7.9 % ] or 52 [ 49–54 ] vs. 58 [ 54–63 ] mmol/mol , P = 0.001 ; triglycerides 148 [ 134–163 ] vs. 204 [ 173–234 ] mg/dL , P lower hemoglobin A1c ( 6.6 % [ 95 % CI 6.3–6.8 % ] vs. 7.2 % [ 6.8–7.5 % ] or 49 [ 45–51 ] vs. 55 [ 51–58 ] mmol/mol ) at 1 year ( P = 0.008 ) . CONCLUSIONS The weight loss program result ed in greater weight loss and improved glycemic control in type 2 diabetes",
"Aims /hypothesisThe study aim ed to compare the effects of a 2 year intervention with a low-fat diet ( LFD ) or a low-carbohydrate diet ( LCD ) , based on four group meetings to achieve compliance . Methods This was a prospect i ve r and omised parallel trial involving 61 adults with type 2 diabetes consecutively recruited in primary care and r and omised by drawing ballots . Patients that did not speak Swedish could not be recruited . The primary outcomes in this non-blinded study were weight and HbA1c . Patients on the LFD aim ed for 55–60 energy per cent ( E% ) and those on LCD for 20 E% from carbohydrate . Results The mean BMI and HbA1c of the participants were 32.7 ± 5.4 kg/m2 and 57.0 ± 9.2 mmol/mol , respectively . No patients were lost to follow-up . Weight loss did not differ between groups and was maximal at 6 months : LFD −3.99 ± 4.1 kg ( n = 31 ) ; LCD −4.31 ± 3.6 kg ( n = 30 ) ; p 0.020 within groups , respectively ) . HbA1c fell in the LCD group only ( LCD at 6 months −4.8 ± 8.3 mmol/mol , p = 0.004 , at 12 months −2.2 ± 7.7 mmol/mol , p = 0.12 ; LFD at 6 months −0.9 ± 8.8 mmol/mol , p = 0.56 ) . At 6 months , HDL-cholesterol had increased with the LCD ( from 1.13 ± 0.33 mmol/l to 1.25 ± 0.47 mmol/l , p = 0.018 ) while LDL-cholesterol did not differ between groups . Insulin doses were reduced in the LCD group ( 0 months , LCD 42 ± 65 E , LFD 39 ± 51 E ; 6 months , LCD 30 ± 47 E , LFD 38 ± 48 E ; p = 0.046 for between-group change ) . Conclusions /interpretationWeight changes did not differ between the diet groups , while insulin doses were reduced significantly more with the LCD at 6 months , when compliance was good . Thus , aim ing for 20 % of energy intake from carbohydrates is safe with respect to cardiovascular risk compared with the traditional LFD and this approach could constitute a treatment alternative . Trial registration : Clinical Trials.gov NCT01005498 Funding : University Hospital of Linköping Research Funds , Linköping University , the County Council of Östergötl and , and the Diabetes Research Centre of Linköping",
"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 & AIMS The usefulness of low-carbohydrate diet ( LCD ) for Japanese patients with type 2 diabetes mellitus ( T2DM ) has not been fully investigated . Therefore , we compared the effectiveness and safety of LCD with calorie restricted diet ( CRD ) . METHODS This prospect i ve , r and omized , open-label , comparative study included 66 T2DM patients with HbA1c > 7.5 % even after receiving repeated education programs on CRD . They were r and omly allocated to either the 130g/day LCD group ( n = 33 ) or CRD group ( n = 33 ) . Patients received personal nutrition education of CRD or LCD for 30 min at baseline , 1 , 2 , 4 , and 6 months . Patients of the CRD group were advised to maintain the intake of calories and balance of macronutrients ( 28 × ideal body weight calories per day ) . Patients of the LCD group were advised to maintain the intake of 130 g/day carbohydrate without other specific restrictions . Several parameters were assessed at baseline and 6 months after each intervention . The primary endpoint was a change in HbA1c level from baseline to the end of the study . RESULTS At baseline , BMI and HbA1c were 26.5 ( 24.6 - 30.1 ) and 8.3 ( 8.0 - 9.3 ) , and 26.7 ( 25.0 - 30.0 ) kg/m2 and 8.0 ( 7.6 - 8.9 ) % , in the CRD and LCD , respectively . At the end of the study , HbA1c decreased by -0.65 ( -1.53 to -0.10 ) % in the LCD group , compared with 0.00 ( -0.68 to 0.40 ) % in the CRD group ( p decrease in BMI in the LCD group [ -0.58 ( -1.51 to -0.16 ) kg/m2 ] exceeded that observed in the CRD group ( p = 0.03 ) . CONCLUSIONS Our study demonstrated that 6-month 130 g/day LCD reduced HbA1c and BMI in poorly controlled Japanese patients with T2DM . LCD is a potentially useful nutrition therapy for Japanese patients who can not adhere to CRD . This trial was registered at http://www.umin.ac.jp/english/ ( University Hospital Medical Information Network : study ID number 000010663 )",
"BACKGROUND The appropriate dietary intervention for overweight persons with type 2 diabetes mellitus ( DM2 ) is unclear . Trials comparing the effectiveness of diets are frequently limited by short follow-up times and high dropout rates . AIM The effects of a low carbohydrate Mediterranean ( LCM ) , a traditional Mediterranean ( TM ) , and the 2003 American Diabetic Association ( ADA ) diet were compared , on health parameters during a 12-month period . METHODS In this 12-month trial , 259 overweight diabetic patients ( mean age 55 years , mean body mass index 31.4 kg/m(2 ) ) were r and omly assigned to one of the three diets . The primary end-points were reduction of fasting plasma glucose , HbA1c and triglyceride ( TG ) levels . RESULTS 194 patients out of 259 ( 74.9 % ) completed follow-up . After 12 months , the mean weight loss for all patients was 8.3 kg : 7.7 kg for ADA , 7.4 kg for TM and 10.1 kg for LCM diets . The reduction in HbA1c was significantly greater in the LCM diet than in the ADA diet ( -2.0 and -1.6 % , respectively , p HDL cholesterol increased ( 0.1 mmol/l + /- 0.02 ) only on the LCM ( p reduction in serum TG was greater in the LCM ( -1.3 mmol/l ) and TM ( -1.5 mmol/l ) than in the ADA ( -0.7 mmol/l ) , p = 0.001 . CONCLUSIONS An intensive 12-month dietary intervention in a community-based setting was effective in improving most modifiable cardiovascular risk factors in all the dietary groups . Only the LCM improved HDL levels and was superior to both the ADA and TM in improving glycaemic control",
"Evidence suggests that diet and exercise are associated with improved glucose tolerance for patients with non-insulin-dependent diabetes mellitus ( NIDDM ) . Seventy-six volunteer adult patients with NIDDM were each assigned to one of four programs : 1 ) diet , 2 ) exercise , 3 ) diet plus exercise , or 4 ) education ( control ) . Each program required ten weekly meetings . Detailed evaluations were completed prior to the program and after three , six , 12 , and 18 months . Evaluations included various psychosocial measures , measures of the quality of life , and fasting blood glucose , glycosylated hemoglobin , and relative weight determinations . Of the 76 original participants , 70 completed the 18-month follow-up study . At 18 months , the combination diet- and -exercise group had achieved the greatest reductions in glycosylated hemoglobin measures . In addition , this group showed significant improvements on a general quality of life measure . These improvements were largely uncorrelated with changes in weight . The authors conclude that the combination of dietary change and physical conditioning benefits NIDDM patients , and that the benefits may be independent of substantial weight loss",
"Context In 2003 , the authors reported that severely obese adults lost more weight and had better serum lipid patterns after 6 months of a low-carbohydrate diet rather than a conventional low-fat diet . Contribution After 1 year , these same patients still had more favorable triglyceride and high-density lipoprotein cholesterol levels on the low-carbohydrate diet than on the conventional diet . However , weight loss and the other metabolic parameters were similar in the 2 diet groups . Caution s The effect of the modest improvements in high-density lipoprotein cholesterol and triglyceride levels on the development of diabetes and cardiovascular disease is unknown . The Editors The prevalence of obesity and its associated metabolic abnormalities has increased markedly over the past 2 decades ( 1 , 2 ) . Although guidelines to follow a highcomplex carbohydrate , low-fat , energy-deficient diet to achieve weight loss are generally accepted ( 3 ) , considerable public interest has focused on low-carbohydrate diets ( 4 ) . We recently reported that persons with severe obesity lost more weight and had greater improvements in triglyceride levels , insulin sensitivity , and glycemic control after 6 months of a low-carbohydrate diet as compared with a conventional weight loss diet based on calorie and fat restriction ( 5 ) . However , these findings were preliminary because of the short duration of that study ( 6 ) . A simultaneously published study by Foster and colleagues suggested that persons on a low-carbohydrate diet tended to regain weight by 1 year ( 7 ) . These findings were limited , however , because few participants completed the study and because the study used a self-help approach , which is less effective than direct counseling for maintaining weight loss ( 8) . Foster and colleagues also excluded persons with diabetes , which is highly prevalent in the obese population . During the development of this study , we decided to analyze and report preliminary results at 6 months and final results at 1 year . We thought that the short-term results would be important , given the high-risk nature of our study sample , but that long-term outcomes would provide more information about the sustainability of any diet-related outcomes . We now report our findings 1 year after r and omization to a low-carbohydrate diet versus a low-fat weight loss diet ( conventional diet ) in severely obese adults with a high prevalence of diabetes or the metabolic syndrome . Methods Study Participants The study design has been previously described ( 5 ) . Participants were recruited from the outpatient practice s of the Philadelphia Veterans Affairs Medical Center and included persons 18 years of age and older with a body mass index ( BMI ) of 35 kg/m2 or greater . The exclusion criteria were a serum creatinine level greater than 133 mol/L ( > 1.5 mg/dL ) , hepatic disease , severe life-limiting medical illness , inability to self-monitor glucose levels , or active use of a weight loss program or weight loss medication . Between May 2001 and November 2001 , 132 persons were r and omly assigned to either a low-carbohydrate diet ( n = 64 ) or a conventional diet ( n = 68 ) . The Institutional Review Committee at the Philadelphia Veterans Affairs Medical Center approved the study , and all participants provided written informed consent . Interventions Diet groups met in weekly counseling sessions for 4 weeks , followed by 11 monthly sessions . Participants on the low-carbohydrate diet were instructed only to reduce carbohydrate intake to less than 30 g per day . Participants on the conventional diet were instructed to reduce caloric intake by 500 calories per day , with less than 30 % of calories derived from fat , in accordance with the National Heart , Lung , and Blood Institute guidelines ( 3 ) . Outcome Measures We collected data , including weight ( single calibrated scale , SR Instruments , Inc. , Tonaw and a , New York ) , medical history ( self-reported ) , and blood pressure , at baseline , 6 months , and 1 year . Fasting blood specimens were obtained for glucose , hemoglobin A1c , and serum lipid levels ( Synchron LX20 , Beckman Coulter , Inc. , Fullerton , California ) . Low-density lipoprotein ( LDL ) cholesterol level was calculated by using the Friedewald formula ( 9 ) . We defined the presence of diabetes by a historical fasting blood glucose level greater than 6.94 mmol/L ( > 125 mg/dL ) or use of antidiabetic medications . The metabolic syndrome was considered present if a participant had 3 or more of the following ( 10 ) : central obesity , fasting blood glucose level of 6.11 mmol/L ( 110 mg/dL ) or greater , fasting triglyceride level of 1.70 mmol/L ( 150 mg/dL ) or greater , high-density lipoprotein ( HDL ) cholesterol level less than 1.04 mmol/L ( blood pressure of 130/85 mm Hg or greater , or antihypertensive therapy . We assumed that all participants had central obesity because of the uniform severity of their obesity ( BMI range , 35.0 to 79.4 kg/m2 ) . Serum insulin was measured by radioimmunoassay ( Laboratory Corporation of America Holdings [ LabCorp ] , Burlington , North Carolina ] ) . Insulin resistance in nondiabetic persons was estimated by the quantitative insulin sensitivity check ( QUICK ) index : 1/[(log ( fasting insulin ( U/mL ) ) + ( log fasting glucose(mg/dL ) ) ] . Statistical Analysis Our primary end point was total weight loss at 1 year . Secondary analyses included the change from baseline in serum lipid levels , insulin sensitivity , and glycemic control . We estimated that we would need 100 persons ( 50 per group ) , assuming a 2-sided type I error of 5 % , for the study to have 80 % power to detect a 5-kg greater mean weight loss in the low-carbohydrate group than in the conventional diet group . These calculations were based on an anticipated maximum weight loss by 6 months , with weight stabilization in both diet groups between 6 months and 1 year . To compensate for an anticipated dropout rate of 25 % , we set our enrollment target at 135 persons . R and omization was performed by using a pre-established algorithm generated from a r and om set of numbers that was constructed and held in a separate center and concealed from those enrolling persons during r and omization . We used stratified r and omization , with blocking within strata , to ensure assignment of approximately equal numbers of women , diabetic persons , and severely obese persons ( BMI 40 kg/m2 ) to each study group . Changes in weight , dietary intake , and metabolic data were compared between the 2 diets by r and om-coefficient analysis ( 11 ) . This type of analysis was selected to allow for a variable number of observations for participants and to take into account that the repeated observations of the outcome variables over time for individuals were correlated . The r and om-coefficient analysis model takes these correlations into account by allowing the intercept to vary r and omly among persons . We used a restricted maximum likelihood analysis , which assumed that changes were distributed according to a bivariate normal distribution and that data were missing at r and om . The outcome variables were changes from baseline in weight , dietary macronutrient consumption , and metabolic measurements . For all of these analyses , the covariates included an indicator variable for time ( 6 months and 1 year ) , diet group , and a diet group by time interaction term . This diet group by time interaction term was kept in the model , regardless of its statistical significance ( P = 0.063 for the weight loss analysis ) . Separate analyses to adjust for baseline differences between diet groups were also made by entering the following covariates to each of these models : age ; race ( white or African American ) ; sex ; baseline BMI ; baseline caloric intake ; and the presence or absence of hypertension , use of lipid-lowering therapy , diabetes , active smoking , and sleep apnea ( 12 ) . All variables were assessed for normality before entry into the analyses . Triglyceride , insulin , and glucose levels were skewed and thus were log-transformed before the analyses . Baseline differences between diet groups were compared by chi-square analysis for dichotomous variables and by the unpaired t-test for continuous variables . All P values are 2-sided , and a P value of 0.05 was considered statistically significant . Analyses were performed with SPSS statistical software , version 11.1 ( SPSS , Inc. , Chicago , Illinois ) . Missing Data Of the 132 enrolled persons , follow-up was done at 6 months for 79 persons and at 1 year for 87 persons . For measurements at 6 months , we retrieved weights on an additional 16 persons on the low-carbohydrate diet and 23 persons on the conventional diet ( total , 39 persons at a mean [ SD ] of 6.6 1.2 months ) . For measurements at 1 year , we retrieved weights on 18 persons on the low-carbohydrate diet and 21 persons on the conventional diet ( total , 39 persons at a mean [ SD ] of 13.5 3.2 months ) . Thus , we had 6-month weights on 118 of 132 persons ( 89 % ) and 1-year weights on 126 of 132 persons ( 96 % ) . Of the 18 persons who missed the 6-month visit but returned for the 1-year visit ( 6 in the low-carbohydrate group and 12 in the conventional diet group ) , all but 2 had 6-month weights retrieved from medical records . Of the 6 persons for whom no 1-year weights were available , 2 were in the low-carbohydrate group and 4 in the conventional diet group . The weights retrieved from medical records were obtained on scales that were different from those used for the study and were probably obtained in a nonuniform manner with regard to clothing . We used several approaches to h and le the 45 participants with missing data for diet recall and metabolic measurements . For the primary analysis by r and om-coefficient analysis , we assumed data were missing at r and om . To verify this assumption , we performed sensitivity analyses based on comparisons of baseline characteristics and weight loss differences between those who dropped out and those who completed the study . We also performed 2 additional sensitivity",
"Background Our aim was to compare the effects of a Paleolithic ( ' Old Stone Age ' ) diet and a diabetes diet as generally recommended on risk factors for cardiovascular disease in patients with type 2 diabetes not treated with insulin . Methods In a r and omized cross-over study , 13 patients with type 2 diabetes , 3 women and 10 men , were instructed to eat a Paleolithic diet based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts ; and a Diabetes diet design ed in accordance with dietary guidelines during two consecutive 3-month periods . Outcome variables included changes in weight , waist circumference , serum lipids , C-reactive protein , blood pressure , glycated haemoglobin ( HbA1c ) , and areas under the curve for plasma glucose and plasma insulin in the 75 g oral glucose tolerance test . Dietary intake was evaluated by use of 4-day weighed food records . Results Study participants had on average a diabetes duration of 9 years , a mean HbA1c of 6,6 % units by Mono-S st and ard and were usually treated with metformin alone ( 3 subjects ) or metformin in combination with a sulfonylurea ( 3 subjects ) or a thiazolidinedione ( 3 subjects ) . Mean average dose of metformin was 1031 mg per day . Compared to the diabetes diet , the Paleolithic diet result ed in lower mean values of HbA1c ( -0.4 % units , p = 0.01 ) , triacylglycerol ( -0.4 mmol/L , p = 0.003 ) , diastolic blood pressure ( -4 mmHg , p = 0.03 ) , weight ( -3 kg , p = 0.01 ) , BMI ( -1 kg/m2 , p = 0.04 ) and waist circumference ( -4 cm , p = 0.02 ) , and higher mean values of high density lipoprotein cholesterol ( + 0.08 mmol/L , p = 0.03 ) . The Paleolithic diet was mainly lower in cereals and dairy products , and higher in fruits , vegetables , meat and eggs , as compared with the Diabetes diet . Further , the Paleolithic diet was lower in total energy , energy density , carbohydrate , dietary glycemic load , saturated fatty acids and calcium , and higher in unsaturated fatty acids , dietary cholesterol and several vitamins . Dietary GI was slightly lower in the Paleolithic diet ( GI = 50 ) than in the Diabetic diet ( GI = 55 ) . Conclusion Over a 3-month study period , a Paleolithic diet improved glycemic control and several cardiovascular risk factors compared to a Diabetes diet in patients with type 2 diabetes . Trial registration Clinical Trials.gov NCT00435240",
"BACKGROUND AND AIM Diets where carbohydrate has been partially exchanged for protein have shown beneficial changes in persons with type 2 diabetes but no studies have enrolled people with albuminuria . We aim to determine if a high protein to carbohydrate ratio ( HPD ) in an energy reduced diet has a beneficial effect on metabolic control and cardiovascular risk factors without negatively affecting renal function . METHOD AND RESULTS Adult , overweight participants with type 2 diabetes , with albuminuria ( 30 - 600 mg/24 h or an albumin-to-creatinine ratio of 3.0 - 60 mg/mmol ) , and estimated GFR of > 40 ml/min/1.73 m(2 ) were enrolled . Participants were r and omized to an HPD or an SPD . Protein : fat : carbohydrate ratio was 30:30:40 % of energy for the HPD and 20:30:50 % for the SPD . Main outcomes were renal function , weight loss , blood pressure , serum lipids and glycaemic control . We recruited 76 volunteers and 45 ( 35 men and 10 women ) finished . There were no overall changes in renal function at 12 months and no significant differences in weight loss between groups ( 9.7 ± 2.9 kg and 6.6 ± 1.4 kg HPD and SPD group respectively ; p = 0.32 ) . Fasting blood glucose decreased significantly with no treatment effect . The decrease in HbA1c differed between treatments at 6 months ( HPD -0.9 vs. SPD -0.3 % ; p = 0.039 ) but not at 12 months . HDL increased significantly with no treatment effects . There were no changes in LDL or blood pressure overall but DBP was lower in the HPD group ( p = 0.024 ) at 12 months . CONCLUSION Weight loss improved overall metabolic control in this group of well controlled participants with type 2 diabetes regardless of diet composition",
"OBJECTIVE —The purpose of this study was to compare the effects of high – monounsaturated fatty acid ( MUFA ) and high-carbohydrate ( CHO ) diets on body weight and glycemic control in men and women with type 2 diabetes . RESEARCH DESIGN AND METHODS —Overweight/obese participants with type 2 diabetes ( n = 124 , age = 56.5 ± 0.8 years , BMI = 35.9 ± 0.3 kg/m2 , and A1C = 7.3 ± 0.1 % ) were r and omly assigned to 1 year of a high-MUFA or high-CHO diet . Anthropometric and metabolic parameters were assessed at baseline and after 4 , 8 , and 12 months of dieting . RESULTS —Baseline characteristics were similar between the treatment groups . The overall retention rate for 1 year was 77 % ( 69 % for the high-MUFA group and 84 % for the high-CHO group ; P = 0.06 ) . Based on food records , both groups had similar energy intake but a significant difference in MUFA intake . Both groups had similar weight loss over 1 year ( −4.0 ± 0.8 vs. −3.8 ± 0.6 kg ) and comparable improvement in body fat , waist circumference , diastolic blood pressure , HDL cholesterol , A1C , and fasting glucose and insulin . There were no differences in these parameters between the groups . A follow-up assessment of a subset of participants ( n = 36 ) was conducted 18 months after completion of the 52-week diet . These participants maintained their weight loss and A1C during the follow-up period . CONCLUSIONS —In individuals with type 2 diabetes , high-MUFA diets are an alternative to conventional lower-fat , high-CHO diets with comparable beneficial effects on body weight , body composition , cardiovascular risk factors , and glycemic control",
"OBJECTIVE Despite their independent cardiovascular disease ( CVD ) advantages , effects of α-linolenic acid ( ALA ) , monounsaturated fatty acid ( MUFA ) , and low-glycemic-load ( GL ) diets have not been assessed in combination . We therefore determined the combined effect of ALA , MUFA , and low GL on glycemic control and CVD risk factors in type 2 diabetes . RESEARCH DESIGN AND METHODS The study was a parallel design , r and omized trial wherein each 3-month treatment was conducted in a Canadian academic center between March 2011 and September 2012 and involved 141 participants with type 2 diabetes ( HbA1c 6.5%–8.5 % [ 48–69 mmol/mol ] ) treated with oral antihyperglycemic agents . Participants were provided with dietary advice on either a low-GL diet with ALA and MUFA given as a canola oil – enriched bread supplement ( 31 g canola oil per 2,000 kcal ) ( test ) or a whole-grain diet with a whole-wheat bread supplement ( control ) . The primary outcome was HbA1c change . Secondary outcomes included calculated Framingham CVD risk score and reactive hyperemia index ( RHI ) ratio . RESULTS Seventy-nine percent of the test group and 90 % of the control group completed the trial . The test diet reduction in HbA1c units of −0.47 % ( −5.15 mmol/mol ) ( 95 % CI −0.54 % to −0.40 % [ −5.92 to −4.38 mmol/mol ] ) was greater than that for the control diet ( −0.31 % [ −3.44 mmol/mol ] [ 95 % CI −0.38 % to −0.25 % ( −4.17 to −2.71 mmol/mol ) ] , P = 0.002 ) , with the greatest benefit observed in those with higher systolic blood pressure ( SBP ) . Greater reductions were seen in CVD risk score for the test diet , whereas the RHI ratio increased for the control diet . CONCLUSIONS A canola oil – enriched low-GL diet improved glycemic control in type 2 diabetes , particularly in participants with raised SBP , whereas whole grains improved vascular reactivity",
"Aims /hypothesisTo compare the effectiveness of low-fat high-protein and low-fat high-carbohydrate dietary advice on weight loss , using group-based interventions , among overweight people with type 2 diabetes . Study design Multicentre parallel ( 1:1 ) design , blinded r and omised controlled trial . Methods Individuals with type 2 diabetes aged 30–75 years and a BMI > 27 kg/m2 were r and omised , by an independent statistician using sequentially numbered sealed envelopes , to be prescribed either a low-fat high-protein ( 30 % of energy as protein , 40 % as carbohydrate , 30 % as fat ) or a low-fat high-carbohydrate ( 15 % of energy as protein , 55 % as carbohydrate , 30 % as fat ) diet . Participants attended 18 group sessions over 12 months . Primary outcomes were change in weight and waist circumference assessed at baseline , 6 and 12 months . Secondary outcomes were body fatness , glycaemic control , lipid profile , blood pressure and renal function . A further assessment was undertaken 12 months after the intervention . Research assessors remained blinded to group allocation throughout . Intention-to-treat analysis was performed . Results A total of 419 participants were enrolled ( mean ± SD age 58 ± 9.5 years , BMI 36.6 ± 6.5 kg/m2 and HbA1c 8.1 ± 1.2 % ( 65 mmol/mol ) ) . The study was completed by 70 % ( 294/419 ) . No differences between groups were found in change in weight or waist circumference during the intervention phase or the 12-month follow-up . Both groups had lost weight ( 2–3 kg , p their waist circumference ( 2–3 cm , p weight loss for the following 12 months . By 6 months , the difference in self-reported dietary protein between groups was small ( 1.1 % total energy ; p outcomes : body fatness , HbA1c , lipids , blood pressure and renal function . There were no important adverse effects . Conclusions /interpretationIn a ‘ real-world ’ setting , prescription of an energy-reduced low-fat diet , with either increased protein or carbohydrate , results in similar modest losses in weight and waist circumference over 2 years . Trial registration : Australia New Zeal and Clinical Trials Register ACTRN12606000490572 Funding : The Health Research Council of New Zeal and ( 06/337 )",
"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",
"BACKGROUND Few well-controlled studies have comprehensively examined the effects of very-low-carbohydrate diets on type 2 diabetes ( T2D ) . OBJECTIVE We compared the effects of a very-low-carbohydrate , high-unsaturated fat , low-saturated fat ( LC ) diet with a high-carbohydrate , low-fat ( HC ) diet on glycemic control and cardiovascular disease risk factors in T2D after 52 wk . DESIGN In this r and omized controlled trial that was conducted in an outpatient research clinic , 115 obese adults with T2D [ mean ± SD age : 58 ± 7 y ; body mass index ( in kg/m(2 ) ) : 34.6 ± 4.3 ; glycated hemoglobin ( HbA1c ) : 7.3 ± 1.1 % ; duration of diabetes : 8 ± 6 y ] were r and omly assigned to consume either a hypocaloric LC diet [ 14 % of energy as carbohydrate ( carbohydrate ] or an energy-matched HC diet [ 53 % of energy as carbohydrate , 17 % of energy as protein , and 30 % of energy as fat ( 10 % saturated fat ) ] combined with supervised aerobic and resistance exercise ( 60 min ; 3 d/wk ) . Outcomes were glycemic control assessed with use of measurements of HbA1c , fasting blood glucose , glycemic variability assessed with use of 48-h continuous glucose monitoring , diabetes medication , weight , blood pressure , and lipids assessed at baseline , 24 , and 52 wk . RESULTS Both groups achieved similar completion rates ( LC diet : 71 % ; HC diet : 65 % ) and mean ( 95 % CI ) reductions in weight [ LC diet : -9.8 kg ( -11.7 , -7.9 kg ) ; HC diet : -10.1 kg ( -12.0 , -8.2 kg ) ] , blood pressure [ LC diet : -7.1 ( -10.6 , -3.7)/-6.2 ( -8.2 , -4.1 ) mm Hg ; HC diet : -5.8 ( -9.4 , -2.2)/-6.4 ( -8.4 , -4.3 ) mm Hg ] , HbA1c [ LC diet : -1.0 % ( -1.2 % , -0.7 % ) ; HC diet : -1.0 % ( -1.3 % , -0.8 % ) ] , fasting glucose [ LC diet : -0.7 mmol/L ( -1.3 , -0.1 mmol/L ) ; HC diet : -1.5 mmol/L ( -2.1 , -0.8 mmol/L ) ] , and LDL cholesterol [ LC diet : -0.1 mmol/L ( -0.3 , 0.1 mmol/L ) ; HC diet : -0.2 mmol/L ( -0.4 , 0.03 mmol/L ) ] ( P-diet effect ≥ 0.10 ) . Compared with the HC-diet group , the LC-diet group achieved greater mean ( 95 % CI ) reductions in the diabetes medication score [ LC diet : -0.5 arbitrary units ( -0.7 , -0.4 arbitrary units ) ; HC diet : -0.2 arbitrary units ( -0.4 , -0.06 arbitrary units ) ; P = 0.02 ] , glycemic variability assessed by measuring the continuous overall net glycemic action-1 [ LC diet : -0.5 mmol/L ( -0.6 , -0.3 mmol/L ) ; HC diet : -0.05 mmol/L ( -0.2 , -0.1 mmol/L ) ; P = 0.003 ] , and triglycerides [ LC diet : -0.4 mmol/L ( -0.5 , -0.2 mmol/L ) ; HC diet : -0.01 mmol/L ( -0.2 , 0.2 mmol/L ) ; P = 0.001 ] and greater mean ( 95 % CI ) increases in HDL cholesterol [ LC diet : 0.1 mmol/L ( 0.1 , 0.2 mmol/L ) ; HC diet : 0.06 mmol/L ( -0.01 , 0.1 mmol/L ) ; P = 0.002 ] . CONCLUSIONS Both diets achieved substantial weight loss and reduced HbA1c and fasting glucose . The LC diet , which was high in unsaturated fat and low in saturated fat , achieved greater improvements in the lipid profile , blood glucose stability , and reductions in diabetes medication requirements , suggesting an effective strategy for the optimization of T2D management . This trial was registered at www.anzctr.org.au as ACTRN12612000369820",
"BACKGROUND AND AIMS Very-low carbohydrate diets can improve glycaemic control in patients with type 2 diabetes ( T2DM ) . However , compared to traditional higher carbohydrate , low fat ( HighCHO ) diets , they have been associated with impaired endothelial function ( measured by flow mediated dilatation [ FMD ] ) that is possibly related to saturated fat . This study aim ed to examine the effects of a 12-month hypocaloric very-low carbohydrate , low saturated fat ( LowCHO ) diet compared to an isocaloric HighCHO diet . METHODS One hundred and fifteen obese patients with T2DM ( age:58.4 ± 0.7 [ SEM ] yr , BMI : 34.6 ± 0.4 kg/m(2 ) , HbA1c:7.33 [ 56.3 mmol/mol ] ± 0.10 % ) were r and omised to consume an energy restricted LowCHO diet ( Carb : Pro : Fat : Sat-Fat 14:28:58 : ) or isocaloric HighCHO diet ( 53:17:30 : ) . Bodyweight , HbA1c and FMD were assessed . RESULTS Seventy eight participants completed the intervention ( LowCHO = 41 , HighCHO = 37 ) . Both groups experienced similar reductions in weight and HbA1c ( -10.6 ± 0.7 kg , -1.05 ± 0.10 % ; p time × diet ) . FMD did not change ( p = 0.11 time , p = 0.20 time × diet ) . CONCLUSIONS In patients with obesity and T2DM , HighCHO diet and LowCHO diet have similar effects on endothelial function ",
"Aims The aim of this study was to compare the effects of calorie-restricted vegetarian and conventional diabetic diets alone and in combination with exercise on insulin resistance , visceral fat and oxidative stress markers in subjects with Type 2 diabetes . Methods A 24-week , r and omized , open , parallel design was used . Seventy-four patients with Type 2 diabetes were r and omly assigned to either the experimental group ( n = 37 ) , which received a vegetarian diet , or the control group ( n = 37 ) , which received a conventional diabetic diet . Both diets were isocaloric , calorie restricted ( -500 kcal/day ) . All meals during the study were provided . The second 12 weeks of the diet were combined with aerobic exercise . Participants were examined at baseline , 12 weeks and 24 weeks . Primary outcomes were : insulin sensitivity measured by hyperinsulinaemic isoglycaemic clamp ; volume of visceral and subcutaneous fat measured by magnetic resonance imaging ; and oxidative stress measured by thiobarbituric acid reactive substances . Analyses were by intention to treat . Results Forty-three per cent of participants in the experimental group and 5 % of participants in the control group reduced diabetes medication ( P decreased more in the experimental group than in the control group [ –6.2 kg ( 95 % CI –6.6 to –5.3 ) vs. –3.2 kg ( 95 % CI –3.7 to –2.5 ) ; interaction group × time P = 0.001 ] . An increase in insulin sensitivity was significantly greater in the experimental group than in the control group [ 30 % ( 95 % CI 24.5–39 ) vs. 20 % ( 95 % CI 14–25 ) , P = 0.04 ] . A reduction in both visceral and subcutaneous fat was greater in the experimental group than in the control group ( P = 0.007 and P = 0.02 , respectively ) . Plasma adiponectin increased ( P = 0.02 ) and leptin decreased ( P = 0.02 ) in the experimental group , with no change in the control group . Vitamin C , superoxide dismutase and reduced glutathione increased in the experimental group ( P = 0.002 , P exercise training . Changes in insulin sensitivity and enzymatic oxidative stress markers correlated with changes in visceral fat . Conclusions A calorie-restricted vegetarian diet had greater capacity to improve insulin sensitivity compared with a conventional diabetic diet over 24 weeks . The greater loss of visceral fat and improvements in plasma concentrations of adipokines and oxidative stress markers with this diet may be responsible for the reduction of insulin resistance . The addition of exercise training further augmented the improved outcomes with the vegetarian diet",
"BACKGROUND AND AIM Hypertension is one of the main cardiovascular risk factors in the elderly . The aims of this work were to evaluate if a one-year intervention with two Mediterranean diets ( Med-diet ) could decrease blood pressure ( BP ) due to a high polyphenol consumption , and if the decrease in BP was mediated by plasma nitric oxide ( NO ) production . METHODS AND RESULTS An intervention sub study of 200 participants at high cardiovascular risk was carried out within the PREDIMED trial . They were r and omly assigned to a low-fat control diet or to two Med-diets , one supplemented with extra virgin olive oil ( Med-EVOO ) and the other with nuts ( Med-nuts ) . Anthropometrics and clinical parameters were measured at baseline and after one year of intervention , as well as BP , plasma NO and total polyphenol excretion ( TPE ) in urine sample s. Systolic and diastolic BP decreased significantly after a one-year dietary intervention with Med-EVOO and Med-nuts . These changes were associated with a significant increase in TPE and plasma NO . Additionally , a significant positive correlation was observed between changes in urinary TPE , a biomarker of TP intake , and in plasma NO ( Beta = 4.84 ; 95 % CI : 0.57 - 9.10 ) . CONCLUSIONS TPE in spot urine sample was positively correlated with plasma NO in Med-diets supplemented with either EVOO or nuts . The statistically significant increases in plasma NO were associated with a reduction in systolic and diastolic BP levels , adding to the growing evidence that polyphenols might protect the cardiovascular system by improving the endothelial function and enhancing endothelial synthesis of NO",
"STUDY OBJECTIVE : To study the clinical and cost outcomes of providing nutritional counselling to patients with one or more of the following conditions : overweight , hypertension and type 2 diabetes . DESIGN : The study was design ed as a r and om controlled trial . Consecutive patients were screened opportunistically for one or more of the above conditions and r and omly allocated to one of two intervention groups ( doctor/dietitian or dietitian ) or a control group . Both intervention groups received six counselling sessions over 12 months from a dietitian . However , in the doctor/dietitian group it was the doctor and not the dietitian who invited the patient to join the study and the same doctor also review ed progress at two of the six counselling sessions . SETTING : The study was conducted in a university group general practice set in a lower socioeconomic outer suburb of Perth , Western Australia . PATIENTS : Of the 273 patients r and omly allocated to a study group , 198 were women . Age ranged from 25 to 65 years . Seventy eight per cent of patients resided in the lower two socioecnomic quartiles , 56 per cent described their occupation as home duties and 78 per cent were partnered . RESULTS : Both intervention groups reduced weight and blood pressure compared with the control group . Patients in the doctor/dietitian group were more likely to complete the 12 month programme than those in the dietitian group . Patients in the doctor/dietitian group lost an average of 6.7 kg at a cost of $ A9.76 per kilogram , while the dietitian group lost 5.6 kg at a cost of $ A7.30 per kilogram . CONCLUSION : General practitioners , in conjunction with a dietitian , can produce significant weight and blood pressure improvement by health promotion methods",
"OBJECTIVE To determine the effects of daily walnut consumption on endothelial function , cardiovascular biomarkers , and anthropometric measures in type 2 diabetic individuals . RESEARCH DESIGN AND METHODS This study was a r and omized , controlled , single-blind , crossover trial . Twenty-four participants with type 2 diabetes ( mean age 58 years ; 14 women and 10 men ) were r and omly assigned to one of the two possible sequence permutations to receive an ad libitum diet enriched with 56 g ( 366 kcal ) walnuts/day and an ad libitum diet without walnuts for 8 weeks . Subjects underwent endothelial function testing ( measured as flow-mediated dilatation [ FMD ] ) and assessment of cardiovascular biomarkers before and after each 8-week treatment phase . The primary outcome measure was the change in FMD after 8 weeks . Secondary outcome measures included changes in plasma lipids , A1C , fasting glucose , insulin sensitivity , and anthropometric measures . RESULTS Endothelial function significantly improved after consumption of a walnut-enriched ad libitum diet compared with that after consumption of an ad libitum diet without walnuts ( 2.2 ± 1.7 vs. 1.2 ± 1.6 % ; P = 0.04 ) . The walnut-enriched diet increased fasting serum glucose and lowered serum total cholesterol and LDL cholesterol from baseline ( 10.0 ± 20.5 mg/dl , P = 0.04 ; −9.7 ± 14.5 mg/dl , P no significant changes in anthropometric measures , plasma A1C , and insulin sensitivity . CONCLUSIONS A walnut-enriched ad libitum diet improves endothelium-dependent vasodilatation in type 2 diabetic individuals , suggesting a potential reduction in overall cardiac risk",
"OBJECTIVE Although caloric restriction is a widely used intervention to reduce body weight and insulin resistance , many patients are unable to comply with such dietary therapy for long periods . The clinical effectiveness of low-carbohydrate diets was recently described in a position statement of Diabetes UK and a scientific review conducted by the American Diabetes Association . However , r and omised trials of dietary interventions in Japanese patients with type 2 diabetes are scarce . Therefore , the aim of this study was to examine the effects of a non-calorie-restricted , low-carbohydrate diet in Japanese patients unable to adhere to a calorie-restricted diet . METHODS The enrolled patients were r and omly allocated to receive a conventional calorie-restricted diet or low-carbohydrate diet . The patients received consultations every two months from a registered dietician for six months . We compared the effects of the two dietary interventions on glycaemic control and metabolic profiles . RESULTS The HbA1c levels decreased significantly from baseline to six months in the low-carbohydrate diet group ( baseline 7.6±0.4 % , six months 7.0±0.7 % , p=0.03 ) but not in the calorie-restricted group ( baseline 7.7±0.6 % , six months 7.5±1.0 % , n.s . ) , ( between-group comparison , p=0.03 ) . The patients in the former group also experienced improvements in their triglyceride levels , without experiencing any major adverse effects or a decline in the quality of life . CONCLUSION Our findings suggest that a low-carbohydrate diet is effective in lowering the HbA1c and triglyceride levels in patients with type 2 diabetes who are unable to adhere to a calorie-restricted diet",
"BACKGROUND Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus , but no large trials have compared interventions . We investigated the effects of diet and physical activity on blood pressure and glucose concentrations . METHODS We did a r and omised , controlled trial in southwest Engl and in adults aged 30 - 80 years in whom type 2 diabetes had been diagnosed 5 - 8 months previously . Participants were assigned usual care ( initial dietary consultation and follow-up every 6 months ; control group ) , an intensive diet intervention ( dietary consultation every 3 months with monthly nurse support ) , or the latter plus a pedometer-based activity programme , in a 2:5:5 ratio . The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c ) ) concentration and blood pressure at 6 months . Analysis was done by intention to treat . This study is registered , number IS RCT N92162869 . FINDINGS Of 593 eligible individuals , 99 were assigned usual care , 248 the diet regimen , and 246 diet plus activity . Outcome data were available for 587 ( 99 % ) and 579 ( 98 % ) participants at 6 and 12 months , respectively . At 6 months , glycaemic control had worsened in the control group ( mean baseline HbA(1c ) percentage 6·72 , SD 1·02 , and at 6 months 6·86 , 1·02 ) but improved in the diet group ( baseline-adjusted difference in percentage of HbA(1c ) -0·28 % , 95 % CI -0·46 to -0·10 ; p=0·005 ) and diet plus activity group ( -0·33 % , -0·51 to -0·14 ; p seen in bodyweight and insulin resistance between the intervention and control groups . Blood pressure was similar in all groups . INTERPRETATION An intensive diet intervention soon after diagnosis can improve glycaemic control . The addition of an activity intervention conferred no additional benefit . FUNDING Diabetes UK and the UK Department of Health",
"Background / objectives : To determine the effects of a low-fat plant-based diet program on anthropometric and biochemical measures in a multicenter corporate setting .Subjects/ methods : Employees from 10 sites of a major US company with body mass index ⩾25 kg/m2 and /or previous diagnosis of type 2 diabetes were r and omized to either follow a low-fat vegan diet , with weekly group support and work cafeteria options available , or make no diet changes for 18 weeks . Dietary intake , body weight , plasma lipid concentrations , blood pressure and glycated hemoglobin ( HbA1C ) were determined at baseline and 18 weeks . Results : Mean body weight fell 2.9 kg and 0.06 kg in the intervention and control groups , respectively ( P fell 8.0 and 8.1 mg/dl in the intervention group and 0.01 and 0.9 mg/dl in the control group ( P HbA1C fell 0.6 percentage point and 0.08 percentage point in the intervention and control group , respectively (P , mean changes in body weight were −4.3 kg and −0.08 kg in the intervention and control groups , respectively ( P fell 13.7 and 13.0 mg/dl in the intervention group and 1.3 and 1.7 mg/dl in the control group ( P HbA1C levels decreased 0.7 percentage point and 0.1 percentage point in the intervention and control group , respectively ( P dietary intervention using a low-fat plant-based diet in a corporate setting improves body weight , plasma lipids , and , in individuals with diabetes , glycemic control",
"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",
"Olive tree ( Olea europaea L. ) leaves have been widely used in traditional remedies in European and Mediterranean countries as extracts , herbal teas , and powder . They contain several potentially bioactive compounds that may have hypoglycemic properties . To examine the efficacy of 500 mg oral olive leaf extract taken once daily in tablet form versus matching placebo in improving glucose homeostasis in adults with type 2 diabetes ( T2DM ) . In this controlled clinical trial , 79 adults with T2DM were r and omized to treatment with 500 mg olive leaf extract tablet taken orally once daily or matching placebo . The study duration was 14 weeks . Measures of glucose homeostasis including Hba1c and plasma insulin were measured and compared by treatment assignment . In a series of animal models , normal , streptozotocin ( STZ ) diabetic , and s and rats were used in the inverted sac model to determine the mechanism through which olive leaf extract affected starch digestion and absorption . In the r and omized clinical trial , the subjects treated with olive leaf extract exhibited significantly lower HbA1c and fasting plasma insulin levels ; however , postpr and ial plasma insulin levels did not differ significantly by treatment group . In the animal models , normal and STZ diabetic rats exhibited significantly reduced starch digestion and absorption after treatment with olive leaf extract compared with intestine without olive leaf treatment . Reduced digestion and absorption was observed in both the mucosal and serosal sides of the intestine . Though reduced , the decline in starch digestion and absorption did not reach statistical significance in the s and rats . Olive leaf extract is associated with improved glucose homeostasis in humans . Animal models indicate that this may be facilitated through the reduction of starch digestion and absorption . Olive leaf extract may represent an effective adjunct therapy that normalizes glucose homeostasis in individuals with diabetes",
"AIMS To study the long-term ( 1- and 2-year ) effect of a lifestyle intervention on non-diabetic first-degree relatives of type 2 diabetic patients , i.e. , the 1-year effect of diet versus diet and exercise in relation to a control group and the 2-year sustainability of these treatment effects . METHOD Seventy-seven healthy first-degree relatives ( men and women ) between the ages of 25 and 55 were allocated to one of three groups : diet group ( D ) , diet and exercise group ( DE ) and control group ( C ) . For ethical reasons , after 1 year the control group began the intervention and were followed for another 2 years . Diet and physical activity counselling was based on current nutrition recommendations , including increased intake of fatty fish and low glycaemic index foods . The fatty acid composition of the erythrocyte membrane was studied as an objective measure of dietary change . Assessment s included fasting insulin , 2-h insulin , oral glucose tolerance test ( OGTT ) , anthropometry and blood lipid measurements . Groups D and DE received intensive follow-up through unannounced telephone interviews during the first 4 months . RESULTS Dietary changes were significant at 1 year , and to a large degree sustained at 2 years . Adherence to advice regarding fat quality was confirmed through changes in the fatty acid composition of the erythrocyte membrane . The least active subjects in DE increased their physical activity ( PA ) . At 1 year , group D showed a reduction in the ratio of LDL to HDL cholesterol ( p=0.028 ) while group DE decreased their body weight by 2.7 % ( p HDL ( p cholesterol levels ( total , LDL and the ratio LDL/HDL ) were reduced within group D and when compared to DE ( p=0.022 , 0.009 , 0.035 , respectively ) . Fasting insulin was reduced within group DE and when compared to group D ( p=0.025 ) . CONCLUSIONS Positive changes in lifestyle , blood lipids and fasting insulin can be achieved and maintained in a non-diabetic population at risk of type 2 diabetes after 2 years",
"OBJECTIVE In this r and omized controlled trial we evaluated the effect of registered dietitian – led management of diabetes on glycemic control and macronutrient intake in type 2 diabetic patients in primary care clinics in Taiwan and studied the association between changes in macronutrient intake and glycemic measures . RESEARCH DESIGN AND METHODS We recruited 154 adult patients with type 2 diabetes and r and omly assigned them to a routine care control group ( n = 79 ) or a registered dietitian – led intervention group ( n = 75 ) who received on-site diabetic self-management education every 3 months over 12 months . RESULTS Over the 1-year period , neither the intervention group ( n = 75 ) nor the control group ( n = 79 ) had significant changes in A1C , whereas the intervention patients with poorly controlled baseline A1C ( ≥7 % ) ( n = 56 ) had significantly greater improvements in A1C and fasting plasma glucose than the control subjects ( n = 60 ) ( −0.7 vs. −0.2 % , P = 0.034 ; −13.4 vs. 16.9 mg/dl , P = 0.007 ) during the same period . We also found significant net intervention-control group differences in overall energy intake ( −229.06 ± 309.16 vs. 56.10 ± 309.41 kcal/day ) and carbohydrate intake ( −31.24 ± 61.53 vs. 7.15 ± 54.09 g/day ) ( P between changes in carbohydrate intake and A1C in the intervention group ( n = 56 ; β = 0.10 , SEM = 0.033 , P = 0.004 ) . CONCLUSIONS On-site registered dietitian – led management of diabetes can improve glycemic control in patients with poorly managed type 2 diabetes in primary care clinics in Taiwan . A reduction in carbohydrate intake may improve glycemic status ",
"OBJECTIVE To evaluate the effects of two low-fat hypocaloric diets differing in the carbohydrate-to-protein ratio , with and without resistance exercise training ( RT ) , on weight loss , body composition , and cardiovascular disease ( CVD ) risk outcomes in overweight/obese patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 83 men and women with type 2 diabetes ( aged 56.1 ± 7.5 years , BMI 35.4 ± 4.6 kg/m2 ) were r and omly assigned to an isocaloric , energy-restricted diet ( female subjects 6 MJ/day , male subjects 7 MJ/day ) of either st and ard carbohydrate ( CON ; carbohydrate : protein : fat 53:19:26 ) or high protein ( HP ; 43:33:22 ) , with or without supervised RT ( 3 days/week ) for 16 weeks . Body weight and composition , waist circumference ( WC ) , and cardiometabolic risk markers were assessed . RESULTS Fifty-nine participants completed the study . There was a significant group effect ( P ≤ 0.04 ) for body weight , fat mass , and WC with the greatest reductions occuring in HP+RT ( weight [ CON : −8.6 ± 4.6 kg , HP : −9.0 ± 4.8 kg , CON+RT : −10.5 ± 5.1 kg , HP+RT : −13.8 ± 6.0 kg ] , fat mass [ CON : −6.4 ± 3.4 kg , HP : −6.7 ± 4.0 kg , CON+RT : −7.9 ± 3.7 kg , HP+RT : −11.1 ± 3.7 kg ] , and WC [ CON : −8.2 ± 4.6 cm , HP : −8.9 ± 3.9 cm , CON+RT : −11.3 ± 4.6 cm , HP+RT : −13.7 ± 4.6 cm ] ) . There was an overall reduction ( P mass ( −2.0 ± 2.3 kg ) , blood pressure ( −15/8 ± 10/6 mmHg ) , glucose ( −2.1 ± 2.2 mmol/l ) , insulin ( −4.7 ± 5.4 mU/l ) , A1C ( −1.25 ± 0.94 % ) , triglycerides ( −0.47 ± 0.81 mmol/l ) , total cholesterol ( −0.67 ± 0.69 mmol/l ) , and LDL cholesterol ( −0.37 ± 0.53 mmol/l ) , with no difference between groups ( P ≥ 0.17 ) . CONCLUSIONS An energy-restricted HP diet combined with RT achieved greater weight loss and more favorable changes in body composition . All treatments had similar improvements in glycemic control and CVD risk markers ",
"AIMS To complete 5-year follow-up of an intensive weight loss programme in established type 2 diabetic subjects . METHODS Forty-five obese type 2 diabetic subjects , Body mass index ( BMI ) > 30 , expressed interest in an intensive weight loss programme . Group 1 comprised 15 who selected very low calorie diet ( VLCD ) , Group 2 , 15 selected intensive conventional diet and exercise ( ICD ) , 15 failed to follow either programme . Group sessions of eight to 15 subjects continued weekly for 6 months , then monthly for 12 months with prospect i ve recording at 3 , 6 and 12 months and then annually of quality of life , BMI , waist/hip ratio , blood pressure , fasting blood glucose , serum fructosamine and serum lipids . RESULTS Weight loss was slower in the intensive conventional diet group than in the VLCD group , but better maintained at 5 years : group 1 , 4.8 + /- 6 kg ; group 2 , 8.9 + /- 4 kg . In the intensive conventional diet group , 5 year high-density lipoprotein cholesterol was increased 1.78 + /- 0.26 mmol L-1 vs. 1.10 + /- 0.32 mmol L-1 at baseline , and diastolic blood pressure reduced 74.5 + /- 13.3 vs. 85.5 + /- 13.3 at baseline , both P VLCD treatment proved safe and effective in overweight diabetic subjects but those who chose conventional diet and exercise had a slower but more sustained weight loss . Diabetic patients willing to attempt VLCD may safely lose sufficient weight to allow major surgery , but weight regain is inevitable . Patients willing to undertake a long-term group programme of conventional diet can sustain significant weight loss for 5 years , but still require antidiabetic medication",
"OBJECTIVE To compare three sets of dietary guidelines for the treatment of non-insulin-dependent diabetes ( NIDDM ) in free-living individuals and to observe the effects on metabolic control over an 18-month period . RESEARCH DESIGN AND METHODS Seventy volunteer subjects with NIDDM were r and omly assigned to one of three diets , a weight-management diet , a high-carbohydrate/fiber diet , or a modified-lipid diet and followed for 18 months . Nutrient intakes , weight , blood lipids , and glycemic control were measured . RESULTS In all diet groups , glycated hemoglobin ( HbA1 ) fell significantly before diet intervention began , remaining lower throughout the study and at follow-up 9 months later . Low-density lipoprotein ( LDL ) cholesterol showed a sustained fall in all groups after diet intervention . Apart from transient changes in high-density lipoprotein ( HDL ) cholesterol and triglyceride ( TG ) in the diet groups with the higher carbohydrate intake , no lasting differences were found between the three diet groups . CONCLUSIONS In the long term , there were few differences in the outcome of the three dietary prescriptions . Even with intensive instruction , participants found it difficult to meet recommended nutrient intakes ; however , specific dietary advice did result in an improvement in LDL cholesterol . Adverse changes in HDL cholesterol and TG because of diet intervention were transient . The significant improvement in glycemic control during the recruitment phase may have been the result of particpants ' previous dietary knowledge and the increased attention that they received during the intervention",
"OBJECTIVE Cohort studies indicate that cereal fiber reduces the risk of diabetes and coronary heart disease ( CHD ) . Therefore , we assessed the effect of wheat bran on glycemic control and CHD risk factors in type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 23 subjects with type 2 diabetes ( 16 men and 7 postmenopausal women ) completed two 3-month phases of a r and omized crossover study . In the test phase , bread and breakfast cereals were provided as products high in cereal fiber ( 19 g/day additional cereal fiber ) . In the control phase , supplements were low in fiber ( 4 g/day additional cereal fiber ) . RESULTS Between the test and control treatments , no differences were seen in body weight , fasting blood glucose , HbA(1c ) , serum lipids , apolipoproteins , blood pressure , serum uric acid , clotting factors , homocysteine , C-reactive protein , magnesium , calcium , iron , or ferritin . LDL oxidation in the test phase was higher than that seen in the control phase ( 12.1 + /- 5.4 % , P the subjects originally recruited , more dropped out of the study for health and food preference reasons from the control phase ( 16 subjects ) than the test phase ( 11 subjects ) . CONCLUSIONS High-fiber cereal foods did not improve conventional markers of glycemic control or risk factors for CHD in type 2 diabetes over 3 months . Possibly longer studies are required to demonstrate the benefits of cereal fiber . Alternatively , cereal fiber in the diet may be a marker for another component of whole grains that imparts health advantages or a healthy lifestyle",
"The role of dietary cholesterol in people with diabetes has been little studied . We investigated the effect of a hypoenergetic high-protein high-cholesterol ( HPHchol ) diet compared to a similar amount of animal protein ( high-protein low-cholesterol , HPLchol ) on plasma lipids , glycaemic control and cardiovascular risk markers in individuals with type 2 diabetes . A total of sixty-five participants with type 2 diabetes or impaired glucose tolerance ( age 54·4 ( sd 8·2 ) years ; BMI 34·1 ( sd 4·8 ) kg/m2 ; LDL-cholesterol ( LDL-C ) 2·67 ( sd 0·10 ) mmol/l ) were r and omised to either HPHchol or HPLchol . Both hypoenergetic dietary interventions ( 6 - 7 MJ ; 1·4 - 1·7 Mcal ) and total carbohydrate : protein : fat ratio of 40:30:30 % were similar but differed in cholesterol content ( HPHchol , 590 mg cholesterol ; HPLchol , 213 mg cholesterol ) . HPHchol participants consumed two eggs per d , whereas HPHchol participants replaced the eggs with 100 g of lean animal protein . After 12 weeks , weight loss was 6·0 ( sd 0·4 ) kg ( P homocysteine remained unchanged . All the subjects reduced total cholesterol ( - 0·3 ( sd 0·1 ) mmol/l , P P ( HDL-C , - 0·4 ( sd 0·1 ) mmol/l , P apo-B ( - 0·04 ( sd 0·02 ) mmol/l , P HbA1c ( - 0·6 ( sd 0·1 ) % , P glucose ( - 0·5 ( sd 0·2 ) mmol/l , P fasting insulin ( - 1·7 ( sd 0·7 ) mIU/l , P pressure ( - 7·6 ( sd 1·7 ) mmHg , P blood pressure ( - 4·6 ( sd 1·0 ) mmHg ; P . Significance was not altered by diet , sex , medication or amount of weight loss . HDL-C increased on HPHchol ( + 0·02 ( sd 0·02 ) mmol/l ) and decreased on HPLchol ( - 0·07 ( sd 0·03 ) mmol/l , P 0·05 ) . Plasma folate and lutein increased more on HPHchol ( P suggest that a high-protein energy-restricted diet high in cholesterol from eggs improved glycaemic and lipid profiles , blood pressure and apo-B in individuals with type 2 diabetes",
"BACKGROUND Legumes , including beans , chickpeas , and lentils , are among the lowest glycemic index ( GI ) foods and have been recommended in national diabetes mellitus ( DM ) guidelines . Yet , to our knowledge , they have never been used specifically to lower the GI of the diet . We have therefore undertaken a study of low-GI foods in type 2 DM with a focus on legumes in the intervention . METHODS A total of 121 participants with type 2 DM were r and omized to either a low-GI legume diet that encouraged participants to increase legume intake by at least 1 cup per day , or to increase insoluble fiber by consumption of whole wheat products , for 3 months . The primary outcome was change in hemoglobin A1c ( HbA1c ) values with calculated coronary heart disease ( CHD ) risk score as a secondary outcome . RESULTS The low-GI legume diet reduced HbA1c values by -0.5 % ( 95 % CI , -0.6 % to -0.4 % ) and the high wheat fiber diet reduced HbA1c values by -0.3 % ( 95 % CI , -0.4 % to -0.2 % ) . The relative reduction in HbA1c values after the low-GI legume diet was greater than after the high wheat fiber diet by -0.2 % ( 95 % CI , -0.3 % to -0.1 % ; P CHD risk reduction on the low-GI legume diet was -0.8 % ( 95 % CI , -1.4 % to -0.3 % ; P = .003 ) , largely owing to a greater relative reduction in systolic blood pressure on the low-GI legume diet compared with the high wheat fiber diet ( -4.5 mm Hg ; 95 % CI , -7.0 to -2.1 mm Hg ; P glycemic control and reduced calculated CHD risk score in type 2 DM",
"Background In type 2 diabetes , acute hyperglycemia worsens endothelial function and inflammation , while resistance to GLP-1 action occurs . All these phenomena seem to be related to the generation of oxidative stress . A Mediterranean diet , supplemented with olive oil , increases plasma antioxidant capacity , suggesting that its implementation can have a favorable effect on the aforementioned phenomena . In the present study , we test the hypothesis that a Mediterranean diet using olive oil can counteract the effects of acute hyperglycemia and can improve the resistance of the endothelium to GLP-1 action . Methods Two groups of type 2 diabetic patients , each consisting of twelve subjects , participated in a r and omized trial for three months , following a Mediterranean diet using olive oil or a control low-fat diet . Plasma antioxidant capacity , endothelial function , nitrotyrosine , 8-iso-PGF2a , IL-6 and ICAM-1 levels were evaluated at baseline and at the end of the study . The effect of GLP-1 during a hyperglycemic clamp , was also studied at baseline and at the end of the study . Results Compared to the control diet , the Mediterranean diet increased plasma antioxidant capacity and improved basal endothelial function , nitrotyrosine , 8-iso-PGF2a , IL-6 and ICAM-1 levels . The Mediterranean diet also reduced the negative effects of acute hyperglycemia , induced by a hyperglycemic clamp , on endothelial function , nitrotyrosine , 8-iso-PGF2a , IL-6 and ICAM-1 levels . Furthermore , the Mediterranean diet improved the protective action of GLP-1 on endothelial function , nitrotyrosine , 8-iso-PGF2a , IL-6 and ICAM-1 levels , also increasing GLP-1-induced insulin secretion . Conclusions These data suggest that the Mediterranean diet , using olive oil , prevents the acute hyperglycemia effect on endothelial function , inflammation and oxidative stress , and improves the action of GLP-1 , which may have a favorable effect on the management of type 2 diabetes , particularly for the prevention of cardiovascular disease",
"Abstract Background We have previously shown that a Palaeolithic diet consisting of the typical food groups that our ancestors ate during the Palaeolithic era , improves cardiovascular disease risk factors and glucose control compared to the currently recommended diabetes diet in patients with type 2 diabetes . To eluci date the mechanisms behind these effects , we evaluated fasting plasma concentrations of glucagon , insulin , incretins , ghrelin , C-peptide and adipokines from the same study . Methods In a r and omised , open-label , cross-over study , 13 patients with type 2 diabetes were r and omly assigned to eat a Palaeolithic diet based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts , or a diabetes diet design ed in accordance with current diabetes dietary guidelines during two consecutive 3-month periods . The patients were recruited from primary health-care units and included three women and 10 men [ age ( mean ± SD ) 64 ± 6 years ; BMI 30 ± 7 kg/m2 ; diabetes duration 8 ± 5 years ; glycated haemoglobin 6.6 ± 0.6 % ( 57.3 ± 6 mmol/mol ) ] with unaltered diabetes treatment and stable body weight for 3 months prior to the start of the study . Outcome variables included fasting plasma concentrations of leptin , adiponectin , adipsin , visfatin , resistin , glucagon , insulin , C-peptide , glucose-dependent insulinotropic polypeptide , glucagon-like peptide-1 and ghrelin . Dietary intake was evaluated by use of 4-day weighed food records . Results Seven participants started with the Palaeolithic diet and six with the diabetes diet . The Palaeolithic diet result ed in a large effect size ( Cohen ’s d = −1.26 ) at lowering fasting plasma leptin levels compared to the diabetes diet [ mean difference ( 95 % CI ) , −2.3 ( −5.1 to 0.4 ) ng/ml , p = 0.023 ] . No statistically significant differences between the diets for the other variables , analysed in this study , were observed . Conclusions Over a 3-month study period , a Palaeolithic diet result ed in reduced fasting plasma leptin levels , but did not change fasting levels of insulin , C-peptide , glucagon , incretins , ghrelin and adipokines compared to the currently recommended diabetes diet . Trial registration : Clinical Trials.gov",
"Objective Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits , particularly in terms of glycemic control , in patients with type 2 diabetes ( T2D ) ; however , no r and omized controlled trial has been conducted in Asians who more commonly depend on plant-based foods , as compared to Western population s. Here , we aim ed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals . Material s and Methods Participants diagnosed with T2D were r and omly assigned to follow either a vegan diet ( excluding animal-based food including fish ; n = 46 ) or a conventional diet recommended by the Korean Diabetes Association 2011 ( n = 47 ) for 12 weeks . HbA1c levels were measured at weeks 0 , 4 , and 12 , and the primary study endpoint was the change in HbA1c levels over 12 weeks . Results The mean HbA1c levels at weeks 0 , 4 , and 12 were 7.7 % , 7.2 % , and 7.1 % in the vegan group , and 7.4 % , 7.2 % , and 7.2 % in the conventional group , respectively . Although both groups showed significant reductions in HbA1C levels , the reductions were larger in the vegan group than in the conventional group ( -0.5 % vs. -0.2 % ; p-for-interaction = 0.017 ) . When only considering participants with high compliance , the difference in HbA1c level reduction between the groups was found to be larger ( -0.9 % vs. -0.3 % ) . The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks . Conclusion Both diets led to reductions in HbA1c levels ; however , glycemic control was better with the vegan diet than with the conventional diet . Thus , the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment . However , further studies are needed to evaluate the long-term effects of a vegan diet , and to identify potential explanations of the underlying mechanisms . Trial Registration CRiS",
"We compared the effects of two diets on glycated hemoglobin ( HbA1c ) and other health-related outcomes in overweight or obese adults with type 2 diabetes or prediabetes ( HbA1c>6 % ) . We r and omized participants to either a medium carbohydrate , low fat , calorie-restricted , carbohydrate counting diet ( MCCR ) consistent with guidelines from the American Diabetes Association ( n = 18 ) or a very low carbohydrate , high fat , non calorie-restricted diet whose goal was to induce nutritional ketosis ( LCK , n = 16 ) . We excluded participants receiving insulin ; 74 % were taking oral diabetes medications . Groups met for 13 sessions over 3 months and were taught diet information and psychological skills to promote behavior change and maintenance . At 3 months , mean HbA1c level was unchanged from baseline in the MCCR diet group , while it decreased 0.6 % in the LCK group ; there was a significant between group difference in HbA1c change favoring the LCK group ( −0.6 % , 95 % CI , −1.1 % to −0.03 % , p = 0.04 ) . Forty-four percent of the LCK group discontinued one or more diabetes medications , compared to 11 % of the MCCR group ( p = 0.03 ) ; 31 % discontinued sulfonylureas in the LCK group , compared to 5 % in the MCCR group ( p = 0.05 ) . The LCK group lost 5.5 kg vs. 2.6 kg lost in MCCR group ( p = 0.09 ) . Our results suggest that a very low carbohydrate diet coupled with skills to promote behavior change may improve glycemic control in type 2 diabetes while allowing decreases in diabetes medications . This clinical trial was registered with Clinical Trials.gov , number NCT01713764",
"Objective Dietary carbohydrate is the major determinant of postpr and ial glucose levels , and several clinical studies have shown that low-carbohydrate diets improve glycemic control . In this study , we tested the hypothesis that a diet lower in carbohydrate would lead to greater improvement in glycemic control over a 24-week period in patients with obesity and type 2 diabetes mellitus . Research design and methods Eighty-four community volunteers with obesity and type 2 diabetes were r and omized to either a low-carbohydrate , ketogenic diet ( LCKD ) or a low-glycemic , reduced-calorie diet ( 500 kcal/day deficit from weight maintenance diet ; LGID ) . Both groups received group meetings , nutritional supplementation , and an exercise recommendation . The main outcome was glycemic control , measured by hemoglobin A1c . Results Forty-nine ( 58.3 % ) participants completed the study . Both interventions led to improvements in hemoglobin A1c , fasting glucose , fasting insulin , and weight loss . The LCKD group had greater improvements in hemoglobin A1c ( -1.5 % vs. -0.5 % , p = 0.03 ) , body weight ( -11.1 kg vs. -6.9 kg , p = 0.008 ) , and high density lipoprotein cholesterol ( + 5.6 mg/dL vs. 0 mg/dL , p Diabetes medications were reduced or eliminated in 95.2 % of LCKD vs. 62 % of LGID participants ( p Dietary modification led to improvements in glycemic control and medication reduction/elimination in motivated volunteers with type 2 diabetes . The diet lower in carbohydrate led to greater improvements in glycemic control , and more frequent medication reduction/elimination than the low glycemic index diet . Lifestyle modification using low carbohydrate interventions is effective for improving and reversing type 2 diabetes",
"OBJECTIVE To compare the effects of a 1-year intervention with a low-carbohydrate and a low-fat diet on weight loss and glycemic control in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS This study is a r and omized clinical trial of 105 overweight adults with type 2 diabetes . Primary outcomes were weight and A1C . Secondary outcomes included blood pressure and lipids . Outcome measures were obtained at 3 , 6 , and 12 months . RESULTS The greatest reduction in weight and A1C occurred within the first 3 months . Weight loss occurred faster in the low-carbohydrate group than in the low-fat group ( P = 0.005 ) , but at 1 year a similar 3.4 % weight reduction was seen in both dietary groups . There was no significant change in A1C in either group at 1 year . There was no change in blood pressure , but a greater increase in HDL was observed in the low-carbohydrate group ( P = 0.002 ) . CONCLUSIONS Among patients with type 2 diabetes , after 1 year a low-carbohydrate diet had effects on weight and A1C similar to those seen with a low-fat diet . There was no significant effect on blood pressure , but the low-carbohydrate diet produced a greater increase in HDL cholesterol",
"BACKGROUND Low-fat vegetarian and vegan diets are associated with weight loss , increased insulin sensitivity , and improved cardiovascular health . OBJECTIVE We compared the effects of a low-fat vegan diet and conventional diabetes diet recommendations on glycemia , weight , and plasma lipids . DESIGN Free-living individuals with type 2 diabetes were r and omly assigned to a low-fat vegan diet ( n = 49 ) or a diet following 2003 American Diabetes Association guidelines ( conventional , n = 50 ) for 74 wk . Glycated hemoglobin ( Hb A(1c ) ) and plasma lipids were assessed at weeks 0 , 11 , 22 , 35 , 48 , 61 , and 74 . Weight was measured at weeks 0 , 22 , and 74 . RESULTS Weight loss was significant within each diet group but not significantly different between groups ( -4.4 kg in the vegan group and -3.0 kg in the conventional diet group , P = 0.25 ) and related significantly to Hb A(1c ) changes ( r = 0.50 , P = 0.001 ) . Hb A(1c ) changes from baseline to 74 wk or last available values were -0.34 and -0.14 for vegan and conventional diets , respectively ( P = 0.43 ) . Hb A(1c ) changes from baseline to last available value or last value before any medication adjustment were -0.40 and 0.01 for vegan and conventional diets , respectively ( P = 0.03 ) . In analyses before alterations in lipid-lowering medications , total cholesterol decreased by 20.4 and 6.8 mg/dL in the vegan and conventional diet groups , respectively ( P = 0.01 ) ; LDL cholesterol decreased by 13.5 and 3.4 mg/dL in the vegan and conventional groups , respectively ( P = 0.03 ) . CONCLUSIONS Both diets were associated with sustained reductions in weight and plasma lipid concentrations . In an analysis controlling for medication changes , a low-fat vegan diet appeared to improve glycemia and plasma lipids more than did conventional diabetes diet recommendations . Whether the observed differences provide clinical benefit for the macro- or microvascular complications of diabetes remains to be established . This trial was registered at clinical trials.gov as NCT00276939",
"OBJECTIVE To determine the effect of a high-protein ( HP ) weight loss diet compared with a lower-protein ( LP ) diet on fat and lean tissue and fasting and postpr and ial glucose and insulin concentrations . RESEARCH DESIGN AND METHODS Replacing dietary protein for carbohydrate ( CHO ) during energy restriction and weight loss has been effective in sparing lean mass and improving insulin sensitivity in obese subjects but has not been tested in subjects with type 2 diabetes . We compared an HP diet ( 28 % protein , 42 % CHO , 28 % fat [ 8 % saturated fatty acids , 12 % monounsaturated fatty acids , 5 % polyunsaturated fatty acids ] ) with an LP diet ( 16 % protein , 55 % CHO , 26 % fat [ 8 % saturated fatty acids , 11 % monounsaturated fatty acids , 5 % polyunsaturated fatty acids ] ) in 54 obese men and women with type 2 diabetes during 8 weeks of energy restriction ( 1,600 kcal ) and 4 weeks of energy balance . Body composition was determined by dual-energy X-ray absorptiometry at weeks 0 and 12 . RESULTS Overall , weight loss of 5.2 + /- 1.8 kg was achieved independently of diet composition . However , women on the HP diet lost significantly more total ( 5.3 vs. 2.8 kg , P=0.009 ) and abdominal ( 1.3 vs. 0.7 kg , P=0.006 ) fat compared with the women on the LP diet , whereas , in men , there was no difference in fat loss between diets ( 3.9 vs. 5.1 kg ) . Total lean mass decreased in all subjects independently of diet composition . LDL cholesterol reduction was significantly greater on the HP diet ( 5.7 % ) than on the LP diet ( 2.7 % ) ( P cardiovascular disease ( CVD ) risk profile as a consequence of weight loss . However , the greater reductions in total and abdominal fat mass in women and greater LDL cholesterol reduction observed in both sexes on the HP diet suggest that it is a valid diet choice for reducing CVD risk in type 2 diabetes",
"BACKGROUND Diabetes is a chronic , potentially debilitating , and often fatal disease . Dietary strategies to reduce postpr and ial glycemia are important in the prevention and treatment of diabetes . Nuts are rich in mono- and polyunsaturated fatty acids , which may reduce hyperglycemia and improve metabolism . OBJECTIVES To evaluate the effectiveness of pistachio nut supplementation on glycemic and inflammatory measures in patients with type 2 diabetes . METHODS In this double-blind , r and omized , placebo-controlled , crossover trial , 48 diabetic patients were equally assigned to groups A and B. Patients in group A received a snack of 25 g pistachio nuts twice a day for 12 weeks and group B received a control meal without nuts . After 12 weeks of intervention , the patients had an 8-week washout . Then the groups were displaced , and group B received the same amount of pistachios for 12 weeks . RESULTS With respect to the total change in variables over both phases , there was a marked decrease in HbA1c ( -0.4 % ) and fasting blood glucose ( FBG ) concentrations ( -16 mg/dl ) in the pistachio group compared with the control group ( p ≤ 0.001 for both ) . There was no overall significant change in BMI , blood pressure , HOMA-IR , and C-reactive protein ( CRP ) concentrations . Analysis of the two phases separately showed a decrease in FBG by 14 mg/dl and in HbA1c by 0.45 % in the treatment group ( A ) after 12 weeks , while no significant differences were seen in group B ( control group ) . In the second phase , FBG decreased from 151.36 ± 39.22 to 137.28 ± 28.65 mg/dl ( -14 mg/dl ) and HbA1c decreased from 7.42 ± 0.97 to 7.15 ± 0.68 mg/dl ( -0.28 % , p = 0.013 and p = 0.033 , respectively ) in the pistachio group ( B ) . Pistachio consumption reduced systolic blood pressure ( p = 0.007 ) , BMI ( p = 0.011 ) , and CRP ( p = 0.002 ) in patients from the treatment groups , but not insulin resistance . CONCLUSIONS Dietary consumption of pistachio nuts as a snack has beneficial effects on glycemic control , blood pressure , obesity , and inflammation markers in diabetic patients",
"Aims /hypothesisThis study compared the long-term weight loss and health outcomes at 1-year follow-up , after a 12-week intensive intervention consisting of two low-fat , weight-loss diets , which differed in protein content . Methods We r and omly assigned 66 obese patients ( BMI : 27–40 kg/m2 ) with Type 2 diabetes to either a low-protein ( 15 % protein , 55 % carbohydrate ) or high-protein diet ( 30 % protein , 40 % carbohydrate ) for 8 weeks of energy restriction ( ~6.7 MJ/day ) and 4 weeks of energy balance . Subjects were asked to maintain the same dietary pattern for a further 12 months of follow-up . Results The study was completed by 38 of the subjects , with equal dropouts in each group . At Week 64 , weight reductions against baseline were −2.2±1.1 kg ( low protein ) and −3.7±1.0 kg ( high protein ) , p diet effect . Fat mass was not different from baseline in either group . At Week 12 , both diets reduced systolic and diastolic blood pressure by 6 and 3 mm Hg respectively , but blood pressure increased more with weight regain during follow-up in the low-protein group ( p≤0.04 ) . At Week 64 , both diets significantly increased HDL cholesterol and lowered C-reactive protein concentrations . There was no difference in the urinary urea : creatinine ratio at baseline between the two groups , but this ratio increased at Week 12 ( in the high-protein group only , p high-protein weight-reduction diet may in the long term have a more favourable cardiovascular risk profile than a low-protein diet with similar weight reduction in people with Type 2 diabetes",
"OBJECTIVE Effective diabetic management requires reasonable weight control . Previous studies from our laboratory have shown the beneficial effects of a low-carbohydrate ketogenic diet ( LCKD ) in patients with type 2 diabetes after its long term administration . Furthermore , it favorably alters the cardiac risk factors even in hyperlipidemic obese subjects . These studies have indicated that , in addition to decreasing body weight and improving glycemia , LCKD can be effective in decreasing antidiabetic medication dosage . Similar to the LCKD , the conventional low-calorie , high nutritional value diet is also used for weight loss . The purpose of this study was to underst and the beneficial effects of LCKD compared with the low-calorie diet ( LCD ) in improving glycemia . METHODS Three hundred and sixty-three overweight and obese participants were recruited from the Al-Shaab Clinic for a 24-wk diet intervention trial ; 102 of them had type 2 diabetes . The participants were advised to choose LCD or LDKD , depending on their preference . Body weight , body mass index , changes in waist circumference , blood glucose level , changes in hemoglobin and glycosylated hemoglobin , total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , triglycerides , uric acid , urea and creatinine were determined before and at 4 , 8 , 12 , 16 , 20 , and 24 wk after the administration of the LCD or LCKD . The initial dose of some antidiabetic medications was decreased to half and some were discontinued at the beginning of the dietary program in the LCKD group . Dietary counseling and further medication adjustment were done on a biweekly basis . RESULTS The LCD and LCKD had beneficial effects on all the parameters examined . Interestingly , these changes were more significant in subjects who were on the LCKD as compared with those on the LCD . Changes in the level of creatinine were not statistically significant . CONCLUSION This study shows the beneficial effects of a ketogenic diet over the conventional LCD in obese diabetic subjects . The ketogenic diet appears to improve glycemic control . Therefore , diabetic patients on a ketogenic diet should be under strict medical supervision because the LCKD can significantly lower blood glucose levels",
"Background / Objectives : Although benefits have been attributed to the Mediterranean diet , its effect on glycaemic control has not been totally eluci date d. The aim of this work was to compare the effect of two Mediterranean diets versus a low-fat diet on several parameters and indices related to glycaemic control in type 2 diabetic subjects . Subjects/ Methods : A multicentric parallel trial was conducted on 191 participants ( 77 men and 114 women ) of the PREDIMED study in order to compare three dietary interventions : two Mediterranean diets supplemented with virgin olive oil ( n=67 ; body mass index ( BMI ) = 29.4±2.9 ) or mixed nuts ( n=74 ; BMI = 30.1±3.1 ) and a low-fat diet ( n=50 ; BMI = 29.8±2.8 ) . There were no drop-outs . Changes in body weight and waist circumference were determined . Insulin resistance was measured by HOMA-IR index , adiponectin/leptin and adiponectin/HOMA-R ratios after 1 year of follow-up . Results : Increased values of adiponectin/leptin ratio ( P=0.043 , P=0.001 and P for low-fat , olive oil and nut diets , respectively ) and adiponectin/HOMA-IR ratio ( P=0.061 , P=0.027 and P=0.069 for low-fat , olive oil and nut diets , respectively ) and decreased values of waist circumference ( P=0.003 , P=0.001 and P=0.001 for low-fat , olive oil and nut diets , respectively ) were observed in the three groups . In both Mediterranean diet groups , but not in the low-fat diet group , this was associated with a significant reduction in body weight ( P=0.347 , P=0.003 and P=0.021 for low-fat , olive oil and nut diets , respectively ) . Conclusions : Mediterranean diets supplemented with virgin olive oil or nuts reduced total body weight and improved glucose metabolism to the same extent as the usually recommended low-fat diet",
"OBJECTIVE To examine the effects of a high-carbohydrate low-fat ( HCLF ) and a modified-fat ( MF ) diet on body weight and metabolic control in subjects with non-insulin-dependent diabetes mellitus ( NIDDM ) living at home . RESEARCH DESIGN AND METHODS Twenty-four NIDDM patients followed HCLF and MF diets alternately and in r and om order for a 3-month period while at home , with a 1-month baseline and washout between diets . Before and after each diet , fasting glucose and lipids , HbAlc , blood pressure , and body weight were measured . Dietary preferences were assessed by question naire . RESULTS Subjects consumed 50 % of energy as carbohydrate and 23 % as fat on the HCLF diet and 40 % of energy as carbohydrate and 36 % as fat ( over half of which was monounsaturated fat ) on the MF diet . Subjects lost weight on both HCLF and MF diets ( mean loss 0.7 and 1.3 kg , respectively ) . Although the MF diet result ed in a small decrease in fasting glucose levels , there was no significant change in HbA1c . Similarly , there was no significant difference between the diets in changes in blood pressure or fasting blood lipids . Most subjects ( 65 % ) preferred the MF diet . CONCLUSIONS Although the MF diet is not a low-fat diet , it did not appear to facilitate weight gain in subjects with NIDDM living at home . The MF diet provides an alternative for individuals unable to comply with HCLF diets",
"Purpose . To determine whether a multicomponent nutrition intervention program at a corporate site reduces body weight and improves other cardiovascular risk factors in overweight individuals . Design . Prospect i ve clinical intervention study . Subjects/ Setting . Employees of the Government Employees Insurance Company ( GEICO ) ( N = 113 ) , aged 21 to 65 years , with a body mass index ≥ 25 kg/m2 and /or previous diagnosis of type 2 diabetes . Intervention . A 22-week intervention including a low-fat , vegan diet . Measures . Changes in body weight , anthropometric measures , blood pressure , lipid profile , and dietary intake . Analysis . Multivariate analyses of variance were calculated for clinical and nutrient measures , followed by univariate analyses of variance , to determine the significance of differences between groups in changes over time . Results . Intervention-group participants experienced greater weight changes compared with control-group participants ( mean , – 5.1 [ SE , .6 ] kg vs. + .1 [ SE , .6 ] kg , p greater changes in waist circumference ( mean , – 4.7 [ SE , .6 ] cm vs. + .8 [ SE , .6 ] cm , p ( mean , – .006 [ SE , .003 ] vs. + .014 [ SE , .005 ] , p = .0007 ) . Weight loss of 5 % of body weight was more frequently observed in the intervention group ( 48.5 % ) compared with the control group ( 11.1 % ) ( χ2[1 , N= 113 ] = 16.99 , p individuals volunteering for a 22-week worksite research study , an intervention using a low-fat , vegan diet effectively reduced body weight and waist circumference ",
"OBJECTIVE Diabetes mellitus requires lifelong treatment , most of which is accomplished in family and community setting s. The present study was design ed to identify the effectiveness of nutrition intervention provided by public dietitian on glycemic control in a community setting in China . METHODS Two communities were selected and r and omly assigned to a routine care group ( 59 subjects ) and a public dietitian-led intervention group ( 58 subjects ) who received diabetic nutrition management for one year . The main measures included fasting plasma glucose , HbA1c , weight , body mass index ( BMI ) , lipid profile , and blood pressure . RESULTS In the intervention group , there was significant improvement in fasting plasma glucose , HbA1c , cholesterol , and triglyceride levels relative to the control subjects ( p energy intake , including reductions in absolute amounts ( grams ) of protein and fat in the intervention group . The energy percent values of carbohydrate , protein , and fat were 50.7 % , 17.0 % , and 32.3 % , respectively , at baseline and 53.0 % , 17.1 % , and 29.9 % ( within the recommended range ) after the intervention . There were significant improvements in total energy , absolute amounts of fat and protein , and the energy percent values of carbohydrates and fat . In the control group , however , these values were similar before and after the intervention , and the energy percent values of fat were still above the recommended range . CONCLUSIONS In a community setting , a diabetes nutrition intervention led by a public dietitian significantly improved the glycemic control of type 2 diabetic patients",
"Aims /hypothesisShort-term dietary studies suggest that high-protein diets can enhance weight loss and improve glycaemic control in people with type 2 diabetes . However , the long-term effects of such diets are unknown . The aim of this study was to determine whether high-protein diets are superior to high-carbohydrate diets for improving glycaemic control in individuals with type 2 diabetes . Methods Overweight/obese individuals ( BMI 27–40 kg/m2 ) with type 2 diabetes ( HbA1c 6.5–10 % ) were recruited for a 12 month , parallel design , dietary intervention trial conducted at a diabetes specialist clinic ( Melbourne , VIC , Australia ) . Of the 108 initially r and omised , 99 received advice to follow low-fat ( 30 % total energy ) diets that were either high in protein ( 30 % total energy , n = 53 ) or high in carbohydrate ( 55 % total energy , n = 46 ) . Dietary assignment was done by a third party using computer-generated r and om numbers . The primary endpoint was change in HbA1c . Secondary endpoints included changes in weight , lipids , blood pressure , renal function and calcium loss . Study endpoints were assessed blinded to the diet group , but the statistical analysis was performed unblinded . This study used an intention-to-treat model for all participants who received dietary advice . Follow-up visits were encouraged regardless of dietary adherence and last measurements were carried forward for study non-completers . Results Ninety-nine individuals were included in the analysis ( 53 in high protein group , 46 in high carbohydrate group ) . HbA1c decreased in both groups over time , with no significant difference between groups ( mean difference of the change at 12 months ; 0.04 [ 95 % CI −0.37 , 0.46 ] ; p = 0.44 ) . Both groups also demonstrated decreases over time in weight , serum triacylglycerol and total cholesterol , and increases in HDL-cholesterol . No differences in blood pressure , renal function or calcium loss were seen . Conclusions /interpretationThese results suggest that there is no superior long-term metabolic benefit of a high-protein diet over a high-carbohydrate in the management of type 2 diabetes . Trial registration ACTRN12605000063617 ( www.anzctr.org.au ) . Funding This study was funded by a nutritional research grant from Meat and Livestock Australia ( MLA ) . J.E. Shaw is supported by NHMRC Fellowship 586623",
"Almond consumption is associated with ameliorations in obesity , hyperlipidemia , hypertension , and hyperglycemia . The hypothesis of this 12-week r and omized crossover clinical trial was that almond consumption would improve glycemic control and decrease the risk for cardiovascular disease in 20 Chinese patients with type 2 diabetes mellitus ( T2DM ) ( 9 male , 11 female ; 58 years old ; body mass index , 26 kg/m² ) with mild hyperlipidemia . After a 2-week run-in period , patients were assigned to either a control National Cholesterol Education Program step II diet ( control diet ) or an almond diet for 4 weeks , with a 2-week washout period between alternative diets . Almonds were added to the control diet to replace 20 % of total daily calorie intake . Addition of approximately 60 g almonds per day increased dietary intakes of fiber , magnesium , polyunsaturated fatty acid , monounsaturated fatty acid , and vitamin E. Body fat determined with bioelectrical impedance analysis was significantly lower in patients consuming almonds ( almonds vs control : 29.6 % vs 30.4 % ) . The almond diet enhanced plasma α-tocopherol level by a median 26.8 % ( 95 % confidence intervals , 15.1 - 36.6 ) compared with control diet . Furthermore , almond intake decreased total cholesterol , low-density lipoprotein cholesterol , and the ratio of low-density lipoprotein cholesterol to high-density lipoprotein cholesterol by 6.0 % ( 1.6 - 9.4 ) , 11.6 % ( 2.8 - 19.1 ) , and 9.7 % ( 0.3 - 20.9 ) , respectively . Plasma apolipoprotein ( apo ) B levels , apo B/apo A-1 ratio , and nonesterified fatty acid also decreased significantly by 15.6 % ( 5.1 - 25.4 ) , 17.4 % ( 2.8 - 19.9 ) , and 5.5 % ( 3.0 - 14.4 ) , respectively . Compared with subjects in the control diet , those in the almond diet had 4.1 % ( 0.9 - 12.5 ) , 0.8 % ( 0.4 - 6.3 ) , and 9.2 % ( 4.4 - 13.2 ) lower levels of fasting insulin , fasting glucose , and homeostasis model assessment of insulin resistance index , respectively . Our results suggested that incorporation of almonds into a healthy diet has beneficial effects on adiposity , glycemic control , and the lipid profile , thereby potentially decreasing the risk for cardiovascular disease in patients with type 2 diabetes mellitus",
"OBJECTIVE To study effects of variation in carbohydrate content of diet on glycemia and plasma lipoproteins in patients with non-insulin-dependent diabetes mellitus ( NIDDM ) . DESIGN A four-center r and omized crossover trial . SETTING Outpatient and inpatient evaluation in metabolic units . PATIENTS Forty-two NIDDM patients receiving glipizide therapy . INTERVENTIONS A high-carbohydrate diet containing 55 % of the total energy as carbohydrates and 30 % as fats was compared with a high-monounsaturated-fat diet containing 40 % carbohydrates and 45 % fats . The amounts of saturated fats , polyunsaturated fats , cholesterol , sucrose , and protein were similar . The study diets , prepared in metabolic kitchens , were provided as the sole nutrients to subjects for 6 weeks each . To assess longer-term effects , a subgroup of 21 patients continued the diet they received second for an additional 8 weeks . MAIN OUTCOME MEASURES Fasting plasma glucose , insulin , lipoproteins , and glycosylated hemoglobin concentrations . Twenty-four-hour profiles of glucose , insulin , and triglyceride levels . RESULTS The site of study as well as the diet order did not affect the results . Compared with the high-monounsaturated-fat diet , the high-carbohydrate diet increased fasting plasma triglyceride levels and very low-density lipoprotein cholesterol levels by 24 % ( P daylong plasma triglyceride , glucose , and insulin values by 10 % ( P = .03 ) , 12 % ( P Plasma total cholesterol , low-density lipoprotein cholesterol , and high-density lipoprotein cholesterol levels remained unchanged . The effects of both diets on plasma glucose , insulin , and triglyceride levels persisted for 14 weeks . CONCLUSIONS In NIDDM patients , high-carbohydrate diets compared with high-monounsaturated-fat diets caused persistent deterioration of glycemic control and accentuation of hyperinsulinemia , as well as increased plasma triglyceride and very-low-density lipoprotein cholesterol levels , which may not be desirable",
"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",
"Summary Type 2 ( insulin independent ) diabetic women were r and omly allocated to receive advice for low fat diets or low carbohydrate diets . By 24 h weighed dietary intakes before and after a mean interval of six months , patients in the low fat group had reduced their fat intake from 41 % to 31 % of total energy , while carbohydrate percentage of total energy intake increased from 38 % to 46 % . Percentage energy intake from fat and carbohydrate in the control group remained unchanged . Body weight fell in both groups , especially for patients in the low fat group who were obese ( weight/height2 ⩾ 28 kg/m2 ) . Mean plasma glucose , HbA1 , and triglycerides were unchanged . Mean plasma total cholesterol fell significantly in the low fat group compared with the controls ( p reduction of high density lipoprotein cholesterol observed in both groups . Thus , adherence to low fat diets occurred without deterioration of diabetes and with benefit for weight and total cholesterol ",
"OBJECTIVE The aim of this study was to examine the effect of a moderate-fat diet inclusive of walnuts on blood lipid profiles in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS This was a parallel r and omized controlled trial comparing three dietary advice groups each with 30 % energy as fat : low fat , modified low fat , and modified low fat inclusive of 30 g of walnuts per day . Fifty-eight men and women , mean age 59.3 + /- 8.1 years , started the trial . Dietary advice was given at baseline with monthly follow-up and fortnightly phone calls for support . Body weight , percent body fat , blood lipids , HbA1c , total antioxidant capacity , and erythrocyte fatty acid levels were measured at 0 , 3 , and 6 months . Data were assessed by repeated- measures ANOVA with an intention-to-treat model . RESULTS The walnut group achieved a significantly greater increase in HDL cholesterol-to-total cholesterol ratio ( P=0.049 ) and HDL ( P=0.046 ) than the two other treatment groups . A 10 % reduction in LDL cholesterol was also achieved in the walnut group , reflecting a significant effect by group ( P=0.032 ) and time ( P=0.036 ) . There were no significant differences between groups for changes in body weight , percent body fat , total antioxidant capacity , or HbA1c levels . The higher dietary polyunsaturated fat-to-saturated fat ratio and intakes of omega-3 fatty acids in the walnut group were confirmed by erythrocyte biomarkers of dietary intake . CONCLUSIONS Structured \" whole of diet \" advice that included 30 g of walnuts/day delivering substantial amounts of polyunsaturated fatty acid improved the lipid profile of patients with type 2 diabetes",
"OBJECTIVE To compare the effects of two calorie-restricted diets that differ in glycemic load ( GL ) on glucose tolerance and inflammation . RESEARCH METHODS AND PROCEDURES Thirty-four healthy overweight adults , ages 24 to 42 years , were r and omized to 30 % provided calorie-restricted diets with high ( HG ) or low ( LG ) glycemic load for 6 months . Outcomes were changes in glucose-insulin dynamics and C-reactive protein ( CRP ) levels . RESULTS Compared with baseline , levels of fasting insulin , homeostasis model assessment of insulin resistance , post-load insulin at 30 minutes , and incremental area-under-the-curve-insulin during the oral glucose tolerance test were significantly lower in both groups at 6 months ( p range , 0.01 to 0.05 ) , but after adjustment for baseline values and weight change , there were no differences between the two groups with regard to changes over time in any parameter . The mean percentage change in insulin sensitivity by a frequently sample d intravenous glucose tolerance test was + 26 % in the HG group and + 24 % in the LG group ( p = 0.83 ) ; first-phase acute insulin release was -20 % in the HG group and -21 % in the LG group ( p = 0.77 ) . More participants on the LG diet ( 14 of 16 subjects ) had a decline in serum CRP , compared with those on the HG diet ( 7 of 16 subjects ) ( p healthy overweight adults provided with food for 6 months , the dietary GL did not seem to influence chronic adaptations in glucose-insulin dynamics above that associated with weight loss . This finding highlights the importance of absolute weight loss over the dietary macronutrient composition used to achieve weight loss . The finding of greater declines in CRP concentration after consumption of a low-GL diet warrants further investigation",
"1 . A prospect i ve r and omized study of two dietary regimens has been started in newly-diagnosed diabetics to determine their effect on circulating metabolites and on diabetic complications . 2 . During the first year of treatment the fasting plasma glucose concentrations on both the low-carbohydrate diet and the high-carbohydrate , modified-fat ( MF ) diet showed a similar decrease . 3 . Plasma cholesterol showed a sustained decrease only in patients recommended a MF diet . Transient changes in plasma triglyceride concentrations occurred in patients on both dietary regimens . 4 . Increased plasma cholesterol levels are associated with atheromatous disease which is common in diabetics in Europe and North America . A MF diet may therefore have an advantage in that it lowers the plasma cholesterol as well as being effective in lowering the plasma glucose",
"PURPOSE To evaluate a year-long behavioral weight control program , used with and without an intermittent very-low-calorie diet ( VLCD ) in the treatment of type II diabetes mellitus . PATIENTS AND METHODS Subjects ( n = 93 ) were r and omly assigned to 50-week treatment programs that used either a balanced low-calorie diet ( LCD ) of 1,000 to 1,000 kilocalories ( kcal ) per day throughout or included 2 12-week periods of a VLCD of 400 to 500 kcal per day alternating with the balanced LCD . Weight , glycemic control , blood pressure , and lipids were assessed at baseline , at the end of the year-long treatment , and at 2-year follow-up . RESULTS Subjects in the VLCD program lost significantly more weight than did LCD subjects at the end of the 50-week program ( 14.2 kg versus 10.5 kg ; P = 0.057 ) and remained off diabetes medication longer ( P VLCD were due primarily to the first 12 weeks of the diet ; the second diet maintained , but did not increase , these effects . Subjects in both groups experienced marked improvements in glycemic control and cardiovascular risk factors over the year-long program , but attendance declined in the latter weeks of treatment and weight was regained . There was also marked recidivism in both groups in the year following treatment . CONCLUSIONS The intermittent VLCD improved weight loss and glycemic control , but these effects were quite modest and do not appear to justify the clinical use of an intermittent VLCD . Moreover , lengthening treatment to a full year did not prevent relapse . Thus , further research is needed to develop a successful approach to long-term weight control",
"BACKGROUND Previously published research that examined the effects of high egg consumption in people with type 2 diabetes ( T2D ) produced conflicting results leading to recommendations to limit egg intake . However , people with T2D may benefit from egg consumption because eggs are a nutritious and convenient way of improving protein and micronutrient contents of the diet , which have importance for satiety and weight management . OBJECTIVE In this r and omized controlled study , we aim ed to determine whether a high-egg diet ( 2 eggs/d for 6 d/wk ) compared with a low-egg diet ( circulating lipid profiles , in particular high-density lipoprotein ( HDL ) cholesterol , in overweight or obese people with prediabetes or T2D . DESIGN A total of 140 participants were r and omly assigned to one of the 2 diets as part of a 3-mo weight maintenance study . Participants attended the clinic monthly and were instructed on the specific types of foods and quantities to be consumed . RESULTS There was no significant difference in the change in HDL cholesterol from screening to 3 mo between groups ; the mean difference ( 95 % CI ) between high- and low-egg groups was + 0.02 mmol/L ( -0.03 , 0.08 mmol/L ; P = 0.38 ) . No between-group differences were shown for total cholesterol , low-density lipoprotein cholesterol , triglycerides , or glycemic control . Both groups were matched for protein intake , but the high-egg group reported less hunger and greater satiety postbreakfast . Polyunsaturated fatty acid ( PUFA ) and monounsaturated fatty acid ( MUFA ) intakes significantly increased from baseline in both groups . CONCLUSIONS High egg consumption did not have an adverse effect on the lipid profile of people with T2D in the context of increased MUFA and PUFA consumption . This study suggests that a high-egg diet can be included safely as part of the dietary management of T2D , and it may provide greater satiety . This trial was registered at the Australia New Zeal and Clinical Trials Registry ( http://www.anzctr.org.au/ ) as ACTRN12612001266853",
"OBJECTIVE To investigate whether glycemic and lipid control in patients with non-insulin-dependent diabetes ( NIDDM ) can be significantly improved using a low-fat , vegetarian ( vegan ) diet in the absence of recommendations regarding exercise or other lifestyle changes . METHODS Eleven subjects with NIDDM recruited from the Georgetown University Medical Center or the local community were r and omly assigned to a low-fat vegan diet ( seven subjects ) or a conventional low-fat diet ( four subjects ) . Two additional subjects assigned to the control group failed to complete the study . The diets were not design ed to be isocaloric . Fasting serum glucose , body weight , medication use , and blood pressure were assessed at baseline and biweekly thereafter for 12 weeks . Serum lipids , glycosylated hemoglobin , urinary albumin , and dietary macronutrients were assessed at baseline and 12 weeks . RESULTS Although the sample was intentionally small in accordance with the pilot study design , the 28 % mean reduction in fasting serum glucose of the experimental group , from 10.7 to 7.75 mmol/L ( 195 to 141 mg/dl ) , was significantly greater than the 12 % decrease , from 9.86 to 8.64 mmol/L ( 179 to 157 mg/dl ) , for the control group ( P mean weight loss was 7.2 kg in the experimental group , compared to 3 . 8 kg for the control group ( P Insulin was reduced in both experimental group patients on insulin . No patient in the control group reduced medication use . Differences between the diet groups in the reductions of serum cholesterol and 24-h microalbuminuria did not reach statistical significance ; however , high-density lipoprotein concentration fell more sharply ( 0.20 mmol/L ) in the experimental group than in the control group ( 0.02 mmol/L ) ( P low-fat , vegetarian diet in patients with NIDDM was associated with significant reductions in fasting serum glucose concentration and body weight in the absence of recommendations for exercise . A larger study is needed for confirmation",
"OBJECTIVE To determine the optimal diet for improving glucose and lipid profiles in obese patients with type 2 diabetes during moderate energy restriction . RESEARCH DESIGN AND METHODS A total of 35 free-living obese patients with type 2 diabetes were assigned to one of three 1,600 kcal/day diets for 12 weeks . The diets were high carbohydrate ( 10 % fat , 4 % saturated ) , high monounsaturated fat ( MUFA ) ( 32 % fat , 7 % saturated ) , or high saturated fat ( SFA ) ( 32 % fat , 17 % saturated ) . RESULTS Diet composition did not affect the magnitude of weight loss , with subjects losing an average of 6.6 + /- 0.9 kg . Energy restriction and weight loss result ed in reductions in fasting plasma glucose ( -14 % ) , insulin ( -27 % ) , GHb ( -14 % ) , and systolic ( -7 % ) and diastolic blood pressure ( -10 % ) levels and the glucose response area ( -17 % ) independent of diet composition . Diet composition did affect the lipoprotein profile . LDL was 10 % and 17 % lower with the high-carbohydrate and high-MUFA diets , respectively , whereas no change was observed with the high-SFA diet ( P HDL was transiently reduced on the high-carbohydrate diet at weeks 1 , 4 , and 8 , whereas higher fat consumption maintained these levels . The total cholesterol : HDL ratio , although significantly reduced on the high-MUFA diet ( P glycemic control ; however , reducing SFA intake by replacing SFA with carbohydrate or MUFA reduces LDL maximally during weight loss and to a greater degree than has been shown in weight-stable studies",
"Abstract Purpose The aim of the present study was to examine the effects of consumption of desserts with low glycemic index ( GI ) and low glycemic load ( GL ) , as part of a balanced hypo-caloric diet , on anthropometric and biochemical parameters in patients with type 2 diabetes mellitus ( T2DM ) . Methods A total of 61 subjects with T2DM were r and omly assigned to the intervention ( n = 30 ) or to the control group ( n = 31 ) . Both groups followed the same hypo-caloric ( −500 kcal ) diet for 12 weeks . Consumption of four portions of low-GI/low-GL desserts/week was included in the diet in the intervention group while one portion of a favorite usual sweet/week was allowed to be consumed in the control group . Results Thirty subjects in the control and 28 subjects in the intervention group completed the trial . Body weight , body mass index , and waist circumference were reduced significantly in both groups . Arterial blood pressure , fasting blood glucose , glycosylated hemoglobin , insulin , and γ-GT were reduced significantly only in the intervention group ; however , there were no significant differences between the two groups at endpoint . C-reactive protein was reduced in the intervention , and HDL cholesterol was also reduced in the control group ; the reductions were significantly different at the end of the trial . No significant changes were observed in the other plasma lipids , uric acid , leptin , adiponectin , and interleukin-6 in either study group . Conclusions Consumption of desserts with low GI/GL in a balanced hypo-caloric diet has a positive impact on anthropometric and metabolic parameters of patients with T2DM",
"OBJECTIVE This study sought to examine the effects of a 3-month programme of dietary advice to restrict carbohydrate intake compared with reduced-portion , low-fat advice in obese subjects with poorly controlled Type 2 diabetes . RESEARCH DESIGN AND METHODS One hundred and two patients with Type 2 diabetes were recruited across three centres and r and omly allocated to receive group education and individual dietary advice . Weight , glycaemic control , lipids and blood pressure were assessed at baseline and 3 months . Dietary quality was assessed at the end of study . RESULTS Weight loss was greater in the low-carbohydrate ( LC ) group ( -3.55 + /- 0.63 , mean + /- sem ) vs. -0.92 + /- 0.40 kg , P = 0.001 ) and cholesterol : high-density lipoprotein ( HDL ) ratio improved ( -0.48 + /- 0.11 vs. -0.10 + /- 0.10 , P = 0.01 ) . However , relative saturated fat intake was greater ( 13.9 + /- 0.71 vs. 11.0 + /- 0.47 % of dietary intake , P short-term weight loss compared with st and ard advice , but this was at the expense of an increase in relative saturated fat intake",
"Approximately 80 % of patients with type 2 diabetes are overweight/obese ( 1 ) , and weight loss is the mainstay of treatment for these individuals . However , there is growing controversy as to whether reduced-fat or reduced-carbohydrate diets are best suited for this purpose , and results ( 2–8 ) in nondiabetic subjects suggest that lower carbohydrate diets are similarly or more efficacious in improving weight , triglycerides , and HDL cholesterol . There are no published r and omized studies evaluating the role of dietary macronutrients with respect to weight loss and cardiovascular risk improvement in patients with type 2 diabetes . Thus , we r and omized diet-treated patients with type 2 diabetes to hypocaloric diets , moderately restricted in either carbohydrate or fat , to determine whether weight loss or metabolic improvement differed as a function of macronutrient composition . A total of 29 patients with diet-treated type 2 diabetes were recruited from the San Francisco Bay area . All subjects gave written informed consent . Inclusion criteria included BMI 27–36 kg/m2 , fasting plasma glucose concentration 7.2–8.3 mmol/l , no use of antihyperglycemic medications , and stable weight for 3 months . Subjects on anti-hypertensive or cholesterol-lowering drugs or aspirin were allowed to continue their medications . Insulin-mediated glucose uptake was quantified by a modification ( 9 ) of the insulin suppression test as originally described ( 10 ) and vali date d ( 11 ) . In this test , a 180-min infusion of somatostatin ( 0.27 μg/m2 per min ) , insulin ( 25 mU/m2 per min ) ,",
"Nineteen obese patients with Type 2 diabetes mellitus were treated for periods of 3 months with placebo , guar gum ( 5 g three times daily ) and metformin ( 500 mg three times daily ) in a r and omized double-blind , double-placebo , cross-over study . Both active agents decreased fasting blood glucose from 11.4 + /- 3.7 mmol l-1 ( mean + /- SD ) to 8.6 + /- 2.8 mmol l-1 on metformin ( p less than 0.001 ) and to 9.5 + /- 3.9 mmol l-1 on guar gum ( p less than 0.01 ) . Metformin significantly reduced the very low density lipoprotein ( VLDL ) cholesterol concentration from 0.62 ( + 0.73 , -0.34 ) mmol l-1 ( geometric mean ( + SD , -SD ) ) to 0.43 ( + 0.58 , -0.25 ) mmol l-1 , ( p less than 0.02 ) , but unless hyperlipidaemia was present there were no changes in other serum lipid or lipoprotein levels . In patients with serum cholesterol greater than 6.5 mmol l-1 decreases in serum triglycerides from 3.29 ( + 3.27 , -1.64 ) to 2.46 ( + 2.55 , -1.25 ) mmol l-1 ( p less than 0.02 ) occurred with metformin . In these patients guar gum produced a reduction in serum cholesterol ( from 7.70 + /- 0.90 to 6.41 + /- 1.11 mmol l-1 , p less than 0.01 ) due to an effect on low density lipoproteins . These differential effects may be important in planning therapy when hyperlipidaemia accompanies Type 2 diabetes",
"High-density lipoprotein ( HDL ) plays an important role in the process of reverse cholesterol transport , which may become suboptimal with increasing body fatness . HDL cholesterol that is reduced in obese subjects paradoxically decreases during weight reduction . To determine how weight reduction affects HDL subclasses that are involved in reverse cholesterol transport , we studied HDL from obese diabetic subjects before and after energy restriction within background diets high in either carbohydrate or monounsaturated fatty acids ( MUFAs ) . Body weight , blood glucose , total cholesterol , and LDL cholesterol decreased after 8 and 12 weeks of weight reduction . With the very-low-fat diet , HDL cholesterol decreased significantly at 8 weeks , but recovered to initial levels after 12 weeks as body weight began to stabilize . Plasma apolipoprotein A-I ( apo A-I ) decreased substantially and significantly at 8 and 12 weeks with both diets , and was reflected in the reduction of apo A-I in HDL subclasses alpha1 , alpha2 , pre-beta1 , and pre-beta2 + pre-beta3 . The calculation of the percentage distribution of apo A-I among HDL species showed that only the proportion of pre-beta1-HDL decreased , whereas alpha2-HDL increased . This led to a significant increase in the alpha1 + alpha2/pre-beta ratio , ie , the ratio of the large cholesterol \" storage \" or \" sink \" HDL to the HDL \" shuttle \" fraction considered to be the initial acceptor of cell cholesterol . These data suggest that despite the reduction in HDL cholesterol and apo A-I , the redistribution of apo A-I in pre-beta1-HDL and alpha-HDL observed with weight reduction appears to revert to the pattern that we have previously reported in lean as opposed to overweight subjects",
"Objective To determine the extent to which intensive dietary intervention can influence glycaemic control and risk factors for cardiovascular disease in patients with type 2 diabetes who are hyperglycaemic despite optimised drug treatment . Design R and omised controlled trial . Setting Dunedin , New Zeal and . Participants 93 participants aged less than 70 years with type 2 diabetes and a glycated haemoglobin ( HbA1c ) of more than 7 % despite optimised drug treatments plus at least two of overweight or obesity , hypertension , and dyslipidaemia . Intervention Intensive individualised dietary advice ( according to the nutritional recommendations of the European Association for the Study of Diabetes ) for six months ; both the intervention and control participants continued with their usual medical surveillance . Main outcome measures HbA1c was the primary outcome . Secondary outcomes included measures of adiposity , blood pressure , and lipid profile . Results After adjustment for age , sex , and baseline measurements , the difference in HbA1c between the intervention and control groups at six months ( −0.4 % , 95 % confidence interval −0.7 % to −0.1 % ) was highly statistically significant ( P=0.007 ) , as were the decreases in weight ( −1.3 kg , −2.4 to −0.1 kg ; P=0.032 ) , body mass index ( −0.5 , −0.9 to −0.1 ; P=0.026 ) , and waist circumference ( −1.6 cm , −2.7 to −0.5 cm ; P=0.005 ) . A decrease in saturated fat ( −1.9 % total energy , −3.3 % to −0.6 % ; P=0.006 ) and an increase in protein ( 1.6 % total energy , 0.04 % to 3.1 % ; P=0.045 ) in the intervention group were the most striking differences in nutritional intake between the two groups . Conclusions Intensive dietary advice has the potential to appreciably improve glycaemic control and anthropometric measures in patients with type 2 diabetes and unsatisfactory HbA1c despite optimised hypoglycaemic drug treatment . Trial registration Clinical trials NCT00124553",
"We analysed participants with type 2 diabetes ( n = 46 ) within a larger weight loss trial ( n = 146 ) who were r and omized to 48 weeks of a low-carbohydrate diet ( LCD ; n = 22 ) or a low-fat diet + orlistat ( LFD + O ; n = 24 ) . At baseline , mean body mass index ( BMI ) was 39.5 kg/m(2 ) ( s.d . 6.5 ) and haemoglobin A1c ( HbA1c ) 7.6 % ( s.d . 1.3 ) . Although the interventions reduced BMI similarly ( LCD -2.4 kg/m(2 ) ; LFD + O -2.7 kg/m(2 ) , p = 0.7 ) , LCD led to a relative improvement in HbA1c : -0.7 % in LCD versus + 0.2 % in LFD + O [ difference -0.8 % , 95 % confidence interval ( CI ) = -1.6 , -0.02 ; p = 0.045 ] . LCD also led to a greater reduction in antiglycaemic medications using a novel medication effect score ( MES ) based on medication potency and total daily dose ; 70.6 % of LCD versus 30.4 % LFD + O decreased their MES by ≥50 % ( p = 0.01 ) . Lowering dietary carbohydrate intake demonstrated benefits on glycaemic control beyond its weight loss effects , while at the same time lowering antiglycaemic medication requirements ",
"Objective : To determine whether glycemic index ( GI ) differentially affects improved glucose and lipid profiles observed during weight loss in overweight subjects previously diagnosed with type 2 diabetes with variable glucose tolerance . Methods : Twenty-three female and twenty-two male overweight subjects participated in 12 weeks of energy restriction ( average BMI 33.2 kg/m2 , age 56.7 years , glycated hemoglobin ( GHb ) 6.7 % ) . After a four-week run-in on a high saturated fat ( SFA ) diet ( 1540 kcal/day , 17 % SFA ) , the free-living subjects were r and omly assigned to either a high- ( 75 GI units ) or low- ( 43 GI units ) GI diet ( 1440 kcal/day , 60 % carbohydrate , 5 % SFA ) for eight weeks . Weight , serum lipids , plasma glucose and glycated hemoglobin were measured every four weeks . An oral glucose tolerance test ( OGTT ) was also performed at baseline , weeks 4 and 12 . From the baseline OGTT results subjects were divided into three groups of low , median and high glucose tolerance . Results : At baseline , BMI , age and glycated hemoglobin concentrations were not different between subjects allocated to the high- or low-GI diets . After four weeks , weight loss was 3.6 ± 0.3 kg . Fasting glucose ( −5.6 % ) , glycated hemoglobin ( −2.8 % ) , area under the glucose curve ( −13.0 % ) and triglyceride ( −13.8 % ) concentrations were reduced ( p reductions were observed in weight ( −4.9 % ) , fasting glucose ( −4.6 % ) , area under glucose curve ( −10.1 % ) , glycated hemoglobin ( −7.2 % ) , triglyceride ( −7.5 % ) and LDL-C ( −13.2 % ) concentrations . Weight loss was not different between low and high-GI diets . However , glycated hemoglobin was reduced twofold more in subjects consuming a low-GI diet as compared to subjects consuming a high-GI diet , but this was not statistically significant . LDL concentrations were also reduced more in subjects with low glucose tolerance on the low-GI diet ( p = 0.02 ) . Conclusion : Weight loss produces substantial improvements in glycemic control and lipoprotein metabolism . Lowering the glycemic index of high carbohydrate , low fat diets increases the fall in LDL cholesterol in subjects with type 2 diabetes with low glucose tolerance , but has little effect on glycemic control",
"The purpose of this study was to investigate whether a weight reduction programme based on a lactovegetarian diet has any beneficial effects on the weight , nutrient intake , blood pressure and skinfold thickness of overweight subjects compared with a programme based on a balanced mixed diet . The subjects consisted of three groups of moderately overweight persons , with a mean age of 38 years and a mean overweight of 38 per cent . Two groups had a weight reduction programme for 1 year ; group 1 ( n = 31 ) had a 1200 kcal lactovegetarian diet and group 2 ( n = 37 ) had an isocaloric mixed diet . Group 3 ( n = 42 ) served as a control group which had no intervention . During the 1-year study period , group 1 lost 9.2 kg in weight , group 2 lost 10.4 kg and group 3 gained 1.6 kg in weight . Weight loss in both weight reduction groups was accompanied by a reduction in blood pressure , skinfold thickness and arm circumference . The results were slightly more favourable in the mixed diet group than in the lactovegetarian group . In the lactovegetarian group 7 persons were not able to follow the lactovegetarian diet throughout the whole year but ate some meat , fish and eggs during the latter part of the study year . The intake of fibre , vitamin C and calcium was greater and the intake of fat lower in the lactovegetarian than in the mixed diet group during the 1-year weight reduction period . The intake of most nutrients was above the recommended level in both weight reduction groups . The intake was somewhat below recommendations for niacin in the lactovegetarian group , for calcium in the mixed diet group and for iron for women in both groups . It seems desirable to recommend a low-calorie nutritionally well-balanced mixed diet , based on familiar foods and rich in vegetables , instead of a lactovegetarian diet , for long-term weight reduction of overweight persons . In the long term some nutrients may need to be supplemented in both diets",
"Context Several studies suggest that blood glucose levels are associated with cardiovascular disease , even at blood glucose values that do not meet diagnostic criteria for diabetes . Contribution Among adult residents of Norfolk , United Kingdom , there was a continuous relationship between hemoglobin A1c levels and cardiovascular disease and total mortality . This relationship was apparent even among persons without diabetes . Implication s These observations justify the need for studies that address whether improvements in glycemic control might improve health outcomes in persons who do not have diabetes . The Editors Diabetes mellitus is of major and increasing global public health importance ( 1 ) . Persons with diabetes are at increased risk for premature disability and death associated with vascular , renal , retinal , and neuropathic complications . Raised fasting and postchallenge blood glucose levels in an oral glucose tolerance test are used to diagnose diabetes . The diagnostic threshold is based on the shape of the risk curve between glucose levels and specific microvascular complications of diabetes ( 2 - 6 ) . Diabetes also increases the risk for macrovascular diseases , such as coronary heart disease and stroke ( 7 ) . In contrast to microvascular disease , increasing evidence suggests that the relationship between blood glucose level and macrovascular disease is continuous and does not have an obvious threshold ( 2 , 8 , 9 ) . Hemoglobin A1c concentration is an indicator of average blood glucose concentrations over the preceding 3 months ; it is useful for characterizing dysglycemia in population studies because it is simpler to perform than the oral glucose tolerance test ( 10 ) . In a 3-year follow-up of men in a prospect i ve study , we previously reported that hemoglobin A1c concentrations were related to cardiovascular disease and all-cause mortality ( 11 ) . However , we had insufficient power to examine risk relationships at concentrations close to the diagnostic threshold of 7 % or to examine the relationship in women . We report the relation between hemoglobin A1c concentrations and fatal and nonfatal coronary heart disease , cardiovascular disease events , and all-cause mortality in men and women after an average of 6 years of follow-up . Methods The European Prospect i ve Investigation into Cancer in Norfolk ( EPICNorfolk ) is a prospect i ve population study of 25 623 men and women who were between 40 and 79 years of age and who resided in Norfolk , United Kingdom . Participants were recruited from general practice registers . Information on the recruitment process is available elsewhere ( 12 ) . Between 1993 and 1997 , participants completed a health and lifestyle question naire . Participants were asked whether a doctor had ever told them that they have any of the conditions contained in a list that included diabetes , heart attack , and stroke . People with known diabetes were defined as those who responded yes to the diabetes option of this question . Smoking history was derived from responses ( yes or no ) to the questions : Have you ever smoked as much as 1 cigarette a day for as long as a year ? and Do you smoke cigarettes now ? At a clinic , trained nurses performed a health examination for each participant . Body mass index was estimated as weight (kg)/height ( m2 ) , and waist-to-hip ratio was determined by measurements of the circumference of the waist and hips . Blood pressure was measured by using an Accutorr ( Data scope , Mahwah , New Jersey ) noninvasive blood pressure monitor after the participant had been seated for 5 minutes . The mean of 2 readings was used for analysis . Nonfasting blood sample s were taken ; sample s for assay were stored in a refrigerator at 4 C until transport within 1 week of sampling to the Department of Clinical Biochemistry , University of Cambridge . Starting in 1995 , hemoglobin A1c was measured on fresh EDTA blood sample s by using high-performance liquid chromatography ( BioRad Diamat Automated Glycosylated Haemoglobin Analyser , Hemel Hempstead , United Kingdom ) . We report results for follow-up to January 2003 , an average of about 6 years . All participants were flagged for death certification at the Office of National Statistics ; vital status was obtained for the entire cohort . Trained nosologists coded death certificates according to the International Classification of Diseases , Ninth or Tenth Revisions ( ICD-9 or ICD-10 ) . Cardiovascular death ( stroke , coronary heart disease , and other vascular causes ) was defined as those whose underlying cause of death was coded as ICD-9 400448 or ICD-10 I10I79 . Death from coronary heart disease was defined as those whose cause of death was coded as ICD-9 410414 or ICD-10 I22I25 . Participants admitted to a hospital were identified by their National Health Service number . Hospitals were linked to the East Norfolk Health Authority data base , which identifies all hospital contacts throughout Engl and and Wales for Norfolk residents . We used the same ICD diagnostic codes described in the preceding paragraphs to ascertain hospital episodes of cardiovascular disease and coronary heart disease in our cohort . Participants were identified as having a coronary heart disease event during follow-up if they had a hospital admission or died with coronary heart disease as the cause of death . Of the coronary heart disease events identified , 21 % ( 112 of 529 ) were fatal ; of the cardiovascular disease events , 23 % ( 197 of 806 ) were fatal . In men , 24 % ( 76 of 321 ) of deaths were attributed to heart disease and 29 % ( 117 of 321 ) were attributed to cardiovascular disease . In women , 18 % ( 36 of 200 ) of deaths were attributed to heart disease and 35 % ( 70 of 200 ) were attributed to cardiovascular causes . The Norwich Ethics Committee approved the study , and participants gave signed informed consent . Statistical Analysis These analyses , undertaken by using SPSS software , version 10.0 ( SPSS , Inc. , Chicago , Illinois ) , included 10 232 men and women age 45 to 79 years who completed the health and lifestyle question naire and had available hemoglobin A1c measurements . We divided the cohort into 7 categories on the basis of baseline data : known diabetes , high likelihood of previously undiagnosed diabetes ( no personal history of diabetes but a hemoglobin A1c concentration 7 % ) , and hemoglobin A1c concentrations in 0.5percentage point intervals ( risk factor distributions and then coronary heart disease , cardiovascular disease , and all-cause mortality rates by hemoglobin A1c and diabetes category . Age-adjusted odds ratios were calculated by using logistic regression models . We used a Cox proportional hazards model to determine the independent contribution of hemoglobin A1c to total mortality and cardiovascular and coronary heart disease after adjustment for age , body mass index , waist-to-hip ratio , systolic blood pressure , blood cholesterol concentrations , cigarette smoking , and history of heart attack or stroke . Participants with missing baseline data for 1 or more risk factors ( 130 men and 186 women ) were excluded from the multivariate analyses . Role of the Funding Sources The funding sources had no role in the design , conduct , and reporting of the study or in the decision to su bmi t the manuscript for publication . Results Table 1 presents characteristics of the participants according to hemoglobin A1c concentration and self-reported diabetes . Those with known diabetes had higher mean ( SD ) hemoglobin A1c concentrations ( 8.0 % 1.9 % ) than the rest of the study sample ( 5.3 % 0.7 % ) . They were older and had a higher body mass index , waist-to-hip ratio , and systolic blood pressure ; they were also more likely to report having had a previous heart attack or stroke . Participants with probable but previously undiagnosed diabetes ( hemoglobin A1c 7 % ) shared these characteristics . Mean risk factor levels rose with increasing concentration of hemoglobin A1c less than 7 % . Table 1 . Distribution of Variables by Hemoglobin A1c Concentration and Known Diabetes in 4662 Men and 5570 Women Age 45 to 79 Years ( European Prospect i ve Investigation into Cancer in Norfolk , 1995 to 1997 ) Table 2 shows adjusted odds ratios for hemoglobin A1c concentrations , diabetes status , and outcomes . Persons with known or undiagnosed diabetes had a greater risk for all-cause mortality and cardiovascular or coronary heart disease than those without diabetes . Risk for coronary heart or cardiovascular disease and total mortality increased throughout the whole range of hemoglobin A1c concentrations ; those with hemoglobin A1c concentrations less than 5 % had the lowest rates . For men , a gradient of increasing rates through the distribution was apparent for all end points . For women , odds ratios for cardiovascular or coronary heart disease did not increase significantly until the hemoglobin A1c concentration reached 6 % ; odds ratios were very high in women with concentrations greater than 7 % . Table 2 . Rates and Age-Adjusted Relative Risks for Total Coronary Heart Disease Events , Cardiovascular Disease Events , and All-cause Mortality by Category of Hemoglobin A1c Concentration and Known Diabetes in 4462 Men and 5570 Women Age 45 to 79 Years ( European Prospect i ve Investigation into Cancer in Norfolk , 1995 to 2003 ) Table 3 shows outcomes after adjustment for age alone and then after adjustment for age and other risk factors . In men , known diabetes predicted coronary heart and cardiovascular disease events and total mortality with approximate 2-fold relative risks . These relative risks were only slightly attenuated after adjustment for known risk factors . In women , known diabetes status predicted an approximate 5-fold increase in risk for coronary heart and 3-fold increase in risk for cardiovascular disease events ; these increases were attenuated after adjustment for known risk factors to 3-fold and 2-fold risk , respectively . In men and women , hemoglobin A1c concentrations predicted an increased risk for",
"Cohort studies are equivocal regarding a relationship between regular nut consumption and reduced risk of type 2 diabetes mellitus . Although acute trials show reductions in postpr and ial glycemia in healthy individuals ingesting 60 to 90 g almonds , trials have not been conducted using a single serving of almonds ( 28 g ) in individuals with type 2 diabetes mellitus . This r and omized crossover trial examined the impact of one serving of almonds at mealtime on postpr and ial glycemia , insulinemia , and plasma glucagon-like peptide-1 in healthy individuals and individuals with type 2 diabetes mellitus . On 2 occasions separated by at least 1 week , 19 adults ( including 7 adults with type 2 diabetes mellitus ) consumed a st and ardized evening meal and fasted overnight before ingesting the test meal ( bagel , juice , and butter ) with or without almonds . A small pilot study ( 6 - 7 subjects per group ) was also conducted to observe whether chronic almond ingestion ( 1 serving 5 d/wk for 12 weeks ) lowered hemoglobin A(1c ) in individuals with type 2 diabetes mellitus . A st and ard serving of almonds reduced postpr and ial glycemia significantly in participants with diabetes ( -30 % , P = .043 ) but did not influence glycemia in participants without diabetes ( -7 % , P = .638 ) . Insulinemia and glucagon-like peptide-1 at 30 minutes postmeal were not impacted by almond ingestion for either group . In the pilot study , regular almond ingestion for 12 weeks reduced hemoglobin A(1c ) by 4 % ( P = .045 for interaction ) but did not influence fasting glucose concentrations . These data show that modest almond consumption favorably improves both short-term and long-term markers of glucose control in individuals with uncomplicated type 2 diabetes mellitus",
"Low-carbohydrate diets have been associated with significant reductions in weight and HbA(1c ) in obese , diabetic participants who received high-intensity lifestyle modification for 6 or 12 months . This investigation sought to determine whether comparable results to those of short-term , intensive interventions could be achieved over a 24-month study period using a low-intensity intervention that approximates what is feasible in outpatient practice . A total of 144 obese , diabetic participants were r and omly assigned to a low-carbohydrate diet ( a low fat diet ( . Participants were provided weekly group nutrition education sessions for the first month , and monthly sessions thereafter through the end of 24 months . Weight , HbA(1c ) , glucose , and lipids were measured at baseline and 6 , 12 , and 24 months . Of the 144 enrolled participants , 68 returned for the month 24 assessment visit . Weights were retrieved from electronic medical records for an additional 57 participants ( total , 125 participants ) at month 24 . All participants with a baseline measurement and at least one of the three other measurements were included in the mixed-model analyses ( n = 138 ) . The low-intensity intervention result ed in modest weight loss in both groups at month 24 . At this time , participants in the low-carbohydrate group lost 1.5 kg , compared to 0.2 kg in the low-fat group ( P = 0.147 ) . Lipids , glycemic indexes , and dietary intake did not differ between groups at month 24 ( or at months 6 or 12 ) ( Clinical Trials.gov number , NCT00108459 )",
"BACKGROUND Low-carbohydrate diets are effective for weight reduction in people without diabetes , but there is limited evidence for people with Type 2 diabetes . Aims To assess the impact of a low-carbohydrate diet on body weight , glycated haemoglobin ( HbA(1c ) ) , ketone and lipid levels in diabetic and non-diabetic subjects . METHODS Thirteen Type 2 diabetic subjects ( on diet or metformin ) and 13 non-diabetic subjects were r and omly allocated to either a low-carbohydrate diet ( or = 40 g carbohydrate/day ) or a healthy-eating diet following Diabetes UK nutritional recommendations and were seen monthly for 3 months . Subjects ( 25 % male ) were ( mean + /- sd ) age 52 + /- 9 years , weight 96.3 + /- 16.6 kg , body mass index 35.1 kg/m(2 ) , HbA(1c ) 6.6 + /- 1.1 % , total cholesterol 5.1 + /- 1.1 mmol/l , high-density lipoprotein cholesterol 1.3 + /- 0.4 mmol/l , low-density lipoprotein cholesterol 3.1 + /- 0.9 mmol/l , triglycerides ( geometric mean ) 1.55 ( 1.10 , 2.35 ) mmol/l and ketones range 0.0 - 0.2 mmol/l . RESULTS Analysis was by intention to treat with last observation carried forward . Twenty-two of the participants ( 85 % ) completed the study . Weight loss was greater ( 6.9 vs. 2.1 kg , P = 0.003 ) in the low-carbohydrate group , with no difference in changes in HbA(1c ) , ketone or lipid levels . CONCLUSIONS The diet was equally effective in those with and without diabetes",
"OBJECTIVE To comprehensively compare the effects of a very low-carbohydrate , high – unsaturated/low – saturated fat diet ( LC ) with those of a high – unrefined carbohydrate , low-fat diet ( HC ) on glycemic control and cardiovascular disease ( CVD ) risk factors in type 2 diabetes ( T2DM ) . RESEARCH DESIGN AND METHODS Obese adults ( n = 115 , BMI 34.4 ± 4.2 kg/m2 , age 58 ± 7 years ) with T2DM were r and omized to a hypocaloric LC diet ( 14 % carbohydrate [ or an energy-matched HC diet ( 53 % carbohydrate , 17 % protein , and 30 % fat [ for 24 weeks . The outcomes measured were as follows : glycosylated hemoglobin ( HbA1c ) , glycemic variability ( GV ; assessed by 48-h continuous glucose monitoring ) , antiglycemic medication changes ( antiglycemic medication effects score [ MES ] ) , and blood lipids and pressure . RESULTS A total of 93 participants completed 24 weeks . Both groups achieved similar completion rates ( LC 79 % , HC 82 % ) and weight loss ( LC −12.0 ± 6.3 kg , HC −11.5 ± 5.5 kg ) ; P ≥ 0.50 . Blood pressure ( −9.8/−7.3 ± 11.6/6.8 mmHg ) , fasting blood glucose ( −1.4 ± 2.3 mmol/L ) , and LDL cholesterol ( −0.3 ± 0.6 mmol/L ) decreased , with no diet effect ( P ≥ 0.10 ) . LC achieved greater reductions in triglycerides ( −0.5 ± 0.5 vs. −0.1 ± 0.5 mmol/L ) , MES ( −0.5 ± 0.5 vs. −0.2 ± 0.5 ) , and GV indices ; P ≤ 0.03 . LC induced greater HbA1c reductions ( −2.6 ± 1.0 % [ −28.4 ± 10.9 mmol/mol ] vs. −1.9 ± 1.2 % [ −20.8 ± 13.1 mmol/mol ] ; P = 0.002 ) and HDL cholesterol ( HDL-C ) increases ( 0.2 ± 0.3 vs. 0.05 ± 0.2 mmol/L ; P = 0.007 ) in participants with the respective baseline values HbA1c > 7.8 % ( 62 mmol/mol ) and HDL-C improvements for several clinical glycemic control and CVD risk markers . These improvements and reductions in GV and antiglycemic medication requirements were greatest with the LC compared with HC . This suggests an LC diet with low saturated fat may be an effective dietary approach for T2DM management if effects are sustained beyond 24 weeks",
"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",
"BACKGROUND AND AIMS To investigate the impact of a diet modeled on the traditional Cretan Mediterranean diet on metabolic control and vascular risk in type 2 diabetes . METHODS AND RESULTS Twenty-seven subjects ( 47 - 77 yrs ) with type 2 diabetes were r and omly assigned to consume either the intervention diet ad libitum or their usual diet for 12 weeks and then cross over to the alternate diet . Most of the meals and staple foods for the intervention diet were provided . Lipids , glycemic variables , blood pressure , homocysteine , C-reactive protein , plasma carotenoids and body composition ( anthropometry and dual energy X-ray absorptiometry ) were assessed at baseline , and at the end of both diet periods . Dietary adherence was monitored using plasma carotenoid and fatty acid ( FA ) analysis , complemented by diet diaries . Compared with usual diet , on the ad libitum Mediterranean intervention diet glycosylated haemoglobin fell from 7.1 % ( 95 % CI : 6.5 - 7.7 ) to 6.8 % ( 95 % CI : 6.3 - 7.3 ) ( p=0.012 ) and diet quality improved significantly [ plant : animal ( g/day ) food ratio increased from 1.3 ( 95 % CI : 1.1 - 1.5 ) to 5.4 ( 95 % CI : 4.3 - 6.6 ) ( p plasma lycopene and lutein/zeaxanthin increased ( 36 % and 25 % , respectively ) , plasma saturated and trans FAs decreased , and monounsaturated FAs increased . CONCLUSION A traditional moderate-fat Mediterranean diet improves glycemic control and diet quality in men and women with well-controlled type 2 diabetes , without adverse effects on weight"
] | 411672b6-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND There is a heightened interest in plant-based diets for cardiovascular disease prevention . Although plant protein is thought to mediate such prevention through modifying blood lipids , the effect of plant protein in specific substitution for animal protein on blood lipids remains unclear . To assess the effect of this substitution on established lipid targets for cardiovascular risk reduction , we conducted a systematic review and meta- analysis of r and omized controlled trials using the Grading of Recommendations Assessment , Development , and Evaluation system . METHODS AND RESULTS MEDLINE , EMBASE , and the Cochrane Registry were search ed through September 9 , 2017 . We included r and omized controlled trials of ≥3 weeks comparing the effect of plant protein in substitution for animal protein on low-density lipoprotein cholesterol , non-high-density lipoprotein cholesterol , and apolipoprotein B. Two independent review ers extracted relevant data and assessed risk of bias . Data were pooled by the generic inverse variance method and expressed as mean differences with 95 % confidence intervals . Heterogeneity was assessed ( Cochran Q statistic ) and quantified ( I2 statistic ) . The overall quality ( certainty ) of the evidence was assessed using the Grading of Recommendations Assessment , Development , and Evaluation system . One-hundred twelve r and omized controlled trials met the eligibility criteria . Plant protein in substitution for animal protein decreased low-density lipoprotein cholesterol by 0.16 mmol/L ( 95 % confidence interval , -0.20 to -0.12 mmol/L ; P ) , non-high-density lipoprotein cholesterol by 0.18 mmol/L ( 95 % confidence interval , -0.22 to -0.14 mmol/L ; P ) , and apolipoprotein B by 0.05 g/L ( 95 % confidence interval , -0.06 to -0.03 g/L ; P Substitution of plant protein for animal protein decreases the established lipid targets low-density lipoprotein cholesterol , non-high-density lipoprotein cholesterol , and apolipoprotein B. More high- quality r and omized trials are needed to improve our estimates . CLINICAL TRIAL REGISTRATION URL : http://www . clinical trials.gov . Unique identifier : NCT02037321 | [
"OBJECTIVE This study investigated the effects of a soy-based low-calorie diet on weight control , body composition , and blood lipid profiles compared with a traditional low-calorie diet . METHODS Thirty obese adults ( mean body mass index 29 - 30 kg/m(2 ) ) were r and omized to two groups . The soy-based low-calorie group consumed soy protein as the only protein source , and the traditional low-calorie group consumed two-thirds animal protein and the rest plant protein in a 1200 kcal/d diet for 8 wk . A diet record was kept everyday throughout the study . Food intake was analyzed before and after the study . Anthropometric data were acquired every week , and biochemical data from before and after the 8-wk experiment were compared . RESULTS Body weight , body mass index , body fat percentage , and waist circumference significantly decreased in both groups ( P body fat percentage in the soy group ( 2.2 % , 95 % confidence interval 1.6 - 2.8 ) was greater than that in the traditional group ( 1.4 % , 95 % confidence interval -0.1 to 2.8 ) . Serum total cholesterol concentrations , low-density lipoprotein cholesterol concentrations , and liver function parameters decreased in the soy-based group and were significantly different from measurements in the traditional group ( P serum triacylglycerol levels , serum high-density lipoprotein cholesterol levels , and fasting glucose levels was found in the soy or traditional group . CONCLUSION Soy-based low-calorie diets significantly decreased serum total cholesterol and low-density lipoprotein cholesterol concentrations and had a greater effect on reducing body fat percentage than traditional low-calorie diets . Thus , soy-based diets have health benefits in reducing weight and blood lipids",
"OBJECTIVE Consumption of soy protein has recently been shown to improve the blood lipid levels in nondiabetic subjects . The purpose of this study was to evaluate if a dietary supplement of soy protein , isoflavones , and cotyledon fiber ( Abalon ) affects cardiovascular risk markers , blood glucose , and insulin levels in type 2 diabetic subjects . RESEARCH DESIGN AND METHODS Twenty type 2 diabetic subjects participated in a crossover trial . They were r and omized to double-blind supplementation for 6 weeks with Abalon ( soy protein [ 50 g/day ] with high levels of isoflavones [ minimum 165 mg/day ] and cotyledon fiber [ 20 g/day ] ) or placebo ( casein [ 50 g/day ] and cellulose [ 20 g/day ] ) , separated by a 3-week wash-out period . RESULTS The results are expressed as means + /- SD . The percentage mean treatment difference between Abalon and placebo demonstrated significantly lower mean values after Abalon for LDL cholesterol ( 10 + /- 15 % , P LDL/UHDL ratio ( 12 + /- 18 % , P apolipoprotein ( apo ) B100 ( 30 + /- 38 % , P triglycerides ( 22 + /- 10 % , P homocysteine ( 14 + /- 21 % , P total cholesterol value tended to be less significant but still lower ( 8 + /- 15 % , P HDL cholesterol , apo B100/apo A1 ratio , plasminogen activator inhibitor 1 , factor VIIc , von Willebr and factor , fibrinogen , lipoprotein(a ) , glucose , HbA1c , or 24-h blood pressure . CONCLUSIONS These results indicate beneficial effects of dietary supplementation with Abalon on cardiovascular risk markers in type 2 diabetic subjects . This improvement is seen even in individuals with near-normal lipid values",
"Background : Postmenopausia and hypercholesterolemia are related to endothelial dysfunction , a pathogenic event in atherosclerosis . Soy protein reduces plasma cholesterol , but there is scanty information about its effect on endothelial function . Objective : To evaluate the effect of isolated soy protein compared to caseinate on plasma lipoproteins and endothelial function in postmenopausal hypercholesterolemic women . Design : R and omized , double-blind , cross-over trial . Setting : Outpatient clinic of the Catholic University of Chile . Subjects : Eighteen healthy , postmenopausal women with hypercholesterolemia were recruited , included and completed the protocol . Interventions : During the trial , all patients followed a low fat/low cholesterol diet and were r and omly assigned to receive isolated soy protein or matching caseinate for 4 weeks , and then the alternative treatment until week 8 . At pre- study and at the end of the first and second period , plasma lipoprotein levels and endothelial function ( flow-mediated dilatation ( FMD ) of the brachial artery ) were evaluated . Results : Plasma total and low density lipoprotein (LDL)-cholesterol concentration were significantly lower with the low fat/low cholesterol diet compared to pre- study , either with caseinate or soy protein . No significant differences in plasma lipid concentration between caseinate or soy protein interventions were observed . FMD did not change with the caseinate . In contrast , when soy protein was administered , FMD was significantly higher compared to pre- study ( 9.471.8 % vs 5.371.2 % ; P caseinate intervention ( 9.471.8 % vs 4.971.5 % ; P postmenopausal hypercholesterolemic women , soy protein improves endothelial function , regardless of changes in plasma lipoproteins . Sponsorship : Pontificia Universidad Católica ( DIPUC99/09E ) , Protein Technology International and Gynopharm Laboratory ( Recalcine Group )",
"Recently the American Heart Association has reported that favorable effects of soy protein on blood lipids were characteristic only for high amounts of soy protein and not observed for an intake less than 30 g/d . However , the period of the studies with the smaller amount was 4 - 6 wk and we thought a longer study was necessary for the conclusion . The death rate by heart disease is very high in Russia ; therefore , we have done this study in Russian subjects with hyperlipidemia . Prior to the study we tried to find a favorable method for subjects to take 30 g protein a day from soybean protein isolate ( SPI ) or skimmed curd protein ( SMP ) and decided to use Russian style cookies . Thirty subjects with hyperlipidemia were recruited ; however , due to the 5-mo long study 28 of them ( 19 females and 9 males aged 50+/-2 y ) could complete the trial . They were r and omly assigned to two groups and were given either cookie for 2 mo separated by a month-long washout interval in a cross-over design . Fasting blood sample s were drawn before and after the dietary treatments . Fasting blood sample s at 1 mo were also measured as a health check and to observe the trends of the blood parameters in the middle of the study period . Serum sample s were used for the lipid and other biochemical measurements . Every month for 3 non-consecutive days , energy and nutrient intakes were assessed and physical activity was estimated by pedometer . With the consumption of SPI for 2 mo , concentrations of total-cholesterol changed from 280+/-7 to 263+/-8 mg/dL ( -6.5 % , p=0.0099 ) , HDL-cholesterol from 57.4+/-2.5 to 62.6+/-2.9 mg/dL ( + 9 % , p=0.0047 ) , non-HDL-cholesterol ( total-cholesterol-HDL-cholesterol ) from 223+/-7 to 201+/-8 mg/dL ( -11 % , p=0.0023 ) and triglycerides from 204+/-23 to 173+/- 19 mg/dL ( -18 % , p=0.022 ) . There were no significant changes with SMP ( p>0.05 ) . Thus , administration of 30 g SPI a day for 2 mo confirmed its favorable effects on serum lipids in Russians with hyperlipidemia",
"High-protein diets have been advocated for weight loss and the treatment of diabetes . Yet animal protein sources are often high in saturated fat and cholesterol . Vegetable protein sources , by contrast , are low in saturated fat and without associated cholesterol . We have therefore assessed the effect on serum lipids of raising the protein intake by 5 % using a cereal protein , barley protein , as part of a st and ard therapeutic diet . Twenty-three hypercholesterolemic men and postmenopausal women completed a r and omized crossover study comparing a bread enriched with either barley protein or calcium caseinate [ 30 g protein , 8374 kJ ( 2000 kcal ) ] taken separately as two 1-mo treatment phases with a minimum 2-wk washout . Body weight and diet history were collected weekly during each treatment . Fasting blood sample s were obtained at wk 0 , 2 , and 4 . Palatability , satiety , and compliance were similar for both the barley protein- and casein-enriched breads , with no differences between the treatments in effects on serum LDL cholesterol or C-reactive protein , measures of oxidative stress , or blood pressure . Nevertheless , because no adverse effects were observed on cardiovascular risk factors , barley protein remains an additional option for raising the protein content of the diet",
"Clinical trials have shown that soya protein reduces the concentrations of some atherogenic lipids in subjects with normal renal function . The present study examined the effects of soya protein on serum lipid concentrations and lipoprotein metabolism in patients on hypercholesterolaemic haemodialysis . Twenty-six hypercholesterolaemic ( total cholesterol > or = 6.21 mmol/l ) patients on haemodialysis were studied in a r and omized , double-blind , placebo-controlled clinical trial . After a 4-week run-in phase , the subjects were r and omly assigned to two groups . Isolated soya protein or milk protein 30 g was consumed daily as a beverage at breakfast or post-dialysis for 12 weeks . Soya protein substitution result ed in significant reductions in total cholesterol ( 17.2 ( sd 8.9 ) % ) , LDL-cholesterol ( 15.3 ( sd 12.5 ) % ) , apo B ( 14.6 ( sd 12.1 ) % ) and insulin ( 23.8 ( sd 18.7 ) % ) concentrations . There were no significant changes in HDL-cholesterol or apo A-I. These results indicate that replacing part of the daily protein intake with soya protein has a beneficial effect on atherogenic lipids and favourably affects lipoprotein metabolism in hypercholesterolaemic patients undergoing haemodialysis",
"Background : Soy protein may reduce coronary heart disease ( CHD ) risk by lowering LDL cholesterol , but few studies have assessed whether whole soy flour displays a similar effect . Objective : The aim of this study was to assess the dose effect of whole soy flour incorporated into muffins on plasma LDL cholesterol in hypercholesterolemic adults . Methods : Adults aged 30–70 y ( n = 243 ) with elevated LDL cholesterol ( ≥3.0 and ≤5.0 mmol/L ) were stratified by LDL cholesterol and r and omly assigned to consume 2 soy muffins containing 25 g soy protein [ high-dose soy ( HDS ) ] , 1 soy and 1 wheat muffin containing 12.5 g soy protein and 12.5 g whey protein [ low-dose soy ( LDS ) ] , or 2 wheat muffins containing 25 g whey protein ( control ) daily for 6 wk while consuming a self-selected diet . Fasting blood sample s were collected at weeks 0 , 3 , and 6 for analysis of plasma lipids [ total , LDL , and HDL cholesterol and triglycerides ( TGs ) ] , glucose , insulin , C-reactive protein ( CRP ) , and isoflavones . Blood pressures also were measured . Dietary intake was assessed at weeks 0 and 4 with the use of 3 d food records . Treatment effects were assessed with the use of intention-to-treat analysis with multiple imputation and LDL cholesterol as the primary outcome . Results : In total , 213 ( 87.6 % ) participants completed the trial . Participants were primarily Caucasian ( 83 % ) and mostly female ( 63 % ) , with a mean ± SD body mass index ( in kg/m2 ) of 28.0 ± 4.6 and systolic and diastolic blood pressures of 122 ± 16 and 77 ± 11 mm Hg , respectively . Despite a dose-dependent increase in plasma isoflavones ( P on LDL cholesterol compared with control ( mean ± SEM changes : control , −0.04 ± 0.05 mmol/L ; HDS , 0.01 ± 0.05 mmol/L ; and LDS , −0.04 ± 0.06 mmol/L ) . There were no significant treatment effects on total or HDL cholesterol , TGs , CRP , homeostatic model assessment of insulin resistance , blood pressure , or the Framingham 10-y CHD risk score . Conclusion : Consuming 12.5 or 25 g protein from defatted soy flour incorporated into muffins does not reduce LDL cholesterol or other CHD risk factors in hypercholesterolemic adults . This trial was registered at clinical trials.gov as NCT01547585",
"BACKGROUND Nitric oxide ( NO ) may protect arteries against atherosclerosis , as suggested by experimental studies . Estrogen therapy enhances the bioactivity of NO in the vasculature of healthy postmenopausal women , but is not acceptable for long-term use by many women . Observational studies have demonstrated beneficial cardiovascular effects of soy protein in premenopausal and postmenopausal women . We examined whether the consumption of isolated soy protein may improve markers of vascular inflammation in postmenopausal women with hypercholesterolemia . METHODS AND RESULTS In a r and omized , double-blind , placebo-controlled , crossover study , 24 postmenopausal women with hypercholesterolemia received 25 g of soy protein or a placebo daily for 6 weeks , with treatment periods separated by 1 month . Markers of vascular inflammation were measured by enzyme-linked immunosorbent assay methods , including : soluble interleukin-2 receptor ( sIL-2r ) , E-selectin , P-selectin , intercellular adhesion molecule-1 ( ICAM-1 ) , and vascular cell adhesion molecule-1 ( VCAM-1 ) . There was no effect of soy protein in comparison with placebo on the inflammatory markers : the sIL-2r level was 942.2 + /- 335.3 pg/mL with soy protein and 868.5 + /- 226.9 pg/mL with placebo ( P = .311 ) ; E-selectin was 39.6 + /- 16.5 ng/mL with soy protein and 42.1 + /- 17.6 ng/mL with placebo ( P = .323 ) ; P-selectin was 157.9 + /- 67.9 ng/mL with soy protein and 157.5 + /- 47.6 ng/mL with placebo , ( P = .977 ) ; ICAM-1 was 266.0 + /- 81.3 ng/mL with soy protein and 252.5 + /- 82.7 ng/mL with placebo ( P = .435 ) ; VCAM-1 was 402.7 + /- 102.1 ng/mL with soy protein and 416.4 + /- 114.8 ng/mL with placebo ( P = .53 ) . CONCLUSIONS Consumption of 25 g of isolated soy protein daily for 6 weeks does not substantially affect markers of vascular inflammation in postmenopausal women with hypercholesterolemia",
"BACKGROUND Many of the benefits of soy have been attributed to soy isoflavones . OBJECTIVE The objective was to determine the effects of high- and low-isoflavone soy-protein foods on both lipid and nonlipid risk factors for coronary artery disease ( CAD ) . METHODS Forty-one hyperlipidemic men and postmenopausal women participated in a study with three 1-mo diets : a low-fat dairy food control diet and high- ( 50 g soy protein and 73 mg isoflavones daily ) and low- ( 52 g soy protein and 10 mg isoflavones daily ) isoflavone soyfood diets . All 3 diets were very low in saturated fat ( blood pressure was measured at the start and end of each diet . RESULTS No significant differences were seen between the high- and low-isoflavone soy diets . Compared with the control diet , however , both soy diets result ed in significantly lower total cholesterol , estimated CAD risk , and ratios of total to HDL cholesterol , LDL to HDL cholesterol , and apolipoprotein B to A-I. No significant sex differences were observed , except for systolic blood pressure , which in men was significantly lower after the soy diets than after the control diet . On the basis of blood lipid and blood pressure changes , the calculated CAD risk was significantly lower with the soy diets , by 10.1 + /- 2.7 % . CONCLUSION Substitution of soyfoods for animal products , regardless of isoflavone concentration , reduces the CAD risk because of both modest reductions in blood lipids and reductions in oxidized LDL , homocysteine , and blood pressure",
"BACKGROUND Health cl aims link soy protein ( SP ) consumption , through plasma cholesterol reduction , to a decreased risk of heart disease . Soy isoflavones ( ISOs ) , particularly in individuals who produce equol , might also contribute to lipid lowering and thus reduce SP requirements . OBJECTIVE The objective was to examine the contributions of SP , ISOs , and equol to the hypocholesterolemic effects of soy foods . DESIGN Nonsoy consumers ( 33 men , 58 women ) with a plasma total cholesterol ( TChol ) concentration > 5.5 mmol/L participated in a double-blind , placebo-controlled , crossover intervention trial . The subjects consumed 3 diets for 6 wk each in r and om order , which consisted of foods providing a daily dose of 1 ) 24 g SP and 70 - 80 mg ISOs ( diet S ) ; 2 ) 12 g SP , 12 g dairy protein ( DP ) , and 70 - 80 mg ISOs ( diet SD ) ; and 3 ) 24 g DP without ISOs ( diet D ) . Fasting plasma TChol , LDL cholesterol , HDL cholesterol , and triglycerides ( TGs ) were measured after each diet . RESULTS TChol was 3 % lower with the S diet ( -0.17 + /- 0.06 mmol/L ; P TGs were 4 % lower with both the S ( -0.14 + /- 0.05 mmol/L ; P LDL cholesterol , HDL cholesterol , or the TChol : HDL cholesterol ratio . On the basis of urinary ISOs , 30 subjects were equol producers . Lipids were not affected significantly by equol production . CONCLUSIONS Regular consumption of foods providing 24 g SP/d from ISOs had no significant effect on plasma LDL cholesterol in mildly hypercholesterolemic subjects , regardless of equol-producing status",
"The effect of plant and animal protein on blood lipid levels was investigated in eight healthy normolipidemic men aged 18 to 27 yr . All subjects were fed both plant and animal protein diets in a cross-over design . Each diet was consumed for a 21-day period . Proteins from commonly used plant sources made up the plant protein diet . Beef protein was substituted for 55 % of the plant proteins in the animal protein diet . Fasting venous blood sample s were collected at the beginning of the study and at 7-day intervals throughout the 42-day study . Serum was analyzed for total cholesterol and triglycerides . Plasma low-density and high-density lipoprotein cholesterol were determined . There were not any statistically significant differences in mean serum total cholesterol or mean plasma low-density lipoprotein cholesterol when subjects consumed the diets . Mean plasma high-density lipoprotein cholesterol levels were significantly ( p less than 0.05 ) elevated at the end of the 21-day period when the animal protein diet was consumed ( 48 + /- 3 mg/dl ) compared to the period when the plant protein diet was fed ( 42 + /- 2 mg/dl ) . Mean serum triglyceride values were significantly ( p less than 0.05 ) increased at day 7 of the plant protein diet period ( 136 + /- 19 mg/dl ) compared to the same time period when the animal protein diet was consumed ( 84 + /- 12 mg/dl ) . The results of the study indicated that the ingestion of a diet in which 55 % of the protein was supplied by beef protein was not associated with a hypercholesterolemic effect in healthy normolipidemic young men",
"Soy protein favorably alters serum lipids and lipoproteins in hypercholesterolemic individuals , thereby reducing cardiovascular disease risk . The primary purpose was to determine the effect of soy protein ( 40 g/d ) on circulating lipids and lipoproteins or coagulation and fibrinolytic factors in normocholesterolemic and mildly hypercholesterolemic perimenopausal women . We also determined the contribution of coagulation and fibrinolytic and other factors ( e.g. , body size and composition ; serum estrogens , ferritin , iron ; dietary intake ) to lipid profiles . Subjects were r and omly assigned to treatment : isoflavone-rich soy ( n = 24 ) , isoflavone-poor soy ( n = 24 ) , or whey control ( n = 21 ) protein . We measured circulating lipids and lipoproteins at baseline , wk 12 and wk 24 , and coagulation/fibrinolytic factors at baseline and wk 24 . Coagulation and fibrinolytic factors were not adversely affected by treatment . Treatment did not alter lipid profiles in mildly hypercholesterolemic ( n = 30 ) or in all subjects combined . Time significantly ( P serum total cholesterol , triacylglycerol , LDL cholesterol and HDL cholesterol concentrations . We could not attribute changes over time to various factors , but at baseline accounted for 57 % of the variability in HDL cholesterol ( P total to HDL cholesterol ratio ( P Dietary vitamin E and % energy from fat had positive effects , whereas plasma plasminogen activator inhibitor-1 , fibrinogen , body weight and serum ferritin had negative effects on HDL and total to HDL cholesterol . Isoflavone-rich or isoflavone-poor soy protein had no effect on lipid profiles or coagulation and fibrinolytic factors , whereas the effect of time suggested that the hormonal milieu during the menopausal transition may have overridden any detectable treatment effect on lipids . The relationship between coagulation factors and serum lipids should be examined further as indices of cardiovascular disease risk in midlife women",
"BACKGROUND Previous research supports a role for soy protein in reducing serum lipids ; however , few studies involved healthy male subjects or focused on soy isoflavones ( or did both ) . OBJECTIVE The objective was to ascertain the effects of soy protein varying in isoflavone content on serum lipids in healthy young men . DESIGN Thirty-five males ( x + /- SD age : 27.9 + /- 5.7 y ) consumed milk protein isolate ( MPI ) , low-isoflavone soy protein isolate ( low-iso SPI ; 1.64 + /- 0.19 mg aglycone isoflavones/d ) , and high-isoflavone SPI ( high-iso SPI ; 61.7 + /- 7.4 mg aglycone isoflavones/d ) for 57 d each , separated by 4-wk washout periods , in a r and omized crossover design . Blood sample s were collected at the beginning and end of each treatment period , and total , LDL , and HDL cholesterol ; triacylglycerols ; apolipoprotein ( apo ) B ; apo A-I ; and C-reactive protein ( CRP ) were measured in serum . Twenty-four-hour urine sample s were collected for 3 consecutive days at the end of each treatment period and analyzed for isoflavones . RESULTS Urinary isoflavones were significantly greater with consumption of the high-iso SPI than with that of the low-iso SPI or MPI . The differences between the 3 treatments with respect to individual serum lipids were not significant , but the ratios of total to HDL cholesterol , LDL to HDL cholesterol , and apo B to apo A-I were significantly lower with both SPI treatments than with MPI treatment . CONCLUSION Soy protein , regardless of isoflavone content , modulates serum lipid ratios in a direction beneficial for cardiovascular disease risk in healthy young men",
"BACKGROUND Controversy exists about the ability of soy protein and isoflavones to modulate vascular reactivity and biochemical cardiovascular disease risk markers in healthy , normolipidemic postmenopausal women . OBJECTIVE The objective was to investigate whether the consumption of soy protein with isoflavones would result in improved vascular reactivity and decreased biochemical markers of endothelial dysfunction and inflammation , independent of enhanced lipid and antioxidant effects . DESIGN Healthy postmenopausal women ( n = 28 ) were enrolled in a r and omized , double-blind , crossover study , and they consumed 25 g of 3 protein products/d for 6 wk each , with intervening washout periods . The products were isolated soy protein with isoflavones , ethanol-washed isolated soy protein with trace isoflavones , and total milk protein , which supplied 107 , 2 , and 0 mg total isoflavone ( aglycone ) units/d , respectively . We studied vascular function by using brachial artery reactivity values , plasma concentrations of vasoactive factors , endothelial inflammatory markers , and plasma isoflavone concentrations . The resistance of whole plasma and isolated LDL to copper-mediated oxidation was measured by conjugated diene formation . RESULTS Postocclusion peak flow velocity of the brachial artery was significantly ( P = 0.03 ) lower after treatment with isolated soy protein with isoflavones , which is consistent with a vasodilatory response , than after treatment with total milk protein . Plasma isoflavones and metabolites were significantly ( P isolated soy protein with isoflavones . There were no significant changes in biochemical cardiovascular disease risk markers or conjugated diene formation between the 3 dietary groups . CONCLUSION Daily consumption of soy protein with isoflavones can result in positive vascular effects that are independent of lipid and antioxidant effects in healthy postmenopausal women",
"Fifty-seven healthy volunteers ( mean age 46 yr ) were fed for 45 days on diets containing 16 % of energy as protein , 35 % as fat ( polyunsaturated/saturated fat ratio = 0.5 ) and about 375 mg cholesterol/day . Of the protein in the diets 60 % was provided as caseinate , as soy protein isolate , or as soy protein concentrate . After a control period of 17 days during which all the subjects received the casein diet , 17 subjects continued on this diet for the next 28 days ( test period ) , 20 subjects switched to the soy isolate diet , and the remaining 20 subjects switched to the soy concentrate diet . Serum cholesterol levels at the end of the control period were 207 + /- 36 , 205 + /- 40 , and 199 + /- 35 mg/dl ( mean + /- SD ) for the casein , isolate , and concentrate groups , respectively . Mean changes over the test period were -2 + /- 10 , -8 + /- 12 , and + 1 + /- 10 mg/dl , respectively . Compared with the casein diet , the isolate diet caused a small , nonsignificant decline in both serum total cholesterol and low-density lipoprotein cholesterol ( -6.5 mg/dl ) and an increase in high-density lipoprotein cholesterol ( + 5.8 mg/dl ) ( p less than 0.05 ) . These effects may have been more obvious if there had been no differences between groups in weight loss . No correlation was found between the response and the initial cholesterol level . No differences in lipoprotein composition were found between the casein and soy concentrate groups . Our data suggest that soy protein preparations do not have dramatic effects on the serum total cholesterol concentration in healthy subjects . However , pure soy protein might have some beneficial effect on the distribution of cholesterol over the lipoproteins . The lack of effect of the less refined soy protein concentrate suggests that the dietary fiber and other nonprotein components of soy concentrate do not have , at least in the short-term , a favorable effect on serum cholesterol and lipoproteins in healthy adults",
"Numerous studies report that soy lowers cholesterol . Probiotic bacteria were also reported to lower total cholesterol ( TC ) and LDL cholesterol ( LDL-C ) . We hypothesized that by altering intestinal microflora , probiotic consumption may also change phytoestrogen metabolism and enhance the effects of soy . To evaluate the independent and interactive effects of probiotic bacteria and soy on plasma TC , LDL-C , HDL cholesterol ( HDL-C ) , and triglycerides ( TG ) , 37 women with a baseline TC of 5.24 mmol/L were given the following 4 treatments for 6 wk each in a r and omized crossover design : soy protein isolate ( 26 + /- 5 g soy protein containing 44 + /- 8 mg isoflavones/d ) ; soy protein isolate + probiotic capsules ( 10(9 ) colony-forming units Lactobacillus acidophilus DDS-1 and Bifidobacterium longum ) ; milk protein isolate ( 26 + /- 5 g milk protein/d ) ; and milk protein isolate + probiotic . Soy consumption decreased plasma TC by 2.2 % ( P = 0.02 ) and LDL-C by 3.5 % ( P = 0.005 ) , increased HDL-C by 4.2 % ( P = 0.006 ) and tended to decrease TG ( P = 0.07 ) compared with milk protein intake . When divided according to initial TC concentration , soy effects were observed only in hypercholesterolemic women ( TC > 5.17 mmol/L ) . In this subgroup , soy treatments decreased plasma TC by 3.3 % ( P = 0.01 ) , LDL-C by 4.5 % ( P = 0.004 ) , and TG by 10.6 % ( P = 0.02 ) , and increased HDL-C by 4.2 % ( P = 0.02 ) . When subjects were divided on the basis of plasma and urine concentrations of the isoflavone metabolite , equol , equol producers and nonproducers did not differ in baseline lipids or in the effects of soy . Probiotics did not lower cholesterol or enhance the effects of soy . These results confirm a beneficial effect of soy on plasma cholesterol in mildly hypercholesterolemic postmenopausal women independent of equol production status , but do not support an independent or additive effect of these particular probiotic bacteria",
"BACKGROUND The magnitude of the effect of soy protein on lipoprotein concentrations is variable . This discordance is likely attributable to the various forms of soy protein used and to unrecognized shifts in dietary fatty acid , cholesterol , and fiber . OBJECTIVE The objective was to evaluate the effect of soybean processing as well as soy consumption relative to animal protein , independent of alterations in major dietary variables , on cardiovascular disease risk factors and vascular endothelial function . DESIGN Twenty-eight hypercholesterolemic subjects ( LDL cholesterol > /=3.36 mmol/L ) aged > 50 y consumed each of 4 diets for 6-wk periods according to a r and omized crossover design . The diets [ 55 % of energy as carbohydrate , 30 % of energy as fat , and 15 % of energy as protein-7.5 % of energy as experimental protein ( 37.5 g/d ) ] were design ed to contain products made from either whole soybeans , soyflour , or soymilk and were compared with a diet containing an equivalent amount of animal protein ( meat , chicken , and dairy products ) . The cholesterol , fiber , and fatty acid profiles of the diets were equalized . All food and drink were provided , and body weight was maintained throughout the study . RESULTS No significant differences in blood pressure , vascular endothelial function , or total cholesterol , VLDL-cholesterol , triacylglycerol , apolipoprotein B , or C-reactive protein concentrations were observed between the diets . Consumption of the soymilk diet result ed in a modest decrease ( 4 % ) in LDL-cholesterol concentrations compared with the animal-protein and soyflour diets ( P HDL-cholesterol ( 1 % ) and apolipoprotein A-I ( 2 % ) concentrations compared with the soybean and soyflour diets ( P soy-based products and different types of protein ( animal and soy ) has little clinical effect on cardiovascular disease risk factors , including peripheral endothelial function , when other major dietary variables are held constant",
"The effect of dietary protein source on the kinetics of plasma very low-density lipoprotein ( VLDL ) ( Sf 60 to 400 ) in hypercholesterolemic men was investigated . Using a crossover design , five subjects received sequentially either 1 ) a high polyunsaturated fat , low cholesterol control diet containing mixed protein from meat , dairy products , and plant sources or 2 ) an all-plant protein experimental diet in which the meat and dairy protein of the former diet was replaced by soybean protein and soy milk . There was no significant change in the mean values for fasting serum cholesterol and triglycerides over the 6-wk period of administration of the control versus experimental diets . The kinetics of VLDL ( Sf 60 to 400 ) apolipoprotein B were studied at the end of each dietary period after reinjection of 125I-labeled autologous VLDL ( Sf 60 to 400 ) . The VLDL apolipoprotein B pool size was similar during the experimental and control protocol s ; however , the fractional catabolic rate was consistently higher during the experimental protocol ( 8.5 + /- 1.3 versus 6.5 + /- 1.2 day-1 , p less than 0.01 ) and the production rate of apoprotein B was higher than control in four of five subjects ( mean values 18.6 + /- 3 versus 12.6 + /- 1 mg/day/kg , respectively ) . Administration of an all-plant protein diet significantly increased the fractional turnover rate of VLDL apolipoprotein B , even when no changes in VLDL ago B pool size or VLDL lipid concentrations were observed",
"Beans improve serum lipids and may reduce the risk of colon cancer by increasing colonic SCFA formation . We assessed whether pinto bean consumption affects in vitro fecal bacterial fermentation and production of SCFA , colonic bacterial population s , and serum lipids . Adults grouped as premetabolic syndrome ( pre-MetSyn ) ( n = 40 ) or controls ( n = 40 ) were r and omly assigned to consume either a bean entrée [ 1/2 cup ( 130 g ) of dried , cooked pinto beans ] or an isocaloric chicken soup entrée daily for 12 wk . Measurements included in vitro fecal fermentation of various resistant starch substrates , fecal bacterial speciation , and blood lipids . When expressed as a difference between baseline and treatment , propionate production from fecal material fermented in vitro with bean flour was higher ( P volunteers consuming beans than in those consuming soup . During the treatment period alone , bean consumption did not affect propionic acid production with any substrate but lowered ( P butyric acid production when cornstarch was the substrate . In all volunteers , bean consumption decreased fecal production of isovaleric ( P isobutyric ( P acids from cornstarch by as much as 50 % . Of the bacterial population s tested , only Eubacterium limosum was affected by bean consumption and was approximately 50 % lower than in those consuming soup . Beans lowered serum total cholesterol ( P . Bean consumption lowered serum HDL-cholesterol ( P LDL-cholesterol ( P serum triglycerides , VLDL cholesterol , or glucose . This study provides evidence that bean consumption can improve lipid profiles associated with cardiovascular disease , but does not clearly confer health benefits related to colon cancer risk",
"BACKGROUND Replacing animal protein with soy protein has been shown to reduce total and LDL-cholesterol concentrations in humans . However , the minimum amount of soy protein required for significant reduction of blood lipids is not known . OBJECTIVE We evaluated the amount of soy protein needed to reduce blood lipids in moderately hypercholesterolemic men . DESIGN Eighty-one men with moderate hypercholesterolemia ( total cholesterol concentration between 5.70 and 7.70 mmol/L ) were studied . After a 3-wk lead-in on a Step I diet , total cholesterol was measured and subjects were r and omly divided into 5 groups . For 6 wk , each group received 50 g protein/d , which included isolated soy protein ( ISP ) and casein , respectively , in the following amounts : 50:0 , 40:10 , 30:20 , 20:30 , and 0:50 ( control group ) g. Blood was collected at baseline and weeks 3 and 6 of the intervention . RESULTS At week 6 , significant reductions ( P non-HDL and total cholesterol and apolipoprotein ( apo ) B for all ISP groups ( except total cholesterol with 40 g ISP ) . At week 3 , significant reductions ( P apo B for the groups that consumed > /=30 g ISP and in non-HDL cholesterol for the groups that consumed > /=40 g ISP . HDL-cholesterol , apo A-I , lipoprotein(a ) , and triacylglycerol concentrations were not significantly affected by dietary treatment . CONCLUSION Our findings show that consuming as little as 20 g soy protein/d instead of animal protein for 6 wk reduces concentrations of non-HDL cholesterol and apo B by approximately 2.6 % and 2.2 % , respectively . 2000;71:-84",
"Soy protein was shown to exhibit several beneficial effects on renal function in nondiabetic patients with nephropathy , and to improve serum lipids . This study examined the effects of isolated soy protein consumption on urinary albumin excretion , serum lipids , plasma amino acids , and isoflavones in diabetic patients with nephropathy . Male patients ( n = 14 ) with type 2 diabetes and nephropathy were followed in a crossover design for 7 mo . The study comprised two 8-wk intervention periods , placed between a 4-wk lead-in and two 4-wk washout periods . In the 2 intervention periods , 0.5 g/(kg . d ) of the dietary protein was provided as either isolated soy protein ( ISP ) or casein , in r and om order . Blood and urine sample s were collected at the beginning and end of each period . Data were analyzed by multiple linear regression for a repeated-measure design . ISP consumption led to changes of -9.5 % in urinary albumin excretion ( P total-to-HDL-cholesterol ratio ( P LDL-to-HDL cholesterol ratio ( P HDL cholesterol ( P = 0.0040 ) . Plasma arginine concentrations , the arginine-to-lysine ratio , and plasma isoflavone concentrations were higher after ISP consumption ( P Urinary albumin excretion was negatively correlated with plasma total isoflavones ( rho = -0.441 ) , daidzein ( rho = -0.326 ) , and O-desmethylangolesin ( rho = -0.389 ) ( P isolated soy protein consumption improves several markers that may be beneficial for type 2 diabetic patients with nephropathy",
"The long-term clinical effects of soy protein containing various amounts of isoflavones on lipoproteins , mononuclear cell LDL receptor messenger RNA concentrations , and other selected cardiovascular risk factors are not well known . Sixty-six hypercholesterolemic , free-living , postmenopausal women were investigated during a 6-mo parallel-group , double-blind trial with 3 interventions . After a control period of 14 d , all subjects were r and omly assigned to 1 of 3 dietary groups ( all with 40 g protein ) : a National Cholesterol Education Program ( NCEP ) Step 1 diet with protein from casein and nonfat dry milk ( control ) , an NCEP Step 1 diet with protein from isolated soy protein containing moderate amounts of isoflavones ( ISP56 ) , or an NCEP Step 1 diet with protein from isolated soy protein containing high amounts of isoflavones ( ISP90 ) . Non-HDL cholesterol in both the ISP56 and ISP90 groups was reduced compared with the control group ( P total cholesterol was not changed . HDL cholesterol increased in both the ISP56 and ISP90 groups ( P ratio of total to HDL cholesterol decreased significantly in both groups compared with the control ( P Mononuclear cell LDL receptor messenger RNA concentrations increased in subjects consuming ISP56 or ISP90 compared with the control ( P soy protein , with different amounts of isoflavones , may decrease the risk of cardiovascular disease via improved blood lipid profiles , and that the mechanism by which apolipoprotein B-containing lipoproteins were depressed may be via alterations in LDL receptor quantity or activity",
"BACKGROUND Studies have shown that soy protein reduces some atherogenic lipid and lipoprotein concentrations , although lipoprotein(a ) concentrations may be increased . The dose response of soy protein has not been established ; neither has its effect on plasma total homocysteine . OBJECTIVE Our objective was to evaluate the effect of 2 doses of soy protein on lipid , lipoprotein , and homocysteine concentrations . DESIGN Four to 24 wk after being instructed to consume a lipid-lowering diet , 130 men and women with LDL-cholesterol concentrations > or = 4 mmol/L were studied during a parallel group trial in which 4 interventions were assigned r and omly . Thirty grams isolated soy protein ( ISP ) and 10 g cotyledon fiber or 50 g ISP and 16.6 g cotyledon fiber or equivalent doses of casein and cellulose were consumed daily as a beverage for 16 wk . RESULTS When the 2 groups who consumed ISP were compared with the 2 groups who consumed casein , the differences in the net changes from baseline to week 16 in the concentrations of LDL cholesterol and plasma total homocysteine were -0.26 mmol/L ( 95 % CI : -0.43 , -0.09 mmol/L ; P = 0.01 ) and -0.8 micromol/L ( -1.4 , -0.2 micromol/L ; P = 0.005 ) , respectively . The effect of the ISP dose was not significant . There were no significant differences between the 2 ISP and the 2 casein groups in changes in lipoprotein(a ) , HDL-cholesterol , or triacylglycerol concentrations . CONCLUSIONS Adding 30 - 50 g soy protein/d to a lipid-lowering diet significantly reduced LDL-cholesterol concentrations without increasing lipoprotein(a ) concentrations . Plasma total homocysteine concentrations also decreased , suggesting a novel , possibly antiatherosclerotic effect",
"In general , vegetarians have lower serum lipids and blood pressures than omnivores have . We tested the blood pressure and serum lipid lowering effects of two fat-modified diets differing primarily in their source of protein . Twenty-six men were r and omized in an incomplete block design to two of three diets : a high-fat diet , a fat-modified lactoovovegetarian diet ( LOV ) and a diet in which 60 % of plant protein in the LOV was replaced with lean meat ( LM ) . Compared with the high-fat diet both prudent diets significantly lowered blood pressure , serum total cholesterol ( TC ) , and LDL cholesterol but significantly increased serum triglycerides . The LOV diet had a significantly greater cholesterol-lowering effect than did the LM diet ( 10 % vs 5 % decrease ) but blood pressure reductions were similar . The partial substitution of lean meat for plant protein in a fat-modified diet did not negate the overall cardiovascular-risk lowering of the lactoovovegetarian diet",
"The effects of casein and soy protein on serum cholesterol levels and lipoprotein composition were studied in 69 healthy volunteers ( 18 to 28 yr of age ) under strict dietary control . Subjects were fed for 6 wk on diets containing 13 % of energy as protein , 38 % as fat ( P/S ratio = 0.6 ) and about 380 mg cholesterol per day . Of the protein in the diets 65 % consisted of casein or soy protein or a 2:1 mixture of casein and soy protein . After a control period of 10 days during which all the subjects received the casein-soy diet , 20 subjects continued on this diet for the next 4 wk as a base-line control , 25 subjects switched to the casein diet , and the remaining 24 subjects switched to the soy diet . Both food records and chemical analysis of double portions revealed that the diets were completely identical except for the type of protein . Average serum cholesterol levels at the end of the control period were 152 + /- 27 mg/dl ( 3.93 + /- 0.69 mmol/l ) and 153 + /- 23 mg/dl ( 3.95 + /- 0.60 mmol/l ) ( mean + /- SD ) for the casein and soy group , respectively . At the end of the test period the levels were 149 + /- 24 and 150 + /- 23 mg/dl , respectively ; thus there was no significant change on either diet . On the casein diet there was no change in the low-density lipoprotein cholesterol concentration , and only a slight , nonsignificant increase in the high-density lipoprotein cholesterol concentration . On the soy diet , however , there was a significant decline in low-density lipoprotein-cholesterol ( -6.6 mg/dl ; -0.17 mmol/l ) and a significant increase in high-density lipoprotein-cholesterol ( + 5.8 mg/dl ; + 0.15 mmol/l ) . The decline in low-density lipoprotein cholesterol in the soy group was significantly different from the small change in the casein group , but the difference in increase in high-density lipoprotein cholesterol in the soy and the casein group was only weakly significant . This suggest that soy protein could have a slight beneficial effect on the distribution of cholesterol over the various lipoprotein fractions , even at constant total cholesterol concentration",
"BACKGROUND Clinical trial data and the results of a meta- analysis suggest a hypocholesterolemic effect of soy protein . The effect may be partially attributable to the isoflavones in soy . Few studies have examined the separate effects of soy protein and isoflavones . OBJECTIVE The objective of this study was to determine the effect of soy protein and isoflavones on plasma lipid concentrations in postmenopausal , moderately hypercholesterolemic women . DESIGN This was a r and omized , double-blind , placebo-controlled clinical trial with 3 treatment groups . After a 4-wk run-in phase during which the women consumed a milk protein supplement , the subjects were r and omly assigned to 12 wk of dietary protein supplementation ( 42 g/d ) with either a milk protein ( Milk group ) or 1 of 2 soy proteins containing either trace amounts of isoflavones ( Soy- group ) or 80 mg aglycone isoflavones ( Soy+ group ) . RESULTS LDL-cholesterol concentrations decreased more in the Soy+ group ( n = 31 ) than in the Soy- group ( n = 33 ) ( 0.38 compared with 0.09 mmol/L ; P = 0.005 ) , but neither of these changes was significantly different from the 0.26-mmol/L decrease observed in the Milk group ( n = 30 ) . The results for total cholesterol were similar to those for LDL cholesterol . There were no significant differences in HDL-cholesterol or triacylglycerol concentrations between the 3 groups . CONCLUSIONS The difference in total- and LDL-cholesterol lowering between the 2 soy-protein supplements suggests an effect attributable to the isoflavone-containing fraction . However , the unexpected LDL-cholesterol lowering observed in the Milk group , and the fact that there was no significant difference between either soy group and the Milk group , suggests that changes may have been due to other factors related to participation in the study",
"Total substitution of soyabean protein for animal protein in the diet has been repeatedly shown to lower plasma cholesterol levels in hypercholesterolaemic individuals . A new , highly palatable , high-protein soya drink may allow replacement of a significant percentage of animal protein in the diet . The soya drink was given , within a crossover design v. a cows ' milk preparation of similar composition and taste , to twenty-one severely hypercholesterolaemic patients ( mean baseline plasma cholesterol 8.74 mmol/l ) with a history of resistance to or intolerance of statin treatment . Each dietary supplement was given for 4 weeks , with a 4-week interval between treatments , Plasma lipid levels were monitored every 2 weeks during each dietary sequence . The concomitant dietary treatment , which had been followed for a long time by all patients , was carefully monitored throughout the study . The soya supplementation reduced plasma total cholesterol level by 6.5 % , when given first , and by 7.4 % when given after cows ' milk . When given first , cows ' milk result ed in a small , non-significant reduction of plasma cholesterol level ( -3.9 % ) , and when given after soya , it changed total plasma cholesterol to a minimal extent ( -1.6 % ) . Changes in total and LDL-cholesterol levels after 2 and 4 weeks of soya v. cows ' milk treatment were , thus , respectively -6.1 , -7.0 and -6.2 , -7.8 % ( both P cholesterol-lowering effect of soyabean protein , even when only partly replacing animal protein in the diet , in individuals with extreme plasma cholesterol elevations",
"Background A couple of studies indicate a favorable impact of lupin protein on cardiovascular risk factors in humans . These studies , however , used relatively high doses of > 33 g/d , which can hardly be consumed under physiological conditions . Therefore , we investigated the effect of 25 g/d lupin protein isolate ( LPI ) on selected cardiovascular markers and on serum amino acids . Methods A total of 33 hypercholesterolemic subjects participated in a r and omized , controlled , double-blind crossover study . LPI and the active comparator milk protein isolate ( MPI ) were incorporated in protein drinks and consumed over 8 wk separated by a 4 wk washout period . Anthropometric data , blood pressure , and nutrient intake were assessed at baseline and after 8 wk of both protein interventions . Blood was sample d at baseline , wk 4 and wk 8 . All 33 subjects were included in final statistical analyses using repeated measures ANOVA with the general linear model or using linear mixed model . Results Except for higher HDL cholesterol at wk 4 of LPI ( P ≤ 0.036 ) , anthropometric parameters , blood pressure , and plasma lipids did not differ among LPI and MPI intervention . Compared to baseline , the primary outcome LDL cholesterol was significantly reduced after 4 wk of both interventions ( P ≤ 0.008 ) , while LDL : HDL cholesterol ratio was decreased only by LPI ( P = 0.003 ) . These time effects were restricted to subjects with higher hypercholesterolemia and disappeared after 8 wk . Blood pressure was reduced after 8 wk of LPI ( P ≤ 0.044 ) . Almost all serum amino acids were higher at wk 4 but not at wk 8 of MPI compared to LPI . Following 4 wk and 8 wk of LPI intervention , most amino acids remained unchanged . Both interventions caused a slight , but significant rise in body weight and body fat after 8 wk ( P ≤ 0.045 ) . Conclusion In conclusion , 25 g LPI can beneficially modulate plasma LDL cholesterol at least over short-term . Using appropriate dietetic conditions that improve consumer compliance and avoid changes in energy intake as well as in body composition , lupin protein could positively impact cardiovascular risk factors particularly in individuals with higher hypercholesterolemia . Trial registration Clinical Trials.gov :",
"Background / Objective : Previous clinical trials have documented that soy protein reduces low-density lipoprotein cholesterol and increases high-density lipoprotein ( HDL ) cholesterol compared with milk protein . However , the effect of soy protein on lipids compared with carbohydrate has not been not well studied . We examined the effect of soy and milk protein supplementation on lipids and lipoproteins compared with carbohydrate among adults without hypercholesterolemia . Subjects/ Methods : We conducted a r and omized , double-blind , 3-phase crossover trial among 352 US adults with serum total cholesterol level of Trial participants were assigned to 40 g/day supplementation of soy protein , milk protein or complex carbohydrate from wheat each for 8 weeks in r and om order with a 3-week washout period between interventions . Overnight fasting blood sample s were collected at the termination of each intervention phase . Results : Compared with carbohydrate , soy protein supplementation was significantly associated with a net change ( 95 % confidence interval ( CI ) ) in total cholesterol and total/HDL cholesterol ratio of −3.97 mg/dl ( −7.63 to −0.31 , P=0.03 ) and −0.12 ( −0.23 to −0.01 , P=0.03 ) , respectively . Compared with milk protein , soy protein supplementation was significantly associated with a net change ( 95 % CI ) in HDL and total/HDL cholesterol ratio of 1.54 mg/dl ( 0.63 to 2.44 , P=0.0009 ) and −0.14 ( −0.22 to −0.05 , P=0.001 ) , respectively . Compared with carbohydrate , milk protein supplementation was significantly associated with a net change ( 95 % CI ) in HDL of −1.13 mg/dl ( −2.05 to −0.22 , P=0.02 ) . Conclusions : This r and omized controlled trial indicates that soy protein , but not milk protein , supplementation improves the lipid profile among healthy individuals",
"Background : High-protein diets increase weight loss ( WL ) during energy restriction ; therefore , it has been suggested that additional protein intake may improve weight maintenance ( WM ) after WL . Objective : We investigated the effect of protein supplements from either whey with or without calcium or soy on WM success after WL compared with that of a control . Design : In a r and omized , controlled , double-blinded trial , 220 participants aged 18 - 60 y with body mass index ( in kg/m2 ) from 27.6 to 40.4 were included . The study was initiated with an 8-wk WL period followed by a 24-wk WM period . During WM , participants consumed the following isocaloric supplements ( 45 - 48 g/d ) : whey and calcium ( whey+ ) , whey , soy , or maltodextrin ( control ) . Data were collected at baseline , before WM , and after WM ( weeks 0 , 8 , and 32 , respectively ) and included body composition , blood biochemistry , and blood pressure . Meal tests were performed to investigate diet-induced-thermogenesis ( DIT ) and appetite sensation . Compliance was tested by 24-h urinary nitrogen excretion . Results : A total of 151 participants completed the WM period . The control and 3 protein supplements did not result in different mean ± SD weight regains ( whey+ : 2.19 ± 4.6 kg ; whey : 2.01 ± 4.6 kg ; soy : 1.76 ± 4.7 kg ; and control : 2.23 ± 3.8 kg ; P = 0.96 ) , fat mass regains ( whey+ : 0.46 ± 4.5 kg ; whey : 0.11 ± 4.1 kg ; soy : 0.15 ± 4.1 kg ; and control : 0.54 ± 3.3 kg ; P = 0.96 ) , or improvements in lean body mass ( whey+ : 1.87 ± 1.7 kg ; whey : 1.94 ± 1.3 kg ; soy : 1.58 ± 1.4 kg ; and control : 1.74 ± 1.4 kg ; P = 0.50 ) during WM . Changes in blood pressure and blood biochemistry were not different between groups . Compared with the control , protein supplementation result ed in higher DIT ( ∼30 kJ/2.5 h ) and resting energy expenditure ( 243 kJ/d ) and an anorexigenic appetite-sensation profile . Conclusion : Protein supplementation does not result in improved WM success , or blood biochemistry after WL compared with the effects of normal dietary protein intake ( 0.8 - 1.0 g · kg-1 · d-1 ) . This trial was registered at clinical trials.gov as NCT01561131",
"Soy-base texturized vegetable protein ( TVP ; Archer Daniels Midl and , Decatur , IL ) has been used to decrease serum cholesterol and as a substitute for animal protein to achieve very low levels of dietary cholesterol . The effect of very low dietary cholesterol and of TVP on biliary lipids and fecal sterols is unclear . The study objective was to determine the effects of very low intake of dietary cholesterol , as well as TVP itself , on serum lipids , biliary lipids , and fecal sterols . We studied eight normal subjects living on a metabolic ward during three r and omly ordered 6- to 7-week periods : ( 1 ) st and ard cholesterol diet ( 190 to 550 mg/d ) , ( 2 ) TVP-low-cholesterol diet ( 17 to 30 mg/d ) , and ( 3 ) TVP-st and ard cholesterol diet . By analysis of covariance ( ANCOVA ) , reducing dietary cholesterol to these very low levels significantly decreased serum low-density lipoprotein ( LDL ) cholesterol ( P=.048 ) but did not affect high-density lipoprotein ( HDL ) cholesterol or triglyceride . TVP result ed in a borderline significant reduction in LDL cholesterol ( P=.058 ) with a highly significant reduction in HDL cholesterol ( P=.004 ) and an increase in serum triglyceride ( P=.010 ) . During TVP ingestion , there was a highly significant increase in the output of fecal neutral sterols ( P=.005 ) and a tendency for a higher output of fecal acidic sterols ( P=.100 ) . Fecal sterol balance was significantly more negative ( indicating increased cholesterol synthesis ) during TVP ingestion ( P=.016 ) . Neither TVP nor the very-low-cholesterol diet appreciably affected the gallbladder bile molar percent cholesterol or saturation index . The data are consistent with the hypothesis that to the extent TVP decreases serum LDL cholesterol ( an effect of borderline significance in this study ) , the effect occurs via a reduction in the absorption of cholesterol and perhaps bile acid . However , the potential benefit of decreasing LDL cholesterol in this way seems to be at least partially offset by a concomitant reduction in HDL cholesterol and an increase in serum triglycerides",
"OBJECTIVE To determine , for individuals with type 2 diabetes and microalbuminuria , the effects of 6 weeks of meals containing plant-based protein ( PP ) versus meals with predominantly animal-based protein ( AP ) on renal function and secondarily on glycemia , lipid levels , and blood pressure . RESEARCH DESIGN AND METHODS In a r and omized crossover trial , we compared 6 weeks of meals containing only PP with meals containing primarily AP ( 60 % animal , 40 % plant ) in 17 subjects with type 2 diabetes and microalbuminuria treated with diet and /or oral antidiabetic agents . Protein content was equivalent to the average American diet , and calories provided weight maintenance . Nutrients were equivalent between the two diets . Meals were prepared and packaged by a metabolic kitchen staff and were sent home weekly . At the beginning and end of each 6-week period , subjects were studied for 36 h on a metabolic unit . RESULTS There were no significant differences between diets for glomerular filtration rate , renal plasma flow , albumin excretion rate , total cholesterol , HDL cholesterol , triglyceride area under the curve ( AUC ) , glucose and insulin AUC , HbA(1c , ) blood pressure , or serum amino acids . For both diets , at the end of the treatment periods as compared with baseline , total cholesterol was significantly lower ( PP and AP : from 4.75 to 4.34 mmol/l , P HbA(1c ) had significantly improved ( PP : from 8.1 to 7.5 % , P diastolic blood pressure was significantly lower ( PP : from 83 to 80 mmHg , P individuals with type 2 diabetes and microalbuminuria . There are , however , potential lipid , glycemic , and blood pressure benefits for following a carefully constructed , weight-maintaining , healthy diet , regardless of protein source",
"Objective : To study whether Abacor ® , a product based on isolated soy protein with high and st and ardised levels of isoflavones and cotyledon soy fibres , was more effective in lowering total and LDL cholesterol than placebo . Design : R and omised , placebo-controlled , double-blind , parallel group , single centre study . Setting : Primary care in Joensuu , North Karelia , Finl and .Subjects : Subjects were screened from the patient data base of the health centre ; 30 were r and omised to the Abacor ® group and 30 subjects to placebo . Eight subjects were withdrawn , six from the active group , two from the placebo group . Intervention : The preparations were given as two daily liquid supplements in addition to the subjects ' regular diets for 6 weeks . Results : Abacor ® showed a statistically significant lipid-lowering effect as compared to placebo , although an unexpected reduction was seen in the placebo group . The estimated difference between active treatment and placebo was 0.25 mmol/l ( 95 % CI 0.01 , 0.50 ; P=0.049 ) for total cholesterol , corresponding to reductions of 8.3 and 5.1 % , respectively . The difference in reduction of LDL-cholesterol was 0.27 mmol/l ( 95 % CI 0.06 , 0.49 ; P=0.014 ) and corresponded to a reduction of 13.2 % in the active treatment group , and 8.0 % in the placebo group . Abacor ® showed a rapid onset of effect , as compared with placebo . During a wash-out period of 4 weeks after treatment , the subjects returned to pre-treatment cholesterol levels . Conclusion : Added to a regular diet , Abacor ® significantly reduced LDL-cholesterol and total cholesterol . These beneficial effects occurred within 6 weeks of treatment . Sponsorship : Commercial organisation",
"Objectives : To investigate the effect of replacing lean meat with a soy product , tofu , on serum lipoprotein concentrations . Study and design : R and omized cross-over dietary intervention study .Subjects : Forty-two free-living healthy males aged 35–62 y completed the dietary intervention . Three additional subjects were non-compliant and excluded prior to analysis . Interventions : A diet containing lean meat ( 150 g/d ) was compared with one with 290 g/d tofu in an isocaloric and isoprotein substitution . Both diet periods were 1 month , and fat intake was carefully controlled . Results : Seven-day diet records showed the two diets were similar in energy , macronutrients and fibre . Total cholesterol ( mean difference 0.23 mmol/l , 95 % CI 0.02 , 0.43 ; P=0.03 ) and triglycerides ( mean difference 0.15 mmol/l , 95 % CI 0.02 , 0.31 ; P=0.017 ) were significantly lower on the tofu diet than the lean meat diet . However , HDL-C was also significantly lower on the tofu diet ( mean difference 0.08 mmol/l , 95 % CI 0.02 , 0.14 ; P=0.01 ) although the LDL-C : HDL-C ratio was similar . Conclusion : The effect on HDL-C and the small LDL-C reduction differ from some other studies , where fat was often less controlled , and the comparison was of soy as textured protein or soymilk against casein . This suggests a differential effect of the various proteins compared to the soy may influence the findings . In practice , the replacement of meat with tofu would usually be associated with a decrease in saturated fat and an increase in polyunsaturated fat and this should enhance any small benefits due to the soy protein . Sponsor : Deakin University with some contribution from a Commonwealth Department of Veterans Affairs research grant . European Journal of Clinical Nutrition ( 2000 ) 54 ,",
"OBJECTIVES To determine whether co-administration of soy during tibolone treatment would prevent tibolone-induced dyslipoproteinemia in postmenopausal monkeys and women . METHODS Surgically postmenopausal cynomolgus monkeys ( n = 18 ) were assigned r and omly to one of four dietary regimens in a Latin Square crossover design , such that all animals received all diets for 14 weeks with a 4-week washout period : ( 1 ) casein/lactalbumin ( CL ) ; ( 2 ) tibolone ( Tib , 1.25 mg/day women 's equivalent ) ; ( 3 ) soy ( 138 mg isoflavones/day women 's equivalent ) ; ( 4 ) Soy + Tib . Postmenopausal women on tibolone treatment were r and omized to receive soy powder ( 52 g of soy protein containing 112 mg isoflavones ) or placebo ( containing 52 g of milk protein ) daily in a crossover trial for 8 weeks with a 4-week washout period . RESULTS Monkeys given Tib alone had approximately 14 % increase in plasma LDL + VLDL-C ; whereas those given soy combined with tibolone had significant ( approximately 22 % ) reductions . Tib treated monkeys had reductions in plasma HDL-C of about 48 % vs. no reductions in Soy + Tib . In postmenopausal women using tibolone , soy reduced plasma LDL-C concentrations by approximately 10 % from baseline without a change in HDL-C. CONCLUSIONS Co-administration of soy during tibolone treatment improved the lipoprotein profile in both monkeys and women ; however , the effects were more robust in monkeys",
"Type 2 diabetes is highly prevalent in North America and is associated with increased risk of cardiovascular disease ( CVD ) . Evidence supports a role for soy protein in the reduction of serum lipids related to CVD risk ; however , few studies have focused on adults with type 2 diabetes who are not on lipid-lowering medications and /or do not have diabetic complications . The purpose of this study was to determine the effect of soy protein isolate ( SPI ) consumption on serum lipids in adults with diet-controlled type 2 diabetes . Using a double-blind , r and omized , crossover , placebo-controlled intervention study design , adults with diet-controlled type 2 diabetes ( n = 29 ) consumed SPI ( 80 mg/d aglycone isoflavones ) or milk protein isolate ( MPI ) for 57 d each separated by a 28-d washout period . Twenty-four-hour urine sample s were collected on d 54 - 56 of each treatment for analysis of isoflavones and blood was collected on d 1 and 57 of each treatment and analyzed for serum lipids and apolipoproteins . SPI consumption increased urinary isoflavones compared with MPI . SPI consumption reduced serum LDL cholesterol ( P = 0.04 ) , LDL cholesterol : HDL cholesterol ( P = 0.02 ) , and apolipoprotein B : apolipoprotein A-I ( P = 0.05 ) compared with MPI . SPI did not affect serum total cholesterol , HDL cholesterol , triacylglycerol , apolipoprotein B , or apolipoprotein A-I. These data demonstrate that consumption of soy protein can modulate some serum lipids in a direction beneficial for CVD risk in adults with type 2 diabetes",
"In a controlled feeding study , the effects of substituting 25 g soy protein for meat on calcium retention and bone biomarkers were determined . Postmenopausal women ( n = 13 ) ate two diets that were similar , except that , in one diet , 25 g high-isoflavone soy protein ( SOY ) was substituted for an equivalent amount of meat protein ( control diet ) , for 7 wk each in a r and omized crossover design . After 3 wk of equilibration , calcium retention was measured by labeling the 2-d menu with (47)Ca , followed by whole-body counting for 28 d. Urinary calcium and renal acid excretion were measured at wk 3 , 5 , and 7 . Biomarkers of bone and cardiovascular health were measured at the beginning and end of each diet . Calcium was similarly retained during the control and SOY diets ( d 28 , percent dose , mean + /- pooled sd : 14.1 and 14.0 + /- 1.6 , respectively ) . Despite a 15 - 20 % lower renal acid excretion during the SOY diet , urinary calcium loss was unaffected by diet . Diet also did not affect any of the indicators of bone or cardiovascular health . Substitution of 25 g high isoflavone soy protein for meat , in the presence of typical calcium intakes , did not improve or impair calcium retention or indicators of bone and cardiovascular health in postmenopausal women",
"The objective was to study whether a yoghurt containing isolated soya protein with st and ardised levels of isoflavones , cotyledon soya fibres and soya phospholipids is more effective in lowering total and LDL-cholesterol than a placebo . One hundred and forty-three subjects were r and omised to the soya group ( n 69 ) or to the placebo ( n 74 ) . The mean baseline levels were 7.6 and 5.1 mmol/l for total and LDL-cholesterol , respectively . Fasting serum lipoproteins were assessed five times during the 8-week intervention period , and 4 weeks thereafter . The results were analysed by a mixed model for unbalanced repeated measurements . During the intervention , there were highly significant differences in lipid-lowering effect in favour of the active soya intervention group compared with the control group . The significant differences were for total cholesterol ( estimated mean difference 0.40 mmol/l ; P LDL-cholesterol ( 0.39 mmol/l ; P non-HDL-cholesterol ( 0.40 mmol/l ; P total : HDL-cholesterol ratio ( 0.23 ; P=0.005 ) . There was no difference in the effects on HDL-cholesterol , triacylglycerols or homocysteine . The lipid-lowering effect occurred within 1 - 2 weeks of intervention , and was not due to weight loss . The safety profile for active soya was similar to the placebo group , except for gastrointestinal symptoms , which caused a significantly higher dropout rate ( fourteen v. three subjects ) among the subjects taking active soya",
"OBJECTIVE —Several short-term trials on the effect of soy consumption on cardiovascular risks are available , but little evidence exists regarding the impact of long-term soy protein consumption among type 2 diabetic patients with nephropathy . To determine the effects of long-term soy consumption on cardiovascular risks , we measured C-reactive protein ( CRP ) and kidney function indexes among type 2 diabetic patients with nephropathy . RESEARCH DESIGN AND METHODS —This longitudinal r and omized clinical trial was conducted among 41 type 2 diabetic patients with nephropathy ( 18 men and 23 women ) . Twenty patients in the soy protein group consumed a diet containing 0.8 g protein/kg body weight ( 35 % animal proteins , 35 % textured soy protein , and 30 % vegetable proteins ) and 21 patients in the control group consumed a similar diet containing 70 % animal proteins and 30 % vegetable proteins for 4 years . RESULTS —Soy protein consumption significantly affected cardiovascular risks such as fasting plasma glucose ( mean change in the soy protein versus control groups : −18 ± 3 vs. 11 ± 2 mg/dl ; P = 0.03 ) , total cholesterol ( −23 ± 5 vs. 10 ± 3 mg/dl ; P = 0.01 ) , LDL cholesterol ( −20 ± 5 vs. 6 ± 2 mg/dl ; P = 0.01 ) , and serum triglyceride ( −24 ± 6 vs. −5 ± 2 mg/dl ; P = 0.01 ) concentrations . Serum CRP levels were significantly decreased by soy protein intake compared with those in the control group ( 1.31 ± 0.6 vs. 0.33 ± 0.1 mg/l ; P = 0.02 ) . Significant improvements were also seen in proteinuria ( −0.15 ± 0.03 vs. 0.02 ± 0.01 g/day ; P = 0.001 ) and urinary creatinine ( −1.5 ± 0.9 vs. 0.6 ± 0.3 mg/dl , P = 0.01 ) by consumption of soy protein . CONCLUSIONS —Longitudinal soy protein consumption significantly affected cardiovascular risk factors and kidney-related biomarkers among type 2 diabetic patients with nephropathy",
"Background Plant and marine n-3 fatty acids ( FA ) may favorably modify select markers of cardiovascular disease risk . Whether supplementing the habitual diet of lacto-ovo-vegetarians ( LOV ) with walnuts ( containing α-linolenic acid , ALA ) and n-3 FA enriched eggs ( containing primarily docosahexaenoic acid , DHA and ALA ) would have equivalent effects on CVD risk factors is explored in this study . Methods In this study , 20 healthy free-living LOVs following their habitual diet were r and omly assigned in a crossover design to receive one of three supplements : n-3 FA enriched egg ( 6/week ) , walnuts ( 28.4 g , 6/week ) or a st and ard egg , 6/week ( control ) for 8 weeks each with 4-wk washout between treatments . Erythrocyte membrane fatty acids , serum lipids and inflammatory markers were measured at the end of each treatment . Results Dietary compliance was observed by an expected increase in erythrocyte membrane ALA following the walnut treatment and in DHA following the n-3 FA enriched egg treatment . Walnut treatment lowered serum triacylglycerol , total cholesterol and Apo B ( p significantly reduced total : HDL cholesterol ratio compared to both egg treatments . There were no differences between treatments for any of the inflammatory markers . Conclusions For LOV , a direct source of DHA such as n-3 FA enriched eggs seems necessary to increase membrane levels of DHA . However for producing an overall favorable blood lipid profile , daily consumption of a h and ful of walnuts rich in ALA may be a preferred option for lacto-ovo vegetarian",
"Objective —The objective of this study was to assess the independent effect of soy relative to common sources of animal protein and soy-derived isoflavones on blood lipids . Methods and Results —Forty-two subjects with LDL cholesterol levels ≥3.36 mmol/L were fed each of four diets in r and omized order for 6 weeks per phase . Diets contained a minimum of 25 g animal protein or isolated soy protein/4.2 MJ , with each containing trace amounts or 50 mg of isoflavones/4.2 MJ . Soy protein had a modest effect on total , LDL and HDL cholesterol , and triglyceride concentrations ( −2 % , P = 0.017 ; −2 % , P = 0.042 ; + 3%;P = 0.034 , −11 % , P effect on plasma lipids in individuals with LDL cholesterol significantly reduced total and LDL cholesterol and triglyceride concentrations in individuals with LDL cholesterol ≥4.14 mmol/L ( −4 % , P = 0.001 ; −5 % , P = 0.003 ; −15 % , P effect of isoflavones on plasma lipid levels was observed either constituent to the soy protein or supplemental to the animal protein . Conclusions —Although potentially helpful when used to displace products containing animal fat from the diet , the regular intake of relatively high levels of soy protein ( > 50 g/day ) had only a modest effect on blood cholesterol levels and only in subjects with elevated LDL cholesterol levels ( ≥4.14 mmol/L ) . Soy-derived isoflavones had no significant effect",
"The lipid-lowering effect of a soy-based protein supplement was evaluated in an 8-week r and omized , placebo-controlled trial in patients with hypercholesterolemia . A total of 117 patients ( 63 men and 54 women ) received soy protein , either 15 or 25 g/d or placebo . In the active treatment groups low-density lipoprotein cholesterol levels decreased significantly by 5.9 % and 1.1 % respectively , but increased by 3.6 % with placebo . Total serum cholesterol and apolipoprotein B levels changed significantly in a similar manner . High-density lipoprotein cholesterol , triglycerides , homocysteine , folic acid , and vitamin B12 levels did not change significantly compared with baseline in any of the study groups . All preparations were well tolerated . Soy protein 25 g/d was twice as effective as 15 g/d . In conclusion , soy protein supplementation may effectively reduce serum cholesterol levels and therefore is likely to diminish the risk for cardiovascular disease",
"OBJECTIVE To determine the effects of soy milk consumption compared with cow ’s milk on inflammation , coagulation , and oxidative stress among patients with diabetic nephropathy . RESEARCH DESIGN AND METHODS This r and omized , crossover clinical trial was conducted on 25 type 2 diabetic patients with nephropathy . This study had two trial phases , each for 4 weeks and one washout period for 2 weeks . Patients were r and omly assigned to consume a diet containing soy milk or a diet containing cow ’s milk . RESULTS Soy milk consumption result ed in a significant reduction in d-dimer level ( percent change : −3.77 vs. 16.13 % ; P soy milk consumption had no significant effects on tumor necrosis factor-α , interleukin-6 , high-sensitivity C-reactive protein ( hs-CRP ) , and malondialdehyde levels . The result was near to significance regarding the effect of soy milk consumption on hs-CRP ( percent change : −35.45 vs. 36.76 % ; P = 0.05 ) . However , this effect was not significant after adjusting for the confounding variable ( carbohydrate intake ) . CONCLUSIONS Soy milk consumption could decrease serum d-dimer level among type 2 diabetic patients with nephropathy . However , markers of inflammation and oxidative stress did not change following soy milk intake among these patients",
"Cardiovascular heart disease is a major health problem in the United States . Elevated blood cholesterol has been shown to significantly increase the risk of cardiovascular heart disease . The National Cholesterol Educational Program ( NCEP ) Step I diet , which restricts fat and cholesterol intakes , is usually recommended as the initial treatment to lower blood cholesterol . Soy protein has been shown to be hypocholesterolemic , particularly in hypercholesterolemic subjects . However , the hypocholesterolemic effect of soy protein in subjects with a blood total cholesterol concentration 5.17 mmol/L is not clear . To determine whether soy protein could enhance the hypocholesterolemic effect of the NCEP Step I diet , 13 normocholesterolemic and 13 hypercholesterolemic men aged 20 - 50 y were enrolled in a r and omized , 2-part , crossover study . Subjects were fed either an NCEP Step I soy-protein diet or an NCEP Step I animal protein diet for 5 wk . After a washout period of 10 - 15 wk , the subjects were fed the alternate diet for 5 wk . The hypocholesterolemic effect of soy protein was found to be independent of age , body weight , pretreatment plasma lipid concentrations , and sequence of dietary treatment . Regardless of plasma lipid status , the soy-protein diet was associated with a statistically significant decrease in the plasma concentrations of LDL cholesterol ( P = 0.029 ) as well as the in the ratio of plasma LDL cholesterol to HDL cholesterol ( P = 0.005 ) . Our results indicate that soy protein enhances the hypocholesterolemic effect of the NCEP Step I diet in both normocholesterolemic and hypercholesterolemic men",
"Summary Background Soy protein is effective in lowering plasma cholesterol , LDL cholesterol and triglyceride concentrations . It has not been conclusively answered , whether and to what extent other soy constituents may also contribute to this effect . Objective To investigate the change in blood lipid levels after application of two soy-based supplements containing soy protein either without ( SuproSoy ® ) or with ( Abacor ® ) soy fiber and phospholipids in a r and omized placebo-controlled triplearmed study . Methods 121 hypercholesterolemic adults ( 66 females , 55 males ) were recruited and r and omly assigned to one of three treatments . Over 8 weeks they received daily either 25 g soy protein ( as a component of the supplements Abacor ® or SuproSoy ® ) or 25 g milk protein ( as a component of placebo ) . Serum lipids were measured at baseline and after 4 , 6 and 8 weeks . Results After 8 weeks of supplementation total cholesterol levels were reduced by 8.0 ± 9.6 % ( Abacor ® ) and 3.4 ± 8.3 % ( SuproSoy ® ) ; LDL cholesterol levels by 9.7 ± 11.7 % ( Abacor ® ) and 5.4 ± 11.6 % ( SuproSoy ® ) ; and Apolipoprotein B levels by 6.9 ± 14.6 % ( Abacor ® ) and 4.0 ± 12.4 % ( SuproSoy ® ) . Serum levels of HDL cholesterol and triglycerides remained unchanged . Conclusions A preparation combining isolated soy protein with soy fibers and phospholipids showed twice the lipid-lowering effect of a preparation containing isolated soy protein alone . Therefore , such soy-based supplements can be useful in reducing the cardiovascular risk ",
"BACKGROUND Soy protein ( SP ) and low-fat dairy product consumption have been suggested to have hypocholesterolemic effects , although the responsible mechanisms are poorly understood . OBJECTIVE This r and omized , controlled , parallel arm trial evaluated the effects of an insoluble fraction of SP and total milk proteins ( TMPs ) with high calcium content on the fasting lipid profile . It also assessed the potential contributions of increased excretion of bile acids and neutral sterols to their lipid-altering effects . METHODS Subjects with hypercholesterolemia ( low-density lipoprotein cholesterol [ LDL-C ] 100 - 199 mg/dL ) followed the Therapeutic Lifestyle Changes diet for 4 weeks , followed by a 2-week lead-in with 3.75 g/d colesevelam HCl . Individuals with LDL-C lowering of ≥5.0 % with colesevelam HCl were r and omly assigned to one of two groups after a 3-week washout : 1 ) 25 g/d of an insoluble fraction of partially hydrolyzed SP or 2 ) 25 g/d TMP . RESULTS Both SP and TMP reduced atherogenic lipoproteins , as indicated by changes in total cholesterol ( -7.4 % and -3.6 % ) , LDL-C ( -10.9 % and -5.9 % ) , nonhigh-density lipoprotein cholesterol ( -10.8 % and -3.9 % ) , and apolipoprotein B ( -9.7 % and -2.4 % ) , respectively ( P for fecal bile acids or neutral sterols . CONCLUSION These results confirm that SP consumption exerts a hypocholesterolemic effect and indicate that TMP elicits a less pronounced response . However , these findings do not support the hypothesis that increased bile acid excretion is an important contributor to the hypocholesterolemic effects of either protein source",
"To address the cardiovascular effects of dietary soy containing phytoestrogens , we measured blood pressure ( BP ) , lipids , vascular function ( systemic arterial compliance and pulse wave velocity ) , and endothelial function ( flow-mediated vasodilation ) in a r and omized , double-blind trial . Two hundred thirteen healthy subjects ( 108 men and 105 postmenopausal women ) , 50 - 75 yr old , received either soy protein isolate ( 40 g soy protein , 118 mg isoflavones ) or casein placebo for 3 months . There were 34 withdrawals ( 16 % ) , with 179 subjects ( 96 men and 83 women ) completing the protocol . After intervention in the soy group , compared with casein placebo , urinary phytoestrogens increased , accompanied by a significant fall in BP reflected by the BP model ( P systolic ( -7.5 + /- 1.2 vs. -3.6 + /- 1.1 mm Hg , P diastolic ( -4.3 + /- 0.8 vs. -1.9 + /- 0.7 mm Hg , P mean BP ( -5.5 + /- 1 vs. -0.9 + /- 1 mm Hg , P low- to high-density lipoprotein ratio ( -0.33 + /- 0.1 vs. 0.04 + /- 0.1 mmol/L , P triglycerides ( -0.2 + /- 0.05 vs. -0.01 + /- 0.05 mol/L , P Lp(a ) lipoprotein ( + /- 95 % confidence interval ) [ 42 ( range , 17 - 67 ) vs. 4 ( range , -22 - 31 ) mg/L , P total , low-density lipoprotein , and high-density lipoprotein cholesterol improved in both groups ; but no treatment effect was demonstrated . The arterial functional model demonstrated no difference between groups ; although again , overall function improved in both groups . On individual analysis , peripheral PWV ( reflecting peripheral vascular resistance ) improved with soy ( P flow-mediated vasodilation ( reflecting endothelial function ) declined ( in males only ) , compared with casein placebo ( P In normotensive men and postmenopausal women , soy improved BP and lipids but , overall , did not improve vascular function . Potential adverse effects were noted , with a decline in endothelial function ( in males only ) and an increase in Lp(a ) . Further research in hypertensive and hyperlipidemic population s is needed",
"SCOPE Equol is produced by the intestinal bacteria from isoflavone daidzein . Studies have reported the health benefits of soy can only present or more pronounced in equol producers . This 6-month r and omized controlled trial examined the effect of whole soy ( soy flour ) and purified daidzein on cardiovascular biomarkers and carotid intima-media thickness ( CIMT ) in prehypertensive postmenopausal women who were equol producers . METHODS AND RESULTS Two hundred seventy eligible women were r and omized to either one of the three treatments : 40 g soy flour ( whole soy group ) , 40 g low-fat milk powder + 63 mg daidzein ( daidzein group ) , or 40 g low-fat milk powder ( placebo group ) daily each for 6 months . Fasting venous sample s were obtained at baseline and end of trial for testing glucose , lipids , high sensitivity C-reactive protein ( hs-CRP ) , and free fatty acid . Changes in common CIMT were also assessed . Serum LDL-C decreased by 7.95 % ( 95 % CI : -15.09∼-0.81 % ) and 6.32 % ( 95 % CI : -13.45∼0.08 % ) , and serum hs-CRP decreased by 0.164 ( 95 % CI : -0.309∼-0.019 ) and 0.054 ( 95 % CI : -0.199∼0.012 ) in the whole soy group compared with daidzein and milk placebo groups , respectively . No significant change in CIMT was found . CONCLUSION Whole soy , but not purified daidzein , had a beneficial effect on reduction of LDL-C and hs-CRP among prehypertensive equol-producing postmenopausal women",
"Objective : Heart and renal diseases are two major problems in diabetic patients . Hyperlipidemia is one of the main risk factors of cardiovascular complications in diabetes . The type of protein consumed also affects the changes in renal blood flow , glomerular resistance and renal function in these patients . Hence , this study was undertaken to show the effect of soy protein consumption on lipid profiles and kidney function of diabetic patients with nephropathy , who attended an educational university hospital as well as a private kidney disease clinic in Tehran . Subjects and methods : This crossover r and omized clinical trial was conducted on 14 patients who were free of any uncontrolled condition or other renal diseases . The patients were asked to follow a usual nephropathy diet ( 0.8 g/kg protein , 70 % animal and 30 % vegetable protein ) for 7 weeks . After a washout period of 4 weeks consuming the pre study diet , subjects were readmitted to repeat the same cycle with a similar diet containing 35 % soy protein and 30 % vegetable protein . Paired t-test , carryover effect and period effect were used for statistical analysis . Results : There were 10 men and four women whose mean ( s.d . ) of weight was 70.6 ( 10.3 ) kg . Significant reductions were seen in total cholesterol ( P triglyceride ( P LDL-c ( P urinary urea nitrogen and proteinuria ( P soy vs animal protein consumption . There were no significant changes in HDL-c , LDL-c/HDL-c levels . We also saw a favorable effect on renal function . Conclusion : Soy inclusion in the diet can modify the risk factors of heart disease and improve kidney function in these patients",
"Objective : To compare the effects of two commercially available soy milks ( one made using whole soy beans , the other using soy protein isolate ) with low-fat dairy milk on plasma lipid , insulin , and glucose responses . Design : R and omized clinical trial , cross-over design . Subjects : Participants were 30–65 years of age , n = 28 , with pre- study LDL-cholesterol ( LDL-C ) concentrations of 160–220 mg/dL , not on lipid lowering medications , and with an overall Framingham risk score of ≤10 % . Intervention : Participants were required to consume sufficient milk to provide 25 g protein/d from each source . The protocol included three 4-week treatment phases , each separated from the next by a wash-out period of ≥4 weeks . Results : Mean LDL-C concentration at the end of each phase ( ± SD ) was 161 ± 20 , 161 ± 26 and 170 ± 24 mg/dL for the whole bean soy milk , the soy protein isolate milk , and the dairy milk , respectively ( p = 0.9 between soy milks , p = 0.02 for each soy milk vs. dairy milk ) . No significant differences by type of milk were observed for HDL-cholesterol , triacylglycerols , insulin , or glucose . Conclusion : A 25 g dose of daily soy protein from soy milk led to a modest 5 % lowering of LDL-C relative to dairy milk among adults with elevated LDL-C. The effect did not differ by type of soy milk and neither soy milk significantly affected other lipid variables , insulin or glucose ",
"Background Lupin protein had hypocholesterolemic effects in laboratory animals . However , the effect in humans has not been eluci date d till now . Aim of the study To investigate the effect of lupin protein on circulating cholesterol in plasma and lipoproteins of hypercholesterolemic subjects . Subjects and methods A r and omised , double-blind , placebo-controlled , parallel trial ( 23 females and 20 males completed the trial ) was conducted to compare the effects of lupin protein versus casein as control protein on plasma lipids and amino acids . Thirty-five grams of the test protein were consumed daily for 6 weeks . Results Both lupin protein and casein result ed in a reduction of circulating plasma cholesterol ( −0.50 ± 0.64 and −0.47 ± 0.79 mM ; P reduction of plasma cholesterol was mainly caused by a reduction of LDL cholesterol in the lupin protein group ( −0.31 ± 0.46 mM ; P casein group HDL cholesterol significantly declined ( −0.17 ± 0.15 mM ; P lupin protein group with the casein group yielded a difference in the net changes from baseline to week 6 in the LDL : HDL cholesterol-ratio of −0.24 ( 95 % CI : −0.007 , −0.479 ; P for plasma concentrations of triglycerides , glucose , homocysteine , taurine and most of the amino acids . Conclusions Lupin protein compared to casein slightly lowered the concentration of LDL cholesterol in hypercholesterolemic subjects , without altering HDL cholesterol . No or minor effects of lupin protein were observed on circulating glucose , homocysteine and plasma amino acids ",
"A drink based on oats has been developed with new technology . In this study the effects of this oat milk , soya milk and cow ’s milk on plasma lipid , glucose , insulin , and antioxidant status ( measured as the ability of serum to suppress the formation of the radical cation ABTS·+ ) were compared in 24 healthy men and women . Half of the subjects ( group A ) consumed 0.75–1 liters/day of oat milk and soya milk for 4 weeks each , and the other half ( group B ) consumed oat milk and cow ’s milk for two 4-week periods . In the combined groups A plus B the oat milk regimen result ed in decreased plasma cholesterol ( 4 % ) and low-density lipoprotein ( LDL ) cholesterol ( 9 % ) levels as compared with baseline , but no changes in high-density lipoprotein cholesterol ( HDL ) and triglyceride values were observed . Also soya milk consumption result ed in decreased LDL cholesterol concentrations . The only significant plasma lipid change observed during consumption of cow ’s milk was an increase in HDL cholesterol . No consistent changes in body weight , fasting blood glucose , serum insulin , and antioxidant status occurred after consumption of any milk regimen . A significant correlation between baseline antioxidant status and total plasma cholesterol was found ( r = –0.56 ) . It is proposed that the high content of β-glucans in oat milk was responsible for the decreased plasma cholesterol and LDL cholesterol concentrations , but the effect could also be due to a replacement of saturated fat in the customary diet by unsaturated fat . It is concluded that oat milk can be used as an alternative to other milk drinks by subjects who would benefit from reduced LDL cholesterol values",
"Aim : To examine cardiovascular health benefits of foods containing a whole soybean extract . Methods : The study design was a r and omized , placebo-controlled crossover trial of consuming soy-based milk and yoghurt ( treatment ) or equivalent dairy products ( control ) for 5 weeks each . Twenty-six mildly hypercholesterolaemic and /or hypertensive volunteers were recruited from the community as study volunteers , of which 23 completed . Main outcome measures included clinic and ambulatory blood pressure , arterial compliance , lipids , fatty acids and isoflavones in fasted blood and 24-hour urinary isoflavone excretion . Nutrient intakes were assessed initially and after each 5-week period . Multiple regression analyses were used to determine predictor variables in statistical models ; order effects were tested by repeated measures ANOVA . Changes in Lp(a ) were determined by Wilcoxon signed ranks tests ; other differences between treatment and control were assessed by t tests . Results : Plasma and urinary isoflavones were markedly increased by whole soy supplementation but there were no overall differences in plasma lipids , blood pressure or arterial compliance between the soy and dairy diets . However , in 8 equol-positive subjects ( equol detected in either plasma or urine ) , retrospective analysis revealed significant reductions in total cholesterol ( 8.5 % ) , LDL cholesterol ( 10 % ) , LDL : HDL ratio ( 13.5 % ) , plasma triglycerides ( 21 % ) and lipoprotein(a ) ( 11 % ) with the soy diet . These reductions were independent of changes in polyunsaturated fat and other macronutrient intakes . Conclusions : Regular consumption of whole soybean milk and yogurt products had no effect on plasma lipids , blood pressure or arterial compliance in at-risk subjects , despite substantially increasing isoflavone levels in blood and urine . Retrospective analysis suggests that improvement of plasma lipids may have been limited to equol-positive subjects",
"♦ Background : Lipid abnormalities , particularly high serum concentration of lipoprotein(a ) [ Lp(a ) ] , are one of the major risk factors for cardiovascular disease ( CVD ) in peritoneal dialysis ( PD ) patients . The present study was design ed to investigate the effects of soy consumption on serum lipids and apoproteins , especially Lp(a ) , in PD patients . ♦ Methods : This study was a r and omized clinical trial in which 40 PD patients ( 20 males , 20 females ) were r and omly assigned to either the soy or the control group . Patients in the soy group received 28 g/day textured soy flour ( containing 14 g of soy protein ) for 8 weeks , whereas patients in the control group received their usual diet , without any soy . At baseline and the end of week 8 of the study , 5 mL of blood was collected from each patient after a 12- to 14-hour fast and serum triglyceride , total cholesterol , low density lipoprotein-cholesterol ( LDL-C ) , high density lipoprotein-cholesterol ( HDL-C ) , apoprotein B100 ( apo B100 ) , apoprotein AI ( apo AI ) , and Lp(a ) were measured . ♦ Results : In the present study , serum Lp(a ) concentrations were above the normal range in 86 % of the PD patients . Mean serum Lp(a ) concentration was reduced significantly , by 41 % , in the soy group at the end of week 8 compared to baseline ( p study , mean serum Lp(a ) concentration did not change significantly in the control group . There were no significant differences between the two groups in mean changes in serum triglyceride , total cholesterol , HDL-C , LDL-C , apo B100 , or apoAI . ♦ Conclusion : The results of our study indicate that soy consumption reduces serum Lp(a ) concentration , which is a risk factor for cardiovascular disease in peritoneal dialysis patients",
"OBJECTIVES To determine whether , in individuals with hypercholesterolemia , substituting dietary soybean products for cows ' milk products improves the plasma lipid profile and whether any change in the profile is due partially to soy oil . DESIGN R and omized 3-treatment crossover trial . SETTING Family practice clinics and an outpatient clinic in London , Ont . PARTICIPANTS Seventeen healthy men and 17 healthy women with elevated plasma levels of total and low-density-lipoprotein ( LDL ) cholesterol and with normal plasma levels of triglycerides . INTERVENTIONS Participants incorporated into their normal diet either 2 % cows ' milk products , soybean products or a combination of skim milk products and soy oil , each over period of 4 weeks , with 22-week wash-out periods . Plasma lipid profile , blood pressure and body weight were assessed after each dietary and wash-out period . OUTCOME MEASURES Plasma levels of total and lipoprotein cholesterol , plasma levels of triglycerides , apolipoprotein B and A1 levels , blood pressure and plasma lipid peroxidation . RESULTS The change in diet had no effect on body mass index , levels of apolipoproteins B and A1 and most plasma lipids . During the soybean period , the subjects ' mean level of high-density-lipoprotein ( HDL ) cholesterol increased 9 % ( p mean LDL/HDL cholesterol ratio decreased 14 % ( p LDL cholesterol level and LDL/HDL cholesterol ratio , the mean LDL cholesterol level decreased 11 % after the soybean period . In all subjects , changes in the LDL/HDL cholesterol ratio induced by a soybean diet were negatively correlated with the initial LDL/HDL cholesterol ratio and positively correlated with the initial HDL cholesterol level . CONCLUSIONS In people with hypercholesterolemia , the plasma lipid profile improved after treatment with a soybean-product diet , and this improvement was partially due to soy oil . The degree of responsiveness was associated with initial risk factors for coronary artery disease",
"Objective : The risk of heart disease increases significantly in women after menopause mostly because of estrogen deficiency . Soy protein , a good source of isoflavones that are known to bind estrogen receptors , has also been promoted as a dietary means for reducing the risk of heart disease . The aim of this study was to examine the effects of soy protein consumption on heart disease risk in postmenopausal women . Methods : Moderately hypercholesterolemic postmenopausal women were r and omly assigned to consume soy or control foods daily for 1 year . Serum sample s were analyzed for total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , triglycerides , apolipoprotein ( Apo ) A , and Apo B. Sixty-two women completed the study . Results : There was a trend for total cholesterol and high-density lipoprotein cholesterol levels to increase after 1 year of soy protein supplementation ( 230.04 ± 6.1 vs 242.57 ± 6.2 mg/dL , P in low-density lipoprotein cholesterol or triglyceride levels ; however , a significant increase in Apo B levels ( 105.5 ± 5.9 vs 120.21 ± 5.9 mg/dL ; P = 0.002 ) and a significant decrease in Apo A levels ( 189.36 ± 10 vs 173.21 ± 10 mg/dL ; P = 0.009 ) were seen . Conclusions : Our data indicate that 1-year soy protein supplementation did not confer cardiovascular benefits , in terms of favorable alterations in the lipid profile , in this cohort of postmenopausal women . These findings , as well as those from other studies , lend credence to the decision of the Food and Drug Administration to reevaluate the soy protein health cl aim issued a decade ago",
"OBJECTIVE This study assessed whether the consumption of soy milk could add significantly to the lipid profile and lipid peroxidation in comparison with non-fat milk . METHODS A double-blind , r and omized , crossover study was conducted on 60 out patients with primary hypercholesterolemia following a lipid-lowering diet for at least 6 wk . Lipid profile was obtained at baseline and at 6 and 12 wk , with the patients r and omly assigned to receive initially 1 L/d of soy milk or non-fat cow milk for 6 wk . Lipid peroxidation was estimated by plasma thiobarbituric reactive substances . Apolipoprotein E genotypes were examined by polymerase chain reaction restriction fragment length polymorphism . RESULTS The soy milk diet was associated with low-density lipoprotein cholesterol reduction ( baseline = 157 + /- 5 mg/dL ; soy milk = 148 + /- 4 mg/dL ; non-fat cow milk = 158 + /- 4 mg/dL ; P high-density lipoprotein cholesterol increase ( baseline = 58 + /- 2 mg/dL ; soy milk = 62 + /- 2 mg/dL ; non-fat cow milk = 57 + /- 2 mg/dL ; P plasma thiobarbituric reactive substances were reduced by the soy milk diet ( baseline = 1.82 + /- 0.12 nM/L ; soy milk = 1.49 + /- 0.09 nM/L ; non-fat cow milk = 1.91 + /- 0.11 nM/mL ; P Changes in lipid profile were not influenced by APOE genotypes . CONCLUSIONS These results indicate that soy milk as part of a lipid-lowering diet has beneficial effects in improving lipid profile and reducing lipid peroxidation",
"In order to evaluate acceptability and effectiveness of a partial addition of soy protein to the daily diet in well-established type II hypercholesterolemic individuals , a double-blind study was carried out with a soy milk providing 25 g/day of protein versus an identically formulated cow ’s milk . Twenty patients with type II hypercholesterolemia , 4 males and 16 females , age range 38–76 years , all with cholesterol levels > 7 mmol/l and low-density lipoprotein cholesterol . Significant triglyceride elevations ( WHO Fredrickson type IIB ) were present in 4 patients , and the body mass index was 24.2 ± 3.47 kg/m2 . Different from prior studies , either with isoflavone-free products or with a moderately isoflavone-rich milk , the milk in the present study did not reduce total and low-density lipoprotein cholesterolemia . A detailed analysis of the composition showed significant differences in the isoflavone content versus products used in prior studies with a positive outcome . Soy milk isoflavones were , in fact , characterized by a high glycitein content and a low genistein/daidzein ratio . Glycitein is a minor component in most soy products , and its role in cholesterol regulation is unclear . In view of the high interest in the use of soy products for the prevention of coronary diseases , the metabolic behavior of different isoflavones in man should be better characterized , and the role of isoflavone composition of soy products given for the control of cholesterolemia needs further clarification",
"Context : Recent interventional studies indicate that post-menopausal hormone replacement therapy is associated with an increased risk of cardiovascular mortality and breast cancer . Isoflavones , a class of plant estrogens , have structural similarities to estradiol . Hence , isoflavones may exert beneficial estrogenic health effects in postmenopausal women with fewer adverse effects . Objective : To evaluate the effect of high-dose isoflavones on self-reported quality of life ( QOL ) , cognition , lipoproteins and and rogen status in post-menopausal women . Design and subjects : Double-blind , r and omized , placebo-controlled , 12-week trial of 93 healthy , ambulatory , post-menopausal women ( mean age 56 yr ) . The study was conducted at a tertiary care center in the United States . Intervention : Participants were r and omly assigned to receive 20 g of soy protein containing 160 mg of total isoflavones vs taste-matched placebo ( 20 g whole milk protein ) . Both soy and the placebo were provided in the form of a powder to be mixed with beverages . Main outcome measures : QOL was judged by the Menopause-specific Quality of Life ( MENQOL ) question naire while cognitive function was assessed with st and ard instruments . Total , free , and bioavailable testosterone , gonadotropins , SHBG , and fasting lipids were measured . Results : Eighty-four women ( 90 % ) completed the study ( active=38 , placebo=46 ) . There was a significant improvement in all 4 QOL subscales ( vasomotor , psychosexual , physical , and sexual ) among the women taking isoflavones , while no changes were seen in the placebo group . No significant changes in cognition , serum and rogens or plasma lipids were seen within any of the groups . However , at the end of the study , a group-by-time interaction was observed such that total testosterone and HDL levels were significantly lower in the isoflavones compared to placebo groups . Conclusion : High-dose isoflavones is associated with improved QOL among women who have become menopausal recently . Hence , the timing of isoflavone supplementation with regards to the onset of menopause appears to be important . The use of isoflavones , as an alternative to estrogen therapy , may be potentially useful and seemingly safe in this group of women who are looking for relief from menopausal symptoms",
"BACKGROUND Information is scarce regarding the effect of dietary protein type , with specific focus on the lysine-to-arginine ( Lys : Arg ) ratio , on cardiovascular risk factors and vascular reactivity in humans . OBJECTIVE Determine the effect of dietary Lys : Arg ratio on cardiovascular risk factors and vascular reactivity in moderately hypercholesterolemic adults . DESIGN R and omized cross-over design of two 35-day diet phases ; thirty adults ( 21 females and 9 males , > or=50 years , LDL cholesterol > or=120 mg/dL ) . Diets had 20 % energy ( E ) protein , 30%E fat , 50%E carbohydrate and were design ed to have low ( 0.7 ) or high ( 1.4 ) Lys : Arg ratio . Measures included fasting and postpr and ial lipid , lipoprotein , apolipoprotein concentrations ; fasting high sensitivity C-reactive protein ( hsCRP ) , small dense LDL ( sdLDL ) cholesterol , remnant lipoprotein cholesterol ( RemLC ) , glycated albumin , adiponectin and immunoreactive insulin concentrations , endogenous cholesteryl ester transfer protein ( CETP ) and lecithin : cholesterol acyl transferase ( LCAT ) activities ; cholesterol fractional synthesis rate ( FSR ) ; and flow mediated dilation ( FMD ) and peripheral artery tonometry ( PAT ) . RESULTS No differences were observed in fasting and /or postpr and ial total , LDL , HDL and sdLDL cholesterol , RemLC , Lp(a ) or apo B concentrations , LCAT and CETP activities , FSR , glycated albumin , immunoreactive insulin , FMD or PAT . The low , relative to the high , Lys : Arg ratio diet result ed in lower postpr and ial VLDL cholesterol ( -24 % , P=0.001 ) and triglycerides ( -23 % , P=0.001 ) , and small but significant differences in fasting ( -3 % , P=0.003 ) and postpr and ial ( -3 % , P=0.018 ) apo AI , and fasting adiponectin concentrations ( + 7 % , P=0.035 ) . Fasting and postpr and ial hsCRP concentrations were 23 % lower after the low Lys : Arg ratio diet ( P=0.020 for both ) . CONCLUSIONS Diets differing in Lys : Arg ratios had no or small effects on cardiovascular risk factors and vascular reactivity",
"BACKGROUND Increased consumption of soy foods has been associated with reduction in low density lipoprotein cholesterol ( LDL-C ) in both clinical and observational studies . However , it is not clear whether adding soy to a low-fat diet has additional lipid-lowering benefits , and few previous studies have examined these effects in women using hormone replacement therapy ( HRT+ ) . METHODS We tested whether adding soy protein to a low-fat , high-fiber , Step I diet improved cardiac risk markers in 18 postmenopausal women and 14 men with hypercholesterolemia and examined whether concurrent use of HRT altered diet responsiveness . Diets were matched for macronutrient content , and all food was provided . After 3 weeks on the Step I diet , subjects were r and omized to diets ( 6 weeks ) containing 25 g/day protein isolate from soy or cow 's milk , with crossover . The soy treatment contained 90 mg/day isoflavones . Lipids , vascular cell adhesion molecule-1 ( VCAM-1 ) , p-selectin , and urinary isoflavonoids were measured at the end of each diet . RESULTS In men and HRT- women only , there were significant reductions in LDL-C ( -17.3 % ) , high-density lipoprotein cholesterol ( HDL-C ) ( -15.3 % ) , and triglycerides ( -11.5 % ) during the Step I diet , and soy had no additional effects . At study entry , HRT+ women had lower LDL-C and higher triglycerides than men . Their LDL-C was unchanged , and triglycerides were significantly reduced ( -15.1 % ) by the Step I diets . Isoflavonoid excretion was unrelated to diet response or HRT status . CONCLUSIONS In men and HRT- women , the diets significantly lowered LDL-C , independent of soy intake . In HRT+ women , the diets improved triglycerides without lowering",
"This study was undertaken to compare the effects on plasma cholesterol concentration of a new isolated soy protein in which the protein structure is kept in its native , nondenaturated form ( verum 1 ) versus a conventional isolated soy protein ( verum 2 ) and milk protein ( placebo ) . This prospect i ve , r and omized , double-blind , placebo-controlled study was conducted in an outpatient clinical study center in Berlin , Germany . Over 8 wk , 120 patients ( total cholesterol , 5.2–7.8 mmol/L ) were given verum 1 , verum 2 , or placebo at a dosage of 25 g protein daily . At the end of the treatment period , total cholesterol levels were significantly reduced by 10.7 % in the verum 1 group compared with placebo ( P ) . Low-density lipoprotein cholesterol levels were significantly reduced with nondenaturated isolated soy protein only : levels were reduced by 9.4 % in the verum 1 group ( P=.002 ) and by 4.9 % in the verum 2 group ( P=.107 ) . Again , the difference between the verum groups was significant ( P=.05 ) . The results of this study confirm that supplementation with isolated soy protein can lead to significant reductions in plasma concentrations of total and low-density lipoprotein cholesterol . These reductions are significantly more pronounced with an isolated soy protein that maintains the native protein structure than with a commercially available reference isolated soy protein",
"CONTEXT Isolated soy protein reduces plasma concentrations of total and low-density lipoprotein ( LDL ) cholesterol . OBJECTIVE To identify the agent(s ) responsible for the cholesterol-lowering effect of soy in mildly hypercholesterolemic volunteers : isoflavones isolated together with soy protein or soy protein itself . DESIGN Double-blind r and omized parallel trial . SETTING Single-center study . PARTICIPANTS A total of 156 healthy men and women with LDL cholesterol levels between 3.62 mmol/L ( 140 mg/dL ) and 5.17 mmol/L ( 200 mg/dL ) after instruction in a National Cholesterol Education Program Step I diet and recruited by advertisement from the community . INTERVENTION One of 5 daily diets ( 25 g of casein [ for isoflavone-free comparison ] or 25 g of isolated soy protein containing 3 , 27 , 37 , or 62 mg of isoflavones ) . MAIN OUTCOME MEASURES Change and percent change from baseline in plasma concentrations of triglycerides and total , LDL , and high-density lipoprotein cholesterol after 9 weeks . RESULTS Compared with casein , isolated soy protein with 62 mg of isoflavones lowered total and LDL cholesterol levels by 4 % ( P = .04 ) and 6 % ( P = .01 ) , respectively . In patients with LDL cholesterol levels in the top half of the population studied ( > 4.24 mmol/L [ > 164 mg/dL ] ) , comparable reductions were 9 % ( P isolated soy protein with 37 mg of isoflavones reduced total ( P = .007 ) and LDL ( P = .02 ) cholesterol levels by 8 % , and there was a dose-response effect of increasing amounts of isoflavones on total and LDL cholesterol levels . Plasma concentrations of triglycerides and high-density lipoprotein cholesterol were unaffected . Ethanol-extracted isolated soy protein containing 3 mg of isoflavones did not significantly reduce plasma concentrations of total or LDL cholesterol . CONCLUSIONS Naturally occurring isoflavones isolated with soy protein reduce the plasma concentrations of total and LDL cholesterol without affecting concentrations of triglycerides or high-density lipoprotein cholesterol in mildly hypercholesterolemic volunteers consuming a National Cholesterol Education Program Step I diet . Ethanol-extracted isolated soy protein did not significantly reduce plasma concentrations of total or LDL cholesterol",
"BACKGROUND Hyperlipidemic factors contribute to the high cardiovascular risk in hemodialysis patients . Soy protein has decreased some atherogenic lipid concentrations in subjects with normal renal function . This study evaluates the effect of soy protein on serum lipid profiles in hyperlipidemic and normolipidemic hemodialysis patients . METHODS Nineteen hyperlipidemic and 18 normolipidemic hemodialysis patients were enrolled in a r and omized , double-blind , placebo-controlled , clinical trial . After a 4-week run-in phase , subjects in each category were r and omly assigned to 2 groups . Thirty grams of isolated soy protein or milk protein was consumed daily as a beverage at breakfast or postdialysis for 12 weeks . RESULTS In hyperlipidemic subjects , soy protein intake significantly decreased total cholesterol levels by 18.6 % ( 95 % confidence interval [ CI ] , -11.4 to -25.8 ; P = 0.04 ) , triglyceride levels by 43.1 % ( 95 % CI , -34.0 to -52.2 ; P = 0.02 ) , non-high-density lipoprotein cholesterol levels by 23.6 % ( 95 % CI , -14.7 to -32.5 ; P apolipoprotein B levels by 15.4 % ( 95 % CI , -5.4 to -25.4 ; P = 0.01 ) , and insulin levels by 49.8 % ( 95 % CI , -23.3 to -66.1 ; P Low-density lipoprotein cholesterol concentration was decreased significantly ( -25.8 % ; 95 % CI , -8.3 to -42.7 ; P = 0.01 ) , and high-density lipoprotein cholesterol level was increased significantly ( 17 % ; 95 % CI , 2 to 32.0 ; P = 0.03 ) , but there was no significant difference compared with the milk protein group ( -5.5 % + /- 16.9 % and 7.0 % + /- 11.8 % , respectively ) . There were no significant changes in serum lipid and lipoprotein concentrations in normolipidemic subjects . CONCLUSION These results indicate soy protein substitution has lipid-lowering effects in hyperlipidemic hemodialysis patients . However , soy protein intake had little effect on plasma lipid levels in normolipidemic hemodialysis patients",
"BACKGROUND AND AIM Postmenopausal modification of the lipid profile plays a major role in the risk of ischemic heart disease . Lifestyle counseling and estrogen replacement therapy have all been proposed as first-line measures , but there is no agreement on the best way to treat climacteric dyslipidemia . Soybean-based diet seems particularly attractive in this context , given its cholesterol lowering potential , its hypothetical anticancerous effects and possible modification of climacteric symptoms . METHODS AND RESULTS We evaluated the effect of 60 g isolated soy protein ( ISP ) daily on the lipid profile of 104 postmenopausal women ( 53.3 + /- 3.3 years ) in a double-blind , parallel , placebo-controlled ( caseinate ) trial , as part of a broader assessment of the effect of ISP on climacteric symptomatology . Serum total cholesterol , LDL-cholesterol , HDL-cholesterol , triglycerides , apo A-I , apo B and lipoprotein ( a ) were determined before and after a 12-week diet modification . Seventy-seven women completed the trial . Both soy and placebo determined a significant reduction in total cholesterol ( -0.42 + /- 0.79 and -0.40 + /- 0.57 mmol/L ) and LDL-cholesterol ( -0.35 + /- 0.72 and -0.31 + /- 0.54 mmol/L ) , but only soy had a significant lowering effect on apo B and the LDL-cholesterol/HDL-cholesterol ratio ( -6 % and -8 % from baseline respectively ) ; lipoprotein ( a ) plasma levels were not significantly changed by either treatment . Forty-four women were dyslipidemic at baseline ; those with increased LDL concentrations showed a somewhat greater improvement in their lipoprotein profile ( LDL-cholesterol and apo B reduction ) with soy rather than placebo . No further information emerged when the subjects were divided into three apo E phenotypes . CONCLUSIONS We conclude that diet supplementation with 60 g ISP is slightly better than caseinate in favorably modifying the lipoprotein metabolism of postmenopausal women ; this effect is more evident in hypercholesterolemic subjects",
"A soybean textured protein induced a 14 % decrease of plasma-cholesterol levels after two weeks and 21 % after three when substituted for animal proteins in a group of 20 patients with type-II hyperlipoproteinaemia . Comparison of soybean diet with a st and ard low-lipid diet in the same patients , according to a cross-over protocol , indicated that this hypocholesterolaemic effect was not due to differences in the lipid composition of the two diets . The hypothesis that a soy protein has a hypocholesterolaemic action per se is supported by the results of a subsequent experiment in 8 type-II patients in whom the addition of cholesterol ( 500 mg/day ) to soy protein did not modify the hypocholesterolaemic response",
"The nutritional composition of dietary intake could produce specific effects on metabolic variables such as mitochondrial oxidation , whose underst and ing could contribute to apply more individualized weight-lowering strategies . This study assessed the effects of four hypocaloric diets with high protein content or different food distribution on metabolic changes and mitochondrial oxidation accompanying weight loss . Thirty-five obese men ( body mass index of 31.8 + /- 3.0 kg/m(2 ) and 38 + /- 7 years old ) were r and omly assigned to one of the four treatments ( 8 weeks ) : control diet ( C-diet ) ; legume diet ( L-diet ) ; fatty fish diet ( FF-diet ) ; or high-protein diet ( HP-diet ) . Body composition , blood pressure , resting energy expenditure , mitochondrial oxidation , blood biomarkers , and dietary intake were assessed . The HP-diet and L-diet achieved the greater body weight reduction ( -8.4 + /- 1.2 % and -8.3 + /- 2.9 % , respectively ) , as compared to the C-diet ( -5.5 + /- 2.5 % ; P = .042 ) . The high-density lipoprotein cholesterol concentrations were reduced in all dietary groups except for the FF-diet . Total and low-density lipoprotein cholesterol levels were significantly improved by the L-diet ( P homeostatic model assessment index of insulin resistance value was significantly reduced in those men following the HP-diet . Mitochondrial oxidation was specifically activated by the HP-diet and L-diet at the end of the study . Interestingly , a lineal regression model explained about 25 % ( P = .029 ) of the mitochondrial oxidation variability as influenced by the diet changes once adjusted by resting energy expenditure . The specific consumption of legumes or high protein content within a hypocaloric diet could activate mitochondrial oxidation , which could involve additional benefits to those associated with the weight reduction",
"Abstract The effects of the isocaloric substitution of soy for animal protein on plasma lipoprotein lipid and apoprotein levels was examined in 12 out patients with primary hypercholesterolemia and 4 normals . After stabilization on either a st and ard NIH-Type IIA low-cholesterol diet ( Type II patients ) , or a regular diet ( normals ) for 6 weeks , the animal and soy protein diets were administered in r and om sequence ( forward studies : animal → soy , reverse studies : soy → animal ) for 6 weeks . The nutrient content and composition of the two experimental diets were the same in all respects except for the type of protein . Body weights remained constant , and the results of both forward ( n = 6 ) and reverse ( n = 10 ) studies were similar . The soy and animal protein diets both lowered plasma cholesterol , low density lipoprotein ( LDL ) cholesterol and apoprotein B levels in the hypercholesterolemic patients significantly below levels achieved on the basal diets . Since the two experimental diets differed only in their protein constituents , the independent effects of soy protein on plasma lipid and apoprotein concentrations could be determined . The isocaloric substitution of soy for animal protein result ed in additional reductions in the plasma concentrations of total cholesterol by −3.5 ± 5 % ( P = 0.05 ) , LDL cholesterol by −6.0 ± 7.2 % ( P",
"OBJECTIVES To study possible synergistic effects of oats and soy on reducing total and low-density lipoprotein cholesterol ( LDL-C ) concentrations in human beings and the efficacy and feasibility of including these adjustments to a National Cholesterol Education Program Step I diet . SUBJECT/ SETTING : One hundred twenty-seven postmenopausal women with moderate hypercholesterolemia were recruited from a large Midwestern workforce and senior centers in the surrounding community . Intervention and clinical visits were conducted in these same facilities . DESIGN After a 3-week lead-in period on the Step I diet , participants were r and omly assigned to 1 of 4 dietary treatments for an additional 6 weeks : an oats/milk group , a wheat/soy group , an oats/soy group , and a wheat/milk group . Clinical measurements included blood draws , body weight and height , blood pressure , and medical history data . Three-day food records were collected at baseline and Weeks 3 and 9 of the intervention . R and omization was stratified based on the status of hormone replacement therapy and was blocked with sizes 4 or 8 for group assignment . RESULTS After 3 weeks on the Step I diet , total cholesterol , LDL-C , and triglyceride levels ; total fat and saturated fat intake , dietary cholesterol intake , Keys score , and body mass index were all reduced . Following an additional 6 weeks on the Step I diet plus intervention , total cholesterol and LDL-C were further reduced for both the oats/soy group and oats/milk group . There were no significant further changes in total cholesterol , LDL-C , or high-density lipoprotein cholesterol levels in the wheat/soy and wheat/milk groups . Body mass index remained stable in all groups from Week 3 to Week 9 . APPLICATIONS Nonpharmacologic dietary interventions like the Step I diet are feasible in a community setting and can produce rapid and significant lipid-lowering benefits . Daily consumption of 2 servings of oats can contribute to further lipid alterations in this population although soy intake at this dose may not . Palatability and convenience are important considerations in achieving dietary adherence",
"Objective : Some clinical trials have demonstrated a beneficial effect of dietary soy protein on improving lipoproteins . Research also has documented that serum lipoproteins and some lipoprotein subclasses are altered as a consequence of menopause , result ing in a more atherogenic lipid profile . The purpose of this study was to determine the effects of isolated soy protein-containing isoflavones on lipoproteins and lipoprotein subclasses in both African American and white postmenopausal women with borderline to moderate low-density lipoprotein cholesterol elevations . Design : This was a r and omized , double-blind , controlled clinical trial including 216 postmenopausal women . After a 4-week run-in period with a casein protein-based supplement , participants were r and omly assigned to continue the casein placebo or receive soy protein-containing isoflavones for a period of 12 weeks . Results : In the soy group , the total cholesterol , low-density lipoprotein cholesterol , and low-density lipoprotein particle number decreased significantly as compared with the placebo group at 6 weeks . Although this decrease continued at 12 weeks in the soy group , the difference from the placebo group was attenuated for total cholesterol and low-density lipoprotein particle number . Multivariate analyses controlling for age , race , change in weight , change in dietary fat intake , and change in kilocalorie energy expenditure revealed that treatment remained a significant independent predictor of change in total cholesterol ( P = 0.01 ) , low-density lipoprotein cholesterol ( P = 0.02 ) , and low-density lipoprotein particle number ( P = 0.002 ) after 6 weeks of dietary soy . Conclusions : Increased consumption of soy protein replacing animal protein that is high in fat may help improve atherogenic lipid profiles",
"Background : Dietary intake of soy protein with isoflavones may be associated with reductions in serum cholesterol . Objectives : To compare the effects of a water-washed soy protein concentrate with a milk-protein based control on blood lipid levels in hyperlipidemic men and women . Methods : A r and omized , double-blind , controlled clinical trial including 159 subjects . After a 3-week run-in period during which all subjects consumed a milk protein-based supplement , participants were r and omized into one of two groups : a control group ( continued milk protein ) and an intervention group ( soy protein ) for a five-week period . Fasting venous blood draws for lipid measurement were obtained at baseline , towards the end of the run-in period and at the end of the intervention . Blood isoflavone concentrations were measured at the end of the study . Results : Blood lipid levels were not significantly different between groups at any point in time ; and there were no significant associations between blood isoflavones and lipid levels . Significant decreases in total cholesterol ( 19 mg/dL ) , and LDL-cholesterol ( 11 mg/dL ) , were observed during the run-in period , with no further decreases in lipids during the intervention period in either group . Conclusions : These results do not support the hypothesis that water-washed soy protein has an effect on blood lipids . Several hypotheses are discussed , highlighting the selective nature of the effect of soy consumption in the population . The cholesterol-lowering effect during the run-in period may be explained by the “ regression to the mean effect ” and by other factors related to study participation , mainly nutrient displacement induced by the protein supplement",
"Background / aim Because of an unfavorable serum lipoprotein profile , postmenopausal women are at risk of cardiovascular disease . Soy protein may help protect against these risk factors , although its effect on paraoxonase 1 ( PON1 ) is not clear . The aim of the present study was to determine the effects of soy protein on serum concentration of lipoproteins and PON1 activity in hypercholesterolemic postmenopausal women . Design In a double-blind r and omized clinical trial with a parallel design , 52 hypercholesterolemic postmenopausal women were r and omly assigned to 50 g/day soy protein containing 164 mg isoflavones or placebo , for 10 weeks . Serum lipoproteins and PON1 activity were measured at baseline and at the 10th week . Results There was significant increase in PON1 activity ( P=0.029 ) and a significant decrease in low-density lipoprotein cholesterol ( LDL-C ) , total cholesterol ( TC ) , LDL-C/high-density lipoprotein cholesterol ( HDL-C ) , triacylglycerol/HDL-C and TC/HDL-C in the soy group compared with the placebo group ( P=0.001 , P=0.008 , P=0.012 , P=0.04 and P=0.029 , respectively ) at the end of the study . Similarly , PON1 activity was significantly increased ( P=0.015 ) and LDL-C , TC , LDL-C/HDL-C , triacylglycerol/HDL-C and TC/HDL-C were significantly decreased ( P=0.001 , P=0.002 , P=0.001 , P=0.016 and P=0.001 ) at the end of the study compared with the beginning value in soy group . Conclusion Soy protein reduces the cardiovascular disease risk in postmenopausal women because of both modest reductions in serum lipoproteins and an increase in PON1 activity",
"CONTEXT Postmenopausal estrogen therapy has been posited to have some beneficial effects on aging processes , but its use has risks . Isoflavones , estrogenlike compounds naturally occurring in plant foods , might confer positive effects with fewer adverse effects . OBJECTIVE To investigate whether soy protein with isoflavones improves cognitive function , bone mineral density , and plasma lipids in postmenopausal women . DESIGN , SETTING , AND PARTICIPANTS Double-blind , r and omized , placebo-controlled trial of 202 healthy postmenopausal women aged 60 to 75 years , recruited from a population -based sample in the Netherl and s , conducted between April 2000 and September 2001 . INTERVENTION Participants were r and omly assigned to receive 25.6 g of soy protein containing 99 mg of isoflavones ( 52 mg genistein , 41 mg daidzein , and 6 mg glycetein or total milk protein as a powder on a daily basis for 12 months . MAIN OUTCOME MEASURES Cognitive function was assessed using the following instruments : dementia , Mini-Mental State Examination ; memory , Rey Auditory Verbal Learning Test , immediate recall , delayed recall , and recognition , the Digit Span forward and reversed , and the Doors test ; complex attention tasks , Digit Symbol Substitution and Trailmaking , A1 , A2 , and B ; and verbal skills , Verbal Fluency A and N , animals and occupations , and the Boston Naming Task . Bone mineral density of the hip and lumbar spine was assessed using dual-energy x-ray absorptiometry scanning . Lipid assessment included lipoprotein(a ) , total cholesterol , low-density lipoprotein , high-density lipoprotein , and triglycerides . RESULTS A total of 175 women completed the baseline and at least 1 postintervention analysis and were included in the modified intent-to-treat analysis . Adherence was good ( median plasma genistein levels , 17.2 and 615.1 nmol/L for placebo and soy group , respectively ) . Cognitive function , bone mineral density , or plasma lipids did not differ significantly between the groups after a year . CONCLUSION This double-blind r and omized trial does not support the hypothesis that the use of soy protein supplement containing isoflavones improves cognitive function , bone mineral density , or plasma lipids in healthy postmenopausal women when started at the age of 60 years or later",
"BACKGROUND & AIMS Observational studies note that regular dietary soy protein intake ( 6 - 11 g day(-1 ) ) has a significant association with lower blood lipids ; however , these observations have not been confirmed by clinical trials . This study aim ed to ascertain the effects of moderate intake of soy protein ( 15 g ) with isoflavones or isoflavones alone on serum lipid profiles , inflammatory markers ( C-reactive protein and uric acid ) and composite cardiovascular risk in Chinese postmenopausal , prediabetic women . METHODS AND RESULTS A double-blind r and omised , placebo-controlled trial was conducted among 180 postmenopausal Chinese women with prediabetes or early untreated diabetes , aged 46 - 70 years and , on average , 6.0 years since menopause . Participants were r and omly assigned to one of the three arms to receive 15-g soy protein and 100-mg isoflavone ( Soy group ) , or 15-g milk protein and 100 mg isoflavone ( Iso group ) or 15-g milk protein ( placebo group ) on a daily basis for 6 months . The results showed that no significant difference was observed in serum high-density lipoprotein-cholesterol ( HDL-C ) , low-density lipoprotein-cholesterol ( LDL-C ) , total cholesterol ( TC ) , triaclyglycerol ( TG ) , high sensitive C-reactive protein and a composite 10-year cardiovascular risk between the three groups at both 3 and 6 months . Serum uric acid marginally increased by 1.22 % in the Soy group and decreased by 4.28 % and 4.82 % in the Iso and placebo groups at 3 months ( P = 0.087 ) , but no difference was observed at 6 months ( P = 0.264 ) . CONCLUSION Soy protein with isoflavones or isoflavones alone at the provided dosage showed no significantly beneficial effects on measured cardiovascular risk factors in postmenopausal Chinese women with early hyperglycaemia",
"Twenty-one mildly hypercholesterolemic men consumed a diet that was low in fat ( protein + 20 g dietary fiber daily from either isolated soybean protein + soybean cotyledon fiber , isolated soybean protein + cellulose , casein + soybean cotyledon fiber or casein + cellulose . All subjects progressed through the low fat , low cholesterol baseline period , lasting 2 wk , and then through all four dietary treatments , lasting 4 wk each , according to a Latin square design . Plasma concentrations of total , LDL , HDL and VLDL cholesterol , total and VLDL triacylglycerols , and apolipoprotein A-I and B were measured at the end of each period . When data from all subjects were analyzed , dietary treatments did not influence lipemia ; however , in subjects with initial total cholesterol concentrations > 5.7 mmol/L , both isolated soybean protein treatments result ed in significantly lower total cholesterol compared with the two casein treatments ( P total or LDL cholesterol change after each of the soybean treatments was regressed against the subject 's baseline cholesterol concentration ( P Apolipoprotein A-I varied dependent on baseline cholesterol with no apparent pattern , whereas apolipoprotein B levels were not affected . Results indicate that consumption of 25 g soybean protein/d is associated with lower total cholesterol concentrations in individuals with initial cholesterol concentrations > 5.7",
"OBJECTIVE We examined if the predominant source of dietary protein influenced the lipoprotein-lipid profile in older men who performed resistive exercise training ( RT ) . DESIGN This is a 14-week , r and omized , repeated- measures study with a 12-week period of RT with supplementation of different sources of dietary protein ( beef and soy ) . SETTING Nutrition , Metabolism , and Exercise Laboratory , Central Arkansas Veteran 's Healthcare System , North Little Rock , Ark. Subjects Twenty-six healthy men were recruited , and 21 men ( age 65 + /- 5 years , body mass index 28.2 + /- 2.6 kg/m 2 ) completed the study . Interventions For 14 weeks , all men were counseled to self-select a lacto-ovo-vegetarian diet . For 2 weeks ( baseline ) , all men also consumed 0.6 g-protein/kg per day from portioned quantities of soy-based texturized vegetable protein foods . For the next 12 weeks , 11 men were r and omized to continue with texturized vegetable protein foods ( VEG group ) , whereas 10 men were r and omized to receive 0.6 g-protein/kg per day from portioned quantities of beef ( BEEF group ) and continue their otherwise lacto-ovo-vegetarian diet . All men participated in RT 3 d/wk during this 12-week period . Assessment s of upper and lower body muscle strength and power , serum lipoprotein-lipid profile , and dietary nutrient intakes were made at baseline and week 12 of RT ( POST ) . RESULTS The BEEF and VEG groups increased ( P overall muscle strength and muscle power with RT , with no differences between groups . From baseline to POST , the BEEF group had increased concentrations of high-density lipoprotein cholesterol ( P = .025 ; HDL-C ) , low-density lipoprotein cholesterol ( P = .027 ; LDL-C ) , and total cholesterol ( P = .015 : CHOL ) , with no changes ( P > .05 ) in triacylglycerol ( TG ) , the CHOL/HDL-C ratio , or the TG/HDL-C ratio . The VEG group did not experience within-group changes ( P > .05 ) in any lipoprotein-lipid parameter . At POST , the concentrations of HDL-C , LDL-C , and CHOL were greater in the BEEF group compared with the VEG group . There were significant interaction effects for HDL-C ( P = .004 ) and the TG/HDL-C ratio ( P = .022 ) . Multiple regression analysis determined that , regardless of intervention , change in the saturated fat/fiber ratio ( SF/fiber ) predicted CHOL ( adjusted R 2 = 0.34 ) ; the SF/fiber ratio predicted LDL-C ( adjusted R 2 = 0.36 ) ; the cholesterol/fiber intake ratio predicted HDL-C ( adjusted R 2 = 0.26 ) , and the change in carbohydrate intake predicted the CHOL/HDL-C ratio ( adjusted R 2 = 0.37 ) and TG ( adjusted R 2 = 0.44 ) . CONCLUSIONS These results suggest that the lipoprotein-lipid profile in these older men was differentially affected by supplementation with beef versus soy-based foods during RT . Regardless of group , the lipoprotein-lipid changes were predicted by differences in the SF/fiber ratio and cholesterol/fiber ratio and increases in carbohydrate intake over time",
"BACKGROUND & AIMS The objectives of this study were to assess whether 25 g/d lupin protein , integrated into a mixed diet , might affect cardiovascular risk factors and whether l-arginine was responsible for these effects . METHODS Seventy-two hypercholesterolemic subjects participated in the r and omized , controlled , double-blind three-phase crossover study . They were assigned to three diets with 25 g/d lupin protein ( LP ) , milk protein ( MP ) or milk protein plus 1.6 g/d arginine ( MPA ) each for 28 d in a r and om order interrupted by 6-week washout periods . Lupin protein and the comparator milk protein were incorporated into complex food products ( bread , roll , sausage , and vegetarian spread ) . Arginine was administered via capsules . Sixty-eight subjects were included in final analyses . RESULTS Compared with MP , LDL cholesterol was significantly lower after LP . Compared with MP and MPA , homocysteine was significantly lower after LP . Compared with baseline , concentrations of total , LDL , and HDL cholesterol significantly decreased after LP and MPA . Triacylglycerols and uric acid significantly decreased after LP . The relative changes in total and LDL cholesterol were significantly greater for subjects with severe hypercholesterolemia ( > 6.6 mmol/L ) than those with moderate hypercholesterolemia ( 5.2 - 6.6 mmol/L ) . CONCLUSIONS The present study showed for the first time that incorporation of 25 g/d of lupin protein into a variety of complex food products lowers total and LDL cholesterol , triacylglycerols , homocysteine , and uric acid in hypercholesterolemic subjects . The hypocholesterolemic effect is stronger in subjects with severe hypercholesterolemia . Arginine might be responsible for some , but not all of the beneficial effects of lupin protein . This trial was registered at http:// clinical trials.gov ( study ID number NCT01598649 )",
"The effects of soy protein ( 35 % of protein energy ) given as a beverage and those of cow-milk proteins were investigated on plasma lipoprotein concentrations in children with familial hypercholesterolemia ( FH ) . Subjects were r and omly assigned to either the soy-protein or cow-milk-protein experimental period , with subsequent crossover after a washout period , each period lasting 4 wk . Diets were planned to provide 20 % energy as protein , 28 % as fat ( polyunsaturated : monounsaturated : saturated fatty acids , 1:3:3 ) and less than 200 mg cholesterol/d . No changes were observed in either plasma cholesterol , low-density-lipoprotein cholesterol , or apolipoprotein concentrations . However , the soy beverage significantly reduced the concentrations of triglyceride and very-low-density-lipoprotein cholesterol ( P less than 0.05 ) and significantly increased the concentrations of high-density-lipoprotein cholesterol ( HDL-C ) and HDL3-C ( P less than 0.04 and P less than 0.03 , respectively ) . These results indicate that the administration of soy protein may induce clinical ly beneficial effects in children with FH",
"Increasing protein intake and soy consumption appear to be promising approaches to prevent metabolic syndrome ( MetS ) . However , the effect of soy consumption on insulin resistance , glucose homeostasis , and other characteristics of MetS is not frequently studied in humans . We aim ed to investigate the effects of a 4-wk , strictly controlled , weight-maintaining , moderately high-protein diet rich in soy on insulin sensitivity and other cardiometabolic risk factors . We performed a r and omized crossover trial of 2 4-wk diet periods in 15 postmenopausal women with abdominal obesity to test diets with 22 energy percent ( En% ) protein , 27 En% fat , and 50 En% carbohydrate . One diet contained protein of mixed origin ( mainly meat , dairy , and bread ) , and the other diet partly replaced meat with soy meat analogues and soy nuts containing 30 g/d soy protein . For our primary outcome , a frequently sample d intravenous glucose tolerance test ( FSIGT ) was performed at the end of both periods . Plasma total , LDL , and HDL cholesterol , triglycerides , glucose , insulin , and C-reactive protein were assessed , and blood pressure , arterial stiffness , and intrahepatic lipid content were measured at the start and end of both periods . Compared with the mixed-protein diet , the soy-protein diet result ed in greater insulin sensitivity [ FSIGT : insulin sensitivity , 34 ± 29 vs. 22 ± 17 (mU/L)(-1 ) · min(-1 ) , P = 0.048 ; disposition index , 4974 ± 2543 vs. 2899 ± 1878 , P = 0.038 ; n = 11 ] . Total cholesterol was 4 % lower after the soy-protein diet than after the mixed-protein diet ( 4.9 ± 0.7 vs. 5.1 ± 0.6 mmol/L , P = 0.001 ) , and LDL cholesterol was 9 % lower ( 2.9 ± 0.7 vs. 3.2 ± 0.6 mmol/L , P = 0.004 ; n = 15 ) . Thus , partly replacing meat with soy in a moderately high-protein diet has clear advantages regarding insulin sensitivity and total and LDL cholesterol . Therefore , partly replacing meat products with soy products could be important in preventing MetS. This trial was registered at clinical trials.gov as NCT01694056",
"Alterations in plasma cholesterol concentrations , especially increases in low-density lipoprotein ( LDL ) , are well-known risk factors in the development of atherosclerosis . Numerous studies have examined the lipid-lowering effects of functional soy-containing foods , but few have specifically examined soymilk , with equivocal findings reported . In September 2008 , a single-blind , r and omized , controlled trial was conducted on 32 postmenopausal women at Baylor University , Waco , TX , USA . After a 2-week run-in period , subjects were r and omly assigned to consume three servings of vanilla soy ( n = 16 ) or reduced-fat dairy ( n = 16 ) milk per day for 4 weeks . Plasma lipid profiles were obtained pre- and post-supplementation . Plasma high-density lipoprotein , LDL , and triglycerides were not significantly different between groups post-intervention ( P = .45 ) or from baseline ( P = .83 ) . Separate analysis of plasma total cholesterol levels yielded similar results ( P = .19 and P = .92 , respectively ) . Furthermore , subanalyses controlling for dyslipidemia ( n = 23 ) and lipid-lowering medication usage ( n = 28 ) did not significantly alter results . Despite good dietary compliance , our study failed to show a significant hypocholesterolemic effect of soymilk consumption in this postmenopausal female population . Potential reasons for this nonsignificant finding are discussed , and future research directions are presented",
"The traditional lipid profile compared with nuclear magnetic resonance ( NMR ) may underestimate the risk for cardiovascular disease and may explain some of the discrepancies in results between studies analyzing the salubrious effects of soy . Our purpose was to compare the traditional lipid profile with NMR quantification of the number of lipoprotein particles , subclasses , and diameters or sizes in 30 sedentary males , between 18 and 30 years of age , consuming 1 of the following 3 supplements daily for 28 days : milk protein ( Milk ) , isoflavone-poor soy protein ( Soy- ) , or isoflavone-rich soy protein ( Soy+ ) . The study used a double-blind , parallel-arm design with r and om assignment to 1 of the 3 protein supplement groups . Fasting EDTA blood sample s were collected at baseline and after 28 days of supplementation and analyzed for the number and size of very low-density lipoprotein ( VLDL ) , low-density lipoprotein ( LDL ) , and high-density lipoprotein ( HDL ) particles , respectively . Fasting serum sample s were analyzed for concentrations of total cholesterol ( TC ) , LDL cholesterol ( LDL-C ) , total HDL cholesterol ( HDL-C ) , HDL(2)-C , HDL(3)-C , triglycerides ( TGs ) , free fatty acids ( FFAs ) , and glucose . Fasting heparin blood sample s were collected at baseline and after supplementation and analyzed for apolipoproteins A-I , A-II , B , C-II , C-III , and E , as well as hepatic and lipoprotein lipase concentrations . HDL3-C increased by 47.2 % after Soy+ supplementation and hepatic lipase decreased 19.2 % after Soy- supplementation ( p HDL-C and apolipoproteins A-I and A-II were found to increase in all 3 groups ( p lipoprotein particle number and size are not more sensitive to the effect of soy protein on CVD risk compared with the traditional lipid profile . Furthermore , the lack of isoflavones in soy protein seems to have a deleterious effect on hepatic lipase"
] | 411672fc-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Childhood cancer survivors are at a higher risk of developing health conditions such as osteoporosis , and cardiovascular disease than their peers . Health-promoting behaviour , such as consuming a healthy diet , could lessen the impact of these chronic issues , yet the prevalence rate of health-protecting behaviour amongst survivors of childhood cancer is similar to that of the general population . Targeted nutritional interventions may prevent or reduce the incidence of these chronic diseases . OBJECTIVES The primary aim of this review was to assess the efficacy of a range of nutritional interventions design ed to improve the nutritional intake of childhood cancer survivors , as compared to a control group of childhood cancer survivors who did not receive the intervention . Secondary objectives were to assess metabolic and cardiovascular risk factors , measures of weight and body fat distribution , behavioural change , changes in knowledge regarding disease risk and nutritional intake , participants ' views of the intervention , measures of health status and quality of life , measures of harm associated with the process or outcomes of the intervention , and cost-effectiveness of the intervention SEARCH METHODS We search ed the electronic data bases of the Cochrane Central Register of Controlled Trials ( CENTRAL ; 2013 , Issue 3 ) , MEDLINE / PubMed ( from 1945 to April 2013 ) , and Embase /Ovid ( from 1980 to April 2013 ) . We ran the search again in August 2015 ; we have not yet fully assessed these results , but we have identified one ongoing trial . We conducted additional search ing of ongoing trial registers - the International St and ard R and omised Controlled Trial Number register and the National Institutes of Health register ( both screened in the first half of 2013 ) - reference lists of relevant articles and review s , and conference proceedings of the International Society for Paediatric Oncology and the International Conference on Long-Term Complications of Treatment of Children and Adolescents for Cancer ( both 2008 to 2012 ) . SELECTION CRITERIA We included all r and omised controlled trials ( RCTs ) that compared the effects of a nutritional intervention with a control group which did not receive the intervention in this review . Participants were childhood cancer survivors of any age , diagnosed with any type of cancer when less than 18 years of age . Participating childhood cancer survivors had completed their treatment with curative intent prior to the intervention . DATA COLLECTION AND ANALYSIS Two review authors independently selected and extracted data from each identified study , using a st and ardised form . We assessed the validity of each identified study using the criteria outlined in the Cochrane H and book for Systematic Review s of Interventions . We used the GRADE criteria to assess the quality of each trial . MAIN RESULTS Three RCTs were eligible for review . A total of 616 participants were included in the analysis . One study included participants who had been treated for acute lymphoblastic leukaemia ( ALL ) ( 275 participants ) . Two studies included participants who had all forms of paediatric malignancies ( 266 and 75 participants ) . All participants were less than 21 years of age at study entry . The follow-up ranged from one month to 36 months from the initial assessment . All intended outcomes were not evaluated by each included study . All studies looked at different interventions , and so we were unable to pool results . We could not rule out the presence of bias in any of the studies .There was no clear evidence of a difference in calcium intake at one month between those who received the single , half-day , group-based education that focused on bone health , and those who received st and ard care ( mean difference ( MD ) 111.60 , 95 % confidence interval ( CI ) -258.97 to 482.17 ; P = 0.56 , low quality evidence ) . A regression analysis , adjusting for baseline calcium intake and changes in knowledge and self-efficacy , showed a significantly greater calcium intake for the intervention as compared with the control group at the one-month follow-up ( beta coefficient 4.92 , 95 % CI 0.33 to 9.52 ; P = 0.04 ) . There was statistically significant higher , self-reported milk consumption ( MD 0.43 , 95 % CI 0.07 to 0.79 ; P = 0.02 , low quality evidence ) , number of days on calcium supplementation ( MD 11.42 , 95 % CI 7.11 to 15.73 ; P use of any calcium supplementation ( risk ratio ( RR ) 3.35 , 95 % CI 1.86 to 6.04 ; P bone density Z-scores measured with a dual-energy X-ray absorptiometry ( DEXA ) scan at 36 months follow-up ( MD -0.05 , 95 % CI -0.26 to 0.16 ; P = 0.64 , moderate quality evidence ) between those who received calcium and vitamin D supplementation combined with nutrition education and those who received nutrition education alone . There was also no clear evidence of a difference in bone mineral density between the intervention and the control group at the 12-month ( median difference -0.17 , P = 0.99 ) and 24-month follow-up ( median difference -0.04 , P = 0.54).A single multi-component health behaviour change intervention , focusing on general healthy eating principles , with two telephone follow-ups brought about a 0.17 lower score on the four-point Likert scale of self-reported junk food intake compared with the control group ( MD -0.17 , 95 % CI -0.33 to -0.01 ; P = 0.04 , low quality evidence ) ; this result was statistically significant . There was no clear evidence of a difference between the groups in the self-reported use of nutrition as a health protective behaviour ( MD -0.05 , 95 % CI -0.24 to 0.14 ; P = 0.60 , low quality evidence ) . AUTHORS ' CONCLUSIONS Due to a paucity of studies , and the heterogeneity of the studies included in this review , we are unable to draw conclusions regarding the effectiveness of nutritional interventions for use with childhood cancer survivors . Although there is low quality evidence for the improvement in health behaviours using health behaviour change interventions , there remains no evidence as to whether this translates into an improvement in dietary intake . There was also no evidence that the studies reduced the risk of cardiovascular and metabolic disorders in childhood cancer survivors , although no evidence of effect is not the same as evidence of no effect . This review highlights the need for further well design ed trials to be implemented in this population | [
"Purpose The purpose of this study is to test the efficacy of the Survivor Health and Resilience Education Program intervention — a manualized , behavioral intervention focusing on bone health behaviors among adolescent survivors of childhood cancer . Methods Participants were 75 teens aged 11–21 years , one or more years post-treatment , and currently cancer-free . Teens were r and omized to a group-based intervention focusing on bone health or a wait-list control . Bone health behaviors were assessed at baseline and 1-month post-intervention . Results Controlling for baseline outcome measures and theoretical predictors , milk consumption frequency ( p = 0.03 ) , past month calcium supplementation ( p days in the past month with calcium supplementation ( p and dietary calcium intake ( p = 0.04 ) were significantly greater at 1-month follow-up among intervention participants compared with control participants . Conclusions The intervention had a significant short-term impact on self-reported bone health behaviors among adolescent survivors of childhood cancer . Research examining long-term intervention effectiveness is warranted",
"BACKGROUND We sought to improve lumbar spine bone mineral density ( LS-BMD ) in long-term survivors of childhood acute lymphoblastic leukemia ( ALL ) using calcium and cholecalciferol supplementation . PROCEDURE This double-blind , placebo-controlled trial r and omized 275 participants ( median age , 17 [ 9 - 36.1 ] years ) with age- and gender-specific LS-BMD Z-scores receive nutritional counseling with supplementation of 1,000 mg/day calcium and 800 International Unit cholecalciferol or placebo for 2 years . The primary outcome was change in LS-BMD assessed by quantitative computerized tomography ( QCT ) at 24 months . Linear regression models were employed to identify the baseline risk factors for low LS-BMD and to compare LS-BMD outcomes . RESULTS Pre-r and omization LS-BMD below the mean was associated with male gender ( P = 0.0024 ) , White race ( P = 0.0003 ) , lower body mass index ( P One hundred eighty-eight ( 68 % ) participants completed the study ; 77 % adhered to the intervention . Mean LS-BMD change did not differ between survivors r and omized to supplements ( 0.33 ± 0.57 ) or placebo ( 0.28 ± 0.56 ) . Participants aged 9 - 13 years and those 22 - 35 years had the greatest mean increases in LS-BMD ( 0.50 ± 0.66 and 0.37 ± 0.23 , respectively ) . Vitamin D insufficiency ( serum 25[OH]D with LS-BMD outcomes ( P = 0.78 ) . CONCLUSION Cholecalciferol and calcium supplementation provides no added benefit to nutritional counseling for improving LS-BMD among adolescent and young adult survivors of ALL ( 93 % of whom had LS-BMD Z-scores above the mean at study entry )",
"Survivors of childhood cancer are a growing and vulnerable population . Cure rates for pediatric cancers now exceed 60 % and , by the year 2000 , an estimated 1 of every 1,000 young adults will be a cancer survivor . Because this population is at increased risk for late medical and neoplastic complications that impact adversely on health‐related quality of life , it is important to investigate methods to promote risk reduction by motivating survivors to practice health‐promoting behaviors . With this background , we initiated a prospect i ve , r and omized , controlled feasibility study in which survivors attending a long‐term follow‐up clinic were r and omized to receive st and ard care or st and ard care plus an educational intervention . Our objectives were to determine if the intervention would improve the survivors ' knowledge about their cancer treatment and risks of late effects and increase their practice of health‐protective behaviors . Since July 1995 , 272 of 318 families ( 86 % ) approached about the study agreed to participate . Of these , 266 are evaluable for assessment of baseline knowledge and health behaviors . Demographic features , baseline knowledge , health perceptions and health behaviors did not differ among r and omized groups . Assessment of the intervention 's efficacy at changing health behaviors of survivors r and omized to the intervention group will be available when the 1‐year follow‐up evaluations are completed for the study cohort . Our preliminary experience with this pilot study supports the feasibility of educational intervention research in a specialty clinic dedicated to monitoring long‐term childhood cancer survivors . Int . J. Cancer Suppl . 12:138–142 , 1999 . © 1999 Wiley‐Liss ,",
"The BONEII study is a large two-phase study . The baseline study ( Study 1 ) aims to estimate the prevalence of diminished bone mineral density ( BMD ) in patients treated for childhood acute lymphoblastic leukemia ( ALL ) and identify risk factors for BMD deficits . The interventional phase ( Study 2 ) of BONEII has a placebo-controlled double-blind r and omized longitudinal design to evaluate the effects of nutritional counseling and calcium and vitamin D supplementation on changes in BMD and serum and urine markers of bone metabolism . The extensive information being collected through this large study will serve as a repository of relational data about BMD and bone turnover and will support further investigations to assess the association of calcium metabolism , bone turnover , nutritional intake , lifestyle factors ( such as exercise and the use of alcohol and tobacco ) , and the specific agents used in ALL therapy in this rapidly increasing population of childhood cancer survivors",
"BACKGROUND Improved cure rates for childhood cancer have produced a growing population of survivors at risk for late toxicities of chemotherapy and radiation therapy . Healthy behaviors can modify these risks . We initiated a controlled prospect i ve trial to determine if a multi-component behavioral intervention could induce change in childhood cancer survivors ' health knowledge , health perceptions , and practice of health-protective behaviors . PROCEDURE Adolescent cancer survivors attending a long-term follow-up clinic were r and omized to receive st and ard follow-up care or st and ard care plus the educational intervention . Baseline measures were obtained at r and omization ( T(0 ) ) and repeated 1 year ( T(1 ) ) later during the survivors ' annual check-up . RESULTS Of 272 patients enrolled and r and omized , 251 are evaluable at both time points . Treatment and control groups were similar in regards to diagnosis , gender , race , and age . The change in outcome measures over the year ( T(1)-T(0 ) ) was not significantly different between the two groups as assessed by a two- sample pooled t test . However , additional exploratory analyses indicated a significant gender difference in knowledge with female survivors in the intervention group having higher scores . In addition , patients who choose certain individual health goals , such as breast/testicular self-examination , showed improved practice of the health behavior . In addition , in a very exploratory analysis , a gender difference in response to the intervention was noted , with females exhibiting a greater improvement in knowledge scores than did males . CONCLUSIONS Although the multi-behavioral educational intervention did not induce change in health knowledge , perceptions , and behaviors of childhood cancer survivors for the treatment group as a whole , gender differences and specific health goal differences were found . These findings suggest that future interventions should be tailored to reflect gender differences and the nature of the health goal under assessment",
"Background Altered nutrient intake and decreased exercise in response to cancer therapies and their side effects , particularly corticosteroids , may be key factors in the increased body weight and differences in physical fitness reported in survivors of childhood acute lymphoblastic leukemia ( ALL ) . Purpose To assess ( 1 ) the effect of a home-based nutrition and exercise intervention program on cardiovascular fitness , strength , and flexibility in children with ALL during maintenance therapy and ( 2 ) the feasibility of conducting and evaluating a home-based exercise and nutrition program in this patient population . Design Children ages 4 to 10 years with st and ard-risk ALL were r and omized when starting maintenance therapy to a 12-month home-based exercise and nutrition program ( n=6 , 3 males/3 females ) or control ( n=7 , 4 males/3 females ) group . Assessment of anthropometrics , dietary intake , physical activity , and fitness was performed at baseline and 6 and 12 months of study . Results Although age , body size , and nutrient intakes were similar between both subject groups at 0 , 6 , and 12 months , exercise and nutrition program children had greater improvement in physical activity and cardiovascular fitness between 6 and 12 months than control children . Conclusions These results suggest that a home-based exercise intervention during maintenance therapy encouraged greater physical activity and improved cardiovascular fitness in children with st and ard-risk ALL . Further investigation involving larger population s of children with ALL is warranted",
"Solid bodies of polypeptides having repeating units of aspartic , glutamic , and aminoadipic esters are reacted with hydrazine or an amine having at least two NH2 groups until the ester moieties of the side chains are partly converted to the hydrazines or amides , and the side chains are partly crosslinked hydrazides other units by reaction with the hydrazine or diamine so as to make the polypeptide insoluble and infusible . The remaining ester moieties are saponified , and the result ing hydrophilic , but water-insoluble solid acts as an ampholyte in contact with water or other polar solvents . It may be used for capturing heavy metal ions from their aqueous solutions",
"OBJECTIVE To assess the construct validity of a milk consumption Stages of Change ( SOC ) algorithm among adolescent survivors of childhood cancer ages 11 to 21 years ( n = 75 ) . METHODS Baseline data from a r and omized controlled trial design ed to evaluate a health behavior intervention were analyzed . Assessment s included a milk consumption SOC algorithm and hypothesized theoretical and behavioral predictors of SOC . RESULTS Compared with survivors who expressed no readiness to change , those expressing readiness to change behavior for both 2 and 4 daily servings of milk reported more frequent milk consumption ( P dietary calcium intake ( P = .006 ) , and were more likely to meet age-specific recommendations for daily calcium intake ( P = .01 ) . CONCLUSIONS AND IMPLICATION S Results provide support for the construct validity of the milk consumption SOC algorithm relative to behavioral criteria . Research is needed to further examine algorithm validity with respect to theoretical predictors of SOC"
] | 41167338-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Peripheral artery disease ( PAD ) is associated with impaired mobility and a high rate of mortality . The aim of this systematic review was to investigate whether reduced lower extremity performance was associated with an increased incidence of cardiovascular and all-cause mortality in people with PAD . METHODS AND RESULTS A systematic search of the MEDLINE , EMBASE , SCOPUS , Web of Science , and Cochrane Library data bases was conducted . Studies assessing the association between measures of lower extremity performance and cardiovascular or all-cause mortality in PAD patients were included . A meta- analysis was conducted combining data from commonly assessed performance tests . The 10 identified studies assessed lower extremity performance by strength tests , treadmill walking performance , 6-minute walk , walking velocity , and walking impairment question naire ( WIQ ) . A meta- analysis revealed that shorter maximum walking distance was associated with increased 5-year cardiovascular ( unadjusted RR=2.54 , 95 % CI 1.86 to 3.47 , P all-cause mortality ( unadjusted RR=2.23 95 % CI 1.85 to 2.69 , P 4-metre walking velocity , a lower WIQ stair-climbing score , and poor hip extension , knee flexion , and plantar flexion strength were also associated with increased mortality . No significant associations were found for hip flexion strength , WIQ distance score , or WIQ speed score with mortality . CONCLUSIONS A number of lower extremity performance measures are prognostic markers for mortality in PAD and may be useful clinical tools for identifying patients at higher risk of death . Further studies are needed to determine whether interventions that improve measures of lower extremity performance reduce mortality | [
"Peripheral arterial disease ( PAD ) is associated with major cardiovascular morbidity and mortality . Abnormalities in nitric oxide metabolism due to excess of the NO synthase inhibitor asymmetric dimethylarginine ( ADMA ) may be pathogenic in PAD . We explored the association between ADMA levels and markers of atherosclerosis , function , and prognosis . A total of 133 patients with symptomatic PAD were enrolled . Ankle — brachial index ( ABI ) , walking time , vascular function measures ( arterial compliance and flow-mediated vasodilatation ) and plasma ADMA level were assessed for each patient at baseline . ADMA correlated inversely with ABI ( r = —0.238 , p = 0.003 ) and walking time ( r = —0.255 , p = 0.001 ) , independent of other vascular risk factors . We followed up 125 ( 94 % ) of our 133 initial subjects with baseline measurements ( mean 35 months ) . Subjects with ADMA levels in the highest quartile ( > 0.84 μmol/l ) showed a significantly greater occurrence of a major adverse cardiovascular event ( MACE ) compared to those with ADMA levels in the lower three quartiles ( p = 0.001 ) . Cox proportional-hazards regression analysis revealed that ADMA was a significant predictor of MACE , independent of other risk factors including age , sex , blood pressure , smoking history , diabetes and ABI ( hazard ratio = 5.1 , p vascular function , such as compliance , flow-mediated vasodilatation ( FMVD ) and blood pressure , as well as markers of PAD severity , including ABI and walking time , were not predictive . In conclusion , circulating levels of ADMA correlate independently with measures of disease severity and major adverse cardiovascular events . Agents that target this pathway may be useful for this patient population . Clinical Trial Registration — URL : http:// www . clinical trials.gov . Unique identifier :",
"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 The objective of this study was to assess the role of a symptom-limited stair climbing test in predicting postoperative cardiopulmonary complications in elderly c and i date s for lung resection . METHODS A consecutive series of 109 patients more than 70 years of age who underwent pulmonary lobectomy for lung carcinoma from January 2000 through May 2003 formed the prospect i ve data base of this study . All patients in the analysis performed a preoperative symptom-limited stair climbing test . Univariate and multivariate analyses were performed to identify predictors of postoperative cardiopulmonary complications . RESULTS At univariate analysis , the patients with complications had a lower forced expiratory capacity percentage of predicted ( p = 0.048 ) , predicted postoperative forced expiratory volume in 1 second percentage of predicted ( p = 0.049 ) , climbed a lower height at preoperative stair climbing test ( p = 0.0004 ) , and presented a greater proportion of cardiac comorbiditiy with respect to the patients without complications ( p = 0.02 ) . After logistic regression analysis , significant predictors of postoperative complications result ed in the presence of a concomitant cardiac disease ( p = 0.04 ) and a low height climbed preoperatively ( p = 0.0015 ) . CONCLUSIONS A symptom-limited stair climbing test was a safe and simple instrument capable of predicting cardiopulmonary complications in the elderly after lung resection",
"OBJECTIVE To establish associations between leg strength and mortality in men and women with lower extremity peripheral arterial disease ( PAD ) . METHODS This was an observational , prospect i ve study of 410 men and women with PAD aged 55 and older recruited from Chicago-area medical centers and followed for a mean of 60 months . The participants were followed for a mean of 60.0 months . Isometric knee extension , knee flexion , hip extension , and hip flexion were measured at baseline . Primary outcomes were all-cause and cardiovascular disease mortality . Cox proportional hazards models were used to assess relations between leg strength and all-cause and cardiovascular disease mortality among men and women , adjusting for age , race , comorbidities , physical activity , smoking , body mass index , and the ankle brachial index . RESULTS Among the 246 male participants , poorer baseline strength for knee flexion ( P trend = .029 ) , knee extension ( P trend = .010 ) , and hip extension ( P trend = .013 ) were each associated independently with higher all-cause mortality . Poorer strength for knee flexion ( P trend = .042 ) and hip extension ( P trend = .029 ) were associated with higher cardiovascular mortality . Compared with those in the fourth ( best ) baseline knee flexion quartile , hazard ratios for all-cause and cardiovascular disease mortality among men in the first ( poorest ) knee flexion quartile were 2.23 ( 95 % confidence interval [ CI ] , 1.02 - 4.87 ; P = .045 ) and 4.20 ( 95 % CI , 1.12 - 15.79 ; P = .044 ) , respectively . No significant associations of leg strength and all-cause mortality were identified among women . CONCLUSIONS Poorer leg strength is associated with increased mortality in men , but not women , with PAD . Future study is needed to determine whether interventions that increase leg strength improve survival in men with PAD",
"OBJECTIVES Among persons with lower extremity peripheral artery disease ( PAD ) , we determined whether objective measures of walking performance predict mortality independently of the ankle brachial index ( ABI ) . BACKGROUND The ability of office-based functional performance measures to predict mortality in patients with PAD is unknown . METHODS Participants were 444 persons with PAD followed prospect ively for 4.8 years . The 6-min walk and 4-m walks at usual and fastest pace were measured at baseline . Cox proportional hazard models were used to assess relations between baseline measures of lower extremity performance with mortality , adjusting for confounders . RESULTS One hundred twenty-seven patients ( 28.6 % ) died during follow-up . Adjusting for age , gender , race , comorbidities , ABI , and other confounders , participants in the poorest baseline quartile of 6-min walk performance had significantly increased total mortality ( hazard ratio [ HR ] 2.36 [ 95 % confidence interval ( CI ) 1.33 to 4.18 ] ) and cardiovascular mortality ( HR 5.59 [ 95 % CI 1.97 to 15.9 ] ) compared with the best quartile of baseline performance . Participants in the poorest baseline quartile of normal-paced 4-m walking speed had significantly increased total mortality ( HR 1.86 [ 95 % CI 1.06 to 3.29 ] ) and cardiovascular mortality ( HR 2.55 [ 95 % CI 1.01 to 6.46 ] ) compared with the best quartile of baseline performance . CONCLUSIONS This study demonstrates for the first time that performance-based measures , which can be administered in an office setting , provide prognostic information regarding mortality in persons with PAD beyond that provided by the ABI"
] | 4116736a-06ff-11f0-808a-c43d1ab1c353 |
PURPOSE To provide guidance to physicians and patients with regard to the use of adjuvant external beam radiation therapy ( RT ) in locally advanced non-small cell lung cancer ( LA NSCLC ) based on available medical evidence complemented by consensus-based expert opinion . METHODS AND MATERIAL S A panel authorized by the American Society for Radiation Oncology ( ASTRO ) Board of Directors and Guidelines Subcommittee conducted 2 systematic review s on the following topics : ( 1 ) indications for postoperative adjuvant RT and ( 2 ) indications for preoperative neoadjuvant RT . Practice guideline recommendations were approved using an a priori-defined consensus-building methodology supported by ASTRO and approved tools for the grading of evidence quality and the strength of guideline recommendations . RESULTS For patients who have undergone surgical resection , high-level evidence suggests that use of postoperative RT does not influence survival , but optimizes local control for patients with N2 involvement , and its use in the setting of positive margins or gross primary /nodal residual disease is recommended . No high-level evidence exists for the routine use of preoperative induction chemoradiation therapy ; however , modern surgical series and a post-hoc Intergroup 0139 clinical trial analysis suggest that a survival benefit may exist if patients are properly selected and surgical techniques/postoperative care is optimized . CONCLUSIONS A consensus and evidence -based clinical practice guideline for the adjuvant radiotherapeutic management of LA NSCLC has been created addressing 2 important questions | [
"PURPOSE Adjuvant cisplatin-based chemotherapy ( ACT ) is now an accepted st and ard for completely resected stage II and III A non-small-cell lung cancer ( NSCLC ) . Long-term follow-up is important to document persistent benefit and late toxicity . We report here up date d overall survival ( OS ) and disease-specific survival ( DSS ) data . PATIENTS AND METHODS Patients with completely resected stage IB ( T2N0 , n = 219 ) or II ( T1 - 2N1 , n = 263 ) NSCLC were r and omly assigned to receive 4 cycles of vinorelbine/cisplatin or observation . All efficacy analyses were performed on an intention-to-treat basis . Results Median follow-up was 9.3 years ( range , 5.8 to 13.8 ; 33 lost to follow-up ) ; there were 271 deaths in 482 r and omly assigned patients . ACT continues to show a benefit ( hazard ratio [ HR ] , 0.78 ; 95 % CI , 0.61 to 0.99 ; P = .04 ) . There was a trend for interaction with disease stage ( P = .09 ; HR for stage II , 0.68 ; 95 % CI , 0.5 to 0.92 ; P = .01 ; stage IB , HR , 1.03 ; 95 % CI , 0.7 to 1.52 ; P = .87 ) . ACT result ed in significantly prolonged DSS ( HR , 0.73 ; 95 % CI , 0.55 to 0.97 ; P = .03 ) . Observation was associated with significantly higher risk of death from lung cancer ( P = .02 ) , with no difference in rates of death from other causes or second primary malignancies between the arms . CONCLUSION Prolonged follow-up of patients from the JBR.10 trial continues to show a benefit in survival for adjuvant chemotherapy . This benefit appears to be confined to N1 patients . There was no increase in death from other causes in the chemotherapy arm",
"BACKGROUND Whether adjuvant chemotherapy improves survival of patients with non-small-cell lung cancer ( NSCLC ) is not known . We aim ed to compare the effect of adjuvant vinorelbine plus cisplatin versus observation on survival in patients with completely resected NSCLC . METHODS 840 patients with stage IB-IIIA NSCLC from 101 centres in 14 countries were r and omly assigned to observation ( n=433 ) or to 30 mg/m(2 ) vinorelbine plus 100 mg/m(2 ) cisplatin ( n=407 ) . Postoperative radiotherapy was not m and atory and was undertaken according to every centre 's policy . The primary endpoint was overall survival . Analysis was by intention to treat . This trial is registered as an International St and ard R and omised Controlled Trial , number IS RCT N95053737 . FINDINGS 367 patients in the chemotherapy group and 431 in the control group received their assigned treatment . 301 ( 36 % ) patients had stage IB disease , 203 ( 24 % ) had stage II disease , and 325 ( 39 % ) had stage IIIA disease . Tolerance to chemotherapy mainly included neutropenia in 335 ( 92 % ) patients and febrile neutropenia in 34 ( 9 % ) ; seven ( 2 % ) toxic deaths were also recorded . Compliance was greater with cisplatin than with vinorelbine ( median dose intensity 89 % [ range 17 - 108 ] vs 59 % [ 17 - 100 ] ) . After a median follow-up of 76 months ( range 43 - 116 ) , median survival was 65.7 months ( 95 % CI 47.9 - 88.5 ) in the chemotherapy group and 43.7 ( 35.7 - 52.3 ) months in the observation group . Adjusted risk for death was significantly reduced in patients assigned chemotherapy compared with controls ( hazard ratio 0.80 [ 95 % CI 0.66 - 0.96 ] ; p=0.017 ) . Overall survival at 5 years with chemotherapy improved by 8.6 % , which was maintained at 7 years ( 8.4 % ) . INTERPRETATION Adjuvant vinorelbine plus cisplatin extends survival in patients with completely resected NSCLC , better defining indication of adjuvant chemotherapy",
"BACKGROUND Results from phase II studies in patients with stage IIIA non-small-cell lung cancer with ipsilateral mediastinal nodal metastases ( N2 ) have shown the feasibility of resection after concurrent chemotherapy and radiotherapy with promising rates of survival . We therefore did this phase III trial to compare concurrent chemotherapy and radiotherapy followed by resection with st and ard concurrent chemotherapy and definitive radiotherapy without resection . METHODS Patients with stage T1 - 3pN2M0 non-small-cell lung cancer were r and omly assigned in a 1:1 ratio to concurrent induction chemotherapy ( two cycles of cisplatin [ 50 mg/m(2 ) on days 1 , 8 , 29 , and 36 ] and etoposide [ 50 mg/m(2 ) on days 1 - 5 and 29 - 33 ] ) plus radiotherapy ( 45 Gy ) in multiple academic and community hospitals . If no progression , patients in group 1 underwent resection and those in group 2 continued radiotherapy uninterrupted up to 61 Gy . Two additional cycles of cisplatin and etoposide were given in both groups . The primary endpoint was overall survival ( OS ) . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00002550 . FINDINGS 202 patients ( median age 59 years , range 31 - 77 ) were assigned to group 1 and 194 ( 61 years , 32 - 78 ) to group 2 . Median OS was 23.6 months ( IQR 9.0-not reached ) in group 1 versus 22.2 months ( 9.4 - 52.7 ) in group 2 ( hazard ratio [ HR ] 0.87 [ 0.70 - 1.10 ] ; p=0.24 ) . Number of patients alive at 5 years was 37 ( point estimate 27 % ) in group 1 and 24 ( point estimate 20 % ) in group 2 ( odds ratio 0.63 [ 0.36 - 1.10 ] ; p=0.10 ) . With N0 status at thoracotomy , the median OS was 34.4 months ( IQR 15.7-not reached ; 19 [ point estimate 41 % ] patients alive at 5 years ) . Progression-free survival ( PFS ) was better in group 1 than in group 2 , median 12.8 months ( 5.3 - 42.2 ) vs 10.5 months ( 4.8 - 20.6 ) , HR 0.77 [ 0.62 - 0.96 ] ; p=0.017 ) ; the number of patients without disease progression at 5 years was 32 ( point estimate 22 % ) versus 13 ( point estimate 11 % ) , respectively . Neutropenia and oesophagitis were the main grade 3 or 4 toxicities associated with chemotherapy plus radiotherapy in group 1 ( 77 [ 38 % ] and 20 [ 10 % ] , respectively ) and group 2 ( 80 [ 41 % ] and 44 [ 23 % ] , respectively ) . In group 1 , 16 ( 8 % ) deaths were treatment related versus four ( 2 % ) in group 2 . In an exploratory analysis , OS was improved for patients who underwent lobectomy , but not pneumonectomy , versus chemotherapy plus radiotherapy . INTERPRETATION Chemotherapy plus radiotherapy with or without resection ( preferably lobectomy ) are options for patients with stage IIIA(N2 ) non-small-cell lung cancer . FUNDING National Cancer Institute , Canadian Cancer Society , and National Cancer Institute of Canada",
"PURPOSE To evaluate mediastinal nodal clearance ( MNC ) rates after induction chemotherapy and concurrent , full-dose radiation therapy ( RT ) in a phase II trimodality trial ( Radiation Therapy Oncology Group protocol 0229 ) . PATIENTS AND METHODS Patients ( n=57 ) with stage III non-small cell lung cancer ( pathologically proven N2 or N3 ) were eligible . Induction chemotherapy consisted of weekly carboplatin ( AUC = 2.0 ) and paclitaxel 50 mg/m(2 ) . Concurrent RT was prescribed , with 50.4 Gy to the mediastinum and primary tumor and a boost of 10.8 Gy to all gross disease . The mediastinum was pathologically reassessed after completion of chemoradiation . The primary endpoint of the study was MNC , with secondary endpoints of 2-year overall survival and postoperative morbidity/mortality . RESULTS The grade 3/4 toxicities included hematologic 35 % , gastrointestinal 14 % , and pulmonary 23 % . Forty-three patients ( 75 % ) were evaluable for the primary endpoint . Twenty-seven patients achieved the primary endpoint of MNC ( 63 % ) . Thirty-seven patients underwent resection . There was a 14 % incidence of grade 3 postoperative pulmonary complications and 1 30-day , postoperative grade 5 toxicity ( 3 % ) . With a median follow-up of 24 months for all patients , the 2-year overall survival rate was 54 % , and the 2-year progression-free survival rate was 33 % . The 2-year overall survival rate was 75 % for those who achieved nodal clearance , 52 % for those with residual nodal disease , and 23 % for those who were not evaluable for the primary endpoint ( P=.0002 ) . CONCLUSIONS This multi-institutional trial confirms the ability of neoadjuvant concurrent chemoradiation with full-dose RT to sterilize known mediastinal nodal disease",
"The role of post-operative radiotherapy for patients with non-small-cell lung cancer ( NSCLC ) is unclear despite five previous r and omised trials . One deficiency with these trials was that they did not include adequate TNM staging , and so the present r and omised trial was design ed to compare surgery alone ( S ) with surgery plus post-operative radiotherapy ( SR ) in patients with pathologically staged T1 - 2 , N1 - 2 . M0 NSCLC . Between July 1986 and October 1993 , 308 patients ( 154 S , 154 SR ) were entered from 16 centres in the UK . The median age of the patients was 62 years , 74 % were male , > 85 % had normal or near normal levels of general condition , activity and breathlessness , 68 % had squamous carcinoma , 52 % had had a pneumonectomy , 63 % had N1 disease and 37 % N2 disease . SR patients received 40 Gy in 15 fractions starting 4 - 6 weeks post-operatively . Overall there was no advantage to either group in terms of survival , although definite local recurrence and bony metastases appeared less frequently and later in the SR group . In a subgroup analysis , in the N1 group no differences between the treatment groups were seen , but in the N2 group SR patients appeared to gain a one month survival advantage , delayed time to local recurrence and time to appearance of the bone metastases . There is , therefore , no clear indication for post-operative radiotherapy in N1 disease , but the question remains unresolved in N2 disease",
"BACKGROUND We have used doses of 60Gy or higher for neoadjuvant chemoradiotherapy for select patients with advanced non-small cell lung cancer ( NSCLC ) , including patients with N2 disease and those with Pancoast lesions , to avoid gaps in radiotherapy in case surgery is ultimately not offered . METHODS A retrospective cohort study using a prospect i ve data base . Patients underwent initial staging with CT , PET/CT and lymph node biopsy ( mediastinoscopy , endoscopic esophageal ultrasound and endobronchial ultrasound ) and then received neoadjuvant high dose radiotherapy and chemotherapy , followed by thoracotomy with intent to cure . RESULTS Between January 1998 and June 2008 there were 216 patients who were eligible for this study . The median dose of radiation was 60Gy ( range 60 - 72Gy ) . Lobectomy was performed in 152 patients ( 70 % ) about 7 weeks after radiotherapy finished ( mean 51 days , range 34 - 89 days).The bronchus was buttressed with an intercostal muscle flap in 97 % patients . Median hospital stay was 4.5 days ( range 2 - 57 ) . Major morbidity occurred in 17 % . There were five ( 2.3 % ) deaths . There were no bronchial-pleural fistulas after lobectomy , but two occurred after right pneumonectomy . Predictors of morbidity were FEV(1 ) 75 years ( p=0.008 ) . The overall 5-year Kaplan-Meier survival was 34 % . It was 42 % for those who underwent R0 resection , 38 % for those with initial N2 disease and 45 % for the 71 complete responders . CONCLUSIONS Pulmonary resection after high dose ( > /=60Gy ) neoadjuvant chemoradiotherapy is safe . Lobectomy can be safely performed and bronchopleural fistula prevented . Sixty Gy allows for maximal medical therapy in case resection is not offered . Since complete response rates may be higher than when 45Gy is used and since surgery is safe , its use deserves further investigation",
"BACKGROUND Stage II non-small-cell lung cancer is regarded as one of the early lung cancers . Although resection , including the mediastinal lymph nodes , is currently regarded as the st and ard treatment , the survival rate of this disease is not encouraging . It is well known that the most common causes of death are locoregional recurrences or distant metastases , or both . However , the best adjuvant treatment to improve survival is as controversial an issue as ever . METHODS This study was design ed as a r and omized , blinded , two-armed study with operation and adjuvant radiotherapy in one arm , versus operation and adjuvant mitomycin C ( 10 mg/m2 ) , vinblastine ( 6 mg/m2 ) , and cisplatin ( 100 mg/m2 ) ( MVP ) chemotherapy in the other arm . We assigned 57 resected patients with pathologic proven stage II non-small cell lung cancer to the groups according to our eligibility criteria . RESULTS The most common pattern of recurrence was distant metastases , and nearly all the recurrences ( 17 of 18 patients ) in both groups were found within 2 years after operation . The rates of the locoregional and distant metastases were 3.6 % and 46.4 % in the adjuvant radiotherapy group and 6.9 % and 10.3 % in the adjuvant chemotherapy group ( p = 0.018 ) . The 5-year disease-free survival rates were 52.0 % in the adjuvant radiotherapy group and 74.0 % in the adjuvant chemotherapy group ( p = 0.16 , log-rank test ) . The 2-year , 5-year , and 6-year survival portions were 60.3 % , 56.5 % , and 28.3 % in the adjuvant radiotherapy group , and 82.8 % , 70.1 % , and 60.1 % in the adjuvant chemotherapy group ( p = 0.01 , p = 0.17 , and p = 0.03 , Z-test ) . The difference of the actuarial survival between these two groups was somewhat significant ( p = 0.09 , log-rank test ) . CONCLUSIONS Our results suggest that the addition of adjuvant MVP chemotherapy may reduce the distant metastasis rates and prolong the survival of the surgically resected stage II non-small-cell lung cancer patients",
"BACKGROUND Surgery is the primary treatment for patients with stage I , II , or IIIA non-small-cell lung cancer ( NSCLC ) . However , long-term survival of NSCLC patients after surgery alone is largely unsatisfactory , and the role of adjuvant chemotherapy in patient survival has not yet been established . METHODS Between January 1994 and January 1999 , 1209 patients with stage I , II , or IIIA NSCLC were r and omly assigned to receive mitomycin C ( 8 mg/m2 on day 1 ) , vindesine ( 3 mg/m2 on days 1 and 8) , and cisplatin ( 100 mg/m2 on day 1 ) every 3 weeks for three cycles ( MVP group ; n = 606 ) or no treatment ( control group ; n = 603 ) after complete resection . R and omization was stratified by investigational center , tumor size , lymph-node involvement , and the intention to perform radiotherapy . The primary endpoint was overall survival and secondary endpoints were progression-free survival and toxicity associated with adjuvant treatment . Survival curves were analyzed using the log-rank test . All statistical tests were two-sided . RESULTS After a median follow-up time of 64.5 months , there was no statistically significant difference between the two patient groups in overall survival ( hazard ratio = 0.96 , 95 % confidence interval = 0.81 to 1.13 ; P = .589 ) or progression-free survival ( hazard ratio = 0.89 , 95 % confidence interval = 0.76 to 1.03 ; P = .128 ) . Only 69 % of patients received the three planned cycles of MVP . Grade s 3 and 4 neutropenia occurred in 16 % and 12 % , respectively , of patients in the MVP arm . Radiotherapy was completed by 65 % of patients in the MVP arm and by 82 % of patients in the control group . In the multivariable analysis , only disease stage and sex were associated with survival . CONCLUSION This r and omized trial failed to prospect ively confirm a statistically significant role for adjuvant chemotherapy in completely resected NSCLC . Given the poor compliance with the MVP regimen used in this study , future studies should explore more effective treatments",
"BACKGROUND We undertook to determine whether adjuvant vinorelbine plus cisplatin prolongs overall survival among patients with completely resected early-stage non-small-cell lung cancer . METHODS We r and omly assigned patients with completely resected stage IB or stage II non-small-cell lung cancer to vinorelbine plus cisplatin or to observation . The primary end point was overall survival ; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimen . RESULTS A total of 482 patients underwent r and omization to vinorelbine plus cisplatin ( 242 patients ) or observation ( 240 ) ; 45 percent of the patients had pathological stage IB disease and 55 percent had stage II , and all had an Eastern Cooperative Oncology Group performance status score of 0 or 1 . In both groups , the median age was 61 years , 65 percent were men , and 53 percent had adenocarcinomas . Chemotherapy caused neutropenia in 88 percent of patients ( including grade 3 febrile neutropenia in 7 percent ) and death from toxic effects in two patients ( 0.8 percent ) . Nonhematologic toxic effects of chemotherapy were fatigue ( 81 percent of patients ) , nausea ( 80 percent ) , anorexia ( 55 percent ) , vomiting ( 48 percent ) , neuropathy ( 48 percent ) , and constipation ( 47 percent ) , but severe ( grade 3 or greater ) toxic effects were uncommon ( Overall survival was significantly prolonged in the chemotherapy group as compared with the observation group ( 94 vs. 73 months ; hazard ratio for death , 0.69 ; P=0.04 ) , as was relapse-free survival ( not reached vs. 46.7 months ; hazard ratio for recurrence , 0.60 ; P Five-year survival rates were 69 percent and 54 percent , respectively ( P=0.03 ) . CONCLUSIONS Adjuvant vinorelbine plus cisplatin has an acceptable level of toxicity and prolongs disease-free and overall survival among patients with completely resected early-stage non-small-cell lung cancer",
"BACKGROUND On the basis of a previous meta- analysis , the International Adjuvant Lung Cancer Trial was design ed to evaluate the effect of cisplatin-based adjuvant chemotherapy on survival after complete resection of non-small-cell lung cancer . METHODS We r and omly assigned patients either to three or four cycles of cisplatin-based chemotherapy or to observation . Before r and omization , each center determined the pathological stages to include , its policy for chemotherapy ( the dose of cisplatin and the drug to be combined with cisplatin ) , and its postoperative radiotherapy policy . The main end point was overall survival . RESULTS A total of 1867 patients underwent r and omization ; 36.5 percent had pathological stage I disease , 24.2 percent stage II , and 39.3 percent stage III . The drug allocated with cisplatin was etoposide in 56.5 percent of patients , vinorelbine in 26.8 percent , vinblastine in 11.0 percent , and vindesine in 5.8 percent . Of the 932 patients assigned to chemotherapy , 73.8 percent received at least 240 mg of cisplatin per square meter of body-surface area . The median duration of follow-up was 56 months . Patients assigned to chemotherapy had a significantly higher survival rate than those assigned to observation ( 44.5 percent vs. 40.4 percent at five years [ 469 deaths vs. 504 ] ; hazard ratio for death , 0.86 ; 95 percent confidence interval , 0.76 to 0.98 ; P chemotherapy also had a significantly higher disease-free survival rate than those assigned to observation ( 39.4 percent vs. 34.3 percent at five years [ 518 events vs. 577 ] ; hazard ratio , 0.83 ; 95 percent confidence interval , 0.74 to 0.94 ; P died of chemotherapy-induced toxic effects . CONCLUSIONS Cisplatin-based adjuvant chemotherapy improves survival among patients with completely resected non-small-cell lung cancer",
"We r and omly assigned 230 patients with resected Stage II or III epidermoid ( squamous-cell ) lung cancer to receive postoperative adjuvant radiotherapy or no adjuvant treatment . Careful intraoperative staging had been performed in all patients . Before r and omization , patients were stratified according to stage , weight loss , age , and institution . Prognostic variables , such as stage , weight loss , age , nodal-disease status , and tumor status , were equally distributed between the two groups . The mean time from r and omization to analysis was 3.5 years among the 210 eligible patients . There was no evidence that radiotherapy improved survival , and although recurrence rates appeared to be somewhat reduced among patients assigned to radiotherapy , these decreases were not statistically significant . However , radiotherapy did produce a striking and significant reduction in recurrences to the ipsilateral lung and mediastinum . Moreover , overall recurrence rates were reduced by radiotherapy in patients with N2 disease ( P less than 0.05 ) , although even this subgroup had no evidence of improved survival . We conclude that radiotherapy can reduce local recurrences after resection of epidermoid carcinoma of the lung , but that it does not increase survival rates",
"PURPOSE We started a phase II trial of induction chemotherapy and concurrent hyperfractionated chemoradiotherapy followed by either surgery or boost chemoradiotherapy in patients with advanced , stage III disease . The purpose is to achieve better survival in the surgery group with minimum morbidity and mortality . PATIENTS AND METHODS Patients treated from 1998 to 2002 with neoadjuvant chemoradiotherapy and surgical resection for stage III NSCLC were analyzed . The treatment consisted of four cycles of induction chemotherapy with carboplatin/paclitaxel followed by chemoradiotherapy with a reduced dose of carboplatin/paclitaxel and accelerated hyperfractionated radiotherapy with 1.5 Gy twice daily up to 45 Gy . After restaging , operable patients underwent thoracotomy . Inoperable patients received chemoradiotherapy up to 63 Gy . Study end points included resectability , pathologic response , and survival . Results One hundred twenty patients were enrolled ; 25 % patients had stage IIIA , 73 % had stage IIIB , and 2 % stage IV . After treatment , 47.5 % had downstaging , 29.2 % had stable disease , and 23.3 % had progressive disease . Thirty patients ( 25 % ) were not eligible for operation because of progressive disease , stable disease , and /or functional deterioration with one treatment-related death . The 30-day mortality was 5 % in patients who underwent operation . The 5-year survival rate for 120 patients was 21.7 % , and it was 43.1 % in patients with complete resection . In postoperative patients with stage N0 disease , 5-year survival was 53.3 % ; if stage N2 or N3 disease was still present , 5-year survival was 33.3 % . CONCLUSION Staging and treatment with chemoradiotherapy and complete resection performed in experienced centers achieve acceptable morbidity and mortality",
"In the period 1988 - 1992 , 74 consecutive radically resected patients with NSCLC were r and omised to postoperative radiotherapy or surgery alone in order to evaluate the influence of postoperative radiotherapy on survival . There were 61 males and 13 females , aged 35 - 80 years , median 59 years . Their distribution by stage was as follows : pT1N2 = 19 , pT2N2 = 54 , pT3N2 = one patient ; histology : 32 squamous , 32 adeno and 10 large cell carcinomas ; surgery : atypical resection in six , lobectomy in 27 , bilobectomy in ten , and pneumonectomy in 31 patients . In 27 patients , only one lymph node in a single mediastinal lymph node site was affected ; in 31 patients more than one lymph node in one site ; in 16 patients more sites were affected . In 35/74 patients radiotherapy of hilar and mediastinal sites with 3000 cGy in 2 weeks was performed . On December 31 , 1994 , 19 patients ( 26 % ) were still alive ; 39/55 patients died of the following causes : locoregional failure-10(26 % ) , distant metastases- 25 ( 64 % ) , other tumor-unrelated causes-four patients ( 10 % ) . Five-year survival rates did not show statistically significant differences between the irradiated and surgically treated patients only with respect to sex , pTNM stage , histology and frequency of locoregional failure . The number of metastatic mediastinal lymph nodes was the only significant prognostic factor ( P < 0.005 ) in both r and omised groups",
"OBJECTIVES Stage III non-small cell lung cancer ( NSCLC ) describes a heterogeneous population with disease presentation ranging from apparently resectable tumors with occult microscopic nodal metastases to unresectable , bulky nodal disease . This review up date s the published clinical trials since the last American College of Chest Physicians guidelines to make treatment recommendations for this controversial subset of patients . METHODS Systematic search es were conducted through MEDLINE , Embase , and the Cochrane Data base for Systematic Review up to December 2011 , focusing primarily on r and omized trials , selected meta-analyses , practice guidelines , and review s. RESULTS For individuals with stage IIIA or IIIB disease , good performance scores , and minimal weight loss , treatment with combined chemoradiotherapy results in better survival than radiotherapy alone . Consolidation chemotherapy or targeted therapy following definitive chemoradiation for stage IIIA is not supported . Neoadjuvant therapy followed by surgery is neither clearly better nor clearly worse than definitive chemoradiation . Most of the arguments made regarding patient selection for neoadjuvant therapy and surgical resection provide evidence for better prognosis but not for a beneficial impact of this treatment strategy ; however , weak comparative data suggest a possible role if only lobectomy is needed in a center with a low perioperative mortality rate . The evidence supports routine platinum-based adjuvant chemotherapy following complete resection of stage IIIA lung cancer encountered unexpectedly at surgery . Postoperative radiotherapy improves local control without improving survival . CONCLUSIONS Multimodality therapy is preferable in most subsets of patients with stage III lung cancer . Variability in the patients included in r and omized trials limits the ability to combine results across studies and thus limits the strength of recommendations in many scenarios . Future trials are needed to investigate the roles of individualized chemotherapy , surgery in particular cohorts or setting s , prophylactic cranial radiation , and adaptive radiation",
"PURPOSE To evaluate the value of adjuvant postoperative external-beam radiation ( EBR ) in patients with radically resected non-small cell lung cancer ( NSCLC ) pT1 - 3 pN0 - 2 compared to patients with resected NSCLC without adjuvant EBR . MATERIAL S AND METHODS In 155 patients ( 121 male , 34 female ; mean age , 59 years ) 105 lobectomies , 12 bilobectomies , and 38 pneumonectomies with radical lymph node dissection of the contralateral [ corrected ] side were performed . Postoperative staging was done according to the TNM system and was as follows : pT1 ( n=38 ) , pT2 ( n=89 ) , pT3 ( n=28 ) ; pN0 ( n=39 ) , pN1 ( n=67 ) and pN2 ( n=49 ) . Histopathologic study revealed 68 squamous cell carcinomas , 53 adenocarcinomas , 21 large cell carcinomas , 6 adenosquamous cell carcinomas , and 7 bronchioloalveolar cell carcinomas . All patients were r and omly assigned into two treatment groups : 72 patients with no further treatment ( control group ) , and 83 patients ( EBR group ) with adjuvant postoperative EBR of the bronchial stump and mediastinum ( 50 to 56 Gy , 8 or 23 MV photons , 2 Gy/d , 5 d/wk ) beginning 4 to 6 weeks after surgery . RESULTS The overall 5-year survival rate ( median observation time , 43 months ) of all patients was 24.1 % ( EBR group , 29.7 % ; control group , 20.4 % ; p>0.05 , not significant ) . The relative risk of the EBR group was 0.85 with a two-sided confidence interval of 0.66 to 1.09 . The overall 5-year recurrence-free survival was 20.6 % ( EBR , 27.1 % ; control group , 15.6 % ; p=0.07 ) . The relative risk of the EBR group was 0.80 with a confidence interval of 0.63 to 1.01 . The rate of local recurrences at the bronchial stump and /or mediastinum was significantly smaller in the EBR group ( n=5 ) than in the control group ( n=17 ) ( p independent influence of postoperative EBR on the incidence of local recurrences . The incidence of distant metastases was slightly but not significantly higher in patients without EBR ( 38 patients ) compared to those who had EBR ( 32 patients ) . CONCLUSION High-dose postoperative EBR to the mediastinum significantly reduces the risk of local recurrence at the bronchial stump and /or mediastinum . Age , sex , histologic subtype , tumor size , surgical approach , or extent of lymph node involvement had no prognostic value -- only postoperative EBR had an independent influence on the risk of local recurrence . The effect of postoperative EBR was on the verge of significance with respect to recurrence-free survival and showed the same tendency in overall survival , however with an attenuated relative risk",
"Abstract Postoperative supervoltage radiotherapy was tested in a controlled clinical trial in an attempt to improve the survival for patients with bronchogenic carcinoma . Radiation therapy began 3 to 4 weeks after surgery ; three fields were used giving a dose of 6,000 rad in six weeks to the mediastinum from a Co 60 unit . Between 1966 and 1975 , 224 patients were included in this study . All had a resection of curative design . 175 patients were evaluable . No increase in survival time was noticed in the irradiated group . The 5 year survival rate was lower in this group ( 24 % versus 43 % for the control group ) but the difference was not statistically significant . For squamous cell carcinoma , the analysis showed a detrimental effect of radiation therapy in the T 2 group (",
"BACKGROUND Preoperative chemotherapy improves survival in patients with stage III non-small-cell lung cancer ( NSCLC ) amenable to resection . We aim ed to assess the additional effect of preoperative chemoradiation on tumour resection , pathological response , and survival in these patients . METHODS Between Oct 1 , 1995 , and July 1 , 2003 , patients with stage IIIA-IIIB NSCLC and invasive mediastinal assessment from 26 participating institutions of the German Lung Cancer Cooperative Group ( GLCCG ) were r and omly assigned to one of two treatment groups . The intervention group were scheduled to receive three cycles of cisplatin and etoposide , followed by twice-daily radiation with concurrent carboplatin and vindesine , and then surgical resection ( those with positive resection margins or unresectable disease were offered further twice-daily radiotherapy ) . The control group were scheduled to receive three cycles of cisplatin and etoposide , followed by surgery , and then further radiotherapy . The primary endpoint was median progression-free survival ( PFS ) in patients eligible for treatment after r and omisation . Secondary endpoints in patients eligible for treatment after r and omisation were overall survival ( OS ) and the proportion of patients undergoing surgery . Secondary endpoints in patients with tumour resection were the proportion with negative resection margins , the proportion with complete resection , the proportion with histopathological response , and the proportion with mediastinal downstaging . Additionally , exploratory ( not prespecified ) post-hoc analyses in terms of PFS and OS were done on patients not amenable to resection and on further subgroups of patients undergoing resection . Analyses were by intention to treat . This trial is registered on the Clinical Trials.gov website , number NCT 00176137 . FINDINGS 558 patients were r and omly assigned . 34 patients did not meet inclusion criteria and were excluded . Of 524 eligible patients , 142 of 264 ( 54 % ) in the interventional group and 154 of 260 ( 59 % ) in the control group underwent surgery ; 98 of 264 ( 37 % ) and 84 of 260 ( 32 % ) underwent complete resection . In patients with complete resection , the proportion of those with mediastinal downstaging ( 45 of 98 [ 46 % ] and 24 of 84 [ 29 % ] , p=0.02 ) and pathological response ( 59 of 98 [ 60 % ] and 17 of 84 [ 20 % ] , p PFS ( primary endpoint ) between treatment groups-either in eligible patients ( median PFS 9.5 months , range 1.0 - 117.0 [ 95 % CI 8.3 - 11.2 ] vs 10.0 months , range 1.0 - 111.0 [ 8.9 - 11.5 ] , 5-year PFS 16 % [ 11 - 21 ] vs 14 % [ 10 - 19 ] , hazard ratio ( HR ) 0.99 [ 0.81 - 1.19 ] , p=0.87 ) , in those undergoing tumour resection , or in patients with complete resection . In both groups , 35 % of patients undergoing surgery received a pneumonectomy ( 50/142 vs 54/154 ) . In patients receiving a pneumonectomy , treatment-related mortality increased in the interventional group compared with the control group ( 7/50 [ 14 % ] vs 3/54 [ 6 % ] ) . INTERPRETATION In patients with stage III NSCLC amenable to surgery , preoperative chemoradiation in addition to chemotherapy increases pathological response and mediastinal downstaging , but does not improve survival . After induction with chemoradiation , pneumonectomy should be avoided . FUNDING German Cancer Aid ( Bonn , Germany )",
"PURPOSE To study the value of postoperative radiotherapy for non-small-cell lung cancer ( NSCLC ) with positive regional lymph metastases ( NI or N2 ) after radical surgery . MATERIAL S AND METHODS From February 1982 to October 1995 , 366 patients with NSCLC and N1 or N2 disease were r and omized into postoperative radiotherapy ( S + R ) ( 183 patients ) and no further treatment ( S alone ) ( 182 patients ) . Postoperative radiotherapy ( RT ) was administrated 3 - 4 weeks after radical operation . Irradiated fields covered the bronchial stump , ipsilateral hilum , and most of the mediastinum . The midplane dose was 6000 cGy/30 fractions/6 weeks , with the spinal cord limited to 4000 cGy/20 fractions/4 weeks or less . One hundred thirty-four patients in S + R group and 162 patients in S alone group were evaluated . Clinical data were comparable in both arms , except for the numbers of N2 patients . RESULTS The 3-year and 5-year overall survival rates were 51.9 % and 42.9 % in the S + R group and 50.2 % and 40.5 % in the S alone Group ( p = 0.56 ) . The 3-year and 5-year disease-free survival rates were 50.7 % + /- 4.7 % and 42.9 % + /- 5.2 % in the S + R group vs. 44.4 % + /- 4.3 % and 38.2 % + /- 4.5 % in the S alone group ( p = 0.28 ) , respectively . In the patients with NI or T3 - 4 tumors , there was a trend toward improved survival in the S + R group , especially in the patients with T3 - 4N1M0 . These patients demonstrated 20 % improvement in overall survival ( p = 0.092 ) and greater than 20 % better disease-free survival ( p = 0.057 ) . Postoperative RT reduced local recurrence but had no impact on distant metastases . CONCLUSION Postoperative RT significantly reduced local relapses , but did not improve overall survival , due to a high frequency of distant metastases in this patient group",
"Postoperative radiotherapy is commonly used to treat patients with completely resected nonsmall cell lung carcinoma , but its effect on overall survival has not been established",
"PURPOSE Based on 5-year or shorter-term follow-up data in recent r and omized trials , adjuvant cisplatin-based chemotherapy is now generally recommended after complete surgical resection for patients with non-small-cell lung cancer ( NSCLC ) . We evaluated the results of the International Adjuvant Lung Cancer Trial study with three additional years of follow-up . PATIENTS AND METHODS Patients with completely resected NSCLC were r and omly assigned to three or four cycles of cisplatin-based chemotherapy or to observation . Cox models were used to evaluate treatment effect according to follow-up duration . Results The trial included 1,867 patients with a median follow-up of 7.5 years . Results showed a beneficial effect of adjuvant chemotherapy on overall survival ( hazard ratio [ HR ] , 0.91 ; 95 % CI , 0.81 to 1.02 ; P = .10 ) and on disease-free survival ( HR , 0.88 ; 95 % CI , 0.78 to 0.98 ; P = .02 ) . However , there was a significant difference between the results of overall survival before and after 5 years of follow-up ( HR , 0.86 ; 95 % CI , 0.76 to 0.97 ; P = .01 v HR , 1.45 ; 95 % CI , 1.02 to 2.07 ; P = .04 ) with P = .006 for interaction . Similar results were observed for disease-free survival . The analysis of non-lung cancer deaths for the whole period showed an HR of 1.34 ( 95 % CI , 0.99 to 1.81 ; P = .06 ) . CONCLUSION These results confirm the significant efficacy of adjuvant chemotherapy at 5 years . The difference in results beyond 5 years of follow-up underscores the need for the long-term follow-up of other adjuvant lung cancer trials and for a better identification of patients deriving long-term benefit from adjuvant chemotherapy"
] | 411673a6-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE Cementless total hip arthroplasty ( THA ) is associated with reliable clinical results and high patient satisfaction . Short-stem prostheses ( SS ) were design ed to achieve superior preservation of proximal bone stock and stability compared with those of conventional-stem prostheses ( CS ) . This meta- analysis was conducted to determine the proximal bone remodelling , revision rate , Harris Hip Score , radiolucent line and maximum total point motion values of both SS and CS for primary THA . METHOD Relevant r and omised controlled trials ( RCTs ) involving SS and CS in primary THA were identified from electronic data bases , such as EMBASE , PubMed and the Cochrane Library . RESULT Ultimately , 12 RCTs involving 1130 patients ( 1387 hips ) were included . The results showed that compared with CS , SS result ed in less bone mineral density ( BMD ) changes in Gruen zone 7 at 1 year and 2 years postoperatively ( mean difference (MD)=5.11 ; 95 % CI , 1.61 , 8.61 ; P=0.30 ; and MD=4.90 ; 95 % CI , 1.01 , 8.79 ; P=0.17 , respectively ) . No difference in BMD changes was found for Gruen zone 1 ( MD=2.66 ; 95 % CI , -3.31 , 8.64 ; P revision rate ( relative risk (RR)=1.52 ; 95 % CI , 0.71 , 3.26 ; P=0.94 ) , Harris Hip Score ( MD=-0.38 ; 95 % CI , -1.02 , 0.26 ; P=0.89 ) or stem migration ( MD=0.02 ; 95 % CI , -0.07 , 0.11 ; P=0.04 ) . CONCLUSION Our results suggest that compared with CS , SS may provide superior bone remodelling and similar survival rates and clinical outcomes . However , the short-term follow-up of the included studies was inadequate to determine the long-term performance of SS | [
"Background and purpose Short femoral stems have been introduced in total hip arthroplasty in order to save proximal bone stock . We hypothesized that a short stem preserves periprosthetic bone mineral density ( BMD ) and provides good primary stability . Methods We carried out a prospect i ve cohort study of 30 patients receiving the collum femoris-preserving ( CFP ) stem . Preoperative total hip BMD and postoperative periprosthetic BMD in Gruen zones 1–7 were investigated by dual-energy x-ray absorptiometry ( DXA ) , stem migration was analyzed by radiostereometric analysis ( RSA ) , and the Harris hip score ( HHS ) was determined . Results 2 patients were excluded intraoperatively and 1 patient was revised due to a deep infection , leaving 27 patients for analysis . The mean HHS increased from 49 ( 24–79 ) preoperatively to 99 ( 92–100 ) after 2 years . DXA after 1 year showed substantial loss of BMD in Gruen zone 7 ( –31 % ) , zone 6 ( –19 % ) , and zone 2 ( –13 % , p The bone loss in these regions did not recover after 2 years , whereas the more moderate bone loss in Gruen zones 1 , 3 , and 5 partially recovered . There was a correlation between low preoperative total hip BMD and a higher amount of bone loss in Gruen zones 2 , 6 and 7 . RSA showed minor micromotion of the stem : mean subsidence was 0.13 ( 95 % CI : –0.28 to 0.01 ) mm and mean rotation around the longitudinal axis was 0.01º ( 95 % CI : –0.1 to 0.39 ) after 2 years . Interpretation We conclude that substantial loss in proximal periprosthetic BMD can not be prevented by the use of a novel type of short , curved stem , and forces appear to be transmitted distally . However , the stems showed very small migration — a characteristic of stable uncemented implants",
"Bone stock-preserving short stem prostheses have gained importance in total hip arthroplasty ( THA ) with the use of minimally invasive surgical procedures . Because of their metaphyseal fixation and their dependency on the calcar radius , it is unknown whether the femoral offset can be reproduced with the same accuracy following short stem vs st and ard stem THA . This study clarifies whether it is possible to restore the femoral offset using a short stem prosthesis ( Fitmore ; Zimmer , Warsaw , Indiana ) compared with a conventional straight stem prosthesis ( CLS ; Zimmer ) following minimally invasive implantation using an anterolateral approach . In a prospect i ve , r and omized , double-blinded study , 80 patients underwent THA using a short stem ( SS group ; n=40 ) or CLS implant ( control group ; n=40 ) . Follow-up examinations were conducted 6 weeks postoperatively . Radiological and functional outcomes were measured . Subjective assessment of quality of life was evaluated using the Harris Hip Score ( HHS ) , the Short Form 36-item health survey ( SF-36 ) , and the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . Pre- and postoperative comparison of the groups ' change in offset showed no significant differences ( SS group difference from pre- to postoperative , 6.1±6.5 mm ; control group difference from pre- to postoperative , 6.5±7.1 mm ; P=.93 ) . Group comparison after 6 weeks revealed no significant differences in HHS , SF-36 , or WOMAC . Based on these data , an equivalent reproducibility of the femoral offset was demonstrated following short stem and straight stem THA using a minimally invasive anterolateral approach . If the long-term results of short stems show a comparable survival , they represent a sensible alternative to st and ard stems ",
"Purpose On the basis of positive clinical results with mid- and long-term follow-up using the Mayo short stem , the Metha neck-preserving stem ( BBraun , Aesculap , Tuttlingen , Germany ) was introduced . The purpose of this study was to vali date the implant design by direct acquisition of bone remodelling data from total hip arthroplasty ( THA ) recipients using dual-energy X-ray absorptiometry ( DEXA ) . Methods After power analysis , 25 patients were included in this prospect i ve study . Patients were examined clinical ly and underwent DEXA examinations preoperatively and postoperatively at one week , six months and one and two years after THA . Gruen zones were adapted to the short stem design ( R1–R7 ) . Results The Harris Hip Score ( HHS ) increased significantly by 31 points . No stem had to be revised . Bone mineral density ( BMD ) in the greater trochanter decreased significantly from 0.78 g/cm2 postoperatively to 0.72 g/cm2 two years after surgery . Marginal changes were seen in the lateral distal regions ( R4–R5 ) . In the minor trochanter region , BMD increased significantly after two years by 12.9 % . In the calcar region , BMD exceeded the baseline value by 6.1 % two years after implantation . Conclusions Stress shielding seems to occur at the greater trochanter due to the vast cross-section of the implant . However , the aim of proximal load transfer of the Metha stem seems to be partially achieved . DEXA analysis revealed a concentrated load distribution on the medial portion of the femur , which is an important region to guarantee long-term implant survival",
"Background Stress shielding of the proximal femur has been observed in a number of conventional cementless implants used in total hip arthroplasty . Short femoral-neck implants are cl aim ing less interference with the biomechanics of the proximal femur . The goal of this study was to investigate the changes of bone-mineral density in the proximal femur and the clinical outcome after implantation of a short femoral-neck prosthesis . Methods We prospect ively assessed the clinical outcome and the changes of bone mineral density of the proximal femur up to one year after implantation of a short femoral neck prosthesis in 20 patients with a mean age of 47 years ( range 17 to 65 ) . Clinical outcome was assessed using the Harris Hip Score . The WOMAC was used as a patient-relevant outcome -measure . The bone mineral density was determined using dual energy x-ray absorptiometry , performed 10 days , three months and 12 months after surgery . Results The Harris Hip Score improved from an average preoperative score of 46 to a postoperative score at 12 months of 89 points , the global WOMAC index from 5,3 preoperatively to 0,8 at 12 months postoperatively . In contrast to conventional implants , the DEXA-scans overall revealed a slight increase of bone mineral density in the proximal femur in the 12 months following the implantation . Conclusion The short femoral neck stem lead to a distinct bone reaction . This was significantly different when compared to the changes in bone mineral density reported after implantation of conventional implants",
"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",
"Ceramic-on-ceramic hip replacements might stress the bone interface more than a metal-polyethylene because of material stiffness , microseparation , and sensitivity to impingement . To ascertain whether this potentially increased stress caused an increased cup migration we compared a ceramic-on-ceramic with a metal-on-polyethylene implant for cup migration . Sixty one patients ( 61 hips ) undergoing THA for osteoarthritis were r and omized to ceramic on ceramic ( Ce/Ce ) or cobalt-chromium on cross-linked polyethylene bearings ( PE ) in the same uncemented cup shell . Migration was followed with RSA . At 2 years we observed similar mean cup translations in the 3 directions ( 0.07 - 0.40 mm vs. 0.05 - 0.31 mm , Ce/Ce vs. PE ) , as well as similar rotations around the 3 axes ( 0.31 - 0.92 ° vs. 0.57 - 1.40 ° ) . WOMAC and SF-36 scores were also similar and no radiolucent lines or osteolysis found . The large migration seen in some cups in both implant groups will require close monitoring to ascertain the reasons . Mean proximal wear of the polyethylene liners measured 0.016 mm between 2 and 24 months . Our data suggest there is no increased cup migration in the ceramic-on-ceramic implant compared with the metal-on-polyethylene , and they seem an equally safe choice . However , the low wear measured with the more versatile and less expensive cross-linked polyethylene makes it a strong contender . Levels of Evidence : Therapeutic Level I. See the Guidelines for Authors for a complete description of levels of evidence",
"Introduction Short stem prostheses have been developed to preserve proximal femoral bone stock . This prospect i ve , r and omized study compared periprosthetic bone remodelling following short and straight stem implantation 1 year after surgery . Material s and methods One hundred and forty-four consecutive patients undergoing total hip arthroplasty were r and omized to either a Fitmore short or a cementless straight stem ( both Zimmer , Winterthur , Switzerl and ) . Periprosthetic bone mineral density ( BMD ) was measured using dual-energy X-ray absorptiometry performed the day before surgery and at 7 days , 3 months and 1 year postoperatively . Furthermore , the HHS and the WOMAC were obtained . Results One hundred and thirty-eight patients completed 1-year follow-up . Periprosthetic BMD changes at 1 year were most pronounced in the proximal medial region of interest ( ROI ) 7 with −17.2 % after short stem and −16.7 % after straight implantation ( p = 0.67 ) . However , there was significantly less BMD reduction in ROI 6 following short ( −4.7 % ) versus straight stem ( −10.8 % ) implantation ( p = 0.01 ) . There were no significant differences between the two groups in terms of the HHS and the WOMAC either before or after surgery . Conclusion One year after surgery , both stems showed an implant-specific periprosthetic bone remodelling . Nevertheless , proximal load transfer was more pronounced after short stem implantation than with a straight stem",
"Background and purpose — We hypothesized that an ultra-short stem would load the proximal femur in a more physiological way and could therefore reduce the adaptive periprosthetic bone loss known as stress shielding . Patients and methods — 51 patients with primary hip osteoarthritis were r and omized to total hip arthroplasty ( THA ) with either an ultra-short stem or a conventional tapered stem . The primary endpoint was change in periprosthetic bone mineral density ( BMD ) , measured with dual-energy x-ray absorptiometry ( DXA ) , in Gruen zones 1 and 7 , two years after surgery . Secondary endpoints were change in periprosthetic BMD in the entire periprosthetic region , i.e. Gruen zones 1 through 7 , stem migration measured with radiostereometric analysis ( RSA ) , and function measured with self-administered functional scores . Results — The periprosthetic decrease in BMD was statistically significantly lower with the ultra-short stem . In Gruen zone 1 , the mean difference was 18 % ( 95 % CI : −27 % to −10 % ) . In zone 7 , the difference was 5 % ( CI : −12 % to −3 % ) and for Gruen zones 1–7 the difference was also 5 % ( CI : −9 % to −2 % ) . During the first 6 weeks postoperatively , the ultra-short stems migrated 0.77 mm more on average than the conventional stems . 3 months after surgery , no further migration was seen . The functional scores improved during the study and were similar in the 2 groups . Interpretation — Up to 2 years after total hip arthroplasty , compared to the conventional tapered stem the ultra-short uncemented anatomical stem induced lower periprosthetic bone loss and had equally excellent stem fixation and clinical outcome ",
"Our aim in this prospect i ve study was to compare the bone mineral density ( BMD ) around cementless acetabular and femoral components which were identical in geometry and had the same alumina modular femoral head , but differed in regard to the material of the acetabular liners ( alumina ceramic or polyethylene ) in 50 patients ( 100 hips ) who had undergone bilateral simultaneous primary total hip replacement . Dual energy X-ray absorptiometry scans of the pelvis and proximal femur were obtained at one week , at one year , and annually thereafter during the five-year period of the study . At the final follow-up , the mean BMD had increased significantly in each group in acetabular zone I of DeLee and Charnley ( 20 % ( 15 % to 26 % ) , p=0.003 ) , but had decreased in acetabular zone II ( 24 % ( 18 % to 36 % ) in the alumina group and 25 % ( 17 % to 31 % ) in the polyethylene group , p=0.001 ) . There was an increase in the mean BMD in zone III of 2 % ( 0.8 % to 3.2 % ) in the alumina group and 1 % ( 0.6 % to 2.2 % ) in the polyethylene group ( p=0.315 ) . There was a decrease in the mean BMD in the calcar region ( femoral zone 7 ) of 15 % ( 8 % to 24 % ) in the alumina group and 14 % ( 6 % to 23 % ) in the polyethylene group ( p mean bone loss in femoral zone 1 of Gruen et al was 2 % ( 1.1 % to 3.1 % ) in the alumina group and 3 % ( 1.3 % to 4.3 % ) in the polyethylene group ( p=0.03 ) , and in femoral zone 6 , the mean bone loss was 15 % ( 9 % to 27 % ) in the alumina group and 14 % ( 11 % to 29 % ) in the polyethylene group compared with baseline values . There was an increase in the mean BMD on the final scans in femoral zones 2 ( p=0.04 ) , 3 ( p=0.04 ) , 4 ( p=0.12 ) and 5 ( p=0.049 ) in both groups . There was thus no significant difference in the bone remodelling of the acetabulum and femur five years after total hip replacement in those two groups where the only difference was in the acetabular liner",
"Background Anatomic short femoral prostheses with a prominent lateral flare have the potential to reduce stress-shielding in the femur through a more physiological stress distribution to the proximal femur . We present the design rationale of a new short uncemented , proximally fixed anatomic femoral implant and the study design of a prospect i ve multi-centre trial to collect long-term patient outcome and radiographic follow up data . Methods A prospect i ve surveillance study ( trial registry NCT00208555 ) in four European centres ( UK , Italy , Spain and Germany ) with a follow up period of 15 years will be executed . The recruitment target is 200 subjects , patients between the ages of 18 and 70 admitted for primary cementless unilateral THA will be included . The primary objective is to evaluate the five-year survivorship of the new cementless short stem . The secondary objectives of this investigation are to evaluate the long term survivorship and the clinical performance of the implant , the impact on the subjects health related Quality of Life and the affect of the prosthesis on bone mineral density . Peri- and postoperative complications will be registered . Clinical and radiographic evaluation of prosthesis positioning will be done post-operatively and at 3 , 6 , 12 , 24 , 60 , 120 and 180 months follow up . Discussion Shortening of the distal stem can maximise bone and soft tissue conservation . New stem types have been design ed to improve the limitations of traditional implants in primary THA . A new , uncemented femoral short stem is introduced in this paper . A long-term follow up study has been design ed to verify stable fixation and to research into the clinical outcome . The results of this trial will be presented as soon as they become available",
"Background We developed a total hip system using osseointegration guidelines , a metaphyseal-loading proximal femoral replacement in the retained neck and a dual-geometry titanium shell in the acetabulum . Patients and methods A r and omized controlled clinical trial was undertaken in 52 patients ( 53 hips ) , using the cemented Spectron stem and cementless Harris-Galante II cup as control implants ( 24 patients in experimental group , 29 control patients ) . Clinical measures of Harris Hip Score ( HHS ) , pain score and radiostereometric analysis ( RSA ) at regular intervals for up to three years were used to monitor progress . Results No statistically significant differences were found in HHS and pain score ; the stability of the cementless experimental implant was also comparable to that of the cemented controls by RSA . 3 revisions were required for migration in the experimental group and 1 was required for component dislocation in the control group . Interpretation Our findings indicate the practicality of osseointegration of titanium implants , but suggest that current performance is inadequate for clinical introduction . However , the stable fixation achieved in the retained neck in the majority of patients is indicative of osseointegration . This finding will encourage technical and design improvements for enhancement of clinical osseointegration and should also encourage further study . Periprosthetic osteolysis might be avoided by the establishment and maintenance of direct implant-bone connection : “ osseointegration ”",
"Clinical function , bone mineral density ( BMD ) , and radiographs of 80 r and omly allocated , hydroxyapatite-coated femoral stems of two differing lengths were studied for 2 years . The short stem was optimized for proximal fixation . The predictive value of bone densitometry was also studied . After 2 years , significantly more bone apposition and a higher BMD percentage were observed in Gruen zone 7 of the short stem . We conclude that stem design can be enhanced to achieve more proximal fixation . However , we found a higher incidence of pain with the short stem , indicating a trade-off between increased proximal fixation and diminished overall mechanical stability . No strong correlations between clinical function and radiographic evaluation of remodeling were found with BMD , suggesting that dual-energy x-ray absorptiometry has no predictive value for short-term clinical outcome",
"BACKGROUND Femurs of dysplastic hips exhibit specific abnormalities , and use of modular or specially design ed components is recommended . An anatomic short stem was previously design ed specifically for dysplastic hips using 3-dimensional data acquired from dysplastic patients . To investigate effects of stem geometry on bone remodeling , we undertook a prospect i ve , r and omized study of patients who had undergone 1-stage bilateral total hip arthroplasty ( THA ) with the anatomic short stem on one side and a conventional straight stem on the other . METHODS The study included 36 patients who underwent the above THA procedure . We assessed bone mineral density as well as the presence of cancellous condensation or bony atrophy due to stress shielding based on the analysis of Gruen 's zones and newly defined equal-interval zones , at an average follow-up period of 9.2 years . RESULTS All stems were bone ingrown stable . Cancellous condensation was observed more proximally , and areas of bone atrophy were narrower on the anatomic short stem side than on the straight stem side . Bone mineral density values reflected results of cancellous condensation and stress shielding and were higher in more proximal zones on the anatomic short stem side than on the straight stem side . CONCLUSION Although radiographic results indicated good midterm outcomes of THA with both stems , the loading pattern differed . The anatomic short stem achieved its design purpose in terms of proximal fixation and load transfer and led to better preservation of the proximal femur",
"We investigated prospect ively the bone mineral density ( BMD ) of the proximal femur after implantation of a tapered rectangular cementless stem in 100 patients with a mean age of 60 years ( 16 to 87 ) . It was determined using dual energy x-ray absorptiometry , performed one week after surgery and then every six months until the end-point of five years . The BMD increased significantly in Gruen zones 2 , 4 and 5 by 11 % , 3 % and 11 % respectively , and decreased significantly in Gruen zones 1 , 6 and 7 by 3 % , 6 % and 14 % respectively , over the five-year period . The net mean BMD did not change over this time period . The changes in the BMD were not confined to the first 12 months after surgery . This investigation revealed no change in the overall periprosthetic BMD , but demonstrated a regional redistribution of bone mass from the proximal to distal zones",
"Hydroxyapatite-coated femoral components were introduced to enhance fixation , but concerns were raised about whether the coating would be maintained over time . We therefore determined the long-term clinical and radiographic results of a proximally hydroxyapatite-coated femoral component and compared the mechanical failure rate to other fixation methods at similar lengths of followup . The study group , culled from a large , multicenter prospect i ve study population , consisted of 146 patients ( 166 hips ) with followup of 15 to 18 years . Average age at time of the index procedure was 51 years , and the most common diagnoses were osteoarthritis ( 71 % ) and osteonecrosis ( 11 % ) . Average Harris hip scores were 42.7 preoperatively and 91.5 at most recent followup . Radiographically , one stem showed stable fibrous fixation , and all other unrevised stems were bony stable . Of 13 stem revisions in the study population , only one stem has been revised for aseptic loosening . Forty-nine percent of hips have an osteolytic lesion in proximal areas of Gruen Zones 1 , 7 , 8 , or 14 only . Both the femoral aseptic revision and mechanical failure rates are 0.6 % at 15-year minimum followup . The data demonstrate excellent long-term survivorship of this hydroxyapatite-coated femoral component used in a relatively young patient group . Level of Evidence : Level IV , therapeutic study . See the Guidelines for Authors for a complete description of levels of evidence",
"BACKGROUND Cementless femoral stems in total hip arthroplasty provide dependable clinical and radiographic results in the treatment of osteoarthritis . Stem length might affect the preservation of proximal bone stock and stability . We hypothesized that a shorter stem decreases proximal bone loss without affecting implant stability . METHODS We r and omly assigned 60 patients aged between 50 and 70 years to either a st and ard cementless femoral stem or a 35-mm shorter version . Patients were followed with dual-energy X-ray absorptiometry , radiostereometric analysis , Harris hip score , Western Ontario and McMaster Universities Osteoarthritis Index score , and clinical follow-up at 3 , 6 , 12 , and 24 months . The trial is registered on Clinical Trials.gov/. RESULTS After 24 months , short stems had on average 3.8 % ( 95 % confidence interval , 1.2%-8.9 % ) more bone loss in zone 1 compared to st and ard stems ( P = .14 ) . In zone 7 , the bone loss was on average 6.5 % ( 95 % confidence interval , 6.6%-19.7 % ) higher compared to st and ard stems ( P = .33 ) . After 24 months , st and ard stems had migrated 0.93 mm ( range , 0.25 - 4.66 mm ) and short stems 0.93 mm ( range , 0.17 - 2.96 mm ; Student t-test after log transformation , P = .3 ) . Patient-reported outcome measures were similar in both groups . One patient in the st and ard stem group was diagnosed with infection , one with a posterior dislocation , and one with a deep venous thrombosis . No stems were revised . CONCLUSION There were no statistically significant differences in periprosthetic bone loss or fixation between the stems at 24 months",
"Background Because the clinical and radiographic performance of an ultrashort anatomic cementless stem has been investigated in only two r and omized controlled studies , well- design ed trials should aim for a thorough comparison of the outcomes of ultrashort anatomic cementless and conventional anatomic cementless stems . Questions / purpose sThe purpose s of this study were to compare ( 1 ) the clinical results , including Harris hip score , thigh pain , and WOMAC index score , ( 2 ) radiographic results , ( 3 ) bone mineral density ; and ( 4 ) proportions of patients undergoing revision of a THA using an ultrashort anatomic cementless stem versus a conventional anatomic cementless stem in the same patients who underwent bilateral sequential THAs under the same anesthetic . Methods Two hundred patients ( mean age , 53 years ; range , 26–54 years ) who underwent bilateral sequential THAs received an ultrashort anatomic cementless stem in one hip and a conventional anatomic cementless stem in the contralateral hip . From January 2004 to December 2005 , we performed 524 same-day bilateral short and conventional anatomic cementless THAs in 262 patients , of whom 212 ( 81 % ) participated in this study . Five patients were lost to followup before 2 years , five were lost between 2 to 10 years , and two were lost between 10 to 13 years , leaving 200 patients . Patients who had end-stage bilateral hip disease and were younger than 55 years were selected for inclusion . The predominant diagnoses were osteonecrosis ( 118 patients , 59 % ) and osteoarthritis ( 44 patients , 22 % ) . One hundred thirty-eight were men and 62 were women . At the time of each followup , the patients were assessed clinical ly and radiographically . In addition , each patient completed the WOMAC and the University of California Los Angeles ( UCLA ) activity scores . The minimum followup was 10 years ( mean , 11.8 years ; range , 10–13 years ) . Followups were done in person , with all images and followup clinic notes . Based on the power analysis , we estimated a sample size of 178 hips was needed in each group to detect a 3-point difference in the Harris hip score with 80 % power . Results At the latest followup , there were no differences between the two groups regarding the mean Harris hip scores ( 94 versus 94 points ; p = 0.189 ) , mean WOMAC scores ( 17 versus 16 points ; p = 0.191 ) , or mean UCLA activity scores ( 9 versus 9 points ; p = 0.381 ) . Two patients in the ultrashort stem group and one patient in the conventional stem group had severe ( 9 points ) thigh pain , and 30 patients ( 15 % ) in the conventional stem group had mild thigh pain ( 2 or 3 points ) after vigorous exercise . Bone mineral density in the ultrashort and conventional stem groups , respectively , was greater in the ultrashort stem group than in the conventional stem group . Bone mineral density in Zone 1 at 12 years was 3.29 versus 1.88 g/cm2 ( p = 0.021 ) , and 2.97 versus 0.91 g/m2 in Zone 7 ( p = 0.001 ) . With the numbers available , there were no differences between the stem design s in terms of the proportion undergoing revision ( one hip , 0.5 % , in the short-stem group versus one hip , 0.5 % , in the conventional group ; p = 1.881 ) . Conclusions At followup into the second decade , ultrashort stems showed no differences from conventional cementless stems in terms of vali date d outcomes scores or fixation , although less stress shielding was observed . Reduction of stress shielding may reduce the long-term risk of periprosthetic fracture , but this was not shown in our study .Level of Evidence Level I , therapeutic study",
"Background : The early experience with cementless total hip replacement led to design modifications to increase the initial press-fit and stability of the femoral component , to reduce the diameter of the femoral head , and to improve the acetabular component , including the locking mechanism of the shell and the quality of the polyethylene liner . We performed a prospect i ve study to assess the results in young patients who had been followed for a minimum of eight years after treatment with a primary total hip arthroplasty with a second-generation cementless prosthesis . Methods : Eighty patients ( 118 hips ) were included in the study . There were fifty-eight men and twenty-two women ; the mean age at the time of the operation was 46.8 years ( range , twenty-one to forty-nine years ) . We used a cementless Duraloc series-100 or 1200 acetabular component with or without screw fixation , a polyethylene liner with a 22-mm inner diameter , and a cementless Profile femoral component in all hips . The average duration of follow-up was 9.8 years ( range , eight to eleven years ) . Clinical follow-up ( with use of the Harris hip score ) and radiographic follow-up were performed at six weeks ; at three , six , and twelve months ; and yearly thereafter . Linear and volumetric wear were measured , and bone-remodeling and osteolysis were assessed . Results : The average Harris hip score improved from 48.8 points preoperatively to 92 points at the final follow-up examination . The prevalence of transitory thigh pain was 10 % ( twelve of 118 hips ) . There was no aseptic loosening . One hip was revised because of recurrent dislocation . The average amount of linear wear was 1.18 mm , and the average wear rate was 0.12 mm/yr . Fourteen hips ( 12 % ) had osteolysis in the calcar femorale and eleven hips ( 9 % ) had acetabular osteolysis , but all of the osteolytic lesions were young patients who were particularly difficult to treat because of a high prevalence of osteonecrosis and developmental dysplasia . Although there was no aseptic loosening of the components and a relatively low prevalence of osteolysis , there was a high rate of linear wear of the polyethylene liner . Level of Evidence : Therapeutic study , Level IV ( case series [ no , or historical , control group ] ) . See p. 2 for complete description of levels of evidence",
"The relatively high prevalence of thigh pain and stress shielding associated with the AML porous-coated cementless femoral component led to the development of the Prodigy ® , a femoral component with more extensive porous-coating and a distal polished bullet tip with medial diaphyseal relief to potentially decrease the flexural rigidity . We prospect ively evaluated a cohort of 100 consecutive cementless total hip arthroplasties performed using this device . The minimum followup was 10 years ( mean , 11.4 years ; range , 10–12 years ) . At 10-year followup , 69 of the 86 patients ( 82 hips ) were living , 14 patients with 15 hips were deceased , and three patients with three hips were lost to followup . No hips required a stem revision . Two patients ( two hips ) complained of thigh pain . All hips were bone ingrown . Distal tip radiolucencies and osteolysis occurred in 13 hips ( 17 % ) and none , respectively . Twenty-one hips ( 28 % ) demonstrated moderate or severe stress shielding . Only further followup will determine if this could be a clinical problem or one with revision surgery . These results encourage the authors to continue using second-generation extensively coated stems in their primary total hip arthroplasty constructs . Level of Evidence : Level III , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence"
] | 411673e2-06ff-11f0-808a-c43d1ab1c353 |
PURPOSE To evaluate the reliability and validity of the six-minute walk test ( 6MWT ) with respect to its ability to predict functional capacity in patients with chronic heart failure . METHODS A systematic review was performed via 8 data bases to assess relevant English language full-text articles published from January 1 , 1980 to October 31 , 2009 . Participant characteristics , interventions , reliability , validity , and predictive value for each article with respect to functional capacity as defined by peak VO(2 ) levels were extracted and compared . Quality Assessment of Diagnostic Accuracy Studies ( QUADAS ) scores were determined for each study . RESULTS Fourteen studies met the selection criteria . Comparison of the studies investigating reliability shows that the 6MWT has good reproducibility . The 6MWT demonstrates moderate correlation with peak VO(2 ) levels , and ability to predict VO(2 ) ( functional capacity ) dependent on distance walked . Cut-off distances vary from 300 to 490 meters depending on the study ; if total distance walked remains equal or less than these values , the 6MWT retains its strong predictive value . CONCLUSION The 6MWT has good reliability , moderate validity , and a significant ability to predict functional capacity in patients with CHF who do not walk greater than 490 meters | [
"Objective To examine the reproducibility and responsiveness to change of a six minute walk test and a quality of life measure in elderly patients with heart failure . Design Longitudinal within patient study . Subjects 60 patients with heart failure ( mean age 82 years ) attending a geriatric outpatient clinic , 45 of whom underwent a repeat assessment three to eight weeks later . Main outcome measures Subjects underwent a st and ardised six minute walk test and completed the chronic heart failure question naire ( CHQ ) , a heart failure specific quality of life question naire . Intraclass correlation coefficients ( ICC ) were calculated using a r and om effects one way analysis of variance as a measure of reproducibility . Guyatt ’s responsiveness coefficient and effect sizes were calculated as measures of responsiveness to change . Results 24 patients reported no major change in cardiac status , while seven had deteriorated and 14 had improved between the two clinic visits . Reproducibility was satisfactory ( ICC > 0.75 ) for the six minute walk test , for the total CHQ score , and for the dyspnoea , fatigue , and emotion domains of the CHQ . Effect sizes for all measures were large ( > 0.8 ) , and responsiveness coefficients were very satisfactory ( > 0.7 ) . Effect sizes for detecting deterioration were greater than those for detecting improvement . Conclusions Quality of life assessment and a six minute walk test are reproducible and responsive measures of cardiac status in frail , very elderly patients with heart failure",
"The assessment of functional capacity reflects the ability to perform activities of daily living that require sustained aerobic metabolism . The integrated efforts and health of the pulmonary , cardiovascular , and skeletal muscle systems dictate an individual ’s functional capacity . Numerous investigations have demonstrated that the assessment of functional capacity provides important diagnostic and prognostic information in a wide variety of clinical and research setting s. This scientific statement , an up date of the previously published American Heart Association ( AHA ) document,1 highlights the major clinical and research applications of functional capacity assessment . For a comprehensive review of exercise testing , the reader is referred to the American College of Cardiology (ACC)/AHA Guidelines for Exercise Testing.2,3 Functional capacity is the ability of an individual to perform aerobic work as defined by the maximal oxygen uptake ( Vo2max ) , that is , the product of cardiac output and arteriovenous oxygen ( a−Vo2 ) difference at physical exhaustion , as shown in the following equation : ! [Formula][1 ] Where HR indicates heart rate and SV indicates stroke volume . Because Vo2max typically is achieved by exercise that involves only about half of the total body musculature , it is generally believed that Vo2max is limited by maximal cardiac output rather than peripheral factors.4 Although Vo2max is measured in liters of oxygen per minute , it usually is expressed in milliliters of oxygen per kilogram of body weight per minute to facilitate intersubject comparisons . In addition , functional capacity , particularly when estimated from the work rate achieved rather than directly measured Vo , is frequently expressed in metabolic equivalents ( METs ) , with 1 MET representing the resting energy expenditure ( ≈3.5 mL O2 · kg−1 · min−1 ) . In this instance , functional capacity is commonly expressed clinical ly as a multiple of the resting metabolic rate . Vo2max … [ 1 ] :",
"CONTEXT Heart failure is often preceded by isolated systolic hypertension , but the effectiveness of antihypertensive treatment in preventing heart failure is not known . OBJECTIVE To assess the effect of diuretic-based antihypertensive stepped-care treatment on the occurrence of heart failure in older persons with isolated systolic hypertension . DESIGN Analysis of data from a multicenter , r and omized , double-blind , placebo-controlled clinical trial . PARTICIPANTS A total of 4736 persons aged 60 years and older with systolic blood pressure between 160 and 219 mm Hg and diastolic blood pressure below 90 mm Hg who participated in the Systolic Hypertension in the Elderly Program ( SHEP ) . INTERVENTION Stepped-care antihypertensive drug therapy , in which the step 1 drug is chlorthalidone ( 12.5 - 25 mg ) or matching placebo , and the step 2 drug is atenolol ( 25 - 50 mg ) or matching placebo . MAIN OUTCOME MEASURES Fatal and nonfatal heart failure . RESULTS During an average of 4.5 years of follow-up , fatal or nonfatal heart failure occurred in 55 of 2365 patients r and omized to active therapy and 105 of the 2371 patients r and omized to placebo ( relative risk [ RR ] , 0.51 ; 95 % confidence interval [ CI ] , 0.37 - 0.71 ; P Older patients , men , and those with higher systolic blood pressure or a history of or electrocardiographic evidence of MI at baseline had higher risk of developing heart failure . CONCLUSION In older persons with isolated systolic hypertension , stepped-care treatment based on low-dose chlorthalidone exerted a strong protective effect in preventing heart failure . Among patients with prior MI , an 80 % risk reduction was observed",
"BACKGROUND We prospect ively evaluated the potential of the 6-minute walk test compared with peak VO2 in predicting outcome of patients with New York Heart Association ( NYHA ) class II or III heart failure . METHODS AND RESULTS Patients with a history of heart failure caused by systolic dysfunction were included . The combined final outcome ( death or hospitalization for heart failure ) was used as the judgment criterion . One hundred twenty-one patients ( age 59+/-11 years ; left ventricular ejection fraction 29.6%+/-13 % ) were included and followed for 1.53+/-0.98 years . Patients were separated into two groups according to outcome : group 1 ( G1 , 74 patients ) , without events , and group 2 ( G2 , 47 patients ) , who reached the combined end point . Peak VO2 was clearly different between G1 and G2 ( 18.5+/-4 vs. 13.9+/-4 ml/kg/min , p=0.0001 ) but not the distance walked ( 448+/-92 vs 410+/-126 m ; p=0.084 , not significant ) . Survival analysis showed that unlike peak VO2 , the distance covered was barely distinguishable between the groups ( p receiver operating characteristic curves revealed that the best performances for the 6-minute walk test were obtained for subjects walking worse prognosis than those walking farther ( p=0.013 ) . In this subset of patients , there was a significant correlation between distance covered and peak VO2 ( r=0.65 , p=0.011 ) . Thus it appears that the more severely affected patients have a daily activity level relatively close to their maximal exercise capacity . Nevertheless , the 300 m threshold suggested by this study needs to be vali date d in an independent population . CONCLUSIONS A distance walked in 6 minutes outcome . Moreover , in these cases there is a significant correlation between the 6-minute walk test and peak VO2 demonstrating the potential of this simple procedure as a first-line screening test for this subset of patients",
"AIMS The 6-min walk test may serve as a more simple clinical tool to assess functional capacity in congestive heart failure than determination of peak oxygen uptake by cardiopulmonary exercise testing . The purpose of the study was to prospect ively examine whether the distance ambulated during a 6-min walk test ( i ) correlates with peak oxygen uptake , ( ii ) allows peak oxygen uptake to be predicted , and ( iii ) provides prognostic information similar to peak oxygen uptake in patients with dilated cardiomyopathy and left ventricular ejection fraction METHODS AND RESULTS In 113 patients ( age : 54+/-12 years , NYHA : 2.2+/-0.8 ) with dilated cardiomyopathy ( left ventricular ejection fraction 19+/-7 % ) a 6-min walk test and cardiopulmonary exercise testing were performed . The 6-min walk test and peak oxygen uptake were closely correlated at the initial visit ( r=0.68 , n=113 ) , as well as after 263+/-114 ( r=0.71 , n=28 ) and 381+/-170 days ( r=0.74 , n=14 ) . During serial exercise testing the 6-min walk test allowed peak oxygen uptake to be reliably predicted ( r=0.76 between calculated and real peak oxygen uptake ) . After 528+/-234 days , 42 patients were hospitalized due to worsening heart failure and /or died from cardiovascular causes . Compared to clinical ly stable patients , these 42 patients walked a shorter distance ( 423+/-104 vs 501+/-95 m , P peak oxygen uptake ( 12.7+/-4.0 vs 17.4 + 5.6 ml x min(-1 ) x kg(-1 ) , P 6-min walk test outperformed other prognostic parameters such as left ventricular ejection fraction , cardiac index and plasma norepinephrine concentration and conferred a prognostic power similar to peak oxygen uptake . This predictive value could be further improved in a multivariate model , by combining the 6-min walk test with independent variables , such as left ventricular ejection fraction or cardiac index . CONCLUSION The 6-min walk test correlated with peak oxygen uptake when tested serially over the course of the disease . Although both tests define two distinct domains of functional capacity , the 6-min walk test provides prognostic information very similar to peak oxygen uptake in congestive heart failure patients with dilated cardiomyopathy",
"BACKGROUND Peak oxygen uptake ( peak VO(2 ) ) is a reference parameter in the assessment of functional capacity of patients with chronic heart failure , but the procedure for cardiopulmonary exercise testing with expired gas analysis is complex and expensive , so more simple and available methods are desirable . METHODS We compared the usefulness of a time-limited walk test , the 6-minute walk test ( 6-MT ) , with that of a symptom-limited walk test , the shuttle walk test ( SWT ) , in the evaluation of patients with moderate to severe chronic heart failure . We prospect ively studied 46 clinical ly stable patients in New York Heart Association class II to IV heart failure with left ventricular ejection fraction Each patient performed two 6-MT , two SWT and a cardiopulmonary exercise testing within 2 weeks . RESULTS We found a close correlation between distance walked in SWT and peak VO(2 ) ( r = 0.83 , P distance in 6-MT and peak VO(2 ) ( r = 0.69 , P 450 m in SWT had a peak VO(2 ) > 14 mL/kg/min . The overall discriminatory accuracy for SWT distance was greater than that for 6-MT distance for predicting a peak VO(2 ) distance walked in SWT was the only independent predictor of peak VO(2 ) ( P VO(2 ) ( % PVO(2 ) ) ( P SWT shows to be a feasible and safe method to evaluate patients with chronic heart failure that strongly and independently predicts peak VO(2 ) and % PVO(2 . ) This symptom-limited walk test seems to be more useful than 6-MT in the assessment of functional capacity in these patients",
"This study investigated the use of an incremental , externally-paced 10 m shuttle walk test ( SWT ) as an objective , reliable and predictive test of functional capacity in patients with heart failure ( CHF ) . The SWT was compared to a 6 minute walk test ( 6WT ) and a maximal symptom-limited treadmill peak oxygen consumption ( VO2peak ) test . Experiment 1 examined the reproducibility of the SWT . Two SWF trials were performed and distance ambulated ( DA ) , heart rate ( HR ) and rate of perceived exertion ( RPE ) results compared . In experiment 2 , SWT , 6WT , and VO2 peak tests were performed and HR . RPE and ambulatory VO2 compared . The SWT demonstrated strong test/retest reliability for DA ( r = 0.98 ) . HR ( r = 0.96 ) and RPE ( r = 0.89 ) . Treadmill VO2 peak was significantly correlated with DA during the SWT ( r = 0.83 , P SWT peak VO2 ( 18.5 + /- 1.8 ml.kg(-1 ) x min(-1 ) ) and treadmill VO2 peak ( 18.3 + /-2.0 ml.kg(-1 ) x min(-1 ) ) were also highly correlated ( r = 0.78 , P 6WT peak VO2 and treadmill VO2 peak were not significantly correlated . This study suggests the SWT is a reliable , objective test , highly predictive of VO2 peak which may be a more optimal field exercise test than the self paced 6WT",
"BACKGROUND Supervised cardiac rehabilitation programs have been offered to patients following myocardial infa rct ( MI ) , coronary artery bypass graft surgery ( CABG ) and percutaneous coronary intervention ( PCI ) for many years . However , limited information is available on the usefulness of rehabilitation programs in chronic heart failure ( CHF ) . The aim of our study was to evaluate the outcome of supervised physical training on CHF patients by measuring both central and peripheral factors . METHODS This was a prospect i ve r and omized study , including 43 patients with CHF , New York Heart Association ( NYHA ) class II or III , mean age 68 years . After initial measurements of VO2 peak , 6 min walk distance , muscle strength , plasma levels of atrial natriuretic peptide ( ANP ) and brain natriuretic peptide ( BNP ) , echocardiogram , measurements of pulmonary function and quality of life question naire , patients were r and omized to either a training group ( n = 21 ) or a control group ( n = 22 ) . The training group had supervised aerobic and resistance training program twice a week for five months . After the training program was completed , all measurements were repeated in both groups . RESULTS No training related adverse events were reported . Significant improvement was found between groups in the six minute walk test ( + 37.1 m vs. + 5.3 m , p = 0.01 ) , work load on the bicycle exercise test ( + 6.1 W vs. + 2.1 W , p = 0.03 ) , time on the bicycle exercise test ( + 41 s vs. + 0 s , p = 0.02 ) and quadriceps muscle strength test ( + 2.8 kg . vs. + 0.2 kg . , p = 0.003 ) . Quality of life factors that reflect exercise tolerance and general health , improved significantly in the training group compared to the control group . No other significant changes were found between the two groups . CONCLUSION Supervised physical training as used in this study appears safe for CHF patients in NYHA class II or III . The improvement in functional capacity observed in the training group seems to be related to peripheral factors rather than in central cardiovascular performance",
"BACKGROUND The value of the 6-minute walk in a population of elderly patients with chronic heart failure ( CHF ) has not yet been established , as it has been in a younger population . METHODS In a prospect i ve trial , 2 exercise tests were compared : the 6-minute walk ( 6 MW ) and a treadmill test with progressive increments in workload . 37 patients ( mean age 81.3 , SD 5.6 years ) : 11 untrained controls , 16 patients with New York Heart Association ( NYHA ) class II and 10 patients with NYHA class III participated . The main outcome measures were the distance walked in 6 minutes , the symptomatic VO2max in the progressive treadmill test and the degree of CHF as scored by the NYHA classification and the Boston Study Group ( BSG ) score . RESULTS For both the 6 MW and the treadmill test there was a significant difference in distance between NYHA class II and III patients ( p distance walked in the 6 MW was well correlated with the distance walked in the treadmill test ( p covered very low distances compared to the 6 MW . The VO2max was lower in NYHA class III than in class II patients ( p = .032 ) . NYHA classification and BSG score correlated reasonably well . CONCLUSION A treadmill exercise test with VO2max measurement in elderly patients with CHF is difficult to accomplish . On the contrary , the 6 MW gives a good impression of the remaining exercise capacity . It is well correlated with the treadmill test . The 6 MW is well tolerated by elderly patients and differentiates between NYHA classes II and III . Untrained controls could not be differentiated from NYHA class II patients"
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BACKGROUND Ankylosing spondylitis ( AS ) is a chronic , inflammatory rheumatic disease . Physiotherapy is considered an important part of the overall management of AS . OBJECTIVES To summarise the available scientific evidence on the effectiveness of physiotherapy interventions in the management of AS . SEARCH STRATEGY We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL ) , MEDLINE , EMBASE , AMED , CINAHL and PEDro up to January 2007 for all relevant publications , without any language restrictions . We checked the reference lists of relevant articles and contacted the authors of included articles . SELECTION CRITERIA We included r and omised and quasi-r and omised studies with AS patients and where at least one of the comparison groups received physiotherapy . The main outcomes of interest were pain , stiffness , spinal mobility , physical function and patient global assessment . DATA COLLECTION AND ANALYSIS Two review ers independently selected trials for inclusion , extracted data and assessed trial quality . Investigators were contacted to obtain missing information . MAIN RESULTS Eleven trials with a total of 763 participants were included in this up date d review . Four trials compared individualised home exercise programs or a supervised exercise program with no intervention and reported low quality evidence for effects in spinal mobility ( Relative percentage differences ( RPDs ) from 5 - 50 % ) and physical function ( four points on a 33-point scale ) . Three trials compared supervised group physiotherapy with an individualised home-exercise program and reported moderate quality evidence for small differences in spinal mobility ( RPDs 7.5 - 18 % ) and patient global assessment ( 1.46 cm ) in favour of supervised group exercises . In one study , a three-week inpatient spa-exercise therapy followed by 37 weeks of weekly outpatient group physiotherapy ( without spa ) was compared with weekly outpatient group physiotherapy alone ; there was moderate quality evidence for effects in pain ( 18 % ) , physical function ( 24 % ) and patient global assessment ( 27 % ) in favour of the combined spa-exercise therapy . One study compared daily outpatient balneotherapy and an exercise program with only exercise program , and another study compared balneotherapy with fresh water therapy . None of these studies showed significant between-group differences . One study compared an experimental exercise program with a conventional program ; statistically significant change scores were reported on nearly all spinal mobility measures and physical function in favour of the experimental program . AUTHORS ' CONCLUSIONS The results of this review suggest that an individual home-based or supervised exercise program is better than no intervention ; that supervised group physiotherapy is better than home exercises ; and that combined inpatient spa-exercise therapy followed by group physiotherapy is better than group physiotherapy alone | [
"Fernández-de-las-Peñas C , Alonso-Blanco C , Morales-Cabezas M , Miangolarra-Page JC : Two exercise interventions for the management of patients with ankylosing spondylitis : A r and omized controlled trial . Am J Phys Med Rehabil 2005;84:407–419 . Objective : The purpose of this clinical trial was to evaluate the impact of a 4-month comprehensive protocol of strengthening and flexibility exercises developed by our research group versus conventional exercises for patients with Ankylosing Spondylitis ( AS ) on functional and mobility outcomes . Design : R and omized controlled trial . Forty-five patients diagnosed with AS according to the modified criteria of New York were allocated to control or experimental groups using a r and om numbers table . The control group was treated with a conventional protocol of physical therapy in AS , whereas the experimental group was treated with the protocol suggested by our research group . The conventional intervention consisted of 20 exercises : motion and flexibility exercises of the cervical , thoracic , and lumbar spine ; stretching of the shortened muscles ; and chest expansion exercises . The experimental protocol is based on the postural affectation of the AS and the treatment of the shortened muscle chains in these patients according to the Global Posture Reeducation ( GPR ) method . This intervention employs specific strengthening and flexibility exercises in which the shortened muscle chains are stretched and strengthened . The study lasted 4 mos . During this period , patients received a weekly group session managed by an experienced physiotherapist . Each session lasted an hour , and there were 15 total sessions . Changes in activity , mobility , and functional capacity were evaluated by an assessor blinded to the intervention , using the following previously vali date d scores from the Bath group : BASMI ( tragus to wall distance , modified Schöber test , cervical rotation , lumbar side flexion , and intermalleolar distance ) , BASDAI ( The Bath Ankylosing Spondylitis Disease Activity Index ) , and BASFI ( The Bath Ankylosing Spondylitis Functional Index ) . Results : Both groups showed an improvement ( prepost scores ) in all the outcome measures , mobility measures of the BASMI index , as well as in BASFI and BASDAI indexes . In the control group , the improvement in tragus to wall distance ( P = 0.009 ) and in lumbar side flexion ( P = 0.02 ) was statistically significant . Although the rest of the outcomes also improved , they did not reach a significant level ( P > 0.05 ) . In the experimental group , the improvement in all the clinical measures of the BASMI index ( P the BASFI index ( P = 0.003 ) was statistically significant . The intergroup comparison between the improvement ( prepost scores ) in both groups showed that the experimental group obtained a greater improvement than the control group in all the clinical measures of the BASMI index , except in tragus to wall distance , as well as in the BASFI index . Conclusions : The experimental protocol developed by our research group , based on the GPR method and specific strengthening and flexibility exercises of the muscle chains , offers promising results in the management of patients suffering from AS . Further trials on this topic are required",
"We investigated the effects of home-based daily exercise on joint mobility , functional capacity , pain , and depression in patients with ankylosing spondylitis ( AS ) . The patients were r and omly assigned to a wait-list control group or to an exercise-therapy group . The exercise-therapy group performed a 20-min exercise program once per day for 8 consecutive weeks . After 8 weeks , compared with the control group , the exercise group showed improvements in joint mobility ( cervical flexion , extension , shoulder flexion , abduction , hip abduction , and knee flexion ) , finger – floor distance , and functional capacity . Pain and depression scores were significantly lower after the exercise program in the exercise group than in the control group . These findings indicate that exercise therapy increases joint mobility and functional capacity , and decreases pain and depression in patients with AS . Home-based exercise , which is easily accessible to patients , might be an effective intervention for AS",
"Abstract . A cohort of 25 patients with spondylarthropathy ( SpA ) participated in a 3-year follow-up study of functional changes before and after an intensive 3-week inpatient course . They answered questions in the following functional status/disability indices : Bath ankylosing spondylitis functional index ( BASFI ) , Dougados functional index ( DFI ) , health assessment question naire for spondylarthropathy ( HAQ-S ) , Bath ankylosing spondylitis disease activity index ( BASDAI ) , Bath ankylosing spondylitis patient global assessment ( BAS-G ) , and horizontal visual analogue scale for stiffness ( stiffness VAS ) before and after the course and 3 years later by mail . A control group of 18 consecutive SpA patients from the waiting list for an inpatient course filled in the same question naires as study patients 3 months before entry and again 3 weeks later at home without rehabilitation . During the waiting time for the inpatient course , control group global assessment s ( BASDAI , BAS-G , and stiffness-VAS ) worsened slightly , and BASFI but not HAQ-S and DFI scores remained unchanged in the 3 weeks without treatment . The results of the 25 study patients showed small and not significant improvements in all functional index scores ( BASFI –0.5 points , DFI –1.1 , and HAQ-S –0.17 ) , whereas improvements were significant in BASDAI , BAS-G , and stiffness-VAS ( –13 mm , –13 mm , and –11 mm , respectively ) after the 3-week inpatient course . At 3-year follow-up , these small changes had disappeared and the changes were not significant . The global indices and BASFI worsened slightly ( 0.4 ) from baseline results , while DFI was slightly better ( –0.4 ) and HAQ-S remained at the post-treatment level after 3 years . Thus , BASFI was the most sensitive to changes , whereas DFI and HAQ-S were relatively insensitive . All six indices correlated highly significantly with each other ( ICC 0.53–0.94 ) . The natural course of spondylarthropathy leads to progression of functional impairments , which seems to be preventable with intensive rehabilitation , at least in the short term . Among the three functional indices , BASFI seems to be the most sensitive tool",
"Fernández-de-las-Peñas C , Alonso-Blanco C , Alguacil-Diego IM , Miangolarra-Page JC : One-year follow-up of two exercise interventions for the management of patients with ankylosing spondylitis : A r and omized controlled trial . Am J Phys Med Rehabil 2006;85:559–567 . Objective : To assess the long-term effects on functional and mobility outcomes of two exercise interventions for the management of patients with ankylosing spondylitis . Design : In an extended 12-mo follow-up of a r and omized controlled trial , 40 patients who were diagnosed with ankylosing spondylitis according to the modified criteria of New York , allocated to control or experimental groups using a r and om numbers table , and who performed their respective exercise program at least three times per month , were included in this long-term study . The control group was treated during 15 sessions with a conventional exercise regimen in ankylosing spondylitis , whereas the experimental group received 15 sessions of exercises based on the treatment of the shortened muscle chains following the guidelines described by the Global Posture Reeducation method . These patients were followed up and assessed again 1 yr after entering the study , reapplying the same vali date d indexes : BASMI ( Bath Ankylosing Spondylitis Metrology Index [ tragus to wall distance , modified Schober test , cervical rotation , lumbar side flexion , and intermalleolar distance ] ) , BASDAI ( Bath Ankylosing Spondylitis Disease Activity Index ) , and BASFI ( Bath Ankylosing Spondylitis Functional Index ) . Results : The intragroup comparison between follow-up and postintervention data showed that both groups decrease their clinical and functional measures during the follow-up period . This decrease was only significant for lumbar side flexion and intermalleolar distance measurements , being more significant in the control group ( P = 0.001 and P = 0.002 , respectively ) . Intragroup differences between follow-up and preintervention assessment s revealed that improvements in all mobility measures of the BASMI index and in the BASFI index were partially maintained at the 12-mo follow-up in the experimental group but not in the control group . The intergroup comparison ( unpaired t test analysis ) between changes on each outcome during the long-term follow-up ( post – follow-up ; and pre – follow-up ) showed no significant differences in the decrease between postintervention and follow-up data between the study groups . On the other h and , the intergroup comparison between preintervention and follow-up data revealed significant differences in almost all mobility measures of the BASMI index ( except for cervical rotation ) and in the BASFI index , in favor of the experimental group . Conclusions : An exercise regimen based on the Global Posture Reeducation method and focusing on specific strengthening and flexibility exercises of the shortened muscle chains offers promising short- and long-term results in the management of patients who have ankylosing spondylitis",
"BACKGROUND Although exercise is a commonly recommended treatment for ankylosing spondylitis ( AS ) , little is known about the effectiveness of unsupervised recreational and back exercises . We examined the effects of recreational exercise and back exercises on patient-reported pain severity , stiffness severity , and functional disability in a prospect i ve longitudinal study of 220 patients with AS . METHODS Participants provided information on exercise habits and health status every 6 months using mailed question naires ( median follow-up , 4.5 years ) . Pain severity and stiffness severity were measured using visual analog scales , and functional disability was measured using the Health Assessment Question naire ( HAQ ) Disability Index . RESULTS Among all patients , there were no associations between either the number of exercise minutes per week or the number of days of back exercise per week and short-term ( 6-month ) changes in pain , stiffness , or HAQ Disability Index . However , among those who had AS for 15 years or less , pain scores were 0.18 points lower ( on a scale of 0 - 3 ; P = .04 ) , and stiffness scores were 6.4 points lower ( on a scale of 0 - 100 ; P = .005 ) during periods with more than 200 minutes per week of exercise compared with periods with 0 to 30 minutes of exercise per week . Among those who had AS for more than 15 years , pain scores were 0.11 points lower ( on a scale of 0 - 3 ; P = . 03 ) , and HAQ Disability Indexes were 0.08 points lower ( on a scale of 0 - 3 ; P back exercise compared with periods when back exercises were not performed . Less intense levels of exercise were not associated with improvements in health status . CONCLUSIONS Unsupervised recreational exercise improves pain and stiffness , and back exercise improves pain and function in patients with AS , but these effects differ with the duration of AS . Health status is improved when patients perform recreational exercise at least 30 minutes per day and back exercises at least 5 days per week . Arch Intern Med . 2000;160:2969 -",
"Sixteen individuals with rheumatoid arthritis ( RA ) and 19 individuals with ankylosing spondylitis ( AS ) participated in this 3-year follow-up study . The individuals in each disease group were allocated to an experimental group ( E group ) and a comparison group ( C group ) . They were investigated by question naire , clinical examination of the stomatognathic system , and laboratory tests . The individuals of the two E groups had performed a physical training program of the stomatognathic system during 3 weeks . After 3 years most of the patients in the E groups reported an unaltered or decreased severity of symptoms and signs from the stomatognathic system compared with the initial status . The clinical dysfunction score according to Helkimo ( CDS ) was lower in the RA group , and the mouth opening capacity was larger than before training . In the AS group there was no long-term change in the CDS but an increase of mouth opening capacity . The general inflammatory disease process in the RA group showed an increased activity during this follow-up period as assessed by erythrocyte sedimentation rate . This study suggests that local physical training of the stomatognathic system has a positive effect in individuals with RA",
"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",
"Summary Long-term effects of three or four-week inpatient physiotherapy and exercise courses were studied in 141 adult patients with ankylosing spondylitis ( AS ) . Eight cervical and thoracolumbar range of motion ( ROM ) measurements and straight leg raise test , vital capacity ( VC ) and fitness index were measured at the beginning and end of an intensive course and 15 months later . All nine mobility measurements , vital capacity and fitness index were significantly improved after the course . Fifteen months later only chest expansion and vital capacity had significantly deteriorated from the baseline , while CR , FFD and fitness index were still significantly better . Disease duration did not influence treatment results .We conclude that it is possible by means of intensive rehabilitation courses to prevent for more than one year deterioration of spinal function and fitness in AS patients irrespective of disease duration",
"AIMS This study is design ed to show the efficacy of balneotherapy and balneotherapy ( BT ) + nonsteroid antiinflammatory drug ( NSAID ) use in Ankylosing spondylitis ( AS ) patients . METHODS In this prospect i ve study , BT , BT+ NSAID and NSAID therapy in 61 patients with AS were evaluated by ASAS core set . BT group ( 21 patients ) was treated only with BT for 20 min , once a day , 5 days a week , over a period of 3 weeks . BT+NSAID group ( 20 patients ) was treated with 1000 mg naproxen as well as BT . NSAID group ( 20 patients ) was treated with 1000 mg naproxen . All of the participants did respiratory and postural exercises for 20 min a day and for the whole study period . Each patient was evaluated on admission ( before treatment ) , at the end of the therapy and 6 months after the treatment . RESULTS At the end of the study , statistically significant improvement was observed in all the clinical parameters of the patients in BT ( G1 ) , BT+NSAID ( G2 ) and NSAID ( G3 ) groups . This significant symptomatic and clinical improvement was maintained even 6 months after the treatment . The changes from baseline to follow up were similar in G1 and G2 except duration of morning stiffness ( DMS ) and chest expansion ( CE ) . Improvements in CE and DMS were better in G1 and G2 , respectively . Improvements observed in G1 and G2 were superior to the improvements observed in G3 for the variables of morning pain , nocturnal pain , DMS , global well being of the patient , occiput-wall distance , CE , finger to floor distance and functional index . In Schober test , improvement observed in G1 was statistically superior to G3 . CONCLUSION We concluded that BT can be suggested as an effective symptomatic treatment modality in patients with AS . Furthermore , sufficient improvement in clinical parameters can be obtained by BT alone",
"Objective : To compare the effect of balneotherapy on physical activity and quality of life as well as the symptoms of pain and stiffness with exercise alone in ankylosing spondylitis ( AS ) patients . Methods : A total of 60 patients who had a diagnosis of AS according to the modified New York criteria were included in the study . The patients were r and omly assigned to two groups . In Group I ( n = 30 ) the patients received balneotherapy in a therapeutic pool for 30 min once a day for 3 weeks . All patients received instructions on the exercise programme , which they were requested to repeat once a day for 30 min during the study . The patients in this group continued the same exercise programme after the end of the balneotherapy protocol to complete a course of 6 months . In Group II the patients were given the same exercise protocol but did not receive balneotherapy . Patients were evaluated before the start of the study and at 3 weeks and 24 weeks . Evaluation parameters were daily and night pain , morning stiffness , the patient 's global evaluation and the physician 's global evaluation ( according to a scoring system of 1 to 5 ) , the Bath Ankylosing Spondilitis Disease Activity Index ( BASDAI ) , Bath Ankylosing Spondylitis Functional Index ( BASFI ) , Dougados Functional Index ( DFI ) , tragus – wall distance , chest expansion , modified Shober test ( MST ) , fingertip – fibula head distance , and Nottingham Health Profile ( NHP ) . Results : Evaluations were completed in 54 patients in the two groups . Comparison of the groups showed significantly superior results for Group I for parameters of BASDAI , NHP total , pain , physical activity , tiredness and sleep score , patient 's global evaluation and the physician 's global evaluation at 3 weeks , but only for the parameters of patient 's global evaluation and MST at 24 weeks . Conclusion : Balneotherapy has a supplementary effect on improvement in disease activity and functional parameters in AS patients immediately after the treatment period . However , in the light of our medium‐term evaluation results , we suggest that further research is needed to assess the role of balneotherapy applied for longer duration s in AS patients",
" Fifty-three patients with ankylosing spondylitis ( AS ) were r and omly allocated ; 26 experimental patients received physiotherapy and disease education , 27 control patients received neither . The primary treatment outcome was change in spinal mobility measured at 4 months by fingertip-to-floor distance . Experimental patients had more improvement in fingertip-to-floor distance ( p2 less than 0.004 ) and in function ( p2 less than 0.001 ) than control patients . Physiotherapy with disease education is effective in the treatment of patients with AS",
"OBJECTIVE Cost effectiveness analysis is helpful in setting priorities for funding of health care programs . We studied the cost effectiveness of supervised group physical therapy compared to unsupervised exercises at home in patients with ankylosing spondylitis ( AS ) . METHODS A total of 144 patients with AS ( modified New York criteria ; mean age : 43 years ) were r and omized to unsupervised daily individualized exercises at home for 9 months or the same plus supervised group physical therapy ( 3 h weekly ) . At baseline and after 9 months we measured spinal mobility ( thoracolumbar flexion and extension ) , fitness ( maximum work capacity by ergometry ) , and patient 's global assessment of change as measured on a visual analog scale . We used a question naire at baseline and a diary during the trial to measure AS related direct medical costs , such as doctor visits , paramedical treatment , medication and hospitalization . RESULTS The mean effects of group therapy and home exercises were , respectively , + 0.9 cm ( 16 % ) and + 0.5 cm ( 9 % ) for mobility , + 7 watts ( 4 % ) and -2 watts ( -1 % ) for fitness , and + 1.7 ( 34 % ) and + 0.3 ( 6 % ) for global health . These 3 differences were significant ( p mobility , p = 0.05 for fitness and p global health ) . During the trial total medical costs decreased by an average of US $ 379 ( 44 % ) for group therapy , and by $ 257 (35%)/patient/year for the \" home \" group . Additional costs of group therapy were estimated at $ 531/patient/year ( $ 177 for accommodation , $ 256 for therapist and $ 98 for material s ) . After the study 75 % of the patients wanted to continue group physical therapy and were willing to pay for it . CONCLUSION Compared to therapy at home , additional benefits of group therapy cost $ 531/year , but reduced direct medical costs by $ 122/year . Hence , the beneficial effects of group therapy cost $ 409/patient with AS/year",
"BACKGROUND AND PURPOSE Few r and omized controlled studies have examined the effects of exercise in patients with ankylosing spondylitis ( AS ) . This study investigated the effects of a 12-week , multimodal exercise program in patients with AS . SUBJECTS A convenience sample of 30 patients with AS ( 18 male , 12 female ) , with a mean age of 34.9 years ( SD=6.28 ) , participated in the study . Twenty-six subjects were classified as having stage I AS and 4 subjects were classified as having stage II AS according to the modified New York Criteria . METHODS This study was a r and omized controlled trial . Subjects were assigned to either a group that received an exercise program or to a control group . The exercise program consisted of 50 minutes of multimodal exercise , including aerobic , stretching , and pulmonary exercises , 3 times a week for 3 months . Subjects in both groups received medical treatment for AS , but the exercise group received the exercise program in addition to the medical treatment . All subjects received a physical examination at baseline and at 12 weeks . The examinations were conducted under the supervision of a physician who specialized in physical medicine and rehabilitation and included the assessment of spinal mobility using 2 methods : clinical measurements ( chin-to-chest distance , Modified Schober Flexion Test , occiput-to-wall distance , finger-to-floor distance , and chest expansion ) and inclinometer measurements ( gross hip flexion , gross lumbar flexion , and gross thoracic flexion ) . In addition , vital capacity was measured by a physiologist , and physical work capacity was evaluated by a doctorally prepared exercise instructor . RESULTS The measurements of the exercise group for chest expansion , chin-to-chest distance , Modified Schober Flexion Test , and occiput-to-wall distance were significantly better than those of the control group after the 3-month exercise period . The spinal movements of the exercise group improved significantly at the end of exercise program , but those of the control group showed no significant change . In addition , the results showed that the posttraining value of gross thoracic flexion of the exercise group was significantly higher than that of the control group . Physical work capacity and vital capacity values improved in the exercise group but decreased in the control group . DISCUSSION AND CONCLUSION In this study , a multimodal exercise program including aerobic , stretching , and pulmonary exercises provided in conjunction with routine medical management yielded greater improvements in spinal mobility , work capacity , and chest expansion",
"AIM The aim of this study was to assess both the opinion of an international group of experts about the place and importance of physiotherapy in the management of ankylosing spondylitis ( AS ) as well as the awareness of the responders about scientific evidence on efficacy and cost-effectiveness of physiotherapy in AS . METHODS An e-mail question naire ' ' Experts ' Beliefs on Physiotherapy for Patients with Ankylosing Spondylitis ' ' has been sent to all 71 international ASsessment of Ankylosing Spondylitis ( ASAS ) members . Completion of the twenty-eight-item question naire was done through the ASAS website ( www.ASAS-group.org ) . RESULTS The number of responders was 53 ( response rate 73 % ) . Altogether 94 % of the responders regard themselves as experts in the field of clinical care for AS patients . There is almost unanimous ( 86 - 92 % ) consensus on the efficacy of physiotherapy ( widely defined , i.e. as physical therapy-including exercises , application of physical modalities and spa-therapy ) for patients with axial and peripheral joint manifestations of AS . Physiotherapy is considered to be indicated for both early AS ( less than 2 years after diagnosis ) ( 88 % ) and AS of longer duration ( 2 to 10 years ) ( 94 % ) , implying that this non-pharmaceutical intervention should be made available for or should be prescribed to AS patients . Also daily exercises at home are considered indicated for both early ( less than 2 years after diagnosis ) AS ( 90 % ) and AS of longer duration of disease ( 90 % ) . High-level evidence ( Cochrane review s or publications of one or more r and omized controlled clinical trials ) favoring efficacy of physiotherapy was considered available by 33 % of the participants , whereas 43 % replied ' ' no ' ' and 24 % did not know . Finally , excluding the costs of the intervention , 39 % of the participants reported that Spa-therapy might reduce health care costs as usage of NSAIDs , physician visits and ability to work or sick leave , whereas 26 % said ' ' no ' ' and 35 % did not know . CONCLUSIONS The international ASAS experts hold a favorable opinion on the efficacy of physiotherapy in AS , including group exercises and spa therapy , almost irrespective of disease duration and type of articular involvement ( axial/peripheral ) . Awareness of published evidence on physiotherapy in AS is unsatisfactory",
"Two sets of criteria have been proposed to discriminate spondylarthropathies ( SA ) from other rheumatic diseases . To evaluate their performance , we conducted a cross-sectional study in the patients observed during one week in 28 French Departments of Rheumatology by 91 staff-teaching physicians . The physicians had to apply these criteria to all their patients and had to classify them as definite SA , definite other rheumatic disease or possible SA . The analysis performed on the 2,088 patients with a definite diagnosis ( 124 SA and 1,964 controls ) showed the following results : ( table ; see text ) Of the 140 patients with possible SA , 37 fulfilled both sets of criteria , 22 the ESSG criteria alone and 12 the Amor criteria alone . These data suggest that a ) the overall performance of these two sets of criteria is similar ; b ) this performance is better in the group of patients with a definite diagnosis ; c ) the patients without a definite diagnosis require a longer follow-up to assess the clinical relevance of these two sets of criteria",
"BACKGROUND The efficacy of spa therapy in ankylosing spondylitis has not been investigated extensively . OBJECTIVE To study the efficacy of balneotherapy and climatic therapy ( climatotherapy ) at the Dead Sea area in patients with ankylosing spondylitis . METHODS In a single-blind r and omized controlled study , 28 patients suffering from ankylosing spondylitis were allocated into two groups of 14 patients each . The first group ( the combined treatment group ) received balneotherapy ( mud packs and sulfur pool ) and exposure to the unique climatic conditions of the Dead Sea . The second group ( the climatotherapy group ) used the fresh water pool and experienced the same climatic conditions . The duration of treatment was 2 weeks and the follow-up period 3 months . RESULTS For both patient groups a significant improvement was found in the outcome measures : Bath AS Disease Activity Index ( P = 0.002 ) , VisuarAnalog Scale for pain ( P = 0.002 ) and VAS for spinal movement ( P = 0.011 ) . The variability was explained by the effect of time ( within group effect ) rather than the type of treatment ( between group effect ) . Quality of life , assessed by the SF-36 question naire , was very low prior to the study , but improved in terms of pain amelioration in the combined treatment group . CONCLUSIONS Climatotherapy at the Dead Sea area can improve the condition of patients suffering from long-st and ing ankylosing spondylitis",
"PURPOSE Group physical therapy in patients with ankylosing spondylitis was studied to determine whether beneficial effects persisted after cessation of the intervention . METHODS After a 9-month period of supervised group physical therapy , 68 patients were r and omized for another 9 months to unsupervised daily exercises at home ( discontinuation group ) or continuation of weekly sessions of supervised group physical therapy ( continuation group ) . Endpoints were spinal mobility ( thoraco-lumbar flexion and extension , chest expansion , cervical rotation ) , fitness ( maximum work capacity ) , functioning ( Sickness Impact Profile ( SIP ) , Health Assessment Question naire for the Spondylarthropathies [ HAQ-S ] , Functional Index [ FI ] ) , and patient 's global health assessment on a visual analogue scale . RESULTS Time for exercises at home was significantly higher in the continuation than in the discontinuation group ( mean duration 1.9 versus 1.2 hr per week , P global health ( mean improvement 1.6 ; 32 % ) and in SIP score . Scores for thoraco-lumbar mobility and HAQ-S did not change very much , whereas chest expansion , cervical rotation , fitness , and FI deteriorated . The average attendance for group therapy sessions was 62 % . The discontinuation group improved only marginally ( 0.2 ; 4 % ) in global health , whereas all other endpoints decreased . Only for global health and HAQ-S were the differences statistically significant in favor of the continuation group . CONCLUSIONS Global health and functioning are sustained or even improved further if group physical therapy is continued . Spinal mobility decreased slightly in both groups",
"OBJECTIVE Our previous r and omized clinical trial showed a 4-month home physiotherapy program was effective for patients with ankylosing spondylitis . This followup study reports on 22 control patients who received the previously withheld treatment and 24 experimental patients who received followup treatment as needed . METHODS The primary outcome measure was spinal mobility measured by fingertip-to-floor distance using a portable measuring device specially design ed and vali date d for this study . RESULTS Following treatment , fingertip-to-floor distance did not change in control patients ( P2 = 0.145 ) . Between 4 and 8 months , fingertip-to-floor distance did not change in experimental patients ( P2 = 0.143 ) ; however , initial improvement achieved was maintained . The experimental group at 4 months was better than the control group at 8 months ( P2 = 0.038 ) . CONCLUSION The home physiotherapy treatment program must be delivered as rigorously as it was in the initial trial to be effective . The benefit from this treatment program can be maintained with very little intervention",
"Objective : The objective was to prospect ively evaluate the short as well as the long‐term effects of intensive physiotherapy in a stable , sunny and warm climate on physical function and health related quality of life in patients with rheumatoid arthritis ( RA ) and spondylarthropathies ( SpA ) . Methods : Ninety‐three Swedish patients with RA and SpA receiving physiotherapy for 4 weeks in Israel or Tenerife were followed for 6 months . Physical function was evaluated by the Swedish version of Stanford Health Assessment Question naire ( HAQ ) and quality of life by the Nottingham Health Profile ( NHP ) question naire . Results : There were significant improvements in HAQ‐scores and global NHP‐scores as well as all subcategories of NHP immediately after the treatment abroad , effects that were still measurable after six months . At that time point nearly half of the patients had clinical ly meaningful reduction of HAQ‐scores ( ≥0.25 ) . Conclusion : Physiotherapy in a warm and stable climate , with many hours of daily sunshine , is a valuable treatment complement for Swedish patients with RA and",
"OBJECTIVE Home based self-care is essential for successful management of ankylosing spondylitis ( AS ) . We design ed an intervention package aim ed at promoting self-care and regular longterm exercise and evaluated its effect on outcome . METHOD Members of our data base ( n = 4569 ) were r and omly selected and r and omized to an intervention group ( IG ) or a followup control group ( CG ) . The intervention consisted of an exercise/information video , exercise progress chart , patient education booklet , and AS exercise reminder stickers . The outcome measures were function ( BASFI ) , disease activity ( BASDAI ) , global well being ( BAS-G ) , exercise self-efficacy ( ESE ) , arthritis self-efficacy ( SES ) , and quantity of AS mobility/aerobic exercise assessed at baseline and 6 months . RESULTS Of the 200 subjects , 155 completed the study ( 75 IG and 80 CG ) . Baseline analysis showed no differences between the CG and the IG . At 6 months , analysis revealed no statistically significant between-group differences for the BASFI , BASDAI , and BAS-G. although the p value of 0.08 for function approached significance . Self-efficacy for exercise showed a significant improvement in the IG ( p = 0.045 ) . There were no between-group differences for the SES pain and other symptoms subscales . Finally , there was a significant increase in self-reported AS mobility ( p aerobic exercise ( p An exercise intervention package design ed to promote self-management in AS ( 1 ) significantly improves self-efficacy for exercise ; ( 2 ) significantly improves self-reported levels of exercise ; ( 3 ) reveals a trend for improvement in function ( BASFI )",
"PURPOSE To study the effects of adding supervised group physical therapy to unsupervised individualized therapy in ankylosing spondylitis . METHODS One hundred forty-four patients were r and omized to exercises at home , or the same plus weekly group physical therapy for 9 months . Endpoints were spinal mobility , fitness ( maximum work capacity by ergometry ) , functioning ( Sickness Impact Profile , Health Assessment Question naire for the Spondylarthropathies , and Functional Index ) , and patient 's global assessment of change on a 10-cm visual analogue scale . RESULTS Thoracolumbar flexion and extension increased by an average of 0.5 cm ( 9 % ) after home exercises , and by 0.9 cm ( 16 % ) after group therapy . Maximum load in ergometry decreased by 2 W ( 1 % ) after home exercises , but increased by 7 W ( 4 % ) after group therapy . Global assessment improved by 0.3 ( 6 % ) after home exercises , and by 1.7 ( 34 % ) after group therapy . These three differences were statistically significant . There were no significant differences in chest expansion , cervical rotation , or the self- assessment s of functioning . CONCLUSIONS Group physical therapy proved superior to individualized therapy in improving thoracolumbar mobility and fitness , and had an important effect on global health reported by the patients",
"OBJECTIVE To evaluate the cost effectiveness and cost utility of a 3-week course of combined spa therapy and exercise therapy in addition to st and ard treatment consisting of antiinflammatory drugs and weekly group physical therapy in ankylosing spondylitis ( AS ) patients . METHODS A total of 120 Dutch out patients with AS were r and omly allocated into 3 groups of 40 patients each . Group 1 was treated in a spa resort in Bad Hofgastein , Austria ; group 2 in a spa resort in Arcen , The Netherl and s. The control group stayed at home and continued their usual activities and st and ard treatment during the intervention weeks . After the intervention , all patients followed weekly group physical therapy . The total study period was 40 weeks . Effectiveness of the intervention was assessed by functional ability using the Bath Ankylosing Spondylitis Function Index ( BASFI ) . Utilities were measured with the EuroQoL ( EQ-5D(utility ) ) . A time-integrated summary score defined the clinical effects ( BASFI-area under the curve [ AUC ] ) and utilities ( EQ-5D(utility)-AUC ) over time . Both direct ( health care and non-health care ) and indirect costs were included . Re source utilization and absence from work were registered weekly by the patients in a diary . All costs were calculated from a societal perspective . RESULTS A total of 111 patients completed the diary . The between-group difference for the BASFI-AUC was 1.0 ( 95 % confidence interval [ 95 % CI ] 0.4 - 1.6 ; P = 0.001 ) for group 1 versus controls , and 0.6 ( 95 % CI 0.1 - 1.1 ; P = 0.020 ) for group 2 versus controls . The between-group difference for EQ-5D(utility)-AUC was 0.17 ( 95 % CI 0.09 - 0.25 ; P mean total costs per patient ( including costs for spa therapy ) in Euros ( euro ; ) during the study period were euro;3,023 for group 1 , euro;3,240 for group 2 , and euro;1,754 for the control group . The incremental cost-effectiveness ratio per unit effect gained in functional ability ( 0 - 10 scale ) was euro;1,269 ( 95 % CI 497 - 3,316 ) for group 1 , and euro;2,477 ( 95 % CI 601 - 12,098 ) for group 2 . The costs per quality -adjusted life year gained were euro;7,465 ( 95 % CI 3,294 - 14,686 ) for group 1 , and euro;18,575 ( 95 % CI 3,678 - 114,257 ) for group 2 . CONCLUSION Combined spa-exercise therapy besides st and ard treatment with drugs and weekly group physical therapy is more effective and shows favorable cost-effectiveness and cost-utility ratios compared with st and ard treatment alone in patients with AS",
"OBJECTIVE To survey and to compare the one year effects of dynamic muscle training and progressive muscle relaxation as home exercise for patients with inflammatory rheumatic diseases ; and to identify predictors for compliance with a longterm home exercise regimen . METHODS Fifty-four patients ( mean age 54 yrs , mean symptom duration 14 yrs ) were assessed for health related quality of life , exercise motivation , joint tenderness , and physical capacities . After r and omization into 2 groups , every patient was instructed on one occasion in a 30 min program of either dynamic training or muscle relaxation to carry out at home , 5 times a week during 3 months , and then 2 - 3 times a week for another 9 months . RESULTS Seventeen patients in each group completed the one year exercise protocol , while 10 from each group did not . Compliance with the one year exercise regimen seemed to be predicted by high self-efficacy for exercise , regular range-of-motion exercises before the intervention , and being unmarried . After one year , minor improvements in physical effect ( p work effect ( p pain effect ( p emotional reactions ( p arm endurance ( p health status , joint tenderness , or physical capacities during the intervention period were found . CONCLUSION These results may improve the selection of patients for home exercise , and form a basis for improved administration of home exercise programs",
"Objective : To compare , in patients with ankylosing spondylitis ( AS ) , the effectiveness on pain , functional and psychological status of an intensive group exercise programme under the supervision of a physiotherapist and a home physiotherapy programme . Design : Fifty-one patients with AS were r and omly allocated into study and control groups . The study was design ed as a prospect i ve , double-blind study . Setting : Outpatient department , Istanbul Medical Faculty . Subjects : Patients who consulted with complaints of pain , morning stiffness and restricted range of movement with a confirmed diagnosis of ankylosing spondylitis . Interventions : Before exercise , both groups were given an education programme about AS . For group I patients an intensive exercise programme was organized under the supervision of a physiotherapist for six weeks . Group II patients had to practise exercises individually at home . Main outcome measures : Both groups were evaluated and compared for pain , functional and psychological status before treatment , at the end of treatment and three months after treatment using a visual analogue scale ( VAS ) for pain , Beck Depression Scale and Bath Ankylosing Spondylitis Functional Index ( BASFI ) . Results : Six patients withdrew , four from group I. Results from the remaining 45 showed more positive changes in the patients undertaking group exercise at six weeks and three months after treatment . Values showed a statistical significant difference in favour of group I. Conclusion : Group exercise in hospital may be more effective than home-based exercises at reducing impairment associated with ankylosing spondylitis",
" Twenty-one patients with ankylosing spondylitis were admitted for two weeks bedrest , postural and mobilizing exercises . Eleven received low-dose corticotrophin and 10 received placebo injections during their admission and all were review ed after two months . In-patient therapy result ed in significant improvements in function , early morning stiffness , spinal pain , lumbar extension and lateral flexion , finger-floor distance and wall-tragus distance . These improvements were maintained at two months . Biplanar radiography confirmed significant improvements of lumbar spine mobility in 14 male subjects studied . Less improvement occurred in neck movements and these were not maintained . There were no differences between the two treatment groups"
] | 4116745a-06ff-11f0-808a-c43d1ab1c353 |
Follicular lymphoma ( FL ) is the most common indolent non-Hodgkin lymphoma ( NHL ) in North America . Because of the heterogeneity of the disease , treatment options vary from observation to aggressive therapies or stem cell transplantation , or both . Although advances in treatment have improved outcomes , the disease remains largely incurable . In Canada , no unified national guideline exists for the front-line treatment of FL ; provincial guidelines vary and are largely based on funding . There is therefore a need for evidence -based national treatment guidelines that are supported by Canadian hematologists to ensure that patients with FL have equitable access to the best available care . A group of experts from across Canada developed a national evidence -based treatment guideline to provide health care professionals with clear guidance on the first-line management of FL . Results of a systematic review of the literature are presented with consensus recommendations based on available evidence | [
"Key points and recommendations Follicular lymphoma is a subgroup of non-Hodgkin lymphomas of B-cell origin , characterized by a pattern of remissions and continued relapses . It is the second most common type of lymphoid cancer in Western Europe , representing 22–40 % of non-Hodgkin lymphomas . The annual incidence of the disease has increased in recent decades . At this time , and with the arrival of new treatment options , patients ’ outcomes have significantly improved . It is therefore essential to st and ardize recommendations for the treatment and follow-up of patients with follicular lymphoma , in each clinical scenario . Search es were performed in Medline ( PubMed , 1966–present ) and The Cochrane Library , using MeSH ( Medical Subject Headings ) terms whenever possible . The best scientific evidence was obtained from selected r and omized studies and meta-analyses . For recommendations where there was no scientific evidence , the consensus of clinical experts was obtained regarding clinical and therapeutic attitudes to improve the treatment of these patients . Recommendations are compiled according to : ( i ) induction treatment in first-line ; ( ii ) post-induction treatment in first-line ; ( iii ) rescue treatment after relapse ; ( iv ) post-induction treatment in relapse and ( v ) subsequent treatments . There are different recommendations for each group . They take into account different variables , such as therapeutic options , patient follow-up , laboratory and imaging data , previous response and special groups . The recommendations contained in this guide have been assigned different grade s ( A , B , C and D ) , depending on the level of evidence on which they are based ( where there is no scientific evidence , they follow the consensus of Good Clinical Practice : see the Appendix ) . These guidelines provide healthcare professionals with up date d and consensual tools for the better management of patients with follicular lymphoma",
"PURPOSE To compare progression-free survival ( PFS ) , overall survival ( OS ) , and toxicity of a doxorubicin-containing regimen administered alone or in combination with interferon alfa-2b ( IFNalpha ) in patients with low- grade follicular lymphoma ( FL ) and poor prognostic factors . PATIENTS AND METHODS Two hundred sixty-eight patients with advanced-stage FL received cyclophosphamide , doxorubicin , teniposide , and prednisone ( CHVP ) monthly for 6 months , then every 2 months for 12 months . After r and omization , 242 patients were evaluated for efficacy : 119 received CHVP alone , and 123 also received IFNalpha at a dose of 5 million units three times weekly for 18 months . RESULTS After a 6-year median follow-up , the patients treated with CHVP + IFNalpha showed significantly longer median PFS than those who received CHVP alone ( 2.9 years v 1.5 years , respectively ; P = .0002 ) and significantly longer median OS ( not reached v 5.6 years , respectively ; P = .008 ) . Although some side effects , which included neutropenia , asthenia , fever , elevated serum transaminase levels , flu-like symptoms , and thrombocytopenia , were more frequently observed in patients who received the combination regimen , these reactions were moderate . IFNalpha was withdrawn because of toxicity in 10 % of the patients , and a dosage reduction or temporary suspension was required in 28 % . CONCLUSION With long-term follow-up of 6 years , these results confirm that the addition of IFNalpha to a doxorubicin-containing regimen for patients with advanced-stage and clinical ly aggressive FL not only increased PFS , as in most other similar trials , but also prolonged OS . Toxicity was moderate . The beneficial effects of this combined chemotherapy and IFNalpha regimen on OS probably reflect the selection of FL patients with poor prognostic factors",
"PURPOSE The aim of the F2 study was to verify whether a prospect i ve collection of data would enable the development of a more accurate prognostic index for follicular lymphoma ( FL ) by using parameters which could not be retrospectively studied before , and by choosing progression-free survival ( PFS ) as principal end point . PATIENTS AND METHODS Between January 2003 and May 2005 , 1,093 patients with a newly diagnosed FL were registered and 942 individuals receiving antilymphoma therapy were selected as the study population . The variables we used for score definition were selected by means of bootstrap resampling procedures on 832 patients with complete data . Procedures to select the model that would minimize errors were also performed . RESULTS After a median follow-up of 38 months , 261 events for PFS evaluation were recorded . beta2-microglobulin higher than the upper limit of normal , longest diameter of the largest involved node longer than 6 cm , bone marrow involvement , hemoglobin level lower than 12 g/dL , and age older than 60 years were factors independently predictive for PFS . Using these variables , a prognostic model was devised to identify three groups at different levels of risk . The 3-year PFS rate was 91 % , 69 % , and 51 % for patients at low , intermediate , and high risk , respectively ( log-rank = 64.6 ; P 3-year survival rate was 99 % , 96 % , and 84 % for patients at low , intermediate , and high risk , respectively ( P patients with FL at different risk in the era of immunochemotherapy",
"In this r and omized multicenter study of 136 patients , 6 courses of CHOP ( cyclo-phosphamide/doxorubicin/vincristine/prednisone ) followed by rituximab ( CHOP-R ) were compared with rituximab-supplemented high-dose sequential chemotherapy with autografting ( R-HDS ) to assess the value of intensified chemo-therapy as a first-line treatment for high-risk follicular lymphoma ( FL ) after the introduction of monoclonal antibodies . The analysis was intention to treat with event-free survival ( EFS ) as the primary endpoint . Complete remission ( CR ) was 62 % with CHOP-R and 85 % with R-HDS ( P 4-year EFS was 28 % and 61 % , respectively ( P overall survival ( OS ) . Molecular remission ( MR ) was achieved in 44 % of CHOP-R and 80 % of R-HDS patients ( P % CR rate and a 68 % 3-year EFS ( MFU , 30 months ) . We conclude that ( 1 ) achieving MR is critical for effective disease control , regardless of which treatment is used ; ( 2 ) R-HDS ensures superior disease control and molecular outcome than CHOP-R , but no OS improvement ; and ( 3 ) CHOP-R failures have a good outcome after salvage R-HDS , suggesting that relapsed/refractory FL could be the most appropriate setting for R-HDS-like treatments . This trial was registered at www . clinical trials.gov as no. NCT00435955",
"This r and omized , noninferiority ( NI ) , global , phase 3 study evaluated the efficacy and safety of bendamustine plus rituximab ( BR ) vs a st and ard rituximab-chemotherapy regimen ( rituximab plus cyclophosphamide , doxorubicin , vincristine , and prednisone [ R-CHOP ] or rituximab plus cyclophosphamide , vincristine , and prednisone [ R-CVP ] ) for treatment-naive patients with indolent non-Hodgkin 's lymphoma or mantle cell lymphoma . Investigators preassigned the st and ard treatment regimen they considered most appropriate for each patient ; patients were r and omized to receive BR ( n = 224 ) or st and ard therapy ( R-CHOP/R-CVP , n = 223 ) for 6 cycles ; 2 additional cycles were permitted at investigator discretion . Response was assessed by a blinded independent review committee . BR was noninferior to R-CHOP/R-CVP , as assessed by the primary end point of complete response rate ( 31 % vs 25 % , respectively ; P = .0225 for NI [ 0.88 margin ] ) . The overall response rates for BR and R-CHOP/R-CVP were 97 % and 91 % , respectively ( P = .0102 ) . Incidences of vomiting and drug-hypersensitivity reactions were significantly higher in patients treated with BR ( P incidences of peripheral neuropathy/paresthesia and alopecia were significantly higher in patients treated with st and ard-therapy regimens ( P ard therapy with regard to clinical response with an acceptable safety profile . This trial was registered at www . clinical trials.gov as # NCT00877006",
"The FL2000 study was undertaken to evaluate the combination of the anti-CD20 monoclonal antibody rituximab with chemotherapy plus interferon in the first-line treatment of follicular lymphoma patients with a high tumor burden . Patients were r and omly assigned to receive either 12 courses of the chemotherapy regimen CHVP ( cyclophosphamide , adriamycin , etoposide , and prednisolone ) plus interferon-alpha2a ( CHVP+I arm ) over 18 months or 6 courses of the same chemotherapy regimen combined with 6 infusions of 375 mg/m(2 ) rituximab and interferon for the same time period ( R-CHVP+I arm ) . After a median follow-up of 5 years , event-free survival estimates were , respectively , 37 % ( 95 % confidence interval [ CI ] , 29%-44 % ) and 53 % ( 95 % CI , 45%-60 % ) in the CHVP+I and R-CHVP+I arm ( P = .001 ) . Five-year overall survival estimates were not statistically different in the CHVP+I ( 79 % ; 95 % CI , 72%-84 % ) and R-CHVP+I ( 84 % ; 95 % CI , 78%-84 % ) arms . In a multivariate regression analysis , event-free survival was significantly influenced by both the Follicular Lymphoma International Prognostic Index score ( hazard ratio = 2.08 ; 95 % CI , 1.6%-2.8 % ) and the treatment arm ( hazard ratio = 0.59 ; 95 % CI , 0.44%-0.78 % ) . With a 5-year follow-up , the combination of rituximab with CHVP+I provides superior disease control in follicular lymphoma patients despite a shorter duration of chemotherapy . This study 's clinical trial was registered at the National Institutes of Health website as no. NCT00136552",
"BACKGROUND Neither chemotherapy with a single-alkylating agent nor aggressive combination chemotherapy cures advanced stage low- grade non-Hodgkin lymphomas , even when combined with radiotherapy . Our aim was to compare administration of immediate chlorambucil treatment with a policy of delaying chlorambucil until clinical progression necessitated its use , in asymptomatic patients with advanced-stage , low- grade non-Hodgkin lymphoma . METHODS 309 patients with asymptomatic , advanced-stage , low- grade non-Hodgkin lymphomas were recruited from 44 UK centres between Feb 1 , 1981 , and July 31 , 1990 . 158 patients were r and omised to receive immediate systemic therapy with oral chlorambucil 10 mg per day continuously . The remaining 151 were r and omised to an initial policy of observation , with systemic therapy delayed until disease progression . In both groups , local radiotherapy to symptomatic nodes was allowed . FINDINGS Median length of follow-up was 16 years . Overall survival or cause-specific survival did not differ between the two groups ( median overall survival for oral chlorambucil 5.9 [ range 0 - 17.8 ] years and for observation 6.7 [ 0.5 - 18.9 ] years , p=0.84 ; median cause-specific survival 9 [ 0 - 17.8 ] years and 9.1 [ 0.67 - 18.9 ] years , respectively p=0.44 ) . In a multivariate analysis , age younger than 60 years , erythrocyte sedimentation rate ( ESR ) 20 mm/h or less , and stage III disease , conferred significant advantages in both overall survival ( p cause-specific survival ( p=0.002 , 0.008 , and 0.001 , respectively ) . In the observation group , at 10 years ' follow-up , 19 patients were alive and had not received chemotherapy . The actuarial chance of not needing chemotherapy ( non-lymphoma deaths censored ) at 10 years was 19 % ( 40 % if older than 70 years ) . INTERPRETATION An initial policy of watchful waiting in patients with asymptomatic , advanced stage low- grade non-Hodgkin lymphoma is appropriate , especially in patients older than age 70 years",
"PURPOSE The CD20 antigen is expressed on more than 90 % of B-cell lymphomas . It is appealing for targeted therapy , because it does not shed or modulate . A chimeric monoclonal antibody more effectively mediates host effector functions and is itself less immunogenic than are murine antibodies . PATIENTS AND METHODS This was a multiinstitutional trial of the chimeric anti-CD20 antibody , IDEC-C2B8 . Patients with relapsed low grade or follicular lymphoma received an outpatient treatment course of IDEC-C2B8 375 mg/m2 intravenously weekly for four doses . RESULTS From 31 centers , 166 patients were entered . Of this intent-to-treat group , 48 % responded . With a median follow-up duration of 11.8 months , the projected median time to progression for responders is 13.0 months . Serum antibody levels were sustained longer after the fourth infusion than after the first , and were higher in responders and in patients with lower tumor burden . The majority of adverse events occurred during the first infusion and were grade 1 or 2 ; fever and chills were the most common events . Only 12 % of patients had grade 3 and 3 % grade 4 toxicities . A human antichimeric antibody was detected in only one patient . CONCLUSION The response rate of 48 % with IDEC-C2B8 is comparable to results with single-agent cytotoxic chemotherapy . Toxicity was mild . Attention needs to be paid to the rate of antibody infusion , with titration according to toxicity . Further investigation of this agent is warranted , including its use in conjunction with st and ard chemotherapy",
"The recognition of several new types of non-Hodgkin 's lymphoma ( NHL ) in recent years has led to proposals for changing lymphoma classifications , including a new proposal put forth by the International Lymphoma Study Group ( ILSG ) . However , the clinical significance of the new entities and the practical utility of this new proposal have not been studied . Therefore , we performed a clinical evaluation of the ILSG classification . A cohort of 1,403 cases of NHL was organized at nine study sites around the world and consisted of consecutive patients seen between 1988 and 1990 who were previously untreated . A detailed protocol for histologic and clinical analysis was followed at each site , and immunologic characterization as to T- or B-cell phenotype was required . Five expert hematopathologists visited the sites and each classified each case using the ILSG classification . A consensus diagnosis was also reached in each case , and each expert re review ed a 20 % r and om sample of the cases . Clinical correlations and survival analyses were then performed . A diagnosis of NHL was confirmed in 1,378 ( 98.2 % ) of the cases . The most common lymphoma types were diffuse large B-cell lymphoma ( 31 % ) and follicular lymphoma ( 22 % ) , whereas the new entities comprised 21 % of the cases . Diagnostic accuracy was at least 85 % for most of the major lymphoma types , and reproducibility of the diagnosis was 85 % . Immunophenotyping improved the diagnostic accuracy by 10 % to 45 % for a number of the major types . The clinical features of the new entities were distinctive . Both the histologic types and the patient characteristics as defined by the International Prognostic Index predicted for patient survival . In conclusion we found that the ILSG classification can be readily applied and identifies clinical ly distinctive types of NHL . However , for clinical application , prognostic factors as defined by the International Prognostic Index must be combined with the histologic diagnosis for appropriate clinical decisions",
"In follicular lymphoma ( FL ) and mantle cell lymphoma ( MCL ) the monoclonal antibody rituximab ( R ) improves the prognosis when combined with chemotherapy . The present study investigated R-maintenance after R-chemotherapy . Patients with recurring or refractory FL and MCL were r and omized to 4 courses of fludarabine , cyclophosphamide , and mitoxantrone ( FCM ) alone or combined with R ( R-FCM ) . Responding patients underwent a second r and omization for R-maintenance comprising 2 further courses of 4-times-weekly doses of R after 3 and 9 months . The first r and omization was stopped after 147 patients , when R-FCM revealed a significantly better outcome . All subsequent patients received R-FCM . Of the 176 patients who are currently evaluable ( as of October 2005 ) , 138 received R-FCM for remission induction . Response duration was significantly prolonged by R-maintenance after R-FCM , with the median not being reached in this evaluation versus an estimated median of 16 months ( P = .001 ) . This beneficial effect was also observed when analyzing FL ( P = .035 ) and MCL ( P = .049 ) separately . Hence , R-maintenance is effective after salvage with R-chemotherapy and significantly prolongs response duration in patients with recurring or refractory FL or MCL",
"PURPOSE Although rituximab ( R ) is commonly used for patients with advanced follicular lymphoma ( FL ) requiring treatment , the optimal associated chemotherapy regimen has yet to be clarified . PATIENTS AND METHODS We conducted an open-label , multicenter , r and omized trial among adult patients with previously untreated stages II to IV FL to compare efficacy of eight doses of R associated with eight cycles of cyclophosphamide , vincristine , and prednisone ( CVP ) or six cycles of cyclophosphamide , doxorubicin , vincristine , and prednisone ( CHOP ) or six cycles of fludarabine and mitoxantrone ( FM ) . The principal end point of the study was time to treatment failure ( TTF ) . RESULTS There were 534 patients enrolled onto the study . Overall response rates were 88 % , 93 % , and 91 % for R-CVP , R-CHOP , and R-FM , respectively ( P=.247 ) . After a median follow-up of 34 months , 3-year TTFs were 46 % , 62 % , and 59 % for the respective treatment groups ( R-CHOP v R-CVP , P=.003 ; R-FM v R-CVP , P=.006 ; R-FM v R-CHOP , P=.763 ) . Three-year progression-free survival ( PFS ) rates were 52 % , 68 % , and 63 % ( overall P=.011 ) , respectively , and 3-year overall survival was 95 % for the whole series . R-FM result ed in higher rates of grade 3 to 4 neutropenia ( 64 % ) compared with R-CVP ( 28 % ) and R-CHOP ( 50 % ; P R-CHOP and R-FM were superior to R-CVP in terms of 3-year TTF and PFS . In addition , R-CHOP had a better risk-benefit ratio compared with R-FM ",
"PURPOSE To evaluate response to single-agent rituximab in patients with indolent non-Hodgkin 's lymphoma ( NHL ) and no previous systemic therapy , and the feasibility , toxicity , and efficacy of maintenance rituximab , administered at 6-month intervals , in patients with objective response or stable disease after first-line rituximab therapy . PATIENTS AND METHODS Patients with indolent NHL ( follicular or small lymphocytic subtypes ) previously untreated with systemic therapy received rituximab 375 mg/m(2 ) intravenously weekly for 4 weeks . Patients were restaged at week 6 for response ; those with objective response or stable disease received maintenance rituximab courses ( identical dose and schedule ) at 6-month intervals . Maintenance was continued for a maximum of four rituximab courses or until progression . Between March 1998 and May 1999 , 62 patients were entered onto this trial ; minimum follow-up was 24 months . RESULTS Sixty patients ( 97 % ) completed the first 4-week course of rituximab and were assessable for response . All have now completed rituximab therapy ; 36 ( 58 % ) received four courses at 6-month intervals . The objective response rate at 6 weeks was 47 % ; 45 % of patients had stable disease . With continued maintenance , final response rate increased to 73 % , with 37 % complete responses . Response was similar in patients with follicular versus small lymphocytic subtypes ( 76 % v 70 % , respectively ) . Median actuarial progression-free survival was 34 months . Two patients experienced grade 3/4 toxicity with the first dose ; one patient was removed from treatment . No cumulative or additional toxicities were seen with maintenance courses . CONCLUSION Rituximab is highly active and extremely well tolerated as first-line single-agent therapy for indolent NHL . First-line treatment with scheduled maintenance at 6-month intervals produces high overall and complete response rates and a longer progression-free survival ( 34 months ) than has been reported with a st and ard 4-week treatment",
"External beam radiation therapy ( RT ) is the st and ard treatment for stage I‐II , grade 1‐2 follicular lymphoma . Because of an indolent natural history , some advocate alternative management strategies , including watchful waiting for this disease . The relative improvement in outcomes for patients treated with and without RT has never been tested in r and omized trials",
"PURPOSE The aim of this multicenter- study was to evaluate the progression-free survival , response rate and toxicity of the combination of bendamustine and rituximab ( BR ) in patients with mantle cell or low- grade lymphomas in first to third relapse or refractory to previous treatment . PATIENTS AND METHODS A total of 245 courses ( median , four courses per patient ) were administered to 63 patients . Bendamustine was given at a dose of 90 mg/m2 as a 30-minute infusion on days 1 and 2 , combined with 375 mg/m2 rituximab on day 1 , for a maximum of four cycles every 4 weeks . Histologies were 24 follicular , 16 mantle cell , 17 lymphoplasmacytoid , and six marginal zone lymphoma . RESULTS Fifty-seven of 63 patients responded to BR , corresponding to an overall response rate of 90 % ( 95 % CI , 80 % to 96 % ) with a complete remission rate ( CR ) of 60 % ( 95 % CI , 47 % to 72 % ) . The median time of progression-free survival was 24 months ( range , 5 to 44 + months ) , and the median duration of overall survival has not yet been reached . In mantle cell lymphomas , BR showed a considerable activity , achieving a response rate of 75 % ( 95 % CI , 48 % to 93 % ) with a CR rate of 50 % . Myelosuppression was the major toxicity , with 16 % grade 3 and 4 leukocytopenia . Thrombocytopenia was rare , with only 3 % grade 3 and 4 . CONCLUSION These results demonstrate that the BR combination is a highly active regimen in the treatment of low- grade lymphomas and mantle cell lymphomas",
"The combination of cyclophosphamide , vincristine , and prednisone ( CVP ) is one of several st and ard treatment options for advanced follicular lymphoma . This , like similar chemotherapeutic regimens , induces response rates of 60 % to 80 % , with a median response duration of under 2 years . Rituximab , a chimeric monoclonal antibody against CD20 , is active in follicular lymphoma , both as monotherapy and in combination with chemotherapy . Previously untreated patients with stages III to IV follicular lymphoma were r and omly assigned to receive either 8 cycles of CVP plus rituximab ( R-CVP ; n = 162 ) or CVP ( n = 159 ) . Overall and complete response rates were 81 % and 41 % in the R-CVP arm versus 57 % and 10 % in the CVP arm , respectively ( P prolonged time to progression ( median 32 months versus 15 months for CVP ; P Median time to treatment failure was 27 months in patients receiving R-CVP and 7 months in the CVP arm ( P toxicity of CVP . The addition of rituximab to the CVP regimen significantly improves the clinical outcome in patients with previously untreated advanced follicular lymphoma , without increased toxicity",
"PURPOSE This study was undertaken to up date our experience with follicular lymphoma treated with central lymphatic irradiation ( CLI ) . METHODS AND MATERIAL S A total of 47 patients were treated with CLI between January 1993 and March 2000 in a prospect i ve manner . CLI consisted of mantle , whole abdomen , and pelvic radiation fields with a 1-month break after each field . Each field was treated to 3000 - 3060 cGy at 150 - 180 cGy per fraction followed by a boost dose of 900 cGy to the areas with gross disease . The median age was 52 years ( range : 29 - 73 years ) . There were 29 males . The diagnoses were as follows : follicular small cleaved-cell lymphoma , 23 patients ; follicular mixed-cell lymphoma , 19 patients ; follicular large-cell lymphoma , 5 patients . Ann Arbor stages were as follows : I , 5 patients ; II , 14 patients ; and III , 28 patients . The International Prognostic Index ( IPI ) categories were as follows : 0 , 14 patients ; 1 , 24 patients ; and 2 , 9 patients . M. D. And erson Tumor Score was as follows : 0 , 14 patients ; 1 , 18 patients ; 2 , 9 patients ; 3 , 4 patients ; 4 , 1 patient ; and unknown , 1 patient . Two patients had abnormal LDH levels , and 11 patients had beta2 M levels > 2 mg/dL. Gender , pathology , stage , IPI , And erson Tumor Score , beta2 M , and number of disease sites were examined for significance in freedom from progression ( FFP ) by univariate analyses . RESULTS The median follow-up was 54 months ( range : 8 - 93 months ) for the 45 surviving patients . Every patient achieved a complete response , except for 1 patient whose lymphoma progressed to diffuse large-cell lymphoma during treatment . The 5-year overall survival and FFP were 94 % and 53 % , respectively . No failure has yet been observed beyond 55 months of follow-up with 13 patients at risk . Patterns of failure were as follows : within the radiation field , 10 ; outside the fields , 4 ; and both , 2 . Of the seven variables investigated , beta2 M > 2 mg/dL and IPI > 1 were the only significant adverse prognostic factors for FFP ( p = 0.023 and 0.046 , respectively ) . CONCLUSIONS CLI is well tolerated and seems to achieve durable FFP in about half of the patients with Stage I-III follicular lymphoma . Most of the experiences with CLI come from the treatment of Stage III disease and are very similar to our previous experience with combined modality treatment . Whether a plateau in FFP can be maintained beyond 5 years remains to be seen",
"PURPOSE To evaluate prospect ively in patients with follicular lymphoma and a low tumor burden three therapeutic options : delay of any treatment until clinical ly meaningful progression , immediate treatment with an oral alkylating agent , or treatment with a biologic response modifier , interferon alfa-2b . PATIENTS AND METHODS Newly diagnosed follicular lymphoma patients with a low tumor burden ( n = 193 ) were r and omly assigned to one of three arms : arm 1 , no initial treatment ( n = 66 ) ; arm 2 , prednimustine 200 mg/m2/d for 5 days per month for 18 months ( n = 64 ) ; or arm 3 , interferon alfa 5 MU/d for 3 months then 5 MU three times per week for 15 months ( n = 63 ) . Clinical characteristics were similar in the three arms . RESULTS Overall response rates with prednimustine and interferon alfa were 78 % and 70 % , respectively . The overall response to therapy , when deferred , was similar at 70 % . With a median follow-up duration of 45 months after r and omization , the median freedom-from-treatment ( FFT ) interval was 24 months in arm 1 and the interval of freedom from treatment failure ( FFTF ) was 40 months in arm 2 and 35 months in arm 3 . The median overall survival time was not reached and the overall survival rate at 5 years was 78 % in arm 1 , 70 % in arm 2 , and 84 % in arm 3 . Therefore , deferred treatment does not adversely influence survival at 5 years . Patients who progressed within 1 year had a significantly shorter survival duration ( median , 48 months ) . CONCLUSION Delayed treatment is feasible in patients with follicular lymphoma and a low tumor burden . For patients with early progression , more intensive therapy should be considered . For others , because delay of treatment until significant clinical progression does not seem to hamper the prognosis or subsequent response to treatment , the long-term toxicity of alkylating agents can be reduced",
"PURPOSE Bendamustine HCl is a bifunctional mechlorethamine derivative with clinical activity in the treatment of non-Hodgkin 's lymphoma . This study evaluated bendamustine plus rituximab in 67 adults with relapsed , indolent B-cell or mantle cell lymphoma without documented resistance to prior rituximab . PATIENTS AND METHODS Patients received rituximab 375 mg/m(2 ) intravenously on day 1 and bendamustine 90 mg/m(2 ) intravenously on days 2 and 3 of each 28-day cycle for four to six cycles . An additional dose of rituximab was administered 1 week before the first cycle and 4 weeks after the last cycle . Sixty-six patients ( median age , 60 years ) received at least one dose of both drugs . RESULTS Overall response rate was 92 % ( 41 % complete response , 14 % unconfirmed complete response , and 38 % partial response ) . Median duration of response was 21 months ( 95 % CI , 18 to 24 months ) . Median progression-free survival time was 23 months ( 95 % CI , 20 to 26 months ) . Outcomes were similar for patients with indolent or mantle cell histologies . The combination was generally well tolerated ; the primary toxicity was myelosuppression ( grade 3 or 4 neutropenia , 36 % ; grade 3 or 4 thrombocytopenia , 9 % ) . CONCLUSION Bendamustine plus rituximab is an active combination in patients with relapsed indolent and mantle cell lymphoma",
"PURPOSE To analyze the long-term results with radiotherapy ( RT ) for early-stage , low- grade follicular lymphomas . METHODS AND MATERIAL S From 1960 to 1988 , 80 patients with Stage I ( n = 33 ) or II ( n = 47 ) , World Health Organization Grade 1 ( n = 50 ) or 2 ( n = 30 ) follicular lymphoma were treated with RT . The lymph nodes or spleen were involved in 97 % of cases . The maximal tumor sizes ranged from 0.5 to 11.0 cm ( median 2.0 ) . The RT fields encompassed only the involved Ann Arbor nodal region ( involved-field RT ) in 9 % of the patients . The fields also included 1 - 3 adjacent , grossly uninvolved nodal regions ( regional RT ) in 54 % of patients but were smaller than mantle or whole abdominopelvic fields . Mantle or whole abdominopelvic fields encompassing up to 6 grossly uninvolved regions ( extended-field RT ) were used in the remaining 37 % of patients . The total RT doses ranged from 26.2 to 50.0 Gy given in daily 1.0 - 3.0-Gy fractions . RESULTS The follow-up of the surviving patients ranged from 3.5 to 28.7 years ( median 19.0 ) . No recurrences were found > 17.0 years after RT , with 13 patients free of disease at their last follow-up visit 17.6 - 25.0 years after treatment . In 58 % of cases , death was not from follicular lymphoma . The 15-year local control rate was 100 % for 44 lymphomas Progression-free survival was affected by the maximal tumor size at the start of RT ( 15-year rate 49 % vs. 29 % for lymphomas or = 3.0 cm , respectively , p = 0.04 ) and Ann Arbor stage ( 15-year rate 66 % vs. 26 % for Stages I and II , respectively , p = 0.006 ) . Ann Arbor stage also affected the cause-specific survival ( 15-year rate 87 % vs. 54 % for Stages I and II , respectively , p = 0.01 ) . No significant difference was found in overall survival between those treated with extended-field RT and those treated with involved-field RT or regional RT ( 15-year rate 49 % and 40 % , respectively , p = 0.51 ) . The 15-year incidence rate of Grade 3 or greater late complications according to the Subjective , Objective , Management , and Analytical scale in patients treated with 26.2 - 30.8 Gy vs. 30.9 - 50.0 Gy was 0 % and 6 % , respectively . CONCLUSIONS RT can cure approximately one half of Stage I and one quarter of Stage II , World Health Organization Grade 1 or 2 follicular lymphomas . Follicular lymphomas late complications with doses of > 30.8 Gy . Doses of 25 - 30 Gy delivered in 15 - 20 fractions should be examined prospect ively in patients with follicular lymphomas of ",
"Aim : To investigate the patterns of failure and survival after involved-field or more extensive radiotherapy for centroblastic-centrocytic non-Hodgkin 's lymphoma ( NHL ) as well as the impact of radiotherapy dose on local control . Patients and Methods : 47 patients with Stage I – III centroblastic-centrocytic NHL were treated with involved-field ( IF ) , extended-field radiotherapy ( EF-RT ) or total lymphatic irradiation ( TLI ) . The involved regions received 25.5–50 Gy , non-involved regions were treated with a dose of 26 Gy in most cases . Results : In Stage I/II , the majority of relapses ( 64 % ) were nodal and were located adjacent or distant to the former radiation portals . 79 % of relapses occurred after IF-RT , 21 % after EF-RT or TLI . 5-year overall survival ( OAS ) after EF-RT/TLI and IF-RT for Stages I/II was 85 % and 83 % , respectively ( n. s. ) ; relapse free survival ( RFS ) was 73 % and 61 % , respectively ( n. s. ) . A tendency for better overall survival was found for patients who relapses at one or two sites ( 5-year overall survival 100 % ) compared to patients with three or more relapse sites ( 5-year overall survival 0 % ) . For Stage III overall survival was 72 % , freedom from progression ( FFP ) was 27 % at 5 years . We found a dose-effect correlation for local control with a relapse rate of 31 % after 26–34 Gy and 4 % after application of 36 Gy ; no relapses occurred after doses of 40 Gy or more . Conclusion : In involved lymph node regions a relatively small number of relapses was observed after application of a minimal dose of 36 Gy . In Stages I/II most relapses were located outside the radiation portals , yet EF-RT was not superior to IF-RT in terms of overall survival and relapse free survival . Prospect i ve r and omized trials are necessary to prove a potentially favorable effect of more extended radiotherapy protals ( TLI or TNI [ total nodal irradiation ] ) and to evaluate the optimal radiotherapy dose . Ziel : Analyse der lokalen Kontrolle , des Rezidivmusters und des Überlebens bei zentroblastisch-zentrozytischen Non-Hodgkin-Lymphomen ( NHL ) nach lokoregionärer Strahlentherapie oder zusätzlicher , adjuvanter Strahlentherapie der nicht befallenen Regionen . Patienten und Method e : 47 Patienten mit zentrozytisch-zentroblastischen NHL in den Stadien I – III erhielten eine Bestrahlung i m Sinne einer Involved-Field- ( IF-RT ) , Extended-Field- ( EF-RT ) oder einer total lymphatischen Strahlentherapie ( TLI ) . In den befallenen Regionen wurden 25,5–50 Gy appliziert , in den adjuvant bestrahlten , nicht befallenen Regionen meist eine Dosis von 26 Gy . Ergebnisse : In den Stadien I und II war die Mehrzahl der Rezidive ( 64 % ) nodal und distant zu den ehemaligen Bestrahlungsfeldern bzw . in den angrenzenden Lymphknotenregionen gelegen . 79 % der Rezidive traten nach IF-RT auf , 21 % nach EF-RT oder TLI . Das 5-Jahres-Gesamtüberleben in den Stadien I/II betrug 85 % für die EF-RT/TLI und 83 % für die IF-RT ( n. s. ) ; das rezidivfreie Überleben betrug entsprechend 73 % und 61 % ( n. s. ) . Bei Patienten , die an ein oder zwei Lokalisationen Rezidive aufwiesen , zeigte sich die Tendenz zu einem besseren Überleben ( 5-Jahres-Gesamtüberleben 100 % ) i m Vergleich zu Patienten mit Rezidiven in drei oder mehr Lymphknotenregionen ( 5-Jahres-Gesamtüberleben 0 % ) . I m Stadium III betrugen das 5-Jahres-Gesamtüberleben 72 % und das progressionsfreie Überleben 27 % . Es zeigte sich eine Dosis-Wirkungs-Beziehung für die lokale Kontrolle : Die Rezidivrate nach Applikation von 26–34 Gy betrug 31 % und 4 % nach einer dosis von 36 Gy ; nach einer Dosis von 40 Gy oder mehr traten keine Rezidive auf . Schlussfolgerung : In befallenen Lymphknotenregionen war die Anzahl der Rezidive nach Applikation von mindestens 36 Gy relativ gering . In den Stadien I/II war die Mehrzahl der Rezidive außerhalb der Bestrahlungsfelder gelegen , die EF-RT war der IF-RT bezüglich Gesamtüberleben und rezidivfreiem Überleben jedoch nicht überlegen . Zur Überprüfung eines evtl . vorteilhaften Effekts einer ausgedehnteren Strahlentherapie ( TLI oder TNI [ total nodale Bestrahlung ] ) und zur Evaluierung der optimalen Dosis sind prospektiv r and omisierte Studien erforderlich",
" Bendamustine hydrochloride is a novel alkylating agent . In this multicenter study , the authors evaluated the efficacy and toxicity of single‐agent bendamustine in patients with rituximab‐refractory , indolent B‐cell lymphoma",
"PURPOSE Rituximab has been shown to be active in follicular lymphoma ( FL ) , both as monotherapy and in combination with chemotherapy . We conducted a r and omized trial comparing mitoxantrone , chlorambucil , and prednisolone ( MCP ) chemotherapy plus rituximab with MCP alone . PATIENTS AND METHODS Previously untreated patients with stage III or IV CD20 + indolent or mantle cell lymphoma were r and omly assigned to either eight 28-day cycles of MCP plus rituximab ( R-MCP ; n = 181 ) or eight cycles of MCP alone ( n = 177 ) . All patients who achieved a complete or partial remission were treated with interferon maintenance until relapse . Herein , we report the results from the primary analysis population of patients with FL , who constituted the majority of patients ( 56 % ) recruited to the trial ( n = 201 ; R-MCP , n = 105 ; MCP , n = 96 ) . RESULTS Rates of overall and complete response were significantly higher in the R-MCP arm than the MCP arm ( overall response , 92 % v 75 % , respectively ; P = .0009 ; complete response , 50 % v 25 % , respectively ; P = .004 ) . With a median follow-up time of 47 months , median event-free survival ( EFS ) and progression-free survival ( PFS ) times were significantly prolonged with R-MCP compared with MCP ( EFS , not reached v 26 months , respectively ; P overall survival ( OS ) was significantly improved with R-MCP compared with MCP ( 4-year OS rate , 87 % v 74 % , respectively ; P = .0096 ) . CONCLUSION The R-MCP regimen significantly improves complete and overall response rates , EFS , PFS , and OS in patients with previously untreated advanced FL , without a clinical ly significant increase in toxicity",
"BACKGROUND Rituximab plus chemotherapy , most often CHOP ( cyclophosphamide , doxorubicin , vincristine , and prednisone ) , is the first-line st and ard of care for patients with advanced indolent lymphoma , and for elderly patients with mantle-cell lymphoma . Bendamustine plus rituximab is effective for relapsed or refractory disease . We compared bendamustine plus rituximab with CHOP plus rituximab ( R-CHOP ) as first-line treatment for patients with indolent and mantle-cell lymphomas . METHODS We did a prospect i ve , multicentre , r and omised , open-label , non-inferiority trial at 81 centres in Germany between Sept 1 , 2003 , and Aug 31 , 2008 . Patients aged 18 years or older with a WHO performance status of 2 or less were eligible if they had newly diagnosed stage III or IV indolent or mantle-cell lymphoma . Patients were stratified by histological lymphoma subtype , then r and omly assigned according to a prespecified r and omisation list to receive either intravenous bendamustine ( 90 mg/m(2 ) on days 1 and 2 of a 4-week cycle ) or CHOP ( cycles every 3 weeks of cyclophosphamide 750 mg/m(2 ) , doxorubicin 50 mg/m(2 ) , and vincristine 1.4 mg/m(2 ) on day 1 , and prednisone 100 mg/day for 5 days ) for a maximum of six cycles . Patients in both groups received rituximab 375 mg/m(2 ) on day 1 of each cycle . Patients and treating physicians were not masked to treatment allocation . The primary endpoint was progression-free survival , with a non-inferiority margin of 10 % . Analysis was per protocol . This study is registered with Clinical Trials.gov , number NCT00991211 , and the Federal Institute for Drugs and Medical Devices of Germany , BfArM 4021335 . FINDINGS 274 patients were assigned to bendamustine plus rituximab ( 261 assessed ) and 275 to R-CHOP ( 253 assessed ) . At median follow-up of 45 months ( IQR 25 - 57 ) , median progression-free survival was significantly longer in the bendamustine plus rituximab group than in the R-CHOP group ( 69.5 months [ 26.1 to not yet reached ] vs 31.2 months [ 15.2 - 65.7 ] ; hazard ratio 0.58 , 95 % CI 0.44 - 0.74 ; p Bendamustine plus rituximab was better tolerated than R-CHOP , with lower rates of alopecia ( 0 patients vs 245 ( 100 % ) of 245 patients who recieved ≥3 cycles ; p toxicity ( 77 [ 30 % ] vs 173 [ 68 % ] ; p infections ( 96 [ 37 % ] vs 127 [ 50 % ] ) ; p=0.0025 ) , peripheral neuropathy ( 18 [ 7 % ] vs 73 [ 29 % ] ; p stomatitis ( 16 [ 6 % ] vs 47 [ 19 % ] ; p were more common in patients in the bendamustine plus rituximab group than in those in the R-CHOP group ( 42 [ 16 % ] vs 23 [ 9 % ] ; p=0.024 ) . INTERPRETATION In patients with previously untreated indolent lymphoma , bendamustine plus rituximab can be considered as a preferred first-line treatment approach to R-CHOP because of increased progression-free survival and fewer toxic effects . FUNDING Roche Pharma AG , Ribosepharm/Mundipharma",
"PURPOSE In 2006 , we published the results of the European Organisation for Research and Treatment of Cancer phase III trial EORTC 20981 on the role of rituximab in remission induction and maintenance treatment of relapsed/resistant follicular lymphoma ( FL ) . At that time , the median follow-up for the maintenance phase was 33 months . Now , we report the long-term outcome of maintenance treatment , with a median follow-up of 6 years . PATIENTS AND METHODS Overall , 465 patients were r and omly assigned to induction with either six cycles of cyclophosphamide , doxorubicin , vincristine , prednisone ( CHOP ) or rituximab plus CHOP ( R-CHOP ) . Those in complete remission or partial remission after induction ( n = 334 ) were r and omly assigned to maintenance treatment with rituximab ( 375 mg/m(2 ) intravenously once every 3 months ) or observation . RESULTS Rituximab maintenance significantly improved progression-free survival ( PFS ) compared with observation ( median , 3.7 years v 1.3 years ; P 5-year overall survival ( OS ) was 74 % in the rituximab maintenance arm , and it was 64 % in the observation arm ( P = .07 ) . After progression , a rituximab-containing salvage therapy was given to 59 % of patients treated with CHOP followed by observation , compared with 26 % after R-CHOP followed by rituximab maintenance . Rituximab maintenance was associated with a significant increase in grade s 3 to 4 infections : 9.7 % v 2.4 % ( P = .01 ) . CONCLUSION With long-term follow-up , we confirm the superior PFS with rituximab maintenance in relapsed/resistant FL . The improvement of OS did not reach statistical significance , possibly because of the unbalanced use of rituximab in post- protocol salvage treatment",
"PURPOSE This multicentre , prospect i ve , r and omised-controlled trial compared efficacy and toxicity of differing radiotherapy doses in non-Hodgkin lymphoma ( NHL ) . PATIENTS AND METHODS Patients with any histological subtype of NHL , requiring radiotherapy for local disease control , whether radical , consolidative or palliative , were included . Three hundred and sixty one sites of indolent NHL ( predominantly follicular NHL and marginal zone lymphoma ) were r and omised to receive 40 - 45Gy in 20 - 23 fractions or 24Gy in 12 fractions . Six hundred and forty sites of aggressive NHL ( predominantly diffuse large B cell lymphoma as part of combined-modality therapy ) were r and omised to receive 40 - 45Gy in 20 - 23 fractions or 30Gy in 15 fractions . Patients with all stages of disease , having first-line and subsequent therapies were included ; first presentations of early-stage disease predominated . RESULTS There was no difference in overall response rate ( ORR ) between st and ard and lower-dose arms . In the indolent group , ORR was 93 % and 92 % , respectively , ( p=0.72 ) ; in the aggressive group , ORR was 91 % in both arms ( p=0.87 ) . With a median follow-up of 5.6years , there was no significant difference detected in the rate of within-radiation field progression ( HR=1.09 , 95%CI=0.76 - 1.56 , p=0.64 in the indolent group ; HR=0.98 , 95%CI=0.68 - 1.4 , p=0.89 in the aggressive group ) . There was also no significant difference detected in the progression free or overall survival . There was a trend for reduced toxicities in the low-dose arms ; only the reduction in reported erythema reached significance . CONCLUSION In a large , r and omised trial , there was no loss of efficacy associated with radiotherapy doses of 24Gy in indolent NHL and 30Gy in aggressive NHL , compared with previous st and ard doses of 40 - 45Gy",
"PURPOSE To compare the long-term outcome of patients with previously untreated follicular lymphoma ( FL ) needing therapy , after treatment with cyclophosphamide , vincristine and prednisone ( CVP ) versus CVP plus rituximab ( R-CVP ) and to evaluate the predictive value of known prognostic factors after treatment with R-CVP . PATIENTS AND METHODS Patients with previously untreated CD20-positive stage III/IV FL were r and omly assigned to eight cycles of R-CVP ( n = 159 ) or CVP alone ( n = 162 ) . The median follow-up period was 53 months . RESULTS The primary end point-time to treatment failure ( TTF ) , which included patients without a response after four cycles as an event-was significantly prolonged in patients receiving R-CVP versus CVP ( P overall and complete response rates ( P time to progression ( TTP ; P response duration ( P time to next antilymphoma treatment ( P overall survival ( OS ; P = .029 ; 4-year OS : 83 % v 77 % ; ) were achieved with R-CVP versus CVP alone . Univariate analyses demonstrated an improvement in TTP with R-CVP versus CVP irrespective of the Follicular Lymphoma International Prognostic Index ( FLIPI ) subgroup , the International Prognostic Index ( IPI ) subgroup , baseline histology , and the presence or absence of B symptoms or bulky disease . By multivariate analysis , FLIPI retains a strong predictive power for TTP in the presence of the trial treatment effect . CONCLUSION Analysis of all outcome measures , including OS , confirm the benefit of adding R to CVP in the front-line treatment of FL",
"PURPOSE Up date d results are presented after a median follow-up of 7.3 years from the phase III First-Line Indolent Trial of yttrium-90 ( (90)Y ) -ibritumomab tiuxetan in advanced-stage follicular lymphoma ( FL ) in first remission . PATIENTS AND METHODS Patients with CD20(+ ) stage III or IV FL with complete response ( CR ) , unconfirmed CR ( CRu ) , or partial response ( PR ) after first-line induction treatment were r and omly assigned to (90)Y-ibritumomab consolidation therapy ( rituximab 250 mg/m(2 ) days -7 and 0 , then (90)Y-ibritumomab 14.8 MBq/kg day 0 ; maximum 1,184 MBq ) or no further treatment ( control ) . Primary end point was progression-free survival ( PFS ) from date of r and om assignment . RESULTS For 409 patients available for analysis ( (90)Y-ibritumomab , n = 207 ; control , n = 202 ) , estimated 8-year overall PFS was 41 % with (90)Y-ibritumomab versus 22 % for control ( hazard ratio [ HR ] , 0.47 ; P CR/CRu after induction , 8-year PFS with (90)Y-ibritumomab was 48 % versus 32 % for control ( HR , 0.61 ; P = .008 ) , and for PR patients , it was 33 % versus 10 % ( HR , 0.38 ; P median PFS was 4.1 years ( v 1.1 years for control ; P Median time to next treatment ( TTNT ) was 8.1 years for (90)Y-ibritumomab versus 3.0 years for control ( P No unexpected toxicities emerged during long-term follow-up . Estimated between-group 8-year overall survival rates were similar . Annualized incidence rate of myelodysplastic syndrome/acute myeloblastic leukemia was 0.50 % versus 0.07 % in (90)Y-ibritumomab and control groups , respectively ( P = .042 ) . CONCLUSION (90)Y-ibritumomab consolidation after achieving PR or CR/CRu to induction confers 3-year benefit in median PFS with durable 19 % PFS advantage at 8 years and improves TTNT by 5.1 years for patients with advanced FL",
"Anti-CD20-containing chemotherapy regimens have become the st and ard of care for patients with follicular lymphoma needing cytotoxic therapy . Four r and omized trials demonstrated a clinical benefit for patients treated with rituximab . However , no long-term follow up ( i.e. > 5 years ) of these trials is yet available . Between May 2000 and May 2002 , 358 newly diagnosed patients with high tumor burden follicular lymphoma were r and omized to receive cyclophosphamide , adriamycin , etoposide and prednisolone plus interferon-α2a or a similar chemotherapy-based regimen plus rituximab , and outcome was up- date d. With a median follow up of 8.3 years , addition of rituximab remained significantly associated with prolonged event-free survival ( primary end point ) ( P=0.0004 ) with a trend towards a benefit for overall survival ( P=0.076 ) . The Follicular Lymphoma International Prognostic Index score was strongly associated with outcome for both event-free and overall survival in univariate analysis and its prognostic value remained highly significant after adjusting for other significant covariates in multivariate models ( P Considering long-term toxicity , the addition of rituximab in the first-line setting was confirmed as safe with regards to development of secondary malignancies . Long-term follow up of patients with follicular lymphoma treated in the FL2000 study confirms the sustained clinical benefit of rituximab without long-term toxicity . This study was registered at Clinical Trials.gov ( Identifier:00136552 )",
"BACKGROUND Patients with advanced-stage , low-tumour-burden follicular lymphoma have conventionally undergone watchful waiting until disease progression . We assessed whether rituximab use could delay the need for chemotherapy or radiotherapy compared with watchful waiting and the effect of this strategy on quality of life ( QoL ) . METHODS Asymptomatic patients ( aged ≥18 years ) with low-tumour-burden follicular lymphoma ( grade s 1 , 2 , and 3a ) were r and omly assigned central ly ( 1:1:1 ) , by the minimisation approach stratified by institution , grade , stage , and age , to watchful waiting , rituximab 375 mg/m(2 ) weekly for 4 weeks ( rituximab induction ) , or rituximab induction followed by a maintenance schedule of 12 further infusions given at 2-monthly intervals for 2 years ( maintenance rituximab ) . On Sept 30 , 2007 , recruitment into the rituximab induction group was closed and the study was amended to a two-arm study . The primary endpoints were time to start of new treatment and QoL at month 7 ( ie , 6 months after completion of rituximab induction ) . All r and omly assigned patients were included in the analysis of time to start of new treatment on an intention-to-treat basis . The main study is now completed and is in long-term follow-up . The study is registered with Clinical Trials.gov , NCT00112931 . FINDINGS Between Oct 15 , 2004 , and March 25 , 2009 , 379 patients from 118 centres in the UK , Australia , New Zeal and , Turkey , and Pol and were r and omly assigned to watchful waiting or maintenance rituximab . 84 patients were recruited to the rituximab induction group before it was closed early . There was a significant difference in the time to start of new treatment , with 46 % ( 95 % CI 39 - 53 ) of patients in the watchful waiting group not needing treatment at 3 years compared with 88 % ( 83 - 92 ) in the maintenance rituximab group ( hazard ratio [ HR ] 0·21 , 95 % CI 0·14 - 0·31 ; p did not need treatment at 3 years , which was significantly more than in the watchful waiting group ( HR 0·35 , 95 % CI 0·22 - 0·56 ; p maintenance rituximab group ( 0·75 , 0·41 - 1·34 ; p=0·33 ) . Compared with the watchful waiting group , patients in the maintenance rituximab group had significant improvements in the Mental Adjustment to Cancer scale score ( p=0·0004 ) , and Illness Coping Style score ( p=0·0012 ) between baseline and month 7 . Patients in the rituximab induction group did not show improvements in their QoL compared with the watchful waiting group . There were 18 serious adverse events reported in the rituximab groups ( four in the rituximab induction group and 14 in the maintenance rituximab group ) , 12 of which were grade 3 or 4 ( five infections , three allergic reactions , and four cases of neutropenia ) , all of which fully resolved . INTERPRETATION Rituximab monotherapy should be considered as a treatment option for patients with asymptomatic , advanced-stage , low-tumour-burden follicular lymphoma . FUNDING Cancer Research UK , Lymphoma Research Trust , Lymphoma Association , and Roche",
"Patients with advanced indolent lymphoma often have long survival ( median , 4 to 8 years ) in spite of frequent relapses . The inability of combination chemotherapy or radiation therapy ( RT ) to render patients disease free has led to radically divergent treatment approaches . Initial treatment may vary from aggressive combined modality therapy to no initial treatment . We sought to evaluate these two divergent approaches in a r and omized trial of advanced indolent lymphomas ( nodular , poorly differentiated lymphocytic ; nodular mixed ; diffuse , well-differentiated lymphocytic ; diffuse , intermediately differentiated lymphocytic ; and diffuse , poorly differentiated lymphocytic ) . A total of 104 patients were entered : 44 were r and omly assigned to \" watch and wait \" in which only carefully defined , limited RT was administered if necessary ; 45 were r and omly assigned to aggressive combined modality treatment with prednisone , methotrexate , doxorubicin , cyclophosphamide , plus etoposide plus mechlorethamine , vincristine , procarbazine , prednisone ( ProMACE-MOPP ) , followed by total nodal irradiation ( TNI ) ; and 15 , with symptoms requiring initial therapy , received the identical combined treatment but were not r and omly assigned . Of 41 evaluable patients on watch and wait , 23 ( 56 % ) have still not required systemic therapy , although 16 ( 39 % ) have received limited RT . Median time to crossover was 34 months . Of 18 patients crossed over , seven of the 16 who completed therapy ( 43 % ) achieved CR ; two ( 11 % ) have relapsed . Histologic progression was seen in six ( 15 % ) of 41 patients on watch and wait without intervening chemotherapy . Of 45 patients r and omly assigned to chemotherapy , 37 ( 82 % ) have completed induction therapy , and 29 of the 37 ( 78 % ) achieved CR . Twenty-five of those 29 patients ( 86 % ) are still in their first remission . Median duration of initial remission has not been reached but will exceed 4 years . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND Patients with follicular lymphoma can have long survival times , but disease progression typically occurs 3 - 5 years after initial treatment . We assessed the potential benefit of 2 years of rituximab maintenance after first-line treatment in patients with follicular lymphoma receiving a rituximab plus chemotherapy regimen . METHODS The r and omised , open-label PRIMA study was undertaken in 223 centres in 25 countries . 1217 patients with previously untreated follicular lymphoma needing systemic therapy received one of three non-r and omised immunochemotherapy induction regimens used in routine practice . 1019 patients achieving a complete or partial response were then r and omly assigned to receive 2 years of rituximab maintenance therapy ( 375 mg/m(2 ) every 8 weeks ) or observation . Treatment was assigned equally by central ised block r and omisation , stratified by induction regimen , response , region , and centre . Neither the participants nor those giving the interventions , assessing outcomes , and analysing data were masked to group assignments . The primary endpoint was progression-free survival ( PFS ) . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00140582 . FINDINGS 505 patients were assigned to rituximab maintenance and 513 to observation ( one patient died during r and omisation ) . With a median follow-up of 36 months ( IQR 30 - 42 ) , PFS was 74·9 % ( 95 % CI 70·9 - 78·9 ) in the rituximab maintenance group ( 130 patients progressed ) and 57·6 % ( 53·2 - 62·0 ) in the observation group ( 218 progressed ; hazard ratio [ HR ] 0·55 , 95 % CI 0·44 - 0·68 , p in complete or unconfirmed complete response versus 268 ( 52·2 % ) in the observation group ( p=0·0001 ) . Overall survival did not differ significantly between groups ( HR 0·87 , 95 % CI 0·51 - 1·47 ) . Grade 3 and 4 adverse events were recorded in 121 patients ( 24 % ) in the rituximab maintenance group and 84 ( 17 % ) in the observation group ( risk ratio 1·46 , 95 % CI 1·14 - 1·87 ; p=0·0026 ) . Infections ( grade s 2 - 4 ) were the most common adverse event , occurring in 197 ( 39 % ) and 123 ( 24 % ) patients , respectively ( risk ratio 1·62 , 95 % CI 1·35 - 1·96 ; p of rituximab maintenance therapy after immunochemotherapy as first-line treatment for follicular lymphoma significantly improves PFS . FUNDING Groupe d'Etude des Lymphomes de l'Adulte ( GELA ) and F Hoffmann-La Roche",
"PURPOSE To determine if maintenance rituximab ( MR ) after st and ard chemotherapy improves progression-free survival ( PFS ) in advanced-stage indolent lymphoma . PATIENTS AND METHODS Patients with stage III-IV indolent lymphoma with responding or stable disease after cyclophosphamide , vincristine , and prednisone ( CVP ) chemotherapy were stratified by initial tumor burden , residual disease after CVP ( minimal or gross ) , and histology , and r and omly assigned to observation ( OBS ) or MR 375 mg/m(2 ) once per week for 4 weeks every 6 months for 2 years . PFS was the primary end point . RESULTS Three hundred eleven ( 282 with follicular lymphoma ) evaluable patients who received CVP were r and omly assigned to OBS ( n = 158 ) or MR ( n = 153 ) . Best response improved in 22 % MR versus 7 % OBS patients ( P = .00006 ) . Toxicity was minimal in both study arms . Three-year PFS after r and om assignment was 68 % MR versus 33 % OBS ( hazard ratio [ HR ] = 0.4 ; P = 4.4 x 10(-10 ) [ all patients ] ) and 64 % MR v 33 % OBS ( HR = 0.4 ; P = 9.2 x 10(-8 ) [ patients with follicular lymphoma ] ) . There was an advantage for MR regardless of Follicular Lymphoma International Prognostic Index score , tumor burden , residual disease , or histology . In multivariate analysis of MR patients , minimal disease after CVP was a favorable prognostic factor . OS at 3 years was 92 % MR versus 86 % OBS ( HR = 0.6 ; log-rank one-sided P = .05 ) and , among patients with follicular lymphoma , OS was 91 % MR versus 86 % ( HR = 0.6 ; log-rank one-sided P = .08 ) . A trend favoring MR was observed among patients with high tumor burden ( log-rank one-sided P = .03 ) . CONCLUSION The E1496 study provides the first phase III data in untreated indolent lymphoma that MR after chemotherapy significantly prolongs PFS",
"PURPOSE The optimal management of stage I follicular lymphoma , according to consensus guidelines , is based on uncontrolled experiences of select institutions . Diverse treatment approaches are used despite guidelines that recommend radiation therapy ( XRT ) . PATIENTS AND METHODS We analyzed outcomes of patients with stage I follicular lymphoma enrolled onto the National LymphoCare data base . RESULTS Of 471 patients with stage I follicular lymphoma , 206 patients underwent rigorous staging as defined by both a bone marrow aspirate and biopsy and an imaging study ( a computed tomography [ CT ] scan of the whole body , a positron emission tomography [PET]/CT scan , or both ) . Rigorously staged patients had superior progression-free survival ( PFS ) compared with nonrigorously staged patients ( hazard ratio [ HR ] , 0.63 ) . Treatments given to rigorously staged patients were rituximab/chemotherapy ( R-chemo ; 28 % ) , XRT ( 27 % ) , observation ( 17 % ) , systemic therapy + XRT ( 13 % ) , rituximab monotherapy ( 12 % ) , and other ( 3 % ) . With a median follow-up of 57 months for PFS , there were 44 progression events ( in 21 % of patients ) for rigorously staged patients . For these patients , PFS was significantly improved with either R-chemo or systemic therapy + XRT compared with patients receiving XRT alone after adjustment for histology , LDH , and the presence of B symptoms . There were no differences in overall survival . CONCLUSION In this largest , prospect ively enrolled group of patients with stage I follicular lymphoma , variable treatment approaches result ed in similar excellent outcomes , which challenges the paradigm that XRT should be st and ard for this presentation",
"PURPOSE To evaluate the efficacy of rituximab maintenance in 60- to 75-year-old patients with advanced follicular lymphoma responding to brief first-line chemoimmunotherapy followed by rituximab consolidation . PATIENTS AND METHODS A total of 234 treatment-naive 60- to 75-year-old patients began chemoimmunotherapy with four monthly courses of rituximab , fludarabine , mitoxantrone , and dexamethasone ( R-FND ) followed by four weekly cycles of rituximab consolidation . Of these , 210 patients completed the planned treatment , and 202 responders were r and omly assigned to rituximab maintenance ( arm A ) for 8 months , once every 2 months for a total of four doses , or to observation ( arm B ) . RESULTS Median ages in arms A and B were 66 and 65 years , respectively . After induction and consolidation therapy , the overall response rate was 86 % , with 69 % complete remissions ( CR ) . After a 42-month median follow-up from diagnosis , 3-year progression-free survival ( PFS ; the primary end point ) and overall survival ( OS ) were 66 % ( 95 % CI , 59 % to 72 % ) and 89 % ( 95 % CI , 85 % to 93 % ) , respectively . After r and omization , 2-year PFS was 81 % for rituximab maintenance versus 69 % for observation , with a hazard ratio of 0.74 ( 95 % CI , 0.45 to 1.21 ; P = .226 ) , although this was not statistically significant . No differences between the two arms were detected for OS . Overall , the regimen was well-tolerated . The most frequent grade 3 to 4 toxicity was neutropenia ( 25 % of treatment courses ) , with 13 infections . Two toxic deaths ( 0.8 % ) occurred during induction treatment . CONCLUSION A brief R-FND induction plus rituximab consolidation achieved excellent results with high CR and PFS rates , supporting the feasibility of this regimen in patients older than 60 years . A short rituximab maintenance did not achieve a statistically significant PFS improvement over observation"
] | 41167496-06ff-11f0-808a-c43d1ab1c353 |
The aim was to report on the longevity of restorations placed using the atraumatic restorative treatment ( ART ) approach compared with that of equivalent placed amalgam restorations . Five data bases were systematic ally search ed for articles up to 16 March 2009 . Inclusion criteria : ( 1 ) titles/ abstract s relevant to the topic ; ( 2 ) published in English ; ( 3 ) reporting on 2-arm longitudinal in vivo trials ; ( 4 ) minimum follow-up period of 12 months . Exclusion criteria : ( 1 ) insufficient r and om or quasi-r and om allocation of study subjects ; ( 2 ) not all entered subjects accounted for at trial conclusion ; ( 3 ) subjects of both groups not followed up in the same way . Fourteen from the initial search of 164 articles complied with these criteria and were selected for review . From these , seven were rejected and seven articles reporting on 27 separate data sets , accepted . Only identified homogeneous data sets were combined for meta- analysis . From the 27 separate computable dichotomous data sets , four yielded a statistically significant improvement of longevity of ART versus amalgam restorations : posterior class V , 28 % over 6.3 years ; posterior class I , 6 % after 2.3 years and 9 % after 4.3 years ; posterior class II , 61 % after 2.3 years . Studies investigating restorations placed in the primary dentition showed no significant differences between the groups after 12 and 24 months . In the permanent dentition , the longevity of ART restorations is equal to or greater than that of equivalent amalgam restorations for up to 6.3 years and is site-dependent . No difference was observed in primary teeth . More trials are needed in order to confirm these results | [
"To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results",
"Objective : The aim of this study was to evaluate the performance of a new glass ionomer filling material ( ChemFlex ™ ) using the atraumatic restorative treatment ( ART ) approach in class I cavities in the permanent dentition of Latvian schoolchildren . Methods : A total of 63 fillings ( 40 test and 23 control ) were placed using the ART technique in 41 schoolchildren in Riga at the Stomatology Institute of the Medical Academy of Latvia . These fillings were then blindly assessed after 2 years . Results : The complete success rate for both the test and the control material fillings were 92.5 and 94.9 % , respectively . Conclusion : The new glass ionomer filling has shown a good performance in terms of retention , marginal failure and fractures in class I cavities",
"The present r and omised clinical trial was aim ed at comparing three minimally invasive restorative treatment approaches for managing dental caries in occlusal surfaces using a non-gamma-2 amalgam and a low-viscosity glass-ionomer as the restorative material . The treatment approaches tested in parallel groups were : conventional in a university setting , modified-conventional and ultraconservative ( Atraumatic Restorative Treatment , ART ) approaches in a field setting . A split-mouth design was used in which the two restorative material s were r and omly placed in 430 matched contralateral pairs of permanent molar teeth . A total of 152 children from five primary schools were recruited and treated by a dental therapist . The restorations were evaluated after 6 years by 2 calibrated independent examiners . The 6-year successes for all occlusal amalgam and glass-ionomer restorations were 72.6 and 72.3 % , respectively . There were no statistically significant differences observed between the successes for both amalgam and glass-ionomer restorations placed either by the ART ( 68.6 % , with 95 % CI = 61–76 % ) approach or by the conventional ( 74.5 % , with 95 % CI = 65–82 % ) and the modified-conventional ( 75.8 % , with 95 % CI = 67–83 % ) approaches after 6 years . There was also no statistically significant difference observed between the successes of occlusal ART restorations with glass-ionomer ( 67.1 % , with 95 % CI = 56–77 % ) and occlusal conventional restorations with amalgam ( 74 % , with 95 % CI = 61–85 % ) after 6 years . ‘ Restoration fracture/marginal defects ’ and ‘ loss of material ’ were the most common causes for failure . The former was more often recorded in amalgam restorations and the latter in glass-ionomer restorations . Secondary caries was observed for 2 % of glass-ionomer and for 10 % of amalgam restorations . This difference was statistically significant ( p = 0.001 ) . The ART approach using glass-ionomer performed equally well as conventional restorative approaches using electrically driven equipment and amalgam for treating dentinal lesions in occlusal surfaces after 6 years",
"OBJECTIVE To compare the survival of glass ionomer cement ( GIC ) restorations placed in a dental clinic setting using both the atraumatic restorative treatment ( ART ) approach with h and instruments , and conventional cavity preparation with rotary instruments . METHOD AND MATERIAL S Two encapsulated high-strength conventional GICs ( Fuji IX GP , Ketac-Molar Aplicap ) were placed in 82 Class I and 53 Class II preparations and one encapsulated non-gamma 2 amalgam alloy ( GK-amalgam ) was placed in 32 Class I preparations , in the primary molars of 60 Chinese children with a mean age of 7.40 + /- 1.24 ( SD ) years . Thus , 9 treatment groups were formed . RESULTS After two years , there were no significant survival differences found among 7 of the 9 treatment groups ( p = 0.99 ) . However , two groups comprising Fuji IX GP and Ketac-Molar Aplicap placed in Class II cavities prepared using the ART approach showed significantly lower restoration survivals ( p GIC material . CONCLUSIONS In a clinic setting , both the ART h and instrument and conventional rotary instrument methods were equally suitable for high Class I restoration survival , but not for Class II restoration survival where the conventional cavity preparation method was preferable",
"AIM The aim of this study was to assess the clinical performance of two adhesive restorative systems ( Single Bond/Filtek P-60 and Single Bond/Filtek Z-250 ) in posterior teeth using a modified United States Public Health Service ( USPHS ) system . METHODS AND MATERIAL S A total of 70 restorations were placed in molars and premolars in 30 patients ( 14 females and 16 males ; 18 - 40 years ) by one operator . All restorations were directly evaluated by two examiners at baseline , six months , and 12 months using the following modified USPHS rating criteria : marginal integrity , marginal discoloration , surface texture , contour , postoperative sensitivity , and recurrent caries . RESULTS At six and 12 months all restorations were available for evaluation of marginal discoloration , surface texture , contour , postoperative sensitivity , and recurrent caries that remained with 100 % Alpha-ratings at recalls for both restorative systems . Marginal integrity for P-60 was scored as 94.3 % and 91.4 % Alpha at six and 12 months , respectively , and rates for Z-250 were 100 % and 97.1 % Alpha at six and 12 months , respectively . Statistical analysis was completed with Fisher 's exact and McNemar Chi-square tests at a significance level of 5 % ( P Posterior resin composite restorations placed under appropriate conditions provide a satisfactory clinical performance",
"BACKGROUND In response to concern that inadequate dental school training may create a barrier to access to care for children , the authors conducted a survey concerning general practitioners ' practice patterns involving child patients . METHODS The authors requested a list of 4,970 r and omly chosen general practitioners from the American Dental Association Survey Center . They then sent those dentists a written survey asking whether and in what numbers they treat children ; the ages and caries levels of any children they do treat ; their perceptions of their educational experiences in pediatric dentistry , and their perceived needs for continuing education in pediatric dentistry . They analyzed data using chi2 . RESULTS Ninety-one percent of the general dentists surveyed treated children , but those younger than 4 years of age , with high levels of caries , and whose care is funded by Medicaid were represented in very low numbers . The types of patients treated and procedures performed by the respondents were significantly ( P educational experiences , except for the number and types of Medicaid patients they treated . CONCLUSIONS These data indicate that the vast majority of general practitioners treat children in their practice s , but there still are groups of children for whom access to dental care is a problem . PRACTICE IMPLICATION S Very young children , children with high levels of caries and Medicaid-covered children have difficulty finding dental care in the general practice community",
"BACKGROUND The authors undertook a study to evaluate the effect of two cavity preparation methods on the initial survival of two more-viscous glass ionomer cements , or GICs , placed in the occlusal surfaces of permanent molar teeth . METHODS Three dentists placed 149 restorations in 68 adult patients in a hospital clinic . They used either atraumatic restorative treatment , or ART , or conventional cavity preparation methods to place two encapsulated esthetic conventional GICs : Fuji IX GP ( GC International Corp. , Tokyo ) and Ketac-Molar Aplicap ( 3 M ESPE , Seefeld , Germany ) . For comparison , they used high-copper-content GK Amalgam Alloy ( Advanced Technology & Material s Co. Ltd. , Beijing ) in conventional preparations . They evaluated the restorations using both direct and indirect observation methods . RESULTS Cavity preparations for which the authors used ART h and instruments took approximately twice as long to complete as did those for which they used conventional rotary instruments . After 12 months , no restorations had failed , but restorations comprising both GICs showed early losses of adjacent sealant material . Both GICs also showed relatively high restoration wear . At 12 months , the mean cumulative net occlusal wear for Fuji IX GP was 77 + /- 47 micrometers , and for Ketac-Molar 83 + /- 51 microm , without statistical significance ( P > .05 ) . Color matching improved significantly with time ( P minor surface tarnishing and marginal discrepancies increased with time ( P restoration performance of the GICs . However , their deterioration requires long-term monitoring . Clinical Implication s. The more viscous GICs appear initially suitable for restricted use in clinical practice when placed using either of two cavity preparation methods in the occlusal surfaces of permanent molar teeth in adults",
"OBJECTIVE The purpose of this study was to evaluate two glass-ionomer cements placed in the occlusal surfaces of permanent molar teeth , using two cavity preparation methods . METHOD AND MATERIAL S Three dentists placed 149 restorations for 68 patients in a hospital clinic . Atraumatic restorative treatment or conventional cavity preparation methods were used for two encapsulated , high-strength conventional glass-ionomer cements : Fuji IX GP and Ketac-Molar . Non-gamma 2 amalgam alloy was used in conventional preparations for comparison . RESULTS The restorative procedures were uneventful , but cavity preparations made with atraumatic restorative treatment h and instruments took approximately twice as long as did conventional rotary instrumentation . After 30 months , only one glass-ionomer cement restoration had failed . Both glass-ionomer cements showed high early losses of sealant material , but caries was not detected in the exposed fissures . Both glass-ionomer cements also showed relatively high restoration wear . At 30 months , the mean cumulative net occlusal wear was 119 + /- 12 mm for Fuji IX GP and 96 + /- 13 mm for Ketac-Molar ; the difference was not statistically significant . Color matching improved significantly by 6 months ; there was no significant difference in color match between the two glass-ionomer cements by 12 months . Minor surface tarnishing and marginal discrepancies were present in the amalgam restorations and increased with time . CONCLUSION The occlusal restorations performed satisfactorily over periods of up to 30 months . However , the continued deterioration of the cements requires longer-term studies to be undertaken",
"Since the last comprehensive review of anticoagulation in acute myocardial infa rct ion four additional r and omized control trials have been reported . The overwhelming majority of all trials favored anticoagulation . Rates of thromboembolism were higher in the control , and hemorrhagic complications in the anticoagulated group . Pooling of all r and omized control trials gives mean case fatality rates of 19.6 % for the control and 15.4 % for the anticoagulated group , a relative reduction of 21 % ( P less than 0.05 or less than 0.001 , depending on the analytic method ) . Five of six r and omized control trials reported \" no effect \" because the difference favoring anticoagulation was not statistically significant . However , sample sizes in these \" negative \" papers were too small to protect against missing a 21 % reduction in true case fatality rate due to anticoagulation ( beta greater than 0.10 ) . All patients who present no specific contraindication should receive anticoagulants during hospitalization for infa rct ion ",
"Previous reports have shown a release of fluoride from glass-ionomer cement ( GIC ) restorations into the oral fluids . Fluoride in the ambient fluids has a caries-preventive effect by enhancing remineralization and inhibiting demineralization of the dental hard tissues . Therefore , the current investigation was undertaken to determine whether GIC fillings could contribute to the remineralization of caries lesions in dentin . Small circular preparations were made in disks of dentin which had incipient caries-like lesions in the remaining tissue . The preparations were filled with amalgam or composite material s ( as controls ) or with GIC . The specimens thus contained a restoration close to a dentinal caries-like lesion . The specimens were placed contralaterally in the buccal surfaces of removable partial dentures and were worn intra-orally by volunteers for a 12-week experimental period , after which the specimens were sectioned and analyzed by microradiography . All specimens with GIC restorations exhibited hypermineralization in the tissue bordering the filling and in the wall of the preparation which had been in contact with the restoration . The ( caries-like ) lesions were remineralized , even under conditions of heavy plaque formation . In contrast , specimens with amalgam or composite restorations showed further extensive demineralization . This study demonstrates a significant remineralization potential exerted by the fluoride-releasing GIC restorative material . Consequently , the choice of the restorative material might be crucial for the occurrence or prevention of recurrent caries around restorations",
"This study compared the survival of restorations produced through the atraumatic restorative treatment ( ART ) approach using glass-ionomer with those produced through the traditional approach using amalgam ( MTA ) in deciduous dentitions over a period of 3 years . Using a parallel group design , 835 grade 1 children , aged 6–7 years , participated . A total of 482 children were treated through the ART and 353 children through the MTA approach . Eight dentists produced a total of 1,891 single- and multiple-surface restorations . After 3 years , 22.1 % of the restorations were lost for evaluation . There was a statistically significant difference in the combined survival of all single- and multiple-surface restorations between the two approaches in favour of the ART approach ( p = 0.04 ) . The study revealed a 3-year cumulative survival percentage of single-surface ART and MTA restorations of 86.1 and 79.6 % , respectively . The difference was statistically significant ( p = 0.03 ) . The main reasons for both single-surface ART and MTA restorations to fail was ‘ restoration missing ’ followed by ‘ gross marginal defect ’ . The 3-year cumulative survival percentages of multiple-surface ART and MTA restorations were 48.7 and 42.9 % , respectively . The difference was not statistically significant ( p > 0.05 ) . The 3-year survival percentages of single- and multiple- surface ART and MTA restorations varied widely amongst the 8 operators with an operator effect ( p = 0.001 ) for multiple-surface MTA restorations . It can be concluded that the ART approach using glass-ionomer yielded better results in treating dentinal lesions in deciduous teeth than did the traditional approach using amalgam after 3 years . It is recommended to select the ART approach to complement the other activities of the school oral health programme",
"OBJECTIVES The aims of this study are to assess the feasibility of the Atraumatic Restorative Treatment ( ART ) approach in primary teeth and to compare the ART approach with traditional amalgam restorations in primary molars . METHODS This study was conducted in a paediatric dentistry clinic in Kuwait between April 1999 and December 2001 . The ART and amalgam restorations were placed r and omly on comparable pairs of primary molars , if available . In addition , the ART approach was used for other primary teeth that had no pulpal involvement and no perceived pain before treatment . The restorations were assessed by both the ART evaluation criteria and USPHS criteria in August-September 2000 and in August-December 2001 . The mean follow-up period for the restorations was 8.3 months in the first assessment ( 2000 ) and 22 months in the second assessment ( 2001 ) . The assessment was possible for 35 children ( mean age = 5.7 years ) , 18 of whom had comparable pairs ( n = 35 pairs ) of restorations in their primary molars . In addition , 48 other ART restorations were assessed in 2000 and 42 in 2001 . RESULTS In a 2-year follow-up , 89.6 % of all ART restorations were considered successful . The failure rate of the comparable pairs of ART and amalgam restorations was 5.7 % . There was no significant difference in success rate between ART and amalgam techniques . CONCLUSIONS Based on a 2-year follow-up evaluation , the class I ART restorations seemed to have a high success rate , indicating the appropriateness of the ART approach in primary teeth",
"The present study was aim ed at comparing the effectiveness of three minimally invasive restorative treatment approaches for dentinal lesions in occlusal surfaces . The approaches tested comprised a conventional and a modified – conventional treatment and a modified Atraumatic Restorative Treatment ( ART ) . The conventional approach was performed in a university dental clinic whilst the modified – conventional , employing portable equipment , and the modified ART , using h and instruments and a caries removal solution ( Caridex ® ) , were carried out in the field . Using the split – mouth design , 430 matched contralateral pairs of occlusal cavities were restored with amalgam or glass – ionomers in permanent molars of 152 school children by one dental therapist . The restorations were assessed using a modified USPHS – Ryge criteria . After 2 years , the cumulative survival percentages for occlusal amalgam and glass – ionomer restorations were 92 and 96 % , respectively . The survival of all restorations in the conventional , modified – conventional and the modified ART group was 96 , 96 and 91 % , respectively . The survival of occlusal amalgam and glass – ionomer restorations per treatment group was as follows : 94 and 99 % , respectively ( conventional group ) ; 95 and 97 % , respectively ( modified – conventional group ) , and 89 and 93 % , respectively ( modified ART group ) . The differences in survival percentage between restorations with amalgam and glass – ionomer , and between the three restorative treatment approaches were not statistically significant . In countries facing scarcity in re sources for dental care , ART seems a promising restorative approach to occlusal caries in posterior teeth . However , a longer clinical observation period is required to substantiate this initial conclusion",
"OBJECTIVE This study compares the quality of class I restorations made with the atraumatic restorative treatment ( ART ) technique and conventional class I amalgam restorations . METHODS The study was carried out among secondary school students in Mzuzu , Malawi . First-year students in 1987 who needed at least two class I restorations were selected . Based on a split-mouth design , each participant received both ART and conventional restorations . The 89 pairs of class I cavities were divided r and omly into two groups , since two different cermet ionomer cement ( CIC ) filling material s were used . Impressions of the restorations and subsequent models were made shortly after restoration , after six months , one year , two years , and three years . The quality of the restorations was determined on the models following the US Public Health Service criteria . Bulk fracture , contour , marginal integrity , and surface texture of the restorations were recorded and evaluated separately . Survival rates were determined by the result ant score of all criteria . RESULTS Though conventional amalgam restorations performed better on all criteria , this difference was significant only for the contour criterion . The survival rates of ART restorations after three years ( 81.0 % ) were lower than those of amalgam restorations ( 90.4 % ) ( P=.067 ) . CONCLUSIONS The quality of ART class I restorations is competitive with that of conventional amalgam restorations",
"OBJECTIVE The purpose of this study was to compare the success rates of glass-ionomer cement restorations placed with the atraumatic restorative treatment approach and conventional cavity preparation methods . METHOD AND MATERIAL S Two encapsulated , high-strength , esthetic conventional glass-ionomer cements were placed in 82 Class I and 53 Class II atraumatic restorative treatment and conventional cavity preparations , and an encapsulated amalgam alloy was placed in 32 Class I conventional preparations , in vital primary molars of 60 Chinese children aged 7 to 9 years . RESULTS The atraumatic restorative treatment preparations , made with h and instruments only , took approximately 50 % longer to complete than did the preparations completed with conventional rotary instrumentation . After 1 year , there were no amalgam failures . For the glass-ionomer cement restorations , when the atraumatic restorative treatment method was used , significantly better survival rates were found for Class I ( 92.9 % ) than for Class II ( 64.7 % ) cavity preparations . There was also a strong trend for relatively better survival rates for the conventional cavity preparation method ( 86.7 % ) than for the atraumatic restorative treatment ( 64.7 % ) method for Class II cavity preparations . However , both the atraumatic restorative treatment and conventional methods appeared equally effective for Class I preparations . CONCLUSION In a clinic setting , the use of atraumatic restorative treatment h and instruments for cavity preparation is more time consuming , and the method may also provide less mechanical retention and /or bulk of glass-ionomer cement for some Class II preparations in primary molars than does the use of conventional rotary instruments",
"The atraumatic restorative treatment technique ( ART ) is based on removing infected tooth material using only h and instruments and filling the subsequently cleaned cavity with adhesive material such as glass ionomer . As its name suggests , the ART technique should be atraumatic during treatment , as well as for the tooth itself as for the patient . It was primarily developed for treating people living in underserved areas of the world where re sources and facilities such as electricity and trained manpower are limited . Many studies have evaluated the ART technique and the results have supported its application . However , a very limited number of studies have compared ART with more conventional techniques . For that reason , a study was conducted in Pakistan , to compare the ART technique with another more conventional treatment technique . The results of this study show that the preparations with h and instruments result ed in smaller sized cavities and therefore may be less traumatic to the tooth . It was also associated with less pain reactions compared to the more conventional technique . Although preparations with h and instruments required more time , this did not seem to affect the survival of restorations . The survival of glass ionomer cement restorations made with h and instruments was comparable with single surface amalgam restorations made with a more conventional technique . Recurrent caries was not associated with any glass ionomer cement restorations made with h and instruments . The retention rate of glass ionomer sealants was low , however one dentist had a sealant retention rate of 81.5 percent that suggests that this procedure can be performed satisfactorily in conjunction with a glass ionomer cement restoration . Operator variances did seem to affect the restorations . Survival of glass ionomer restorations made with both h and and rotary instruments varied for different operators . Similarly , the retention of fissure sealant also varied amongst operators . Operator differences also influenced the extent of tooth substance lost due to cavity preparation . The ART technique is a feasible approach towards the treatment of dental caries especially of one-surface lesions for underserved population",
"OBJECTIVE To evaluate the remineralization of carious dentine following the restoration of an extensive lesion in a permanent molar with a high strength glass-ionomer cement ( GIC ) . MATERIAL S AND METHODS Thirteen first permanent molars , which were scheduled for extraction because of the presence of extensive caries lesions , were selected for this study . They were first restored , according to the ART technique , using encapsulated Fuji IX(GP ) , which contains a strontium glass rather than the traditional calcium glass . The cavities were prepared with a clean enamel margin and minimal removal of the carious dentine around the walls . After a period of 1 - 3 months they were harvested and subsequently sectioned and examined using an electron probe micro analysis ( EPMA ) and scanning electron microscopy ( SEM ) . RESULTS EPMA demonstrated that both fluorine and strontium ions had penetrated deep into the underlying demineralized dentine . The only possible source of these ions was the GIC restoration . CONCLUSION The pattern of penetration of the fluorine and strontium ions into the dentine was consistent with a remineralization process",
"OBJECTIVES The Atraumatic Restorative Treatment ( ART ) approach was compared with the traditional amalgam ( TA ) approach in order to test their appropriateness to complement a preventive and educational school oral health programme in Syria . METHODS Using a parallel group design , 370 and 311 grade 2 children were r and omly assigned to the ART and the TA group respectively . Eight dentists placed 1117 single- and multiple-surface restorations . A modified actuarial method was used to estimate survival curves . The jackknife method was applied to calculate the st and ard error in the cumulative survival percentages . RESULTS A statistically significant difference in cumulative survival percentages between single-surface non-occlusal ART and comparable amalgam restorations was observed after 4.3 , 5.3 and 6.3 years . The survival of single-surface non-occlusal ART posterior restorations ( 80.2 + /- 4.9 % ) was statistically significantly higher than that of occlusal posterior ART restorations ( 64.8 + /- 3.9 % ) at evaluation year 6.3 . There was no statistically significant difference observed between survival percentages of large ( 55.8 + /- 10 % ) and that of small ( 69.2 + /- 4.6 % ) single-surface posterior ART restorations after 6.3 years . There was an operator effect observed for single-surface ART and comparable amalgam restorations . Secondary caries was observed in 2.3 % of single-surface ART restorations and in 3.7 % of single-surface amalgam restorations during the 6.3 year observation period . CONCLUSIONS The ART approach provided higher survival percentages for single-surface restorations than the TA approach over 6.3 years and is therefore appropriate for use in school oral health programmes . Secondary caries was only a minor reason for ART restorations to fail . An operator effect was observed for both treatment approaches",
"The None hypothesis tested was that there is no difference in the survival percentages of all restorations placed through the Atraumatic Restorative Treatment ( ART ) approach , with high-viscosity glass ionomer , and those produced through the traditional approach , with amalgam ( TA ) , in the permanent dentitions of children after 6.3 years . Using a parallel group design , we r and omly assigned a total of 370 children , aged 6 to 9 years , to the ART group and 311 children , also aged 6 to 9 years , to the TA group . Eight dentists placed a total of 1117 single- and multiple-surface restorations . The cumulative survival percentages for ART glass-ionomer restorations were statistically significantly higher than those of amalgam restorations at all time intervals except the first ( p ≤ 0.044 ) . After 6.3 years , the cumulative survival percentages of ART and amalgam restorations were 66.1 % ( SE = 3.1 % ) and 57.0 % ( SE = 3.3 % ) , respectively . We concluded that the restorations produced with the ART approach , with high-viscosity glass ionomer , survived longer than those produced with the traditional approach , with amalgam , in the permanent teeth of young children"
] | 411674dc-06ff-11f0-808a-c43d1ab1c353 |
INTRODUCTION The aim of this review was to systemically analyse trials evaluating the efficacy of routine on-table cholangiography ( R-OTC ) versus no on-table cholangiography ( N-OTC ) in patients undergoing cholecystectomy . METHODS R and omised trials evaluating R-OTC versus N-OTC in patients undergoing cholecystectomy were selected and analysed . RESULTS Four trials ( 1 r and omised controlled trial on open cholecystectomy and 3 on laparoscopic cholecystectomy ) encompassing 860 patients undergoing cholecystectomy with and without R-OTC were retrieved . There were 427 patients in the R-OTC group and 433 patients in the N-OTC group . There was no significant heterogeneity among trials . Therefore , in the fixed effects model , N-OTC did not increase the risk ( p=0.53 ) of common bile duct ( CBD ) injury , and it was associated with shorter operative time ( p fewer peri-operative complications ( p R-OTC was superior in terms of peri-operative CBD stone detection ( p readmission ( p N-OTC is associated with shorter operative time and fewer peri-operative complications , and it is comparable to R-OTC in terms of CBD injury risk during cholecystectomy . R-OTC is helpful for peri-operative CBD stone detection and there is therefore reduced readmission for retained CBD stones . The N-OTC approach may be adopted routinely for patients undergoing laparoscopic cholecystectomy providing there are no clinical , biochemical or radiological features suggestive of CBD stones . However , a major multicentre r and omised controlled trial is required to vali date this conclusion | [
"Opinion is divided whether intra-operative cholangiography should be performed routinely or on a selective basis during laparoscopic cholecystectomy . We therefore performed the first prospect i ve r and omized trial of static cholangiography in patients who did not have indications for cholangiograms . Laparoscopic cholecystectomy was attempted on 164 consecutive patients , of whom 49 ( 30 % ) patients were excluded from the trial due to indications for or against cholangiography . In the remaining 115 ( 70 % ) patients , 56 were r and omized to the cholangiography group while 59 patients did not receive cholangiograms . Duration of postoperative hospitalization and interval to return to full activity were identical in the two groups . Static cholangiograms added 16 ± 1 min ( mean ± SEM ) to the procedures ( p Cholangiography increased the total charges for the operation by almost $ 700 ( p ) . Cholangiograms were performed successfully in 94.6 % of the patients and changed the operative management in 4 ( 7.5 % ) patients . There was 1 ( 1.9 % ) false negative study . Intra-operative cholangiography did not reveal aberrant bile ducts at risk of injury from the operative dissection . There was no mortality or cholangiogram-related morbidity in either group . In follow-up ranging from 2–12 months , there has been no clinical evidence of bile duct injury or retained common bile duct stones . In summary , in patients without indications for cholangiography , the performance of static cholangiograms markedly increased the operative time and cost of laparoscopic cholecystectomy . The operative management of a minority of patients was changed by the information obtained , but laparoscopic cholecystectomy may be performed safely in the absence of cholangiograms with little risk of injury to the major ductal system or retained calculi . RésuméLes avis sont partagés quant à la pratique systématique , ou seulement élective , d'une cholangiographie lors de la cholécystectomie coelioscopique . Nous avons mené le premier essai r and omisé prospect if de cholangiographie peropératoire chez des patients n'ayant pas d'indication formelle de cholangiographie . Dans une série de 164 cholécystectomies coelioscopiques consécutives , 49 patients ( 30 % ) ont été éliminés de l'étude parce qu'il existait une indication ou une contreindication formelles à la cholangiographie peropératoire . Les 115 patients restants ( 70 % ) ont été r and omisés ; 56 ont eu une cholangiographie alors que 59 n'ont pas eu de cholangiographie peropératoire . La durée de l'hospitalisation postopératoire et le délai entre l'intervention et la reprise de travail étaient similaires dans les deux groupes . La cholangiographie a prolongé l'intervention de 16 ± 1 min ( moyenne ± écart type de la moyenne ) ( p cholangiographie peropératoire a été estimé à environ 700 $ US ( p cholangiographie a pu être effectuée chez 94.6 % des patients , et celle-ci a changé la tactique opératoire chez 4 ( 7.5 % ) patients . Il y a eu un résultat faussement négatif ( 1.9 % ) . La cholangiographie peropératoire n'a pas montré d'anomalie anatomique des voies biliares pouvant les compromettre lors de la dissection . La mortalité a été Nonee dans chaque groupe . De même , il n'y a eu aucune morbidité en rapport direct avec la cholangiographie . Dans la période du suivi allant de 2 à 12 mois , il n'y a eu acune lésion biliaire ni de lithiase résiduelle de la voie biliaire cliniquement évidentes . En conclusion , chez un patients ans indication formelle de cholangiographie , la réalisation d'une cholangiographie peropératoire augmente considérablement la durée et le coût de l'intervention . La tactique opératoire a été très peu influencée très peu par les donées de la cholangiographie . La cholécystectomie coelioscopique peut être réalisée sans cholangiographie peropératoire systématique sans augmenter pour autant le risque de lésions des voies biliaires ou de calcul résiduel . ResumenLas opiniones se encuentran divididas respecto a si se debe realizar colangiografía intraoperatoria en forma rutinaria o en forma selectiva en el curso de una colecistectomía laparoscópica . Por ello hemos realizado el primer estudio aleatorizado de colangiografía estática en pacientes que no tenían indicaciones para colangiograma . Se intentó la colecistectomía laparoscópica en 164 pacientes consecutivos ; 49 ( 30 % ) fueron excluidos debido a indicaciones en favor o en contra de colangiografía . Los otros 115 pacientes ( 70 % ) se repartieron al azar 56 a colangiografía y 59 al grupo de no colangiografía . La duración de la hospitalización postoperatoria y del tiempo de retorno a actividad normal fueron idénticos en los dos grupos . Los colangiogramas estáticos añadieron 16 ± 1 min . al procedimiento ( p elevaron el costo de la operación en $ 700 ( p colangiogramas fueron exitosamente realizados en 49.6 % de los pacientes y modificaron el manejo operatorio en 4 ( 7.5 % ) ; hubo un falso positivo ( 1.9 % ) . La colangiografía intraoperatoria no reveló la prescencia de canales biliares aberrantes en riesgo de lesión por la disección opeatoria . No hubo mortalidad o morbilidad relacionada con la colangiografía , y en un seguimiento de 2–12 meses no se registró evidencia clínica de lesión de canales biliares o de cálculos retenidos en el colédoco . En resumen , en pacientes sin indicaciones para colangiografía , la realización de colangiogramas estáticos aumentó notoriamente el tiempo operatorio y el costo de la colecistectomia laparoscópica . Aunque el manejo operatorio de una minoría de pacientes sí fue modificado por la información obtenida , se considera que la colecistectomía laparoscópica puede ser practicada en forma segura en ausencia de colangiogramas con mínimo riesgo de lesión del sistema biliar o de cálculos retenidos",
"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",
"Objective This study evaluated , in a large , heterogeneous population , the outcome of open cholecystectomy as it is currently practice d. Summary Background and Data Although cholecystectomy has been the gold st and ard of treatment for cholelithiasis for more than 100 years , it has recently been challenged by the introduction of several new modalities including laparoscopic cholecystectomy . Efforts to define the role of these alternative treatments have been hampered by the lack of contemporary data regarding open cholecystectomy . Methods A population -based study was performed examining all open cholecystectomies performed by surgeons in an eastern and western state during a recent 12-month period . Data compiled consisted of a computerized analysis of Uniformed Billing ( UB-82 ) discharge analysis information from all non-Veterans Administration ( VA ) , acute care hospitals in California ( Office of Statewide Planning and Development [ OSHPD ] ) and in Maryl and ( Health Services Cost Review Commission [ HSCRC ] ) between January 1 , 1989 , and December 31 , 1989 . This data base was supplemented with a 5 % r and om sample of Medicare UB-82 data from patients who were discharged between October 1,1988 , and September 30 , 1989 . Patients undergoing cholecystectomy were identified based on diagnosis-related groups ( DRG-197 and DRG-198 ) , and then classified by Principal Diagnosis and divided into three clinical ly homogeneous subgroups : acute cholecystitis , chronic cholecystitis , and complicated cholecystitis . Results A total of 42,474 patients were analyzed , which represents approximately 8 % of all patients undergoing cholecystectomy in the United States in any recent 12-month period . The overall mortality rate was 0.17 % and the Incidence rate of bile duct injuries was approximately 0.2 % . The mortality rate was 0.03 % in patients younger than 65 years of age and 0.5 % in those older than 65 years of age . Mortality rate , length of hospital stay , and charges were all significantly correlated ( p open cholecystectomy currently is a very safe , effective treatment for cholelithiasis and is being performed with near zero mortality . The ultimate role of",
"Since the introduction of laparoscopic cholecystectomy ( LC ) , an increase in accidental common bile duct ( CBD ) injuries of up to 1.2–1.6 % has been reported . In the present prospect i ve study of 1,710 patients undergoing cholecystectomy ( 1,241 LC procedures and 469 open cholecystectomies [ OC ] ) , we tested the predicative value of routine intraoperative cholangiography ( IOC ) . The IOC was feasible in 92.4 % of the cases in the LC group and in 83 % of cases in the OC group and presented a complete depiction of the extrahepatic bile system in 98.3 % . Anatomic variations of the bile duct system , which influenced the operative management , were found in 13.2 % of cases ( 13.4 % LC versus 12.8 % OC ) . In 2.5 % of the patients , preoperatively undetected CBD stones were also found . Method -specific complications did not occur in any of the patients . Additionally , in a controlled subgroup analysis of 163 patients , we evaluated preoperative intravenous cholangiography ( IVC ) and IOC . Intravenous cholangiography showed only 72.4 % of the operation-relevant anatomic variations ( vs. 100 % by IOC ) ; in 6.1 % of the cases , there were reactions to the dye ( vs. none in IOC ) , and in only 28.6 % of the patients , CBD stones were detected ( vs. 71.4 % IOC ) . There were four bile duct injuries ( 0.29 % ) during LC and two ( 0.4 % ) during OC . All injuries were detected intraoperatively and fixed in the same setting without postoperative complications . In conclusion , we recommend the use of routine IOC during cholecystectomy . By this technique , anatomic variations of the bile duct system will be visualized and therefore accidental injuries will be avoided",
"Background The role of routine intraoperative cholangiography is controversial . The aim of this study was to assess the impact of routine intraoperative cholangiography on the incidence of common bile duct injuries , and to evaluate the operative outcome of laparoscopic cholecystectomy carried out in a major teaching hospital and review the literature . Methods Prospect ively collected data on 3,145 laparoscopic cholecystectomies performed mainly by surgical trainees in the period 1990 to 2002 using routine intraoperative cholangiography with fluoroscopy were review ed . Results The mean age of the study sample ( 65.6 % male , 34.4 % female ) was 54 years , and 16.9 % of the patients had clinical acute cholecystitis . The conversion rate to open cholecystectomy was 4.3 % . Intraoperative cholangiography was attempted for 90.7 % of the patients with a 95.9 % success rate . Five patients ( 0.16 % ) had common bile duct injuries . Four injuries had occurred in the first 5 years . One injury ( 0.06 % ) had occurred after 1995 . This injury was identified intraoperatively and repaired laparoscopically . Routine intraoperative cholangiography prevented one definite common bile duct transection . Conclusions In this series using routine intraoperative cholangiography , there was a low rate and severity of common bile duct injuries , with a high intraoperative recognition rate . There was no bile duct transection or major injury requiring common bile duct reconstruction . Although intraoperative cholangiography helped in the immediate identification of injuries and the institution of appropriate therapy , injury was not completely prevented",
"INTRODUCTION Common bile duct ( CBD ) stones can cause serious morbidity or mortality , and evidence for them should be sought in all patients with symptomatic gallstones undergoing cholecystectomy . Routine intra-operative cholangiography ( IOC ) involves a large commitment of time and re sources , so a policy of selective cholangiography was adopted . This study prospect ively evaluated the policy of selective cholangiography for patients suspected of having choledocholithiasis , and aim ed to identify the factors most likely to predict the presence of CBD stones positively . PATIENTS AND METHODS Data from 501 consecutive patients undergoing laparoscopic cholecystectomy ( LC ) for symptomatic gallstones , of whom 166 underwent IOC for suspected CBD stones , were prospect ively collected . Suspicion of choledocholithiasis was based upon : ( i ) deranged liver function tests ( past or present ) ; ( ii ) history of jaundice ( past or present ) or acute pancreatitis ; ( iii ) a dilated CBD or demonstration of CBD stones on imaging ; or ( iv ) a combination of these factors . Patient demographics , intra-operative findings , complications and clinical outcomes were recorded . RESULTS Sixty-four cholangiograms were positive ( 39 % ) . All indications for cholangiogram yielded positive results . Current jaundice yielded the highest positive predictive value ( PPV ; 86 % ) . A dilated CBD on pre-operative imaging gave a PPV of 45 % for CBD calculi ; a history of pancreatitis produced a 26 % PPV for CBD calculi . Patients with the presence of several factors suggestive of CBD stones yielded higher numbers of positive cholangiograms . Of the 64 patients having a laparoscopic common bile duct exploration ( LCBDE ) , four ( 6 % ) required endoscopic retro grade cholangiopancreatography ( ERCP ) for retained stones ( 94 % successful surgical clearance of the common bile duct ) and one ( 2 % ) for a bile leak . Of the 335 patients undergoing LC alone , three ( 0.9 % ) re-presented with a retained stone , requiring intervention . There were 12 ( 7 % ) requiring conversion to open operation . CONCLUSIONS A selective policy for intra-operative cholangiography yields acceptably high positive results . Pre-operatively , asymptomatic bile duct stones rarely present following LC ; thus , routine imaging of the biliary tree for occult calculi can safely be avoided . Therefore , a rationing approach to the use of intra-operative imaging based on the pre-operative indicators presented in this paper , successfully identifies those patients with bile duct stones requiring exploration . Laparoscopic bile duct exploration , performed by an experienced laparoscopic surgeon , is a safe and effective method of clearing the bile duct of calculi , with minimal complications , avoiding the necessity for an additional intervention and prolonged hospital stay",
"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 trial was undertaken to determine if selective peroperative cholangiography result ed in greater morbidity and mortality from missed common bile duct ( CBD ) stones . Five hundred and thirty-nine consecutive cholecystectomies were performed over a 3-year period . Two hundred and fifty-four had indications for m and atory peroperative cholangiography and were excluded from the trial . The remaining 285 patients , without a history of jaundice , pancreatitis or abnormal liver function tests , were r and omized blindly into two groups . Group 1 underwent peroperative cholangiography ( PC ) and group 2 did not . If the surgeon found a dilated CBD at surgery then these patients were also excluded from the trial . Selective peroperative cholangiography revealed an unsuspected CBD calculus in 16 of the 132 patients ( 12 % ) . Up to the time of review no patient from group 2 presented with symptoms or complications from retained CBD stones . One patient in group 1 had endoscopic removal of a retained CBD calculus 16 months after cholecystectomy . All patients were sent a question naire at least three years after surgery and 210 responded ( 74 % ) . One hundred and thirty ( 62 % ) of the respondents had peroperative cholangiography . There were 11 deaths from unrelated causes . No difference between the two groups was found for postoperative dietary habit , dyspepsia , pain , flatulence , diarrhoea or signs of biliary obstruction . It seems from these results that a policy of selective cholangiography in our h and s may miss a 12 % incidence of unsuspected stones but , importantly , this does not appear to influence postoperative morbidity or mortality . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Abstract . Bile duct injury ( BDI ) during laparoscopic cholecystectomy ( LC ) which may result in patient disability or death are reported to occur more frequently when compared to open surgery . The aim of this nationwide prospect i ve study beyond the laparoscopic learning curve was to analyze the incidence , risk factors , and management of major BDI . During a 3-year period ( 1995–1997 ) 130 items of all LC data were collected on a central computer system from 84 surgical institutions in Switzerl and by the Swiss Association of Laparoscopic and Thoracoscopic Surgery and evaluated for major BDIs . Simple biliary leakage was excluded from analysis . There were 12,111 patients with a mean age of 55 years ( 3–98 years ) enrolled in the study . The overall BDI incidence was 0.3 % , 0.18 % for symptomatic gallstones , and 0.36 % for acute cholecystitis . In cases of severe chronic cholecystitis with shrunken gallbladder , the incidence was as high as 3 % . Morbidity and mortality rates were significantly increased in BDIs . BDI was recognized intraoperatively in 80.6 % , in 64 % of cases by help of intraoperative cholangiography . Immediate surgical repair was performed laparoscopically ( suture or T-drainage ) in 21 % ; in 79 % , open repair ( 34 % simple suture , 66 % Roux-en-Y reconstruction ) was needed . The BDI incidence did not decrease during the last 7 years . In 47 % , BDIs were caused by experienced laparoscopic surgeons , perhaps because they tend to operate on more difficult patients . In conclusion , the incidence of major BDIs remains constant in Switzerl and at a level of 0.3 % , which is still higher when compared to open surgery . However , most cases are now detected intraoperatively and immediately repaired which ensures a good long-term outcome . For preventing such injuries , exact anatomical knowledge with its variants and a meticulous surgical dissecting technique especially in case of acute inflammation or shrunken gallbladder are m and atory",
"A prospect i ve , controlled , r and omized trial was conducted in 275 patients with symptomatic gall stone disease , whose history , laboratory data or sonographical findings did not suggest common bile duct stones . Of these patients , 137 did not undergo intraoperative fluoroscopic cholangiography ( IOC ) , but in the remaining 138 patients IOC was attempted . In 111 cases ( 80.4 % ) the biliary system was sufficiently visualized . In 3 patients ( 2.7 % ) calculi in the cystic or common bile duct were diagnosed , which would have been overlooked without IOC . IOC was false-positive in one case . One year after the operation the patients were asked to return for a follow-up examination . Three patients in the group without IOC had had symptomatic passage of a stone , and one had a common bile duct stone removed by endoscopic papillotomy . A retained stone was discussed as etiology for a pancreatitis in a fifth patient in this group . No patient sustained long-term sequelae from the retained common bile duct stones . None of the patients in the IOC group had evidence of cholangiolithiasis at follow-up . There was no difference between the study groups concerning the incidence of post-operative complications . The operations with IOC lasted significantly longer ( 92 + /- 31 min vs 77 + /- 28 min ) . According to our data and those published earlier , the additional financial and logistic expenditure associated with routine IOC is not justified . Patients with the preoperative suspicion of a common bile duct stone should have endoscopic bile duct clearance ( ERCP and EPT ) prior to cholecystectomy",
"The role of intraoperative cholangiography during laparoscopic cholecystectomy was prospect ively evaluated in 514 patients undergoing laparoscopic cholecystectomy . Before surgery , all patients were assigned to one of three groups depending on the likelihood of their having common bile duct stones . Stratification was based on objective historical , laboratory , or radiologic criteria . In 453 patients deemed unlikely to have stones , laparoscopic cholecystectomy was performed without cholangiography . Of these patients , four had retained stones ( 0.9 % ) . In 25 patients likely to have stones , preoperative endoscopic retro grade cholangiopancreatography identified stones in six patients ( 24 % ) . In 36 patients whose likelihood of having stones was deemed indeterminate , intraoperative cholangiography was performed at laparoscopic cholecystectomy . A common bile duct stone was identified in one patient ( 2.8 % ) . One common bile duct injury occurred in the group deemed unlikely to have stones , and this injury would not have been prevented by intraoperative cholangiography . We conclude that preoperative assessment will identify common bile duct stones and that routine cholangiography is not warranted . Meticulous dissection of the cystic duct at its origin at the infundibulum will prevent common bile duct injury",
"To assess the value of routine peroperative cholangiography ( PC ) , 457 patients undergoing cholecystectomy for gallstone disease were prospect ively screened for the presence of 11 predefined criteria indicating possible choledocholithiasis . Two hundred and eighty patients who had no positive criteria and in whom preoperative endoscopic retro grade cholangiography ( ERC ) had not been performed were r and omized to PC or no PC . The patients were followed up 12 months postoperatively , and those who had signs or symptoms of possible retained common bile duct calculi were referred to ERC . The difference in mean operative time between the 2 treatment groups was 23.3 minutes . Four patients ( 2.8 % ) in the PC group had unsuspected common bile duct calculi , and in 3 patients ( 2.1 % ) , the PC was false-positive . On follow-up , no case of retained common bile duct calculi was found in either group . The rate of postoperative complications was significantly higher in the PC group than in the non-PC group . It is concluded that PC should be performed only in patients with indications of common bile duct disease or in whom clarification of the anatomy is necessary . RésuméPour apprécier la valeur de la cholangiographie opératoire de routine , 457 sujets subissant une cholécystectomie pour lithiase vésiculaire ont été étudiés prospect ivement en fonction de 11 critères de présomption de lithiase cholédocienne . Deux cent quatre-vingts d'entre eux qui ne présentaient pas un critère de présomption et chez qui n'avait pas été pratiquée une cholangiographie rétro grade endoscopique ont été soumis à une cholangiographie opératoire à la suite d'un choix par tirage au sort . Ils furent ensuite suivis pendant une période de 12 mois au décours de l'intervention de manière que ceux qui présentaient des symptômes et des signes en faveur de la présence de calculs oubliés dans le cholédoque fussent soumis à une cholangiographie rétro grade endoscopique . Premier élément , la durée de l'intervention fut augmentée en moyenne de 23.3 minutes lorsque fut pratiquée la cholangiographie opératoire . Quatre malades ( 2.8 % ) ainsi explorés présentaient des calculs cholédociens . Trois cas de faux positifs ( 2.1 % ) furent enregistrés . Aucun cas de lithiase résiduelle n'a été découvert dans les 2 groupes . Le taux des complications postopératoires fut plus élevée lorsque la cholangiographie opératoire fut pratiquée . On peut conclure de ces faits , que cette exploration doit Être proposée seulement lorsque la présence de calculs dans la voie biliare principale est à envisager ou qu and il est nécessaire de préciser l'anastomie des voies biliares . ResumenCon el objeto de determinar el valor de la colangiografía peroperatoria ( CP ) , 457 pacientes programados para colecistectomía por enfermedad litiásica biliar fueron preoperatoriamente tamizados para establecer la presencia de 11 criterios predefinidos indic and o posible coledocolitiasis . Doscientos ochenta pacientes que no presentaban criterios positivos y en quienes la colangiografía retrógrada endoscópica ( CRE ) no había sido practicada fueron asignados al azar a CP o a no CP . Los pacientes fueron seguidos por 12 meses después de la operación , y aquellos con signos o síntomas de posibles cálculos retenidos en el colédoco fueron referidos para CRE . La diferencia en el tiempo operatorio promedio entre los 2 grupos fue de 23.3 minutos . Cuatro pacientes ( 2.8 % ) en el grupo con CP presentaron cálculos inesperados en el colédoco , y en 3 casos ( 2.1 % ) , la CP result ó falsapositiva . En el curso del seguimiento , ningÚn caso de cálculos retenidos en el colédoco fue hallado en uno u otro grupo . La tasa de complicaciones postoperatorias fue significativamente mayor en el grupo con CP que en el grupo sin CP . Se concluye que la CP debe ser practicada sólo en pacientes con criterios de patología coledociana o en quienes sea necesario clarificar la anatomía"
] | 41167518-06ff-11f0-808a-c43d1ab1c353 |
Abstract In 2006 , PAIN published a systematic review of the measurement properties of self-report pain intensity measures in children and adolescents ( Stinson JN , Kavanagh T , Yamada J , Gill N , Stevens B. Systematic review of the psychometric properties , interpretability and feasibility of self-report pain intensity measures for use in clinical trials in children and adolescents . PAIN 2006;125:143–57 ) . Key developments in pediatric pain necessitate an up date of this work , most notably growing use of the 11-point numeric rating scale ( NRS-11 ) . Our aim was to review the measurement properties of single-item self-report pain intensity measures in children 3 to 18 years old . A secondary aim was to develop evidence -based recommendations for measurement of child and adolescent self-report of acute , postoperative , and chronic pain . Method ological quality and sufficiency of measurement properties for reliability , validity , responsiveness , and interpretability was assessed by at least 2 investigators using COnsensus based St and ards for the selection of health Measurement INstruments ( COSMIN ) . Search es identified 60 unique self-report measures , of which 8 ( reported in 80 papers ) met inclusion criteria . Well-established measures included the NRS-11 , Color Analogue Scale ( CAS ) , Faces Pain Scale – Revised ( FPS-R ; and original FPS ) , Pieces of Hurt , Oucher — Photographic and Numeric scales , Visual Analogue Scale , and Wong-Baker FACES Pain Rating Scale ( FACES ) . Quality of studies ranged from poor to excellent and generally reported sufficient criterion and construct validity , and responsiveness , with variable reliability . Content and cross-cultural validity were minimally assessed . Based on available evidence , the NRS-11 , FPS-R , and CAS were strongly recommended for self-report of acute pain . Only weak recommendations could be made for self-report measures for postoperative and chronic pain . No measures were recommended for children younger than 6 years , identifying a need for further measurement refinement in this age range . Clinical practice and future research implication s are discussed | [
"Background The COSMIN checklist is a tool for evaluating the method ological quality of studies on measurement properties of health-related patient-reported outcomes . The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist ( n = 114 ) . Methods 75 articles evaluating measurement properties were r and omly selected from the bibliographic data base compiled by the Patient-Reported Outcome Measurement Group , Oxford , UK . Raters were asked to assess the method ological quality of three articles , using the COSMIN checklist . In a one-way design , percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item . Results 88 raters participated . Of the 75 selected articles , 26 articles were rated by four to six participants , and 49 by two or three participants . Overall , percentage agreement was appropriate ( 68 % was above 80 % agreement ) , and the kappa coefficients for the COSMIN items were low ( 61 % was below 0.40 , 6 % was above 0.75 ) . Reasons for low inter-rater agreement were need for subjective judgement , and accustom to different st and ards , terminology and definitions . Conclusions Results indicated that raters often choose the same response option , but that it is difficult on item level to distinguish between articles . When using the COSMIN checklist in a systematic review , we recommend getting some training and experience , completing it by two independent raters , and reaching consensus on one final rating . Instructions for using the checklist are improved",
"The present study cross-vali date d self-report pain scales : Verbal Rating Scale ( VRS ) , Facial Expression Scale ( FACES ) , Color Analogue Scale ( CAS ) and Poker Chip Tool ( PCT ) in Thai children aged 5 - 12 years . The concordance with observational measure , Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) was also tested . Among 100 students , test-retest reliability of all self-report measures was moderate to good ( K = 0.501 - 0.712 ) and only FACES yielded acceptable face validity(IC > 0.5 ) . Validation in 87 patients , all scales showed construct and concurrent validity . FACES was the most preferred scale . Agreement of self-report measures and CHEOPS was better in the age group 5 - 8 years ( K = 0.417 - 0.826 ) than 9 - 12 years ( K = 0.231 - 0.529 ) . In conclusion , FACES is a valid , reliable and practical tool . Self-report measures are more in concordance with CHEOPS in the younger age group",
"OBJECTIVE To determine the construct , content , and convergent validity of 2 self-report pain scales for use in the untrained child in the emergency department ( ED ) . METHODS A prospect i ve study was conducted of all children who presented to an urban ED between 5 and 16 years of age inclusive after written informed consent was obtained . Children were excluded if they were intoxicated , had altered sensorium , were clinical ly unstable , did not speak English , or had developmental delays . Children marked their current pain severity on a st and ardized Color Analog Scale ( CAS ) and a 7-point Faces Pain Scale ( FPS ) . They were then asked whether their pain was mild , moderate , or severe . Children were then administered an analgesic at the discretion of the attending physician and asked to repeat these measurements . For assessing content validity , the scales were also administered to age- and gender-matched children in the ED for nonpainful conditions . Convergent validity was assessed by determining the Spearman correlation coefficient between the 2 pain scales . RESULTS A total of 60 children were enrolled , 30 with pain and 30 without , with a mean age of 9.3 + /- 3.3 years . Boys accounted for 38 of the enrollees ( 63.3 % ) . The median score before analgesic administration was 6.0 cm ( interquartile range [ IQR ] : 4.0 - 8.0 ) on the CAS and 3.0 faces ( IQR : 2.0 - 5.0 ) on the FPS ; after analgesic administration , the median scores decreased to 3.1 cm ( IQR : 1.1 - 4.3 ) and 2.0 faces ( IQR : 1.0 - 3.0 ) , respectively . As the reported pain intensity increased , so did the scores on the 2 pain scales . The 30 children with no pain had a median score on the CAS of 0.0 ( IQR : 0.0 - 1.0 ) and on the FPS of 0.0 ( IQR : 0.0 - 1.0 ) , whereas the 13 children with severe pain had a median CAS of 7.0 ( IQR : 6.0 - 8.0 ) and a median FPS of 5.0 ( IQR : 4.0 - 6.0 ) . The Spearman correlation coefficient between the CAS and the FPS was positive and strong ( r = 0.894 ) . CONCLUSION The CAS and the FPS exhibit construct , content , and convergent validity in the measurement of acute pain in children in the ED",
"Objective To evaluate the psychometric properties of 4 measures of acute pain in youth with sickle cell disease ( SCD ) during a medical procedure . Methods Heart rate , child self-report , parent proxy-report , and observable pain behaviors were examined in 48 youth with SCD ages 2 to 17 years . Criterion validity for acute pain was assessed by responsiveness to a st and ardized painful stimulus ( venipuncture ) in a prospect i ve pre-post design . Convergent validity was evaluated through the correlation across measures in reactivity to the stimulus . Results Child self-reported pain , parent proxy-report , and behavioral distress scores increased in response to venipuncture ( concurrent and convergent validity ) . In contrast , heart rate did not reliably change in response to venipuncture . Extent of change in response to venipuncture showed moderate intercorrelation across child and parent pain ratings , and behavioral distress . Preprocedure pain ratings correlated with pain experienced during the procedure . An item analysis of observable pain behaviors suggested differences in the presentation of pain in SCD compared with previous pediatric research . Conclusions Criterion and convergent validity were demonstrated for child-report , parent-report , and observable pain behaviors . These measures seem to tap into distinct , yet overlapping aspects of the pain experience . Assessment of acute procedural pain responses in SCD requires evaluation of preprocedural pain due to the frequent presence of low-level , baseline pain",
"There are inadequate age-specific data to support the use of current self-report pain scales in 3- and 4-year-old children . Most preschool-aged children also lack the necessary cognitive development to use st and ard scales . We aim ed to evaluate the validity and feasibility of 2 novel simplified scales ( Simplified Faces Pain Scale , S-FPS ; Simplified Concrete Ordinal Scale , S-COS ) for preschool-aged children . These simplified scales used a 2-step self-report method : children were first asked whether they have pain ( yes/no ) ; only if yes , then pain intensity was self-reported using a 3-point scale with visual aids signifying mild/moderate/severe . We recruited 180 3- to 6-year-old children undergoing routine blood collection . Each child was r and omly assigned 2 of 3 scales-S-FPS , S-COS , Faces Pain Scale-Revised (FPS-R)-to self-report pain before venipuncture , immediately after , and 5 minutes later , using both scales at each time-point . Pain was also assessed using observation ( Face Legs Activity Cry Consolability ) at each time point . The ability to discriminate pain from no pain was improved with S-FPS and S-COS , compared with the FPS-R , among 4-year-olds , but not 3-year-olds . Correlation with Face Legs Activity Cry Consolability was moderate to strong and cooperation rates were similar for all self-report scales . The simplified scales can improve and simplify pain assessment for 4-year-olds . Quantitative pain rating remains challenging for 3-year-olds . PERSPECTIVE This study evaluated 2 novel simplified pain assessment tools for preschool-aged children undergoing blood sampling . These scales demonstrated good validity and feasibility compared with the FPS-R , suggesting these simplified pain scales may have a role in clinical practice for children as young as 4 years",
"BACKGROUND : Self-reported pain scores are used widely in clinical and research setting s , yet little is known about their interpretability in children . In this prospect i ve , observational study we evaluated the relationship between 0 to 10 numerical rating scale ( NRS ) pain scores and other self-reported , clinical ly meaningful outcomes , including perceived need for medicine ( PNM ) , pain relief ( PR ) , and perceived satisfaction ( PS ) with treatment in children postoperatively . METHODS : This study included children ages 7 to 16 years undergoing surgery associated with postoperative pain . One to 4 observations were recorded in each child within the first 24 hours postoperatively . At each assessment , children rated their pain with the NRS , stated their PNM , and rated their satisfaction with pain management . Assessment s were repeated within 1 to 2 hours , and children additionally rated their PR as the same , better , or worse in comparison with the earlier assessment . Receiver operator characteristic curves were developed to examine potential NRS cut-points for PNM and PS , and the minimum clinical ly significant difference ( MCSD ) in pain score associated with PR was calculated . RESULTS : Three hundred ninety-seven observations ( including 189 pairs ) were recorded in 113 children . NRS scores associated with PNM were significantly higher than “ no need ” ( median 6 vs. 3 ; P NRS scores > 4 had good sensitivity ( 0.81 ) and specificity ( 0.70 ) to discriminate PNM , but with a large number of false positives and negatives ( e.g. , 42 % of children with scores > 4 did not need analgesia ) . The MCSD in NRS scores was −1 ( 95 % confidence interval [ CI ] −0.5 to 1 ) or + 1 ( CI 0.5 to 2.7 ) in relation to feel “ a little better ” or “ worse , ” respectively ( P NRS scores > 6 had a sensitivity of 0.82 and specificity of 0.76 in discriminating dissatisfaction with treatment , yet 46 % and 24 % of children with scores > 6 , respectively , were somewhat to very satisfied with their analgesia . CONCLUSIONS : This study provides important information regarding the clinical interpretation of NRS pain scores in children . Data further support the NRS as a valid measure of pain intensity in relation to the child 's PNM , PR , and PS in the acute postoperative setting . However , the variability in scores in relation to other clinical ly meaningful outcomes suggests that application of cut-points for individual treatment decisions is inappropriate",
"OBJECTIVE The purpose of this study is to quantify , using the Color Analog Scale ( CAS ) , the degree of change in pain severity required to achieve a clinical ly significant improvement in pain . METHODS A prospect i ve descriptive study , using convenience sampling of children aged 5 and 12 years presenting to a pediatric emergency department ( ED ) with acute pain , was done . Children were asked to mark their pain severity on a previously vali date d CAS . After a pain intervention , the child was again asked to mark their pain intensity on the CAS and asked to describe the relative change in their pain . The main outcome measure was to quantify the smallest change required for the child to state that their pain was improved . RESULTS One hundred twenty-six children with a mean age of 8.6 years ( SD , 2.8 years ) were enrolled . Males accounted for 56 % . Pain was traumatic in 47.6 % and nontraumatic in 52.4 % . Of the 126 pain comparisons made , 28 children described their pain as \" the same \" and had a mean change in score of -0.10 cm ( 95 % confidence interval [ CI ] , -2.27 to 2.07 cm ) . Pain was judged to be a \" little less \" in 58 children , and the CAS score changed by a mean of -2.4 cm ( 95 % CI , -3.15 to -1.72 cm ) . In the 29 children who judged their pain to be \" much less , \" the CAS score decreased by a mean of -5.4 cm ( 95 % CI , -6.50 to -4.40 ) . CONCLUSION A decrease on the CAS pain scale of 2.4 cm ( 95 % CI , 2.95 - 1.92 ) is a clinical ly significant change in pain for children aged 5 to 12 years with acute pain . The CAS is a valuable tool in assessing responses to pain interventions",
"OBJECTIVES The Wong-Baker FACES Pain Rating Scale ( WBS ) , used in children to rate pain severity , has been vali date d outside the emergency department ( ED ) , mostly for chronic pain . The authors vali date d the WBS in children presenting to the ED with pain by identifying a corresponding mean value of the visual analog scale ( VAS ) for each face of the WBS and determined the relationship between the WBS and VAS . The hypothesis was that the pain severity ratings on the WBS would be highly correlated ( Spearman 's rho > 0.80 ) with those on a VAS . METHODS This was a prospect i ve , observational study of children ages 8 - 17 years with pain presenting to a suburban , academic pediatric ED . Children rated their pain severity on a six-item ordinal faces scale ( WBS ) from none to worst and a 100-mm VAS from least to most . Analysis of variance ( ANOVA ) was used to compare mean VAS scores across the six ordinal categories . Spearman 's correlation ( rho ) was used to measure agreement between the continuous and ordinal scales . RESULTS A total of 120 patients were assessed : the median age was 13 years ( interquartile range [ IQR ] = 10 - 15 years ) , 50 % were female , 78 % were white , and six patients ( 5 % ) used a language other than English at home . The most commonly specified locations of pain were extremity ( 37 % ) , abdomen ( 19 % ) , and back/neck ( 11 % ) . The mean VAS increased uniformly across WBS categories in increments of about 17 mm . ANOVA demonstrated significant differences in mean VAS across face groups . Post hoc testing demonstrated that each mean VAS was significantly different from every other mean VAS . Agreement between the WBS and VAS was excellent ( rho = 0.90 ; 95 % confidence interval [ CI ] = 0.86 to 0.93 ) . There was no association between age , sex , or pain location with either pain score . CONCLUSIONS The VAS was found to have an excellent correlation in older children with acute pain in the ED and had a uniformly increasing relationship with WBS . This finding has implication s for research on pain management using the WBS as an assessment tool",
"OBJECTIVE To augment available validation data for the Faces Pain Scale - Revised ( FPS-R ) and to assess interscale agreement and preference in comparison with the Coloured Analogue Scale ( CAS ) in pediatric acute pain . METHOD The present prospect i ve , multicentre study included 131 in patients five to 15 years of age ( mean age 8.8 years ; 56 % male ) seen in postoperative recovery . They provided CAS and FPS-R pain scores before and after administration of analgesic medication . Nurses and physicians used the same tools as observational scales . Children and health care providers indicated which scale they preferred . RESULTS FPS-R scores for the intensity of postoperative pain correlated highly with the corresponding CAS scores in all age groups ( 0.66 significant mean differences in any age group between the scales . Scores on the two scales differed by 210 or less in 81 % to 91 % of children , depending on age . Both scales demonstrated expected changes in postoperative pain following administration of an analgesic . Scores at the upper end point were given by approximately 20 % of children five to six years of age on both scales , compared with 2 % to 9 % in the older age groups . Health care providers ' observational ratings were significantly lower than self-ratings . The FPS-R was preferred over the CAS by most children in all age groups and both sexes . Global satisfaction of the health care providers was similar for both tools . DISCUSSION These results support the use of the FPS-R for most children five years of age or older in the postoperative period . Further research is needed to identify young children , particularly those younger than seven years of age , who have difficulty with self-report tools , and to establish methods for training them in the reliable use of these measures",
"OBJECTIVE The main objective was to compare the utility of the Faces Pain Scale ( Bieri et al. , 1990 ) with three alternative self-report measures of pain intensity in children , as well as with pain ratings based on observations of the child 's behavior . DESIGN Fifty children used 4 self-report scales to rate the severity of needle pain from routine immunization . Using videotapes , the child 's pain-related behavior was coded in detailed fashion , and a subset of the sample were also rated globally by 60 registered pediatric nurses . MAIN OUTCOME MEASURES Faces Pain Scale ; Poker Chip Tool ; Visual Analogue Toy ; Verbal Rating Scale ; behavioral checklist ( scoring observable facial , motor , verbal and vocal reactions ) . RESULTS AND CONCLUSIONS The Faces Pain Scale was simple to use , readily understood by the children , and showed a realistic distribution of scores with respect to the type of pain being measured . With the exception of verbal reactions ( which were not meaningfully related to self-report ) , observer ratings based on detailed coding of the child 's behavior correlated only poorly to moderately well with self-report scores ( r = .39 to r = .58 ) . Similarly , although confident in their judgments , the nurses ' ratings showed only moderate agreement with those of the children . In estimating the child 's pain , all observers appeared to appropriately weigh changes in the child 's facial behavior , which showed evidence of being the most sensitive behavioral index to the intensity of short sharp ( needle ) pain in 4 to 6 years olds",
"BACKGROUND AND OBJECTIVES : The Faces Pain Scale – Revised ( FPS-R ) and Color Analog Scale ( CAS ) are self-report pain scales commonly used in children but insufficiently vali date d in the emergency department setting . Our objectives were to determine the psychometric properties ( convergent validity , discriminative validity , responsivity , and reliability ) of the FPS-R and CAS , and to determine whether degree of validity varied based on age , sex , and ethnicity . METHODS : We conducted a prospect i ve , observational study of English- and Spanish-speaking children ages 4 to 17 years . Children with painful conditions indicated their pain severity on the FPS-R and CAS before and 30 minutes after analgesia . We assessed convergent validity ( Pearson correlations , Bl and -Altman method ) , discriminative validity ( comparing pain scores in children with pain against those without pain ) , responsivity ( comparing pain scores pre- and postanalgesia ) , and reliability ( Pearson correlations , repeatability coefficient ) . RESULTS : Of 620 patients analyzed , mean age was 9.2 ± 3.8 years , 291(46.8 % ) children were girls , 341(55 % ) were Hispanic , and 313(50.5 % ) were in the younger age group ( 8 years ) . Pearson correlation was 0.85 , with higher correlation in older children and girls . Lower convergent validity was noted in children discriminative validity and responsivity for both scales . Reliability was acceptable for both the FPS-R and CAS . CONCLUSIONS : The FPS-R and CAS overall demonstrate strong psychometric properties in children ages 4 to 17 years , and between subgroups based on age , sex , and ethnicity . Convergent validity was question able in children < 7 years old",
"& NA ; The numerous pain rating scales using faces depicting varying degrees of distress to elicit reports of pain from children fall into two categories ; those with a neutral face as the ‘ no pain ’ anchor , and those with a smiling face as the ‘ no pain ’ anchor . This study examined the potentially biasing impact of these anchor types on children 's self‐reports of pain in response to a series of vignettes . Participants were 100 children stratified by age ( 5–6 years , 7–8 years , 9–12 years ) and r and omly assigned to one of three groups : ( 1 ) neutral scale/sensory instructions ; ( 2 ) smiling scale/sensory instructions ; ( 3 ) smiling scale/affective instructions . Children completed a faces scale , a VAS , and emotions ratings in response to four scenarios depicting : ( 1 ) no pain/negative emotions ; ( 2 ) pain/negative emotions ; ( 3 ) no pain/positive emotions ; ( 4 ) pain/positive emotions . Results showed that children who used the smiling scale had significantly higher pain scores for no pain and pain/negative emotions vignettes and significantly lower faces scale scores for pain/positive vignettes than children who used the neutral faces scale . Instructions varying in focus on sensory or affective qualities of pain had no effect on children 's pain ratings . Group differences in children 's ratings with the VAS and emotions measure suggested that rating pain with a smiling faces scale may alter a child 's concept of pain . Age differences indicated the younger children rated the negative emotion vignettes as more painful than the older children . These findings suggest that children 's pain ratings vary depending on the types of faces scale used , and that faces scales with smiling anchors may confound affective states with pain ratings",
"OBJECTIVES The objective was to determine the minimum and ideal clinical ly significant differences ( MCSD , ICSD ) in pain intensity in children for the Faces Pain Scale-Revised ( FPS-R ) and the Color Analog Scale ( CAS ) and to identify any differences in these estimates based on patient characteristics . METHODS This was a prospect i ve study of children aged 4 to 17 years with acute pain presenting to two urban pediatric emergency departments . Participants self-reported their pain intensity using the FPS-R and CAS and qualitatively described their changes in pain . Changes in pain score reported using the FPS-R and CAS that were associated with \" a little less \" and \" much less \" pain ( MCSD and ICSD , respectively ) were identified using a receiver operating characteristic-based method and expressed as raw change score and percent reductions . Estimates of MCSD and ICSD were determined for each category of initial pain intensity ( mild , moderate , and severe ) and patient characteristics ( age , sex , and ethnicity ) . Post hoc exploratory analyses evaluated categories of race , primary language , and etiology of pain . RESULTS A total of 314 children with acute pain were enrolled ; mean ( ±SD ) age was 9.8 ( ±3.8 ) years . The FPS-R raw change score and percent reduction MCSD estimates were 2/10 and 25 % , with ICSD estimates of 3/10 and 60 % . For the CAS , raw change score and percent reduction MCSD estimates were 1/10 and 15 % , with ICSD estimates of 2.75/10 and 52 % . For both scales , raw change score and percent reduction estimates of the MCSD remained unchanged in children with either moderate or severe pain . For both scales , estimates of ICSD were not stable across categories of initial pain intensity . There was no difference in MCSD or ICSD based on age , sex , ethnicity , race , primary language , or etiology of pain . CONCLUSIONS The MCSD estimates can be expressed as raw change score and percent reductions for the FPS-R and CAS . These estimates appear stable for children with moderate to severe pain , irrespective of age , sex , and ethnicity . Estimates of ICSD were not stable across different categories of initial pain intensity , therefore limiting their potential generalizability",
"This study explored whether global unidimensional self-report pain scales based on facial expression help children separately estimate the sensory and affective magnitude of post-operative pain . Ninety paediatric elective surgery patients ( in two age groups : 5 - 9 and 10 - 15 years ) used each of four scales to estimate pain intensity and pain affect during the first 2 days after surgery . The four scales were : Faces Pain Scale ( FPS ) , Facial Affective Scale ( FAS ) , and the Coloured Analogue Scale ( CAS ) ( one for intensity and one for unpleasantness ) . As hypothesised , ratings on the FPS correlated more highly with analogue scale ratings for intensity than for unpleasantness , whereas ratings on the FAS correlated more highly with those on the analogue scale for unpleasantness than for intensity . Factor analysis indicated that although all measures loaded on a single dimension of distress , there was an additional weaker factor corresponding to a unique contribution of the FAS . No systematic age effects were observed . It was concluded that the FPS and the FAS may partly measure different aspects of the postoperative pain experience in children , although shared instrument variance may obscure true estimates of covariation in ratings of intensity and affective magnitude . The clinical relevance of the present results remains to be determined",
"UNLABELLED Cl aims regarding the ability of preschool-age children to provide accurate self-reports using st and ard pain scales are not well supported by age-specific evidence . Responses of children younger than 5 years are often idiosyncratic and subject to biases . Simplifying the task of self-report of pain would make it more developmentally appropriate for 3- to 5-year-olds . A binary question is asked : \" Does it hurt ? \" or an equivalent . If yes , a simplified scale is presented , comprising 3 categories representing low , medium , and high pain severity . Children aged 3 to 5 years ( N = 184 ) were recruited from preschools and day care centers . Following parental consent and child assent , children were r and omly assigned to use either the Faces Pain Scale-Revised or a 3-face scale preceded by a yes-no question to rate pain in 9 picture stories from the Charleston Pediatric Pain Pictures portraying no pain , moderate pain , and severe pain . The simplified pain rating task made no difference for 5-year-olds , whose mean scores were nearly identical using the 2 approaches . However , discrimination of the 3 levels of Charleston Pediatric Pain Pictures items was significantly better in 3- and 4-year-olds with the simplified task than with the Faces Pain Scale-Revised . Simplifying the task improved preschool-age children 's ability to estimate pain intensity . PERSPECTIVE St and ard self-report pain scales with 6 faces are confusing for many 3- and 4-year-olds . In basic preparatory research for future development of a preschool self-report pain scale , we simplified the task . This simplification made no difference for 5-year-olds but improved the performance of 3- and 4-year-olds",
"& NA ; Although the verbal numeric scale ( VNS ) is used frequently at patients ’ bedsides , it has never been formally vali date d in children with acute pain . In order to vali date this scale , a prospect i ve cohort study was performed in children between 8 and 17 years presenting to a pediatric emergency department ( ED ) with acute pain . Pain was grade d using the VNS , the visual analogue scale ( VAS ) , and the verbal rating scale ( VRS ) . A second assessment was done before discharge . We determined a priori that in order to be valid , the VNS would need to : correlate with the VAS ( concurrent validity ) ; decrease after intervention to reduce pain ( construct validity ) ; and be associated with the VRS categories ( content validity ) . The VNS interchangeability with the VAS , its minimal clinical ly significant difference , and test – retest reliability were also determined . A total of 202 patients ( mean age : 12.2 ± 2.6 years ) were enrolled . The VNS correlated with the VAS : ric = 0.93 , p VNS before versus after interventions ( p VNS/VAS were outside the a priori set limit of ±2.0 : −1.8 , 2.5 . The VNS minimal clinical ly significant difference was 1 . The VNS had good test – retest reliability with 95 % limits of agreement of −0.9 and 1.2 . In conclusion , the VNS provides a valid and reliable scale to evaluate acute pain in children aged 8–17 years but is not interchangeable with the VAS ",
"OBJECTIVE To quantify , using two pain assessment scales , the amount of change in pain severity required to achieve a clinical ly significant improvement in pain in children presenting to a pediatric emergency department ( ED ) with pain . METHODS Prospect i ve , descriptive study involving all children presenting to a pediatric ED between 5 and 16 years of age inclusive with acute pain . Children were excluded if they 1 ) were intoxicated or had altered sensorium , 2 ) were clinical ly unstable , 3 ) were non-English-speaking , or 4 ) were developmentally delayed . Written informed consent was obtained . Children were asked to mark their current pain severity on the st and ardized Color Analogue Scale ( CAS ) and Faces Pain Scale ( FPS ) . After each pain control intervention the child was asked to repeat these measurements and to describe whether his or her pain was \" much less , \" \" a little less , \" \" about the same , \" \" a little worse , \" or \" much worse \" compared with before . This process was repeated until the child was discharged from the ED or had a score of zero . The main outcome measure was the smallest change on the CAS or FPS necessary to cause the child to describe his or her pain as a \" little less . \" This was defined as the clinical ly significant change in pain . The \" ideal \" change in pain was defined as the amount of change necessary for the child to describe the pain as \" much less \" or at which point the child thought he or she no longer required any medicine to help the pain go away . RESULTS One hundred twenty-one children were enrolled with a mean age of 9.8 years ( SD + /- 3.15 ) . Males accounted for 56 % . Pain was traumatic in 65 % and nontraumatic in 35 % . A total of 153 pain comparisons were made using the CAS and 154 using the FPS . Only three children complained that their pain got worse ( two a little worse and one much worse ) . Pain was described as \" the same \" in 20 . Of the 60 pain comparisons judged to be a \" little less , \" the CAS score changed by a median of 2.0 cm [ interquartile ratio ( IQR ) 1 - 3 ] , and the FPS by 1.0 face ( IQR 1 - 2 ) . In the 71 children who judged their pain to be \" much less , \" the CAS decreased by a median of 4.0 cm ( IQR 2 - 5 ) and the FPS by 2.0 faces ( IQR 2 - 3 ) . CONCLUSIONS The assessment and treatment of pain in children are an important component of pediatric practice , especially in the ED . This study provides health care professionals and clinical investigators the information necessary to assess whether their method of pain control in children is clinical ly relevant",
"AIMS To explore inconsistencies and the reliability in worst pain intensity ratings in children . BACKGROUND Asking for worst pain always requires a retrospective evaluation which is controversially discussed . DESIGN Retrospective analysis of registry data and a prospect i ve study . METHODS Retrospective study : 5970 patients [ age : 10·2(4·0 ) years , female : 41 % data collection : 2008 - 2015 ] ; Prospect i ve study : 240 patients [ age : 14·7(1·9 ) years , female : 43 % , data collection 2013 - 2014 ] were included . In both studies , the number of implausible pain intensity ratings was calculated ( both studies : worst pain lower than movement pain or pain at rest , prospect i ve study : number of patients reporting lower pain intensity ratings in worst pain items for the same time period in a second assessment ) . Test-retest reliability was calculated for the prospect i ve study . Changes in worst pain ratings were analyzed using Wilcoxon signed ranks test . RESULTS Test-retest reliability ranged from ρ = 0·77 - 0·90 . In the retrospective study , 8·9 % ( 95%CI : 8·2 - 9·6 % ) of our patients reported higher movement and /or pain at rest compared with worst pain . In the prospect i ve study , 35·8 % ( 95%CI : 30·0 - 42·1 % ) reported higher activity pain ratings compared with worst pain ratings in at least one pain assessment ; 13·8 % of the pediatric patients reported lower pain intensity ratings in worst pain items in a second assessment compared with the first assessment . CONCLUSION Nine to 36 % of our patients showed inconsistent worst pain ratings . To overcome this problem , more specific pain intensity items , more than one item or a better instruction for pediatric patients could be used",
"Objectives The aims of this study were to define the Faces Pain Scale – Revised ( FPS-R ) and Color Analog Scale ( CAS ) scores associated with no pain , mild pain , moderate pain , and severe pain in children with acute pain , and to identify differences based on age , sex , and ethnicity . Methods We conducted a prospect i ve observational study in 2 pediatric emergency departments of children aged 4 to 17 years with painful and nonpainful conditions . We assessed their pain intensity using the FPS-R , CAS , and qualitative measures . Pain score cut points that best differentiated adjacent categories of pain were identified using a receiver operating characteristic – based method . Cut points were compared within subgroups based on age , sex , and ethnicity . Results We enrolled 620 patients , of whom 314 had painful conditions . The mean age was 9.2 years ; 315 ( 50.8 % ) were in the younger age group ( aged 4–7 years ) ; 291 ( 46.8 % ) were female ; and 341 ( 55 % ) were Hispanic . The scores best representing categories of pain for the FPS-R were as follows : no pain , 0 and 2 ; mild pain , 4 ; moderate pain , 6 ; and severe pain , 8 and 10 . For the CAS , these were 0 to 1 , 1.25 to 2.75 , 3 to 5.75 , and 6 to 10 , respectively . Children with no pain frequently reported nonzero pain scores . There was considerable overlap of scores associated with mild and moderate pain . There were no clinical ly meaningful differences of scores representing each category of pain based on age , ethnicity , and race . Conclusions We defined pain scores for the FPS-R and CAS associated with categories of pain intensity in children with acute pain that are generalizable across subgroups based on patient characteristics . There were minor but potentially important differences in pain scores used to delineate categories of pain intensity compared to prior convention",
"Objective The Wong-Baker FACES Pain Rating Scale ( WBS ) is preferred by parents and patients for reporting pain severity . However , it is speculated that the “ no hurt ” and “ hurts worst ” anchors confound pain measurement with nonnociceptive states . The objective of our study was to determine if fear confounds reporting of pain severity on the WBS . We hypothesized that the WBS would correlate with a psychometrically different pain severity scale ( the visual analog scale [ VAS ] ) and not correlate with a fear measure , the Child Medical Fear Scale ( CMFS ) . Methods This was a prospect i ve observational study of children 7 to 12 years presenting to a university-based suburban pediatric ED with acute pain . Patients rated pain severity on the WBS ordinal scale and a 100-mm unhatched VAS with marked end points of “ no pain ” and “ worse pain ever . ” Patients also completed a 26-item CMFS . Correlations between the WBS and VAS with the CMFS total score were assessed with Spearman correlation and exploratory factor analysis . Results All 3 scales were completed in 197 children . Correlation between the severity scales ( WBS-VAS ) was moderate : 0.63 ( 95 % confidence interval [ CI ] , 0.54–0.71 ) . However , correlations between the WBS-CMFS and VAS-CMFS were poor : −0.02 ( 95 % CI , −0.16 to −0.12 ) and 0.01 ( 95 % CI , −0.13 to 0.15 ) , respectively . Correlations did not differ by sex , grade , pain location , or cause of pain ( traumatic vs atraumatic ) . Exploratory factor analysis demonstrated excellent loadings within 2 factors : pain and fear . Conclusions The WBS demonstrates moderate correlation with another measure of pain ( VAS ) and is not mistaken for fear among school-aged patients presenting to the ED with pain",
"& NA ; Assumptions of reliability and consistency of self‐report of pain by patients using visual analogue scales ( VAS ) and numerical rating scales ( NRS ) are based on narrow considerations of possible sources of error . This study examined patients ’ use of VASs and NRSs , by their own description , with particular attention to rating of multiple pains , of different dimensions of pain , and of interpretation and use of lower and upper endpoints and increments on the scales . These have implication s for the approximation of the scales to psychometric requirements . An interview developed from a small pilot project was given to 78 volunteer chronic pain patients embarking on a pain management course , and consisted of both forced choice questions and free response . Data are described with reference to lack of concordance between patients and of consistency within patients ; responses suggested that ratings incorporate multiple partially differentiated dimensions of pain , with particular importance placed on function or mobility . Labels assigned to scale endpoints by research ers , whether lexical or numerical , appeared to affect their use ; however , covert relabelling of scale points was revealed in free response . The action of arriving at a rating is better conceptualised as an attempt to construct meaning , influenced by and with reference to a range of internal and external factors and private meanings , rather than as a task of matching a distance or number to a discrete internal stimulus",
"This study examined concurrent self-reports of pain intensity and behavioral responses in 25 children aged 3 - 7 yr . Behavioral ( Children 's Hospital of Eastern Ontario Pain Scale , CHEOPS ) and self-report ( the Oucher and Analogue Chromatic Continuous Scale ) measures of pain were obtained following major surgery . The two self-report measures were strongly and significantly correlated , and the pattern of scores over the 36-hr observation period was as expected . There was little relationship between the scores for the self-report and the behavioral measures . Many children who reported severe pain manifested few of the behavioral indicators of distress used in the CHEOPS . This behavioral response pattern may occur commonly in children experiencing pain after surgery and may limit the applicability of current behavioral scales as sole measures of pain intensity in younger children",
"Objective . To compare the Faces Pain Scale and Color Analogue Scale among children aged 6–12 years undergoing selected procedures ( Venipuncture , Intravenous cannulation , Intramuscular injection , Lumbar puncture , Bone marrow aspiration ) and to compare the procedural pain in a child as perceived by the child , parents and health care professionals using the above mentioned scales Methods . This was a prospect i ve , descriptive correlational study of children aged 6–12 years , who had undergone selected procedures . Children were assessed for their pain severity using Faces Pain Scale and Color Analogue Scale . Parents and health care professionals also independently assessed the child 's pain using the same scales Results . 181 children who fulfilled the eligibility criteria were enrolled in the study . There was a significant positive correlation ( r = > 0.8 ) between both the pain scales . There was fair to moderate positive correlation ( r = 0.29 to 0.58 ) of pain perception of child with parents and health care professionals Conclusions . Faces Pain Scale and Color Analogue Scales seem to be appropriate instruments for measuring pain intensity among Indian children aged 6–12 years undergoing selected",
"& NA ; A new instrument was design ed to provide a practical clinical measure for assessing children 's pain intensity and pain affect . The pocket size measure includes a Coloured Analogue Scale ( CAS ) to assess intensity and a facial affective scale to assess the aversive component of pain . Both scales have numerical ratings on the back , so that the person administering it can quickly note the numbers that represent a child 's pain . This study was conducted to determine : the validity of the new instrument by evaluating the psychophysical properties of the intensity scale and by evaluating the discriminant validity of the intensity and affective scales . Since visual analogue scales ( VAS ) are valid and reliable measures for assessing children 's pain , children 's ability to use the new analog scale was compared with their performance on a VAS . Children 's ability to rate pain affect using an affective scale , in which the 9 faces on a Facial Affective Scale ( FAS ) are presented in an ordered sequence from least to most distressed , was compared to their performance on the original FAS , in which the same faces were presented in a r and om order . Using a parallel groups design , 104 children ( 5–16 years ; 60 female , 44 male ; 51 healthy and 53 with recurrent headaches ) were r and omized into two groups : CAS or VAS . Children used the assigned scale to complete a calibration task , in which they rated the sizes of 7 circles varying in area ( 491 , 804 , 1385 , 2923 , 3848 , 5675 and 7854 mm2 ) . The psychophysical function relating perceived circle size to actual physical size was determined for the CAS and VAS . Children 's CAS and VAS responses on the calibration task yielded similar mathematical relationships ; & PHgr;cas = 0.035I0.87 , & PHgr;vas = 0.027I0.89 , where & PHgr ; = perceived magnitude and I = stimulus intensity . The R2 values were 0.921 and 0.922 for the CAS and VAS groups , respectively . Analyses of covariance revealed no significant differences in the characteristics of these relationships , i.e. , R2 , slope , or y intercept , by scale type . Children used the same scale to complete the Children 's Pain Inventory ( CPI ) , in which they rated the intensity and affect of 16 painful events ( varying in nature and extent of tissue damage ) . Children 's CAS and VAS responses on the CPI were similar . Analyses of covariance indicated that there were no differences in either intensity or affective ratings by scale type . However , the mean number of painful events experienced by children increased significantly with age ( P = 0.0001 ) . Intensity ratings decreased significantly with age ( P = 0.002 ) , but affective ratings did not vary with age . The new instrument has equivalent psychometric properties to a 165 mm VAS . However , the CAS was rated as easier to administer and score than the VAS , so it may be more practical for routine clinical use . Since the CAS has fulfilled the first two criteria for a pain measure ( psychophysical properties and discriminant validity ) , it is ethical to proceed with the formal definitive test for construct validity , in which children from various clinical population s use the CAS scale to assess their own pain",
"STUDY OBJECTIVE We sought to determine the minimum clinical ly significant difference in visual analog scale ( VAS ) pain score for children . METHODS We performed a prospect i ve , single-group , repeated- measures study of children between 8 and 15 years presenting to an urban pediatric emergency department with acute pain . On presentation to the ED , patients marked the level of their pain on a 100-mm nonhatched VAS scale . At 20-minute intervals thereafter , they were asked to give a verbal categoric rating of their pain as \" heaps better , \" \" a bit better , \" \" much the same , \" \" a bit worse , \" or \" heaps worse \" and to mark the level of pain on a VAS scale of the same type as used previously . A maximum of 3 comparisons was recorded for each child . The minimum clinical ly significant difference in VAS pain score was defined as the mean difference between current and preceding scores when the subject reported \" a bit worse \" or \" a bit better \" pain . RESULTS Seventy-three children were enrolled in the study , yielding 103 evaluable comparisons in which pain was rated as \" a bit better \" or \" a bit worse . \" The minimum clinical ly significant difference in VAS score was 10 mm ( 95 % confidence interval 7 to 12 mm ) . CONCLUSION This study found the minimum clinical ly significant difference in VAS pain score for children aged 8 to 15 years ( on a 100-mm VAS scale ) to be 10 mm ( 95 % confidence interval 7 to 12 mm ) . In studies of population s , differences of less than this amount , even if statistically significant , are unlikely to be of clinical significance",
"Summary The repeatability coefficient of the 100‐mm visual analogue scale in children , a measure of test‐retest reliability , is 12 mm when pain did not change . Abstract In children , many psychometric properties of the visual analogue scale ( VAS ) are known , including the minimum clinical ly significant difference ( 10 mm on a 100‐mm VAS ) . However , its imprecision or reliability is not well known . Thus , in order to determine the reliability of this scale , a prospect i ve cohort study was performed in patients aged 8–17 years presenting to a pediatric emergency department with acute pain . Pain was grade d 4 times using a paper VAS ( 0–100 mm ) : T0 , T3 , T6 , and T⩾36 minutes . After T6 , patients were asked if their pain had changed since T0 minute . The primary analysis was the repeatability coefficient of the VAS , determined according to the Bl and ‐Altman method for measuring agreement using repeated measures in patients reporting that their pain was the same for T0 , T3 , and T6 . In order to appropriately estimate the within‐subject SD , 96 patients were required if we obtained 3 measurements for each patient . A total of 151 patients with a mean age of 12.2 ± 2.5 years were enrolled . Among them , 100 mentioned that their pain was the same for T0 , T3 , and T6 minutes . The repeatability coefficient of the VAS for these children was 12 mm when the pain did not change . This implies that , for a child , all pain intensity measurements within 12 mm should be considered the same pain intensity on a paper VAS . This measure should also be evaluated on other types of VAS ",
"Faces scales have become the most popular approach to eliciting children 's self-reports of pain , although different formats are available . The present study examined : ( a ) the potential for bias in children 's self-reported ratings of clinical pain when using scales with smiling rather than neutral ' no pain ' faces ; ( b ) levels of agreement between child and parent reports of pain using different faces scales ; and ( c ) preferences for scales by children and parents . Participants were 75 children between the ages of 5 and 12 years undergoing venepuncture , and their parents . Following venepuncture , children and parents independently rated the child 's pain using five different r and omly presented faces scales and indicated which of the scales they preferred and why . Children 's ratings across scales were very highly correlated ; however , they rated significantly more pain when using scales with a smiling rather than a neutral ' no pain ' face . Girls reported significantly greater levels of pain than boys , regardless of scale type . There were no age differences in children 's pain reports . Parents ' ratings across scales were also highly correlated ; however , parents also had higher pain ratings using scales with smiling ' no pain ' faces . The level of agreement between child and parent reports of pain was low and did not vary as a function of the scale type used ; parents overestimated their children 's pain using all five scales . Children and parents preferred scales that they perceived to be happy and cartoon-like . The results of this study indicate that subtle variations in the format of faces scales do influence children 's and parents ' ratings of pain in clinical setting",
"OBJECTIVES As pain is a subjective and difficult parameter to assess in children , we aim ed to evaluate the correspondence of two pain scales - parents ' post-operative pain measure ( PPPM ) and faces pain scale-revised ( FPS-R ) with analgesic intake in the assessment of post-tonsillectomy pain in a pediatric population . METHODS Children aged 4 - 10 years ( n=174 ) undergoing tonsillectomy with or without adenoidectomy had their pain monitored by PPPM and FPS-R over 7 days following surgery . The amount of analgesic ( acetaminophen or dipyrone ) intake was also recorded each day . Linear regression and correlation analysis were performed for pain scales and Poisson regression model for analgesic administration . To evaluate influence of gender linear regression and logistic regression with r and om effects were performed . RESULTS PPPM and FPS-R presented a significant positive correlation ( τ=0.5 ; R(2)=0.36 ; p with analgesic use over the 7 post-operative days ( p in pain levels by both scales . CONCLUSIONS Our data demonstrate that PPPM and FPS-R are equivalent pain scales to quantify post-tonsillectomy pain in children and are useful tools in post-tonsillectomy clinical research",
"STUDY OBJECTIVE In children , the agreement between the many scales used to document the intensity of pain is not well known . Thus , to determine the agreement , we evaluate the visual analog scale , the st and ardized color analog scale , the Wong-Baker FACES Pain Rating Scale , and a verbal numeric scale in children with acute abdominal pain suggestive of appendicitis in a pediatric emergency department ( ED ) . METHODS Participants were children who were aged 8 to 18 years , presented to a pediatric ED with abdominal pain suggestive of appendicitis , and were recruited to participate in a r and omized controlled trial evaluating the efficacy of morphine . Patients were initially asked to grade their pain on a plasticized color analog scale , a paper visual analog scale , a paper Wong-Baker FACES Pain Rating Scale , and then with a verbal numeric scale . Thirty minutes after morphine or placebo administration , the assessment was repeated . All scores were then converted to a value of 0 to 100 . Agreements between scores were evaluated with the Bl and -Altman method , and the 95 % lower and upper limits were reported . We defined a priori the maximum limit of agreement at + /-20 mm . RESULTS A total of 87 children were included in the study , 58 of them with confirmed appendicitis . The 95 % limits of agreement for each pair of scales were visual analog scale/color analog scale -18.6 , 14.4 ; visual analog scale/Wong-Baker FACES Pain Rating Scale -20.1 , 33.7 ; visual analog scale/verbal numeric scale -30.2 , 20.7 ; color analog scale/Wong-Baker FACES Pain Rating Scale -18.5 , 36.3 ; color analog scale/verbal numeric scale -26.9 , 22.1 ; and Wong-Baker FACES Pain Rating Scale/verbal numeric scale -38.7 , 15.7 . CONCLUSION Our study suggests that only the visual analog scale and the color analog scale have acceptable agreement in children with moderate to severe acute abdominal pain . In particular , the verbal numeric scale is not in agreement with the other evaluated scales",
"Summary The widely used “ optimal ” cut point procedure developed by Serlin et al. in 1995 results in highly variable cut points . This variability obviates any substantial interpretation of differences between groups . Abstract Defining cut points for mild , moderate , and severe pain intensity on the basis of differences in functional interference has an intuitive appeal . The statistical procedure to derive them proposed in 1995 by Serlin et al. has been widely used . Contrasting cut points between population s have been interpreted as meaningful differences between different chronic pain population s. We explore the variability associated with optimally defined cut points in a large sample of chronic pain patients and in homogeneous sub sample s. Ratings of maximal pain intensity ( 0–10 numeric rating scale , NRS ) and pain‐related disability were collected in a sample of 2249 children with chronic pain managed in a tertiary pain clinic . First , the “ optimal ” cut points for the whole sample were determined . Second , the variability of these cut points was quantified by the bootstrap technique . Third , this variability was also assessed in homogeneous sub sample s of 650 children with constant pain , 430 children with chronic daily headache , and 295 children with musculoskeletal pain . Our study revealed 3 main findings : ( 1 ) The optimal cut points for mild , moderate , and severe pain in the whole sample were 4 and 8 ( 0–10 NRS ) . ( 2 ) The variability of these cut points within the whole sample was very high , identifying the optimal cut points in only 40 % of the time . ( 3 ) Similarly large variability was also found in sub sample s of patients with a homogeneous pain etiology . Optimal cut points are strongly influenced by r and om fluctuations within a sample . Differences in optimal cut points between study groups may be explained by chance variation ; no other substantial explanation is required . Future studies that aim to interpret differences between groups need to include measures of variability for optimal cut points",
"& NA ; Altogether 553 children ( 195 first grade rs , mean age 6.8 years , and 358 third grade rs , mean age 8.7 years ) participated in the development of a self‐report measure to assess the intensity of children 's pain . The first step was the derivation , from children 's drawings of facial expressions of pain , of 5 sets of 7 schematic faces depicting changes in severity of expressed pain from no pain to the most pain possible . With the set of faces that achieved the highest agreement in pain ordering , additional studies were conducted to determine whether the set had the properties of a scale . In one study , children rank‐ordered the faces on 2 occasions , separated by 1 week . All 7 faces were correctly ranked by 64 % ( retest 1 week later , 61 % ) of grade 1 children and by 86 % ( retest 89 % ) of grade 3 children . In a second study , the faces were presented in all possible paired combinations . All 7 faces were correctly placed by 62 % ( retest 86 % ) of the younger and by 75 % ( retest 71 % ) of the older subjects . A third study asked children to place faces along scale : a procedure allowing a check on the e quality of intervals . The fourth study checked on whether pain was acting as an underlying construct for ordering the faces in memory . We asked whether children perceived the set as a scale by asking if memory for an ordered set of faces was more accurate than for a r and om set . The final study checked , with 6‐year‐old children , the test‐retest reliability of ratings for recalled experiences of pain . Overall , the faces pain scale incorporates conventions used by children , has achieved strong agreement in the rank ordering of pain , has indications that the intervals are close to equal , and is treated by children as a scale . The test‐retest data suggest that it may prove to be a reliable index over time of self‐reported pain",
"OBJECTIVES The objective was to assess in a pediatric emergency department ( ED ) the reliability of the color analog scale ( CAS ) for acute pain assessment , overall and between traumatic and nontraumatic pain etiology . METHODS This was a prospect i ve study of children aged 5 to 16 years in the ED of a children 's hospital who had a complaint of pain . The CAS was administered to the patient at admission and at 30 minutes . To evaluate repeatability , a second measurement was obtained 1 minute following each assessment . This assumed there would be no substantial change in pain intensity within 1 minute . The authors used the intraclass correlation coefficient ( ICC ) to evaluate the repeatability of 1-minute interval measurements . RESULTS A total of 170 patients were enrolled . The origin of pain was traumatic in 81 cases ( 48 % ) . Regardless of pain etiology , the CAS scores were highly repeatable ( r = 0.97 , 95 % confidence interval [ CI ] = 0.95 to 0.98 ) . CONCLUSIONS The color analog scale is both a valid and a reliable self-reporting tool in the assessment of acute pain in children"
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Utility is a simple expression of health-related quality of life in individuals with different states of health . A number of studies on utility measurements were conducted and published in the past . We retrieved 164 English- language articles which appeared in 1966 through 1999 for a systematic review . The number of reports has been increasing at an accelerating pace , especially during the past decade . The most widely used method of utility measurement was time trade-off , TTO ( 40 % ) , followed by rating scale , RS ( 31 % ) and st and ard gamble , SG ( 29 % ) . The utility of chronic health status was more frequently reported as compared with acute health status ( 907 vs 86 ) . Accordingly , frequently explored clinical categories were cardiology , neurology , nephrology , and gastroenterology . Specifically , coronary heart disease ( 52 utilities ) , physical disability due to neurological diseases ( 45 utilities ) , chronic renal failure ( 74 utilities ) , and colorectal cancer ( 29 utilities ) were subject to utility measurement . Mental or social dysfunctioning accounted for only a small proportion ( 48 utilities ) . There is a strong tendency for RS to yield the lowest and SG to yield the highest values . We compiled an extensive list of the results of studies on utility as a reference for health care professionals in this field | [
"Contingent valuation using willingness to pay ( WTP ) is one of the methods available for assessing the value of a new technology or treatment for a disease in monetary terms . Experience with this method is lacking in epilepsy . The objectives of this study were to assess the acceptability of the WTP method in epilepsy , the level of the responses , and to investigate its validity by comparison with other non-monetary preference measures . Among 397 patients with epilepsy responding to a comprehensive question naire , 82 were r and omly selected for an interview . They were asked about their WTP for an imaginary new technology which could permanently cure their epilepsy . Fifty-nine patients participated and 57 completed the interview ( 32 women ; mean age 44 years ) , the majority with well-controlled epilepsy . The patients indicated a median WTP of Norwegian Kroner ( NOK ) 150,000 ( USD 20,000 ; GBP 11,800 ) , interquartile range NOK 50,000 - 350,000 ( USD 6 , 667 - 46 , 667 ; GBP 3,937 - 27,559 ) for this cure . Non-response was low , indicating high acceptability of this method . There was little association between WTP and other preference measures ; the Spearman rank correlation coefficient was -0.09 and -0.12 with time trade-off and st and ard gamble respectively , question ing the validity of this method",
"We describe the relation between self-reported hypertension and measures of health-related quality of life ( HRQOL ) in a community-dwelling population . In a cross-sectional study , 1430 r and omly selected adults , aged 45 to 89 years , were interviewed to obtain a medical history and health status measures , including the SF-36 question naire , the Quality of Well Being ( QWB ) index , and time trade-off ( TTO ) assessment s. A total of 519 participants reported being affected by hypertension ( HTN group ) . The HTN group , compared to the No HTN group , had significantly lower age-adjusted health status scores measured by the General Health scale of the SF-36 and by TTO , with differences between groups for each measure comprising approximately 5 % of the total scale . HTNs also had a significant decline in general health status measures associated with increasing numbers of antihypertensive medications but not with specific classes of medications . We conclude that hypertension and hypertension drug therapy are associated with clinical ly meaningful decreases in reported health status",
"Levels of Well-Being are social preferences , or weights that members of society associate with time-specific states of function . A Weighted Life Expectancy , which can be used to measure program outputs , is created by summing the levels across diverse cases and multiplying them by probable transitions ( prognoses ) among the states and levels . This operation requires however , that the Levels of Well-Being be measured on underlying metric scale . The present analysis compares preference measurements from a simple category rating procedure with those obtained using the more complex and difficult magnitude estimation method which has been cl aim ed to yield ratio level measures . In a r and omly counterbalanced design , 65 college students rated 30 case descriptions representing the range of the Well-Being continuum . The results exhibit the classical logarithmic relation observed for a prothetic continua . When transformed to a meaningful 0–1 unit scale , however , the magnitude responses are compressed at the lower end of the scale near death . Such results are inconsistent not only with category rating , but also with intuitive notions of the relative importance of the function states , with the results of rating procedures that simulate social choice , and with evidence that confirms the interval properties of the category ratings themselves . Furthermore , the ease of administration of category rating means that multiple attributes of cases can be considered jointly , avoiding the need to aggregate scale values for different attributes by arbitrary rules . In sum , magnitude estimation is inappropriate as a measurement method for a Health Status Index and is probably also inappropriate for other measures of utility and social choice",
"Abstract Treatment with recombinant human erythropoietin ( r-hu-Epo ) in patients with rheumatoid arthritis ( RA ) and anaemia of chronic disease ( ACD ) result ed in improvement of both anaemia and disease activity . Utilities represent a generic and comprehensive quality of life measure , capable of integrating domain-specific information into one overall value which a patient assigns to his state of health . Therefore , the effect of r-hu-Epo on quality of life was studied by measuring utilities , derived from the rating scale and st and ard gamble , in a 52-week placebo-controlled r and omised double-blind study with r-hu-Epo in 70 patients with active RA and ACD . Furthermore , the relation between anaemia as assessed by haemoglobin levels ( Hb ) , disease activity as assessed with the Disease Activity Score ( DAS ) , and utilities was investigated . Compared to the placebo group , significant improvement of Hb ( P DAS ( P = 0.01 ) and rating scale utilities ( P = 0.002 ) , but not of st and ard gamble utilities , was observed in the Epo group . Rating scale utilities correlated strongly with DAS ( r = –0.47 , P Hb ( r = 0.37 , P both DAS ( r = –0.74 , P and Hb ( r = 0.44 , P DAS and Hb contributed significantly to the variance in rating scale utilities ( 21 % and 3 % respectively ) and to changes in rating scale utilities ( 43 % and 3 % respectively ) . St and ard gamble utilities correlated less well with clinical disease variables than rating scale utilities did . These results indicate , that r-hu-Epo improves utility-derived health-related quality of life , most probably by improving both disease activity and anaemia . Utilities , particularly rating scale utilities , correlated well with conventional disease activity variables and proved sensitive to change . Utilities may be a useful tool for investigating quality of life in RA- patients",
"Several specific and general measures are available for the assessment of overall health related quality of life in epilepsy . Few of the commonly used measures provide utility weights for use in cost-utility analyses . This study compares four methods for measuring utility weights : time trade-off ( TTO ) , st and ard gamble ( SG ) , 15D , end the EuroQol visual analog scale . All patients aged 18 - 67 years with a diagnosis of epilepsy , who had been admitted to or attended the outpatient clinic at a large county hospital 1987 - 1994 , received a comprehensive question naire . From 397 respondents , 82 patients were r and omly selected . Most of the 57 patients completing the study generally had well-controlled epilepsy , but were still on anti-epileptic medication . Mean age was 44 years . Fourty-one percent were male and 59 % female . The result ing utility weights differed considerably between the measures , both with regard to central tendency and dispersion . Median utility scores : EuroQol visual analog scale 0.75 , 15D 0.90 , TTO 0.98 , SG 0.99 . There was a good association between the EuroQol rating scale and the 15D , and a moderate association between SG and TTO . These preference instruments measure different aspects of health-related quality of life and thus yield different results . Caution should be taken when interpreting cost-utility studies , as results will depend on the choice of utility instrument",
"This paper outlines a model for valuing the benefits of antenatal screening based on the analysis of individual decision making with respect to consequent diagnostic test ing . Central to the model is the idea that the benefits of screening can be measured by valuing the improved information generated from screening . The model is developed in the context of antenatal carrier screening for cystic fibrosis ( CF ) . Benefits are as sessed by surveying women in the general population in order to establish their pref erences for two alternative methods of CF carrier screening — stepwise and couple screening . Preferences are elicited using st and ard-gamble questions in which women from a population -based r and om sample are asked to trade off risk of fetal loss with improved information from diagnostic testing . A series of st and ard-gamble questions is employed to elicit utility values for each of the possible information outcomes from screening . The expected utilities of both screening methods are calculated at both individual and group levels . The results suggest that the use of individual decision making with respect to diagnostic testing as a means of valuing the benefits of screen ing may have wide applications . Key words : benefits ; antenatal screening ; information ; st and ard gamble ; expected utility . ( Med Decis Making 1996;16:161 - 168",
"The significance of sub clinical thiamine deficiency in the elderly was determined by assessing response to thiamine supplementation in a r and omized double-blind , placebo-controlled trial . Thirty-five of 222 people aged > or = 65 y had two concentrations of erythrocyte thiamine pyrophosphate ( TPP ) Both groups were r and omly assigned in a double-blind trial to oral thiamine ( 10 mg/d ) or a placebo . All subjects r and omly assigned to receive thiamine showed increases in TPP concentrations compared with control subjects . Only the subjects with persistently low TPP concentrations showed subjective benefits from treatment with improvements in quality of life ( measured on a visual analogue scale ; P = 0.02 ) and decreases in systolic blood pressure ( P = 0.05 ) and weight ( P placebo . There was a trend toward benefits in sleep and energy ( P = 0.07 ) . We conclude that a low TPP concentration on two occasions is a better predictor of response to treatment than an isolated measurement . Quality of life was enhanced by providing thiamine supplements . Blood pressure and weight were lower after thiamine supplementation",
"The Beaver Dam Health Outcomes Study ( BDHOS ) is an ongoing longitudinal cohort study of health status and health-related quality of life for a r and om sample of adults ( age range at interview was 45 to 89 years ; mean = 64.1 , SD = 10.8 ) in a community population . In a face-to-face interview lasting approximately an hour , each participant responds to several batteries of questions . Included are a history of chronic medical conditions , current medi cations , and past surgeries ; the SF-36 ( a general health-status question naire ) ; the Quality of Well-being index ; self-rated health status on a five-point scale from \" excellent \" to \" poor \" ; and evaluation of current health using the method of time tradeoffs . The authors present results from 1,356 interviews on these four principal measures , reporting mean scores by sex , by age , and for persons reporting being affected by various medical conditions . They believe data from the BDHOS will provide research ers and policy makers a reference col lection of vital statistics for health-related quality of life . Additionally , the data provide a way to compare results from studies that utilize different indices from among the four principal measures of the BDHOS . Key words : health status ; quality of life ( health-related ) ; population study ; cohort study . ( Med Decis Making 1993;13:89 - 102",
"To gain a complete picture of a child 's health-status , measurement of health-related quality of life ( HRQL ) is necessary . Since parents do not accurately perceive children 's HRQL , information must be obtained from the children themselves . The aim of this study was to determine the minimum age and reading skills required by children to complete competently the Paediatric Asthma Quality of Life Question naire ( PAQLQ ) , the Health Utilities Index ( HUI ) , the Feeling Thermometer and the St and ard Gamble , and to evaluate the validity of each for measuring HRQL in children with asthma . Fifty two children ( age 7 - 17 yrs ) with symptomatic asthma participated in a 9 week single cohort study with HRQL and clinical asthma control assessed every 4 weeks . All children provided very reliable data for the PAQLQ and the HUI but they needed > or = grade 6 reading skills to complete the St and ard Gamble and > or = grade 2 skills for the Feeling Thermometer . In those children who were able to provide reliable data , the PAQLQ had the best discriminative and evaluative measurement properties , followed closely by the Feeling Thermometer . Measurement properties in the St and ard Gamble were weaker and although the HUI was very reliable it was not actually measuring asthma-specific HRQL . The Paediatric Asthma Quality of Life Question naire may be used with confidence in clinical studies and practice to provide a profile of children 's day-to-day experiences . In those children with adequate skills to complete the test reliably , the Feeling Thermometer provides a good estimate of the value that children place on their asthma health status",
"OBJECTIVE : To examine the long-term benefits and safety of aerobic training in patients with chronic heart failure . DESIGN : Non-r and omised control trial with 52 weeks follow up . SETTING : Outpatient cardiac rehabilitation referral centre . PATIENTS : Patients with compensated chronic heart failure ( mean ( SD ) age 62 ( 6 ) years , New York Heart Association stage III , initial resting ejection fraction 22 (7)% ) . Experimental group of 17 men , 4 women ; control group 8 men , 1 woman . INTERVENTIONS : Experimental group : progressive , supervised aerobic walking programme for 52 weeks . Control group : st and ard medical treatment . MAIN OUTCOME MEASURES : Six-minute walk distance , progressive cycle ergometer test to subjective exhaustion , disease-specific quality of life question naire , and st and ard gamble test , all measured at entry , 4 , 8 , 12 , 16 , 26 , and 52 weeks . RESULTS : Control data showed no changes except a small trend to improved emotional function ( P = 0.02 at 12 weeks only ) . Fifteen of the 21 patients completed all 52 weeks of aerobic training ; two withdrew for non-cardiac reasons ( 16 , 52 weeks ) . Three were withdrawn because of worsening cardiac failure unrelated to their exercise participation ( 4 , 4 , 8 weeks ) , and one had a non-fatal cardiac arrest while shopping ( 16 weeks ) . Gains of cardiorespiratory function plateaued at 16 - 26 weeks , with 10 - 15 % improvement in six-minute walk , peak power output , and peak oxygen intake linked to gains in oxygen pulse and ventilatory threshold and reductions in resting heart rate . Marked improvements in quality of life followed a parallel course . CONCLUSIONS : Aerobic training is safe and beneficial in compensated chronic heart failure . Gains in aerobic function and quality of life persisted over a programme lasting 52 weeks",
"This study examined the relationship between health utility and psychometric health status measures . Utility scores derived by st and ard gamble and categorical rating methods were also compared to determine if they produce equivalent preference scales . Health status and utility was assessed in 73 chronic renal disease patients with anemia ( hematocrit less than or equal to 30 ) participating in a 48-week clinical study . Patient preferences for current health and three hypothetical states were assessed using st and ard gamble and categorical rating procedures . St and ard gamble utility was related to home management ( P less than .05 ) ; categorical rating utility was related to home management ( P less than .05 ) , energy ( P less than .05 ) , alertness behavior ( P less than .05 ) , social interaction ( P less than .05 ) , and life satisfaction scale scores ( P less than .05 ) . Only 25 - 27 % of the variance in utility scores was explained by the health status measures . St and ard gamble utilities were consistently higher than categorical rating values for end-stage renal disease with hemodialysis ( P less than .0001 ) and severe anemia requiring blood transfusions ( P less than .0001 ) . Patient preferences for current health may be influenced in part by their functional status and well-being , risk aversion or risk-taking attitudes , and the cognitive evaluation processes involved in making judgments necessary for the measurement task , as well as their actual preferences",
"To estimate patient preferences for gallstone-related treatments and outcomes , and assess how preferences vary by patient characteristics and scaling technique , the authors r and omly assigned 40 patients without gallstones to interviews based on a rating scale ( n = 22 ) and a st and ard gamble ( n = 18 ) . The patients assigned preference values ( possible values 0 to 1 ) to open cholecystectomy ( mean 0.45 by rating scale , 0.78 by st and ard gamble ) , laparoscopic cholecystectomy ( 0.71 , 0.91 ) , extracorporeal shock-wave lithotripsy ( 0.77 , 0.89 ) , acute cholecystitis ( 0.36 , 0.77 ) , lifetime biliary colic ( 0.41 , 0.71 ) , postcholecystectomy syn drome ( 0.43 , 0.79 ) , asymptomatic stone necessitating treatment with bile acids ( 0.76 , 0.96 ) , and surgical scar ( 0.79 , 0.998 ) . Preferences varied little by age , gender , or race . St and ard gamble values were highly correlated with , but significantly greater than , rating scale values . The authors conclude that patients ' preferences for gallstone-related conditions generally are significantly less than one , and differ markedly by the scaling technique used to derive them . These results should be considered when patient preferences are incorporated into analyses of gallstone treatments . Key words : patient preference values ; rating scale ; stan dard gamble ; gallstones ; cholecystectomy ; lithotripsy . ( Med Decis Making 1994;14:307- 314",
"& NA ; Endoscopic carpal tunnel release is a controversial procedure used in the treatment of carpal tunnel syndrome . Although endoscopic carpal tunnel release is associated with less incisional pain and faster recovery time than the open carpal tunnel release , opponents of endoscopic carpal tunnel release suggest that its benefits are outweighed by its higher complication rates from median nerve transection and transient numbness of the fingers . Because of the huge economic and social impact of carpal tunnel syndrome in this country , we performed a cost‐effectiveness analysis comparing endoscopic carpal tunnel release and open carpal tunnel release using guidelines established by the Panel on Cost‐Effectiveness in Health and Medicine of the U.S. Public Health Service . A decision analytic model was used to measure differences in cost and effectiveness — expressed as quality ‐adjusted life‐years (QALYs)—between endoscopic carpal tunnel release and open carpal tunnel release . The societal perspective was chosen , and probabilities for various outcomes for the two procedures were obtained from published r and omized‐controlled trials . Cost data were derived from the Medicare Re source ‐Based Relative Value Units published in the Federal Register . QALYs were obtained from two groups of health care providers using a utility‐ assessment question naire . Using probabilities for various outcomes from the two published r and omized‐controlled trials comparing endoscopic carpal tunnel release and open carpal tunnel release , we constructed a decision tree to derive both the cost and the QALYs for the two procedures . The incremental cost difference between endoscopic carpal tunnel release and open carpal tunnel release was $ 46 , using Medicare cost and probabilities of various outcomes derived from a study by Brown et al. in 1993 . We calculated QALYs for five age groups—25 , 35 , 45 , 55 , 65—assuming a life expectancy of 75 years . The marginal effectiveness ( QALY of endoscopic carpal tunnel release minus QALY of open carpal tunnel release ) ranged from 0.235 QALY for the 25‐year‐old age group to 0.066 QALY for the 65‐year‐old age group , giving a cost‐effectiveness ratio of $ 195/QALY and $ 693/QALY , respectively . When compared with other accepted medical interventions such as breast cancer screening ( $ 4836/QALY ) and exercise to prevent coronary heart disease ( $ 13,508/QALY ) , endoscopic carpal tunnel release seems to be cost‐effective . However , our sensitivity analysis indicated that the costeffectiveness ratio was very sensitive to a major complication such as median nerve injury . For endoscopic carpal tunnel release to be a cost‐effective procedure , the incidence of median nerve injury must be one percentage point less for endoscopic carpal tunnel release than for open carpal tunnel release . Based on the data from the r and omized‐controlled trials , endoscopic carpal tunnel release seems to be a cost‐effective procedure ; however , before it can be recommended , greater emphasis must be given to the training of surgeons in this new technique , so that major complications such as median nerve injuries can be avoided . In addition , future studies must better define the actual incidence of nerve injuries for both endoscopic carpal tunnel release and open carpal tunnel release in the community setting . ( Plast . Reconstr . Surg . 102 : 1089 , 1998 .",
"The development of methods to measure willingness to pay ( WTP ) has renewed interest in cost-benefit analysis ( CBA ) for the economic evaluation of health care programs . The authors studied the construct validity and test-retest reliability of WTP as a measure of health state preferences in a survey of 102 persons ( mean age 62 years ; 54 % male ) who had chronic lung disease ( forced expiratory volume Interview measurements in cluded self-reported symptoms , the oxygen-cost diagram for dyspnea , Short-Form 36 for general health status , rating scale and st and ard gamble for value and utility of current health state relative to death and healthy lung functioning , and WTP for a hypothetical intervention offering a 99 % chance of healthy lung functioning and a 1 % chance of death . WTP was elicited by a simple bidding game . To test for starting-point bias , the respondents were r and omly assigned to one of five starting bids . All health status and preference measurements except WTP ( controlling for income ) showed significant ( p WTP was significantly ( p = 0.01 ) associ ated with household income , but other health status and preference measures were not . The measure most highly correlated with WTP was st and ard gamble ( r = -0.46 ) . There was no association between starting bid and mean WTP adjusted for income and health status . The test-retest reliability of WTP was acceptable ( r = 0.66 ) but lower than that for the st and ard gamble ( r = 0.82 ) . It is concluded that : 1 ) large variation in WTP responses may compromise this measure 's discriminant validity ; 2 ) there is some evidence of convergent validity for WTP with preferences measured by st and ard gamble ; 3 ) there was no evidence of starting point bias ; 4 ) the test-retest reliability of WTP is comparable to those of other preference measures . Key words : willingness to pay ; health state preferences ; economics . ( Med Decis Making 1994;14:289 - 297",
"OBJECTIVE Assessment of the cost-effectiveness and cost-utility of early intervention in rheumatoid arthritis ( RA ) patients , with combined step-down prednisolone , methotrexate and sulphasalazine , compared to sulphasalazine alone . METHODS Multicentre 56 week r and omized double-blind trial with full economic analysis of direct costs and utility analysis with rating scale and st and ard gamble measurement techniques . RESULTS The combined-treatment group included 76 patients and the sulphasalazine group 78 patients . The mean total costs per patient in the first 56 weeks of follow-up were $ 5519 for combined treatment and $ 6511 for treatment with sulphasalazine alone ( P = 0.37 ) . Out-patient care , in-patient care and non-health care each contributed about one-third to the total costs . The combined-treatment group appeared to generate savings in the length of hospital stay for RA , non- protocol drugs and costs of home help , but comparisons were not statistically significant . Protocol drugs and monitoring were slightly more expensive in the combined-treatment group . Clinical , radiographic and functional outcomes significantly favoured combined treatment at week 28 ( radiography also at week 56 ) . Utility scores also favoured combined treatment . CONCLUSION Combined treatment is cost-effective due to enhanced efficacy at lower or equal direct costs",
"Quality of life measures are increasingly used as important efficacy endpoints in studies of drugs for asthma . The purpose of this study was to assess both the sensitivity to change and the construct validity of four different quality of life instruments in patients with asthma . In a double-blind , parallel group study , 120 moderate asthma patients , aged between 18 - 70 yrs , received either inhaled salmeterol 50 micrograms b.i.d . or inhaled salbutamol 400 micrograms b.i.d . In addition to respiratory outcomes , quality of life was measured at a 6 weeks follow-up using : 1 ) Asthma Quality of Life Question naire ( AQLQ ) ; 2 ) Living With Asthma Question naire ( LWAQ ) ; 3 ) Sickness Impact Profile ( SIP ) ; 4 ) Rating Scale ( RS ) ; and St and ard Gamble ( SG ) utilities . Salmeterol led to significant improvements over salbutamol on virtually all clinical outcomes . Although all the quality of life instruments showed the same trend in favour of salmeterol , only the AQLQ and RS utilities showed significantly greater improvement on salmeterol than on salbutamol . Except for the AQLQ , the correlation between change in lung function and change in quality of life was generally low . Whereas , the AQLQ correlated well with the patient 's overall assessment of efficacy ( r = 0.64 ) , the LWAQ , SIP and utilities failed to show such a correlation . The AQLQ showed the best correlation with symptom scores . The cross-sectional correlation between the AQLQ and the LWAQ was 0.73 , whereas the longitudinal correlation was only 0.29 . The SG generally showed poor correlation with other measures , including the RS . In conclusion , patients given salmeterol showed a greater improvement in quality of life compared to patients given salbutamol . Of the disease-specific question naires the Asthma Quality of Life Question naire was found to be more responsive to change than the Living With Asthma Question naire and showed greater validity . Of the generic instruments , the rating scale utilities were most responsive . The St and ard Gamble showed poor correlation with other measures",
"STUDY OBJECTIVE --The aim was to assess patients willingness to accept mortal risk in the drug treatment of chronic rheumatic disease . DESIGN --A non-r and om sample of consecutive patients were interviewed with a st and ardised survey instrument . SETTING --The study took place in the Royal National Hospital for Rheumatic Diseases , Bath , UK . PATIENTS --100 consecutive in- and out- patients aged 65 or less were interviewed , 50 with rheumatoid arthritis and 50 with ankylosing spondylitis . Mean age was 48 years with mean disease duration of 14 years . The rheumatoid arthritis group was mainly female ( 84 % ) , v 26 % in the ankylosing spondylitis group . MEASUREMENTS AND MAIN RESULTS --Risk preferences were elicited using the method of st and ard gamble in the context of a hypothetical new drug . Patients indicated the maximum percentage probability of mortality they regarded as acceptable to achieve four different levels of benefit : total cure ( 20.7 % ) , relief of pain ( 16.9 % ) , relief of stiffness ( 13.1 % ) , return to normal functioning ( 14.5 % ) . Rheumatoid arthritis patients displayed a higher ( p less than 0.05 ) willingness to accept risk than ankylosing spondylitis patients for all gambles except relief of stiffness . Analysis of variance indicated that willingness to accept risk decreases with the duration of disease and increases with reductions in self assessed health status . CONCLUSIONS --Evaluative methods such as st and ard gamble can elicit useful risk-benefit preference data from patients to assist those who manage clinical risks",
"In the st and ard gamble and time trade-off methods of health state utility assessment , a specified health state and an alternative are compared . This alternative can be framed in terms of a loss or a gain in reference to the first health state . In this paper , we test whether this framing affects the estimated health state utilities . The experiment was carried out on a group of pharmacy students , r and omly divided between the loss or gain version ( n = 182 ) . The None hypothesis of no difference between the loss and gain versions is rejected for the st and ard gamble method , but not for the time trade-off method",
"The current study uses utility analysis to assess economic and quality -of-life benefits of risperidone in patients with chronic schizophrenia . A retrospective analysis was performed on Positive and Negative Syndrome Symptoms ( PANSS ) data obtained from the published Canadian multicenter risperidone trial ( part of the North American trial ) . Cluster analysis applied to endpoint PANSS scores , including all patients ( N = 135 ) , identified three clusters representing 130 patients with mild , moderate , and severe symptomatology . A narrative health state profile was written for each cluster , and 100 psychiatric nurses from Washington , DC , were asked to assign preference ratings to each one using linear analog and st and ard gamble ( SG ) methods . Mean utility values ( confidence interval 95 % ) obtained from the SG ratings for the three health state profiles were 0.61 + /- 0.069 ( mild ) ; 0.36 + /- 0.073 ( moderate ) ; and 0.29 + /- 0.071 ( severe ) . The mild health state ( including the majority of risperidone 6 mg-treated patients ) was rated by nurses to have a 0.25 + /- 0.0501 greater utility than the moderate health state ( composed of the majority of haloperidol-treated patients ) . The results of these utility evaluations ( SG ) by the nurses were related to the clinical outcome for three of the six drug treatment groups ( N = 65 ) by multiplying the percentage of patients in each of the three clusters , both at baseline and end-point , who were receiving risperidone 6 mg/day , haloperidol , or placebo , by the utility value for the health state assigned to that cluster . The gain in utility for risperidone-treated patients was 2.6 times higher ( 0.125 ) compared with haloperidol-treated patients ( 0.049 ) , and 7 times higher compared with placebo ( -0.021 ) . After multiplying the gain in utility of each treatment by the remaining expected life span for men and women , it was found that risperidone-treated patients obtained more than twice as many quality -adjusted years as haloperidol patients . The incremental drug treatment cost divided by the incremental benefit of risperidone versus haloperidol was found to yield a favorable , generally accepted cost-utility ratio",
"An economic evaluation of a r and omized trial of cyclophosphamide , Adriamycin ( doxorubicin ; Adria Laboratories , Columbus , OH ) , and vincristine alone or alternating with etoposide ( VP-16 ) and cisplatin in extensive small-cell lung cancer ( SCLC ) was undertaken . A survival benefit of 1.6 months in favor of alternating chemotherapy was associated with an additional cost of $ 450 ( 1984 Canadian dollars ) per patient . This translated to a cost of $ 3,370 per year of life gained . Sensitivity analyses demonstrated that the cost-effectiveness ( CEA ) of alternating chemotherapy was greatest when treatment was given on an outpatient basis . The results of the evaluation were sensitive to hospitalization rates , but even the most unfavorable analyses revealed the CEA of alternating chemotherapy to be comparable to that of treatments of common nonmalignant diseases . It is concluded that the CEA of alternating chemotherapy for SCLC was favorable when compared with accepted treatments for nonmalignant diseases . The survival benefit seen with alternating chemotherapy was felt to be clinical ly significant and alternating chemotherapy is recommended as routine therapy for extensive SCLC",
"Abstract Objective : Lamotrigine as add-on treatment ( 500 mg per day ) is effective in patients with refractory epilepsy , but its high cost requires a pharmacoeconomic analysis . We conducted a retrospective lifetime cost – utility study in which clinical data were derived from a recent placebo-controlled clinical trial , cost-of-illness data were drawn from a previous ad-hoc study , and quality -of-life values were obtained by prospect ively interviewing a separate group of 81 patients referred to our institution with epilepsy . Results : Our analysis showed that chronic lamotrigine treatment implies an incremental lifetime cost of about $ 1 600 000 for every 100 patients . Incremental lifetime utility was around 40 quality -adjusted life-years ( QALYs ) for every 100 patients . On the basis of these data , adjunctive lamotrigine was estimated to cost approximately $ 41 000 per QALY gained . Sensitivity testing suggested a range of $ 25 000–$85 000 per QALY gained . Conclusion : Adjunctive lamotrigine ( 500 mg per day ) in refractory epilepsy seems to have a worse pharmacoeconomic profile than many pharmacological treatments commonly used in areas other than epilepsy . Further data are needed to determine if lamotrigine can be equally effective at lower ( and less costly ) daily doses which could markedly improve its pharmacoeconomic characteristics",
"Objective To compare the impact of endometrial resection and abdominal hysterectomy on a range of health outcomes and health service costs , based on longer term follow up of patients r and omised to a clinical trial",
"To assess the health values of patients infected with human immunodeficiency virus ( HIV ) and examine the relationships between their health values and health status at two points in time , the authors sought to determine whether patients ' physical and mental health statuses were good predictors of how they valued their current state of health . One hundred thirty-nine patients with various stages of HIV infection were interviewed in a prospect i ve cohort study based in a primary care practice of a community-based teaching hospital . Patients were interviewed twice at 6-month intervals using three health value measures --the time trade off , rating scale , and Quality of Well-being Scale-- and three health status measures : the 18-item Mental Health Inventory , the Dyspnea-Fatigue Index , and the Medical Outcomes Study SF-36 Health Survey . The health status of HIV-infected patients was compromised and , with the exception of mental health , generally was worse among patients with more advanced HIV-infection . Rating scale and Quality of Well-being Scale scores were related inversely to disease stage , but time-trade off scores generally were higher regardless of disease stage . Health value measures showed moderate relationships with measures of physical functioning ( r = 0.34 - 0.68 ) but only a fair relationship with mental health ( r = 0.00 - 0.48 ) . The health status of HIV-infected patients who remained asymptomatic or remained symptomatic but without developing acquired immunodeficiency syndrome ( AIDS ) changed little over 6 months , whereas the health status of patients with AIDS and of patients manifesting progression of HIV-infection deteriorated over time . In contrast , health values , particularly time-tradeoff scores , remained stable even in the face of changes in health status and disease progression . With the exception of mental health , the impact of HIV infection on health status tends to parallel the clinical stage of disease . Health values of HIV-infected patients , however , generally are high and correlate better with physical functioning than with mental health",
"OBJECTIVE To determine the value of diagnostic information to patients with suspected multiple sclerosis ( MS ) . Because treatment choices would be only minimally affected by earlier diagnosis for most patients with this clinical problem , this study assessed the \" nondecisional \" value of diagnosis . DESIGN Prospect i ve survey of patients before and after diagnostic workup , including imaging with magnetic resonance scanning . We assessed the effect of diagnostic information on patients ' sense of well-being , as well as direct measures of the utility of information ( using time trade-off and willingness-to-pay techniques ) . SETTING Patients referred from primary care practice s for diagnostic workup for suspected MS to neurology clinics and practice s. PATIENTS Sixty-eight individuals , mean age 37.5 years , 53 female and 15 male . Thirty-one patients were classified as having \" probable MS , \" and 37 were classified as having \" possible MS \" by the examining neurologist before workup . MEASUREMENTS Present and future health perception , uncertainty about diagnosis-prognosis , and level of anxiety . Willingness to pay for diagnostic information , quality of life as measured by the time trade-off technique , and psychological state of the patient before and after diagnosis . RESULTS Diagnostic uncertainty fell significantly as a result of the diagnostic workup . Most patients ( 59/62 ) said that they were better off having received diagnostic information . Although anxiety seemed to be reduced by testing , overall anxiety levels did not decrease as much as anticipated . Patients also became less optimistic about their future health after testing . On average , patients were willing to forgo 4.5 quality -adjusted life days to receive an earlier diagnosis and their quality of life after diagnosis improved slightly . Subgroups of patients differed in their response to diagnostic information . Those in whom no definitive diagnosis emerged tend to be more anxious rather than being reassured by the \" negative \" workup . Individuals with \" positive \" workups became less anxious and expressed favorable feelings about the diagnostic workup even though they often faced a chronic disease . CONCLUSIONS Overall , the diagnostic workup seemed to benefit patients and improve their sense of well-being . However , whether the effects were beneficial or not depended on the results of the diagnostic workup itself . In clinical practice the decision to undergo testing in situations in which definitive treatment is unavailable should be individualized . The potential for negative as well as positive consequences should be recognized",
"Although there are extensive clinical evaluations of cardiac rehabilitation after acute myocardial infa rct ion ( AMI ) , no full economic evaluation is available . Patients with AMI and mild to moderate anxiety or depression , or both , while still in hospital were r and omized to either an 8-week rehabilitation intervention ( n = 99 ) or usual care ( n = 102 ) . Comprehensive costs and health-related quality of life , measured with the time trade-off preference score , were obtained in a 12-month trial , and together with survival data derived from published meta-analyses , cost-utility and cost-effectiveness of early cardiac rehabilitation were estimated . The best estimate of the incremental net direct 12-month costs for patients r and omized to rehabilitation was $ 480 ( United States , 1991)/patient . During 1-year follow-up , rehabilitation patients had fewer \" other rehabilitation visits \" ( p quality -adjusted life-year more than did the group with usual care . The cost-utility ratio was $ 9,200/ quality -adjusted life-year gained with cardiac rehabilitation during the year of follow-up . This economic evaluation of cardiac rehabilitation does not consider the important distinctions between affordability and worth of alternative health-care services . The data provide evidence that brief cardiac rehabilitation initiated soon after AMI for patients with mild to moderate anxiety or depression , or both , is an efficient use of health-care re sources and may be economically justified",
"Left ventricular hypertrophy ( LVH ) is a major risk factor for cardiovascular morbidity in hypertensive patients . The effects of diuretics on LVH have raised controversies , but recent studies suggest that diuretics are able to reduce LVH in hypertensive patients , mainly through a reduction in ventricular diameter . The present multicenter open study was design ed to test the effects of indapamide , a widely used nonthiazide diuretic , on LVH in patients with essential hypertension . Patients had to have mild-to-moderate essential hypertension ( supine diastolic blood pressure [ sDBP ] 95 to 115 mm Hg ) with echocardiographic evidence of LVH ( left ventricular mass index [ LVMI ] > 130 g/m2 for men and > 110 g/m2 for women ) . After a 2 week placebo run-in period , eligible patients underwent a 6 month treatment with 2.5 mg indapamide daily . All echograms were performed by the same investigator before and after 6 months of indapamide . Clinical and biological acceptability and quality of life ( visual analog scale ) were also studied . One hundred and thirty patients were included in the study and 112 completed the trial . Indapamide induced a significant reduction i systolic and diastolic blood pressures . Indapamide induced a marked reduction in posterior wall thickness ( from 12.1 + /- 2.0 to 11.2 + /- 1.6 mm ) and in interventricular wall thickness ( from 12.7 + /- 1.7 to 11.8 + /- 1.9 mm ; each P left ventricular diameter ( P = .049 ) . This result ed in a 13 % reduction in LVMI ( from 161.9 + /- 37.9 to 140.7 + /- 33.8 g/m2 , P Left ventricular fractional shortening remained unchanged . There was no significant relation between changes in LVMI and changes in systolic , diastolic , or mean blood pressure . No significant adverse clinical or biological effects were reported during the study . The increased score of the visual analog scale indicated that overall well-being was improved ( P indapamide , in addition to blood pressure control , is able to reduce LVH . This effect was achieved mainly through a reduction in wall thicknesses rather than in internal cavity diameter",
"The purpose of this study was to compare the performance of measures of health-related quality of life in a r and omized controlled trial of respiratory rehabilitation versus conventional community care for patients with chronic airflow limitation . The study included 89 stable patients with moderate to severe chronic airflow limitation with measurement of health status at 12 , 18 , and 24 weeks . Outcomes included two disease-specific ( the Oxygen Cost Diagram and the Chronic Respiratory Question naire [ CRQ ] ) measures , a generic health profile ( the Sickness Impact Profile [ SIP ] ) , and two utility measures ( the St and ard Gamble and the Quality of Well-Being index [ QWB ] ) . Of the measures , only the four domains of the CRQ ( dyspnea , fatigue , mastery , and emotional function ) showed statistically significant differences ( P CRQ and change in other relevant measures , including the 6-minute walk test and global ratings of change in dyspnea , fatigue , and emotional function were generally weak to moderate ( from 0.19 to 0.51 ) . All correlations between change in the QWB , SIP , and St and ard Gamble and other measures were very weak or weak ( up to 0.30 ) . Correlation between change in the three generic measures were all very weak ( health-related quality of life in controlled trials in chronic diseases , they risk misleading conclusions about the effect of treatments on health status",
"The effect of recombinant human erythropoietin ( EPO ) on the quality of life and exercise capacity of 118 hemodialysis patients was assessed in a r and omized , double-masked placebo-controlled trial . Patients were r and omized into three groups : 1 ) placebo , 2 ) EPO to achieve a hemoglobin of 95 - 110 g/L and 3 ) EPO to achieve a hemoglobin of 115 - 130 g/L. Patients were followed for six months . Quality of life was assessed using a disease-specific measure [ the Kidney Disease Question naire ( KDQ ) ] and two generic measures [ Sickness Impact Profile ( SIP ) and the Time Trade OFF ( TTO ) ] . The KDQ contains five dimensions . Functional capacity was assessed with a Six-Minute Walk test ( SMW ) and an Exercise Stress Test ( EST ) . The mean hemoglobin at six months was 74 , 102 , and 117 gm/l in groups one , two and three , respectively . There was a marked improvement in quality of life with EPO therapy , but no difference between groups 2 and 3 . The outcome measure that was the most responsive to change was the KDQ ( P less than .001 for the fatigue and physical symptoms dimensions ) . The aggregate global ( P less than .02 ) and physical ( P = .005 ) scores of the SIP improved with EPO therapy , the psychosocial score did not . There was no improvement in the TTO . There was an improvement in the EST ( P = .02 ) but not in the SMW . The reproducibility of the outcome measures in placebo-treated patients varied between 0.80 and 0.98 ( intra-class correlation coefficient ) . The correlation among the outcome measures at six months was statistically significant in most cases , as was the correlation of change scores between baseline and six months",
"Each year , approximately 4300 people in the United States receive a diagnosis of chronic myelogenous leukemia ( CML ) at a median age of 50 years [ 1 ] . Median survival is 3 to 6 years , and death usually results from progression to acute leukemia [ 2 ] . Although several studies [ 3 - 6 ] have shown improved survival with the use of certain chemotherapeutic agents , bone marrow transplantation is the only proven curative therapy . For patients younger than 50 years of age who have an HLA-identical related donor , transplantation within the first year after diagnosis is recommended [ 7 - 11 ] . The use of HLA-compatible unrelated donor transplantation has been advocated for patients without a related donor , but this recommendation is controversial because unrelated donor transplantation is associated with high morbidity and mortality rates [ 12 , 13 ] . In contrast to patients with many other diseases for which transplantation is considered , patients with chronic-phase CML generally feel well , continue to work , and require few medications or medical interventions . Treatment is necessary only to control symptoms and blood counts . Hydroxyurea is an inexpensive , relatively nontoxic , effective oral medication . Interferon- is more expensive , is toxic , and must be administered by subcutaneous injection , but it is also effective and may prolong survival . Patients may be stratified into broad prognostic groups on the basis of their clinical characteristics at the time of diagnosis [ 2 , 14 - 19 ] . However , no clinical features accurately predict an individual patient 's progression to acute leukemia [ 20 ] . Once progression occurs , both st and ard chemotherapy and transplantation have minimal success in prolonging survival [ 7 , 21 - 24 ] . The process of deciding whether and when to undergo unrelated donor transplantation is complicated by the extreme unpredictability of outcomes . The risk for unsalvageable progression of CML must be weighed against the substantial risk for illness and death that may result from the acute and chronic side effects of transplantation [ 25 ] . Some physicians advise waiting until disease progression is evident or interferon- therapy has failed before proceeding to transplantation , accepting the risks of the delay in exchange for the possibility of postponing or avoiding transplantation . Others advise performing a transplantation as soon as possible to afford the best chance of a successful transplantation outcome and long-term survival . We used decision analytic techniques to combine historical data on risk for CML progression with data from the International Bone Marrow Transplant Registry ( IBMTR ) and the National Marrow Donor Program ( NMDP ) on transplantation outcomes . A Markov model [ 26 ] was constructed to allow comparison of the treatment options available to a patient with a new diagnosis of chronic-phase CML . This approach allows the simultaneous and quantitative consideration of patient age , quality of life , risk aversion , risk for CML progression , and likelihood of transplantation success to help guide decision making . Methods Markov Model A Markov model is an analytic structure that tracks the clinical events occurring in a hypothetical cohort of patients in various scenarios . We constructed a model to analyze the decision faced by a patient with a new diagnosis of chronic-phase CML who is considering having unrelated donor bone marrow transplantation . Five strategies were compared : no transplantation ; transplantation within the first year ; transplantation 1 to 2 years after diagnosis ; transplantation delayed until 2 to 3 years after diagnosis ; and transplantation delayed until more than 3 years after diagnosis . At any time point , the model considered a patient to be in one of the following clinical states : alive with chronic-phase CML ; alive without chronic graft-versus-host disease after transplantation ; alive with chronic graft-versus-host disease after transplantation ; or dead from progressive CML , complications of transplantation , or other causes ( Figure 1 ) . Time spent in each state was adjusted for the quality of life experienced while in that state , and a discount factor was applied . Using the model , we calculated discounted , quality -adjusted life expectancy for each strategy , considering competing risks for illness and death from CML and transplantation . A cycle length of 6 months was chosen to match the available clinical data . All analyses were done with DATA ( TreeAge Software , Inc. , Williamstown , Massachusetts ) , a decision analysis program . Figure 1 . Structure of the Markov model . Data Sources Data from the medical literature , transplant registries , and physician assessment s were used in the model . Prognosis of Patients with Chronic Myelogenous Leukemia Who Do Not Receive Transplants The life expectancy of patients with CML who do not undergo transplantation was calculated by using the survival curves from six published studies , including interferon trials and prognostic staging studies [ 4 - 615 , 19 , 26 , 27 ] . After published information ended , the survival curves were extrapolated by using a function fitted to the clinical data until the entire cohort had died . Life expectancy estimates for 35-year-old patients with CML who do not undergo transplantation are shown in Table 1 . Similar analyses were performed for 25- and 45-year-old patients ( data not shown ) . For the 15 survival curves analyzed , the mean undiscounted expected survival was 5.15 years ( range , 3.66 to 7.58 years ) . A survival curve derived from patients with intermediate-prognosis CML ( Table 1 , rank 6 ) who had an expected survival of 5.31 years was chosen as the baseline curve [ 15 ] . Sensitivity analysis was performed by using data from the best ( Table 1 , rank 1 ) [ 15 ] and worst ( Table 1 , rank 15 ) [ 19 ] survival curves to illustrate results for patients with the best and worst prognoses . The life expectancy of the Sokal low-risk group ( Table 1 , rank 1 ) is superior to that in the groups r and omly assigned to receive interferon in the major studies [ 4 - 6 , 27 ] and thus was chosen to represent the patients with the best prognosis . Table 1 . Life Expectancy of a 35-Year-Old Patient with Chronic Myelogenous Leukemia Who Does Not Have Bone Marrow Transplantation , Based on Published Studies Outcomes of Unrelated Donor Bone Marrow Transplantation Data from 778 unrelated donor transplantations performed between 1987 and 1994 for chronic-phase CML were provided by the IBMTR and the NMDP . To eliminate overlap from patients reported to both registries , we combined patients reported to the NMDP ( transplantations done in the United States ; n = 465 ) with those reported to the IBMTR ( transplantations done outside of the United States ; n = 313 ) . The final population included both 5/6 and 6/6 serologic matches . Each Kaplan-Meier curve is based on data from time of transplantation to death , and a separate Kaplan-Meier curve was calculated for each stratum . Kaplan-Meier survival curves through 5 years after transplantation were stratified by patient age ( 15 to 29 years of age , 30 to 39 years of age , 40 years of age ) and time from diagnosis to transplantation ( 3 years ) to generate 12 strata containing 40 to 125 patients each . Finer stratification was not possible because of the size of the entire population . Fifty-eight percent of patients were male , median age at the time of transplantation was 36 years , and median time from diagnosis to transplantation was 20 months . No modeling assumptions were made for time periods for which clinical data were available . Data were not stratified by CML prognostic groups because these groups are not predictive once a patient proceeds to transplantation ( [ 28 ] ; IBMTR . Unpublished data ) . When registry data ended , we estimated a 2 % annual excess mortality rate for patients who had transplantation and did not have chronic graft-versus-host disease [ 10 ] and a 3 % annual excess mortality rate for patients who had chronic graft-versus-host disease . These figures were extrapolated from analyses of large related-donor cohorts and are due to late relapses and treatment-related death [ 10 , 29 , 30 ] . The incidence of chronic graft-versus-host disease in this cohort was 55 % to 100 % . On the basis of published literature [ 25 ] , we modeled a 59 % cumulative incidence of this complication and then performed sensitivity analyses . Patients with chronic graft-versus-host disease tend to have worse quality of life and decreased survival [ 28 , 29 ] . Although chronic graft-versus-host disease often resolves in practice , our model considers patients with this complication to have ongoing compromised quality of life and increased mortality . This assumption causes underestimation of the value of transplantation . Adjustments for Quality of Life Estimates of the quality of life in different health states ( utilities ) were derived from st and ard gamble questions [ 31 ] posed to 12 physicians who were familiar with transplantation outcomes . This technique assigns a utility between 0.0 ( death ) and 1.0 ( perfect health ) to quality of life by identifying the maximum gamble between perfect health and death that a person is willing to accept to avoid a compromised health state . For example , a utility of 0.9 means that a person gives equal value to remaining in a compromised health state and accepting a gamble with a 90 % chance of perfect health and a 10 % chance of immediate death . The mean utility for life without chronic graft-versus-host disease after transplantation was 0.979 ( range , 0.95 to 1.0 ) , and the mean utility for life with chronic graft-versus-host disease after transplantation was 0.9 ( range , 0.75 to 1.0 ) . These estimates were tested by using sensitivity analyses . Time Discount Rate : Time Preference and Risk Aversion The value of future years of life relative to the present were discounted on the basis of two assumptions . Time preference for life-years assumes that persons value present time more than they do distant time . Risk aversion",
"OBJECTIVE To compare in patients with ankylosing spondylitis ( AS ) utilities derived by rating scale and st and ard gamble method , to relate these values to other outcome measures , and to assess the sensitivity to change of utilities relative to changes in other outcomes . METHODS Patients with AS were r and omly allocated to either weekly sessions of supervised group physical therapy for a period of 9 months or daily exercises at home . Analysis was restricted to the 59 patients who completed the Maastricht Utility Measurement Question naire ( MUMQ ) at baseline and after 9 months ' followup and who were seen by the same interviewer . Reliability was assessed by intraclass correlation coefficient and change scores for marker states of disease . Construct validity was evaluated by correlation and multiple regression of baseline values with a variety of disease outcomes ( pain and stiffness , patient 's and physician 's global assessment , Sickness Impact Profile , Health Assessment Question naire for the Spondyloarthropathies , Arthritis Impact Measurement Scale , functional , articular , and enthesis indices and spinal mobility measures ) . Sensitivity to change was assessed against changes in these outcome measures at followup . RESULTS The test-retest intraclass correlation coefficients for patient utilities were 0.95 ( rating scale ) and 0.79 ( st and ard gamble ) , and for the marker state of mild disease 0.70 ( rating scale ) and 0.77 ( st and ard gamble ) . A multiple regression analysis with the baseline rating scale or st and ard gamble utilities as dependent variable showed that patient 's global assessment explained 59 and 11 % of the total variance respectively . By multiple regression analysis 10 % of the variance of change in rating scale utilities was explained by changes of patient 's global assessment . In contrast , variance in change in st and ard gamble utilities was not explained by changes in other disease outcomes . CONCLUSION Findings obtained by rating scale and st and ard gamble differ considerably . St and ard gamble utilities seem to address different aspects of health status than do rating scale utilities and more traditional outcomes . Utility measurement is sensitive to the method chosen to elicit patient well being",
"BACKGROUND Stroke is the most feared complication of thrombolysis for acute myocardial infa rct ion because of the result ing mortality and disability . We analyzed the incidence , timing , and outcomes of stroke in an international trial . METHODS AND RESULTS Patients were r and omly assigned to one of four thrombolytic strategies . Neurological events were confirmed clinical ly and anatomically and were adjudicated by a blinded committee . Stroke survivors , categorized by residual deficit and disability , assessed their quality of life with a time trade-off technique . Multivariable regression identified patient characteristics associated with intracranial hemorrhage . Over-all , 1.4 % of the patients had a stroke ( 93 % anatomic documentation ) . The risk ranged from 1.19 % with streptokinase/subcutaneous heparin therapy to 1.64 % with combination thrombolytic therapy ( P = .007 ) . Primary intracranial hemorrhage rates ranged from 0.46 % with streptokinase/subcutaneous heparin to 0.88 % with combination therapy ( P died and 25 % were disabled versus 17 % dead and 40 % disabled with nonhemorrhagic infa rct ions . Patients with moderate or severe residual deficits showed significantly decreased quality of life . Advanced age , lower weight , prior cerebrovascular disease or hypertension , systolic and diastolic blood pressures , r and omization to tissue plasminogen activator , and an interaction between age and hypertension were significant predictors of intracranial hemorrhage . CONCLUSIONS Stroke remains a rare but catastrophic complication of thrombolysis . Additional studies should assess the net clinical benefit of thrombolysis in high-risk subgroups , particularly the elderly and patients with prior cerebrovascular events",
"Previous research indicates that persons assigning values to ranges of health states consider some states to be worse than death . In a study of decisions regarding life-sustaining treat ments , the authors adapted and assessed existing methods for their ability to identify and quantify preferences for health states near to or worse than death in a population of well adults and nursing home residents . The cognitive burdens involved in these decisions were also evaluated . Hypothetical health states based on six attributes of functional status were constructed to describe severe constant pain , dementia , and coma . The methods of rank order , category scaling , time tradeoff , and st and ard gamble were adapted to quantify states worse than death . Cognitive burden was assessed using completion rates , interviewer as sessments , respondents ' self-reporting , and investigators ' evaluations . For both respondent groups , all methods showed similar degrees of cognitive burden for those able to complete the tasks and were similar in their ability to identify and quantify preferences . The majority of nursing home residents , however , were unable to complete or comprehend the mea surement tasks . Most respondents evaluated their current health and severe constant pain as better than death ; dementia and coma were more often considered equal to or worse than death . These results indicate that respondents can and do evaluate some health states as worse than death . The authors recommend systematic inclusion of states worse than death to describe a more complete range of preference values and routine assessment of the cognitive burdens of assessment techniques to evaluate method ologies . Keywords : health status measurement ; preference weights ; utility measurement ; health-state prefer ences ; cognitive burden . ( Med Decis Making 1994;14:9 - 18",
"OBJECTIVE To measure preferences for initial outpatient vs hospital care among low-risk patients who were being actively treated for community-acquired pneumonia ( CAP ) . METHODS Study patients included 159 patients with CAP , 57 ( 36 % ) initially hospitalized , who were identified as being at low risk for early mortality using a vali date d prediction model . Subjects were enrolled from university and community health care facilities located in Boston , Mass , Halifax , Nova Scotia , and Pittsburgh , Pa , participating in the Pneumonia Patient Outcome Research Team prospect i ve cohort study of CAP . Three utility assessment techniques ( category scaling , st and ard gamble , and willingness to pay ) were used to measure the strength of patient preferences for the site of care for low-risk CAP . At the time of initial therapy or during the early recuperative period , patient preferences were assessed across a spectrum of potential clinical outcomes using 7 st and ardized pneumonia clinical vignettes . RESULTS Responses to the 7 pneumonia scenarios indicated that most patients consistently preferred outpatient-based therapy . This pattern was observed regardless of whether patients had actually been treated initially at home or in a hospital . Patients ( 74 % ) who stated that they generally preferred home care for low-risk CAP were willing to pay a mean of 24 % of 1 month 's household income to be assured of this preference . Preference for home care , as measured by the category scaling and the willingness to pay , persisted after adjustment for sociodemographic and baseline health status covariates . Sixty nine percent of interviewed patients said that their physician alone determined whether they would be treated in the hospital or at home . Only 11 % recalled being asked if they had a preference for either site of care . CONCLUSIONS Most patients , even those treated initially in a hospital , who were at low risk for mortality from CAP prefer outpatient treatment . However , most physicians appear not to involve patients in the site-of-care decision . More explicit discussion of patient preferences for the location of care would likely yield more highly valued care by patients as well as less costly treatment for CAP",
"Health-Related Quality of Life ( HRQOL ) measurement has become a key element in the assessment of chronic diseases during the execution of clinical research and in the delivery of health care . Poor HRQOL is clearly recognized in patients with inflammatory bowel disease ( IBD ) and relates to the type of disease ( Crohn 's disease or ulcerative colitis ) and disease severity . It is also linked to non-disease elements e.g. , gender , age , personality , cultural factors and coping skills . The dynamic properties of HRQOL may be depicted using different measurement tools and the portrayal may well differ when using a generic- or a disease-specific instrument . HRQOL status also changes with time , as do disease and non-disease parameters . Several examples of population selection bias are demonstrated using the Sickness Impact Profile ( SIP ) , the time trade-off and the McMaster Inflammatory Bowel Disease Question naire ( IBDQ ) . While HRQOL is generally good in IBD patients , mean HRQOL scores are still significantly depressed compared to normal controls . The IBDQ , a disease-specific HRQOL instrument , has yielded consistent results in both cross-sectional studies and prospect i ve clinical trials . Such HRQOL instruments can be used to identify the types of new therapies that are needed , subgroups of patients which might benefit from specific treatments , patient satisfaction , treatment efficacy and efficiency . These applications must always be undertaken with careful attention to rigorous research methodology",
"OBJECTIVE To compare in patients with fibromyalgia ( FM ) utilities derived by rating scale and st and ard gamble methods ; to gain insight into construct validity by relating utility values to other outcome measures ; to assess the sensitivity to change of utilities . METHODS A total of 73 patients with FM were r and omized into one of 3 groups : low impact fitness training , biofeedback , or controls . At baseline and after 6 mo the Maastricht Utility Measurement Question naire was applied . By means of both the rating scale and st and ard gamble method patients were asked to value their own health status . Construct validity of patient utility measurements was evaluated by Spearman correlation and multiple regression of baseline values with pain , stiffness , patient 's global assessment , Sickness Impact Profile ( SIP ) , modified Health Assessment Question naire and Arthritis Impact Measurement Scale ( AIMS ) . Sensitivity to change was assessed against changes in these outcomes . RESULTS Rating scale utilities correlated significantly ( p patient 's global assessment ( rs = 0.53 ) , pain ( rs = -0.47 ) , SIP ( rs = -0.43 ) , and with 9 of 11 dimensions of the AIMS ( rs ranging from 0.23 to 0.62 ) . St and ard gamble utilities correlated significantly with mobility , pain , and arthritis impact of the AIMS scale ( rs from 0.22 to 0.36 ) and with pain by visual analog scale ( rs = -0.24 ) and patient 's global assessment ( rs = 0.32 ) . Multiple regression analysis showed that patient 's global assessment explained 41 % ( rating scale ) and 10 % ( st and ard gamble ) of total variance in baseline utilities . Also , 16 % of the variance in change in rating scale utility values was explained by changes in patient 's global assessment . In contrast , variance of changes in st and ard gamble utility values was not explained significantly by changes in other disease outcomes . CONCLUSION Rating scale utilities correlated more strongly with disease outcome measures than st and ard gamble utilities . Also , construct validity for the rating scale was better than for the st and ard gamble . In FM , utility measurement is sensitive to the method chosen to elicit patient priorities",
"The main goal of current pain management approaches is to increase the patients ' quality of life by improving pain coping skills and by reducing the levels of disability in daily life , often despite persistent pain . Direct measurement of quality of life is of crucial importance in economic evaluation research , in which not only is the estimation of financial costs and benefits included , but so is the evaluation of costs and benefits in terms of changes in health states . The purpose of this study is to compare the psychometric qualities of two instruments for assessing patients ' utilities , the rating scale ( RS ) and the st and ard gamble ( SG ) . Such instruments are design ed for their application in economic evaluation research , but have seldomly been used in chronic pain trials . Both methods provide a single measure between 0 and 1 . The relationship between these utility measures and descriptive and domain-specific quality of life measures was examined in 133 fibromyalgia patients and 148 patients with chronic non-specific low back pain . Mean utility score at baseline was 0.43 with the RS and 0.78 for the SG . The correlation between both methods was found to be poor ( r = 0.21 ) . Both measures appeared to be fairly stable in a 2-week test-retest period ( intra class correlation coefficient ( ICC ) = 0.74 and 0.77 ) . Scores on the description of patient 's own health on six domains , global assessment of change and domain specific measures correlated moderately with the RS scores and low with the SG . Multiple regression analyses demonstrated that 32 % of the variance in RS values and only 13 % of the variance in SG utilities could be explained by domain-specific measures . These results suggest an acceptable construct validity for the RS but insufficient construct validity for the SG . Valuations of ones own health appear only partially to be related to the assessment of the pain-specific measures and measures of distress . It can be concluded that the RS and domain-specific measures assess partly different , but nevertheless complementary aspects of health-related quality of life . It is therefore recommended to include in economic evaluation studies both domain-specific measures and valuation measures . Finally , in chronic musculoskeletal pain patients , RS scores were found to be more responsive in detecting significant changes in preferences than SG scores . For use in patients with chronic musculoskeletal pain , the RS is preferred to the SG for establishing accurate decisions about the impact of new interventions on their health outcomes",
"Abstract Metastatic bone disease is a common complication of advanced breast cancer . Recently , the results of a large r and omized placebo-controlled trial demonstrated that monthly pamidronate infusions reduce the incidence of skeletal related events in these patients . In the current study , a cost – utility analysis was performed from a Canadian health care system perspective to estimate the incremental cost-effectiveness of pamidronate in patients with advanced breast cancer . Twenty-five advanced breast cancer patients who were bisphosphonate naïve and had developed skeletal related complications were identified . Total hospital re source consumption was then collected for all patients . This included direct costs for hospitalization and costs for radiation treatment to bone , surgery , analgesics , blood products , diagnostic imaging , paramedical services and all related physician fees . Treatment preferences were estimated from a r and om sample of 25 women selected from the general population and 25 female health care professionals , using the Time Trade-Off technique . The outcomes were then generated through a decision-analytic model . Over a 12-month period , total costs in the pamidronate arm were approximately 44 % higher than those in the no-treatment alternative ( Can$ 9,180 vs Can$ 6,380 ) . When treatment preferences were incorporated into the analysis , the results of the decision model revealed an incremental pamidronate cost of $ 18,700 per quality -adjusted life year gained . The results of the sensitivity analysis suggested that this estimate was dependent on the cost of treating skeletal related events , particularly bone surgery . Even though pamidronate has a high drug acquisition cost , the results of the cost – utility analysis suggest that this agent does provide patients with a substantial quality -adjusted survival benefit at a reasonable cost to the Canadian health care system",
"The Health Utilities Index Mark 2 ( HUI:2 ) is a generic multiattribute , preference-based system for assessing health-related quality of life . Health Utilities Index Mark 2 consists of two components : a seven-attribute health status classification system and a scoring formula . The seven attributes are sensation , mobility , emotion , cognition , self-care , pain , and fertility . A r and om sample of general population parents were interviewed to determine cardinal preferences for the health states in the system . The health states were defined as lasting for a 60-year lifetime , starting at age 10 . Values were measured using visual analogue scaling . Utilities were measured using a st and ard gamble technique . A scoring formula is provided , based on a multiplicative multiattribute utility function from the responses of 194 subjects . The utility scores are death-anchored ( death = 0.0 ) and form an interval scale . Health Utilities Index Mark 2 and its utility scores can be useful to other research ers in a wide variety of setting s who wish to document health status and assign preference scores",
"Abstract Objective : Amyotrophic lateral sclerosis ( ALS ) is a fatal , degenerative neuromuscular disease characterised by a progressive loss of voluntary motor activity . Recombinant human insulin-like growth factor I ( rhIGF-I ) has been shown to be useful in treating ALS . The purpose of this study was to examine the cost effectiveness of rhIGF-I therapy in patients who have ALS . Design : We performed a cost-effectiveness analysis from the societal perspective on 177 patients who received treatment with rhIGF-I or placebo in a North American r and omised clinical trial . We estimated the incremental cost-effectiveness ratio of rhIGF-I using re source utilisation and functional status measurements from the clinical trial . Costs were estimated from 1996 US Medicare reimbursement schedules . Utility weights were elicited from ALS healthcare providers using the st and ard gamble technique . Main outcome measures and results : The overall cost per quality -adjusted lifeyear ( QALY ) gained for rhIGF-I therapy compared with placebo was $ US67 440 . For the subgroups of patients who were progressing rapidly or were in earlier stages of disease at enrolment , rhIGF-I cost $ US52 823 and $ US43 197 per QALY gained , respectively . Conclusions : Treatment with rhIGF-I is most cost effective in ALS patients who are either in earlier stages of the disease or progressing rapidly . The cost effectiveness of rhIGF-I therapy compares favourably with treatments for other chronic progressive diseases",
"OBJECTIVE To assess and compare quality of life of patients six months after an acute myocardial infa rct ion treated with one of two thrombolytic agents , streptokinase ( SK ) or recombinant tissue plasminogen activator ( tPA ) . DESIGN A cohort study of consecutive patients r and omly allocated to thrombolytic therapy and treated in hospitals participating in the Australian arm of the International tPA/SK Mortality Trial ( AUS-TASK ) . PATIENTS AND SETTING 776 patients with acute myocardial infa rct ion were asked to complete question naires at their follow-up clinic visit six months after the infa rct . MAIN OUTCOME MEASURES Two measures were used : ( i ) the York Health Measurement Question naire , which measures activities and distress and provides basic descriptors of quality of life ; and ( ii ) a time trade-off question about the number of years a person would be willing to give up in exchange for returning to full health . RESULTS The quality of life of the 714 respondents ( 92 % ) was generally high , with a mean index of 0.98 . The five main areas causing distress were : lack of energy ; breathlessness ; anxiety ; difficulty sleeping ; and pain . In the time trade-off question , the mean number of years respondents were willing to forgo , out of 15 years , was 0.87 years ; while 76 % did not think it worthwhile to forgo any time . The 8 % of patients who declined to answer the question naire were in significantly poorer health ( New York Heart Association classification , P = 0.01 ; and Karnofsky index , P quality of life or time trade-off answers between patients allocated to streptokinase or tPA ( P = 0.96 and 0.73 , respectively ) . CONCLUSIONS Quality of life six months after myocardial infa rct ion is generally high , and most patients are able to return to normal activities . However , it is significantly impaired in a small group of patients , mainly those with a subsequent stroke or re-infa rct ion . There was no significant difference in quality of life between those treated with tPA and those with streptokinase",
"Abstract Objective : To test the clinical equivalence and re source consequences of day care with inpatient care for active rheumatoid arthritis . Design : R and omised controlled clinical trial with integrated cost minimisation economic evaluation . Setting : Rheumatic diseases unit at a teaching hospital between 1994 and 1996 . Subjects : 118 consecutive patients with active rheumatoid arthritis r and omised to receive either day care or inpatient care . Main outcome measures : Clinical assessment s recorded on admission , discharge , and follow up at 12 months comprised : the health assessment question naire , Ritchie articular index , erythrocyte sedimentation rate , hospital anxiety and depression scale , and Steinbrocker functional class . Re source estimates were of the direct and indirect costs relating to treatment for rheumatoid arthritis . Secondary outcome measures ( health utility ) were ascertained by time trade off and with the quality of well being scale . Results : Both groups had improvement in scores on the health assessment question naire and Ritchie index and erythrocyte sedimentation rate after hospital treatment ( P The mean hospital cost per patient for day care , £ 798 ( 95 % confidence interval £ 705 to £ 888 ) , was lower than for inpatient care , £ 1253 ( £ 1155 to £ 1370 ) , but this difference was offset by higher community , travel , and readmission costs . The difference in total cost per patient between day care and inpatient care was small ( £ 1789 ( £ 1539 to £ 2027 ) v £ 2021 ( £ 1834 to £ 2230 ) ) . Quantile regression analysis showed a cost difference in favour of day care up to the 50th centile ( £ 374 ; £ 639 to £ 109 ) . Conclusions : Day care and inpatient care for patients with uncomplicated active rheumatoid arthritis have equivalent clinical outcome with a small difference in overall re source cost in favour of day care . The choice of management strategy may depend increasingly on convenience , satisfaction , or more comprehensive health measures reflecting the preferences of patients , providers , and service commissioners",
"Method ologically sound measures of quality of life are required to judge accurately the impact of successful renal transplantation on patient well-being . The time trade-off ( TTO ) method is a reproducible and valid measure which we used to prospect ively assess changes in the quality of life of 27 patients on maintenance dialysis who subsequently underwent renal transplantation . TTO scores approaching 0 signify a very poor quality of life , while scores approaching 1 represent perfect health . Of 98 dialysis patients who completed baseline TTO interviews , 31 consecutive patients subsequently received 28 cadaveric and 3 living related kidney transplants . Four of 31 patients did not complete a second TTO assessment , because of death in 2 patients and graft loss in 2 others . The remaining 27 patients completed a second TTO interview an average of 30.9 months following transplantation ( range 1.5 - 52 , 95 % confidence interval [ CI ] 24.4 - 37.5 ) and formed the study cohort . At the time of study the mean serum creatinine for the cohort was 173 mumol/L ( range 90 - 290 , 95 % CI 152 - 195 mumol/L ) . The employment rate rose 27 % following transplantation ( P = 0.10 ) ; but when males alone were analyzed , a significant increase of 38 % ( P = 0.048 ) was noted . During the dialysis period , the mean baseline TTO score was 0.41 ( 95 % CI 0.33 - 0.49 ) , confirming the observations of others . Following transplantation , the mean TTO score rose to 0.74 ( 95 % CI 0.67 - 0.81 ) , a difference that is statistically significant ( P mean increase in TTO score observed as a result of successful transplantation was 0.33 ( 95 % CI 0.26 - 0.40 ) . This magnitude of improvement was found in 20 of 27 patients ( 74 % ) , whose TTO scores lay within or above the 95 % CI ( 0.26 - 0.40 ) for the mean change in score of 0.33 . One patient 's score fell , while the remaining 6 patients had improvements in their TTO score which fell below the lower 95 % CI value ( 0.26 ) for the mean change in score . We conclude that the 95 % CI of 0.26 - 0.40 identifies a range in which clinical ly important improvements in quality of life will be found for the majority of patients receiving successful kidney transplants",
"The effect of total hip replacement on the health-related quality of life of patients who have osteoarthrosis was examined as part of a r and omized , controlled trial comparing femoral head prostheses that were inserted with or without cement . One hundred and eighty-eight patients were followed for three months : 179 of them , for six months ; 156 , for one year ; and ninety , for two years . The health-related quality of life was assessed with use of the Harris hip score , the Merle d'Aubigné hip score , the Sickness Impact Profile , the Western Ontario and McMaster University ( WOMAC ) Osteoarthritis Index , the McMaster -- Toronto Arthritis ( MACTAR ) Patient Preference Disability Question naire , and the time trade-off technique as a measure of utility . Patients also took the six-minute-walk test . The mean age of the patients in the study was sixty-four years ( range , forty to seventy-five years ) ; ninety-seven patients ( 53 per cent ) were men and ninety-four ( 50 per cent ) had a prosthesis inserted with cement . Only three of 188 patients refused to return for quality -of-life assessment s. There was significant improvement in all health-related quality -of-life measures and in the six-minute-walk test after the operation ( p work dimension of the Sickness Impact Profile at three months [ p = 0.07 ] ) . Most of the improvement had occurred by three months postoperatively . ( ABSTRACT TRUNCATED AT 250 WORDS",
"A series of ‘ scenarios ’ describing the physical , social and emotional characteristics , limitations and duration of different health states have been successfully applied to a r and om sample of the general public in order to determine their social utility . The result ing mean daily health state utilities differ among disorders and vary with age , the duration of the disorder , the ‘ label ’ used to describe the disorder and the health status of the respondent . These health state utilities have considerable potential application in the planning and financing of health services",
"OBJECTIVES This study sought to assess the cost-effectiveness of captopril therapy for survivors of myocardial infa rct ion . BACKGROUND The recent r and omized , controlled Survival and Ventricular Enlargement ( SAVE ) trial showed that captopril therapy improves survival in survivors of myocardial infa rct ion with an ejection fraction The present ancillary study was design ed to determine how the costs required to achieve this increase in survival compared with those of other medical interventions . METHODS We developed a decision-analytic model to assess the cost-effectiveness of captopril therapy in 50- to 80-year old survivors of myocardial infa rct ion with an ejection fraction Data on costs , utilities ( health-related quality of life weights ) and 4-year survival were obtained directly from the SAVE trial , and long-term survival was estimated using a Markov model . In one set of analyses , we assumed that the survival benefit associated with captopril therapy would persist beyond 4 years ( persistent-benefit analyses ) , whereas in another set we assumed that captopril therapy incurred costs but no survival benefit beyond 4 years ( limited-benefit analyses ) . RESULTS In the limited-benefit analyses , the incremental cost-effectiveness of captopril therapy ranged from $ 3,600/ quality -adjusted life-year for 80-year old patients to $ 60,800/ quality -adjusted life-year for 50-year old patients . In the persistent-benefit analyses , incremental cost-effectiveness ratios ranged from $ 3,700 to $ 10,400/ quality -adjusted life-year , depending on age . The outcome was generally not sensitive to changes in estimates of variables when they were varied individually over wide ranges . In a \" worst-case \" analysis , incremental cost-effectiveness ratios for captopril therapy remained favorable ( $ 8,700 to $ 29,200/ quality -adjusted life-year ) for 60- to 80-year old patients but were higher ( $ 217,600/ quality -adjusted life-year ) for 50-year old patients . CONCLUSIONS We conclude that the cost-effectiveness of captopril therapy for 50- to 80-year old survivors of myocardial infa rct ion with a low ejection fraction compares favorably with other interventions for survivors of myocardial infa rct ion",
"The objective of this study was to assess the cost-utility of renal transplantation compared with dialysis . To accomplish this , a prospect i ve cohort of pre-transplant patients were followed for up to two years after renal transplantation at three University-based Canadian hospitals . A total of 168 patients were followed for an average of 19.5 months after transplantation . Health-related quality of life was assessed using a hemodialysis question naire , a transplant question naire , the Sickness Impact Profile , and the Time Trade-Off Technique . Fully allocated costs were determined by prospect ively recording re source use in all patients . A societal perspective was taken . By six months after transplantation , the mean health-related quality of life scores of almost all measures had improved compared to pre-transplantation , and they stayed improved throughout the two years of follow up . The mean time trade-off score was 0.57 pre-transplant and 0.70 two years after transplantation . The proportion of individuals employed increased from 30 % before transplantation to 45 % two years after transplantation . Employment prior to transplantation [ relative risk ( RR ) = 23 ] , graft function ( RR 10 ) and age ( RR 1.6 for every decrease in age by one decade ) , independently predicted employment status after transplantation . The cost of pre-transplant care ( $ 66,782 Can 1994 ) and the cost of the first year after transplantation ( $ 66,290 ) were similar . Transplantation was considerably less expensive during the second year after transplantation ( $ 27,875 ) . Over the two years , transplantation was both more effective and less costly than dialysis . This was true for all subgroups of patients examined , including patients older than 60 and diabetics . We conclude that renal transplantation was more effective and less costly than dialysis in all subgroups of patients examined",
"BACKGROUND --A study was undertaken to determine the impact of different doses of inhaled terbutaline on peak flow rates , spirometric parameters , functional exercise capacity , and quality of life in patients with chronic airflow limitation . METHODS --A double blind , r and omised , placebo controlled , multiple crossover trial was conducted with treatment periods of one week . Patients with a clinical diagnosis of chronic airflow limitation and FEV1 below 70 % predicted after administration of bronchodilator were recruited from secondary care respiratory practice s , and the effect of 500 , 1000 , and 1500 micrograms inhaled terbutaline four times daily on spirometric parameters ( FEV1 , FVC ) , maximum inspiratory pressures , six minute walking distance , and health-related quality of life ( Chronic Respiratory Disease Question naire , Quality of Well Being , St and ard Gamble ) was measured . RESULTS --Twenty five patients completed the trial . Peak flow rates and FEV1 showed statistically significant but clinical ly trivial improvement on the higher drug doses . Results of maximum inspiratory pressure measurements , walk test distance , and quality of life measures showed minimal differences on the different dosages , and none of the differences approached conventional statistical significance . CONCLUSIONS --Regular use of beta agonists in doses higher than two puffs four times a day is very unlikely to provide additional functional or symptomatic benefit to patients with chronic airflow limitation"
] | 41167590-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE This systematic review of recent r and omized trials was conducted to determine if cardiovascular nursing interventions improve outcomes in patients with coronary artery disease ( CAD ) and /or heart failure . METHODS R and omized controlled trials of nursing interventions in patients with CAD or heart failure published from January 2000 to December 2008 were eligible . Pilot studies and trials with greater than 25 % attrition with no intention-to-treat analyses were excluded . Study characteristics and results were extracted and trials were grade d for method ological quality . RESULTS A total of 2,039 citations from electronic data bases were identified ; 55 articles were eligible for inclusion . The primary intervention strategy was education plus behavioral counseling and support ( 65 % of interventions ) using a combination of intervention modes . More than half of the trials ( 57 % ) reported statistically significant results in at least 1 outcome of blood pressure , lipids , physical activity , dietary intake , cigarette smoking , weight loss , healthcare utilization , mortality , quality of life , and psychosocial outcomes . However , there were no consistent relationships observed between intervention characteristics and the effects of interventions . The average measure of study quality was 2.8 ( possible range , 0 - 4 , with higher score equaling higher quality ) . CONCLUSION Most trials review ed demonstrated a beneficial impact of nursing interventions for secondary prevention in patients with CAD or heart failure . However , the optimal combination of intervention components , including strategy , mode of delivery , frequency , and duration , remains unknown . Establishing consensus regarding outcome measures , inclusion of adequate , representative sample s , along with cost-effectiveness analyses will promote translation and adoption of cost-effective nursing interventions | [
"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 — The long-term impact of chronic heart failure management programs over the typical life span of affected individuals is unknown . Methods and Results — The effects of a nurse-led , multidisciplinary , home-based intervention ( HBI ) in a typically elderly cohort of patients with chronic heart failure initially r and omized to either HBI ( n=149 ) or usual postdischarge care ( UC ) ( n=148 ) after a short-term hospitalization were studied for up to 10 years of follow-up ( minimum 7.5 years of follow-up ) . Study end points were all-cause mortality , event-free survival ( event was defined as death or unplanned hospitalization ) , recurrent hospital stay , and cost per life-year gained . Median survival in the HBI cohort was almost twice that of UC ( 40 versus 22 months ; P deaths overall ( HBI , 77 % versus 89 % ; adjusted relative risk , 0.74 ; 95 % CI , 0.53 to 0.80 ; P ) . HBI was associated with prolonged event-free survival ( median , 7 versus 4 months ; P ) . HBI patients had more unplanned readmissions ( 560 versus 550 ) but took 7 years to overtake UC ; the rates of readmission ( 2.04±3.23 versus 3.66±7.62 admissions ; P life-years per 100 patients treated compared with UC ( 405 versus 285 years ) at a cost of $ 1729 per additional life-year gained when we accounted for healthcare costs including the HBI . Conclusions — In altering the natural history of chronic heart failure relative to UC ( via prolonged survival and reduced frequency of recurrent hospitalization ) , HBI is a remarkably cost- and time-effective strategy over the longer term",
"Abstract Objectives : To determine whether specialist nurse intervention improves outcome in patients with chronic heart failure . Design : R and omised controlled trial . Setting : Acute medical admissions unit in a teaching hospital . Participants : 165 patients admitted with heart failure due to left ventricular systolic dysfunction . The intervention started before discharge and continued thereafter with home visits for up to 1 year . Main outcome measures : Time to first event analysis of death from all causes or readmission to hospital with worsening heart failure . Results : 31 patients ( 37 % ) in the intervention group died or were readmitted with heart failure compared with 45 ( 53 % ) in the usual care group ( hazard ratio=0.61 , 95 % confidence interval 0.33 to 0.96).Compared with usual care , patients in the intervention group had fewer readmissions for any reason ( 86 v 114 , P=0.018 ) , fewer admissions for heart failure ( 19 v 45 , P fewer days in hospital for heart failure ( mean 3.43 v 7.46 days , P=0.0051 ) . Conclusions : Specially trained nurses can improve the outcome of patients admitted to hospital with heart failure . What is already known on this topic Studies have suggested that nurse intervention may reduce readmission in patients with heart failure What this study adds Home based intervention from nurses reduces readmissions for worsening heart failure Regular contact to review treatment and patient education are likely to contribute to this",
"Cardiac pain arising from chronic stable angina ( CSA ) is a cardinal symptom of coronary artery disease and has a major negative impact on health-related quality of life ( HRQL ) , including pain , poor general health status , and inability to self-manage . Current secondary prevention approaches lack adequate scope to address CSA as a multidimensional ischemic and persistent pain problem . This trial evaluated the impact of a low-cost six-week angina psychoeducation program , entitled The Chronic Angina Self-Management Program ( CASMP ) , on HRQL , self-efficacy , and re source fulness to self-manage anginal pain . One hundred thirty participants were r and omized to the CASMP or three-month wait-list usual care ; 117 completed the study . Measures were taken at baseline and three months . General HRQL was measured using the Medical Outcomes Study 36-Item Short Form and the disease-specific Seattle Angina Question naire ( SAQ ) . Self-efficacy and re source fulness were measured using the Self-Efficacy Scale and the Self-Control Schedule , respectively . The mean age of participants was 68 years , 80 % were male . Analysis of variance of change scores yielded significant improvements in treatment group physical functioning [ F=11.75(1,114 ) , P general health [ F=10.94(1,114 ) , P=0.001 ] aspects of generic HRQL . Angina frequency [ F=5.57(1,115 ) , P=0.02 ] , angina stability [ F=7.37(1,115 ) , P=0.001 ] , and self-efficacy to manage disease [ F=8.45(1,115 ) , P=0.004 ] were also significantly improved at three months . The CASMP did not impact re source fulness . These data indicate that the CASMP was effective for improving physical functioning , general health , anginal pain symptoms , and self-efficacy to manage pain at three months and provide a basis for long-term evaluation of the program",
"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",
"OBJECTIVES We sought to identify whether home telemonitoring ( HTM ) improves outcomes compared with nurse telephone support ( NTS ) and usual care ( UC ) for patients with heart failure who are at high risk of hospitalization or death . BACKGROUND Heart failure is associated with a high rate of hospitalization and poor prognosis . Telemonitoring could help implement and maintain effective therapy and detect worsening heart failure and its cause promptly to prevent medical crises . METHODS Patients with a recent admission for heart failure and left ventricular ejection fraction ( LVEF ) were assigned r and omly to HTM , NTS , or UC in a 2:2:1 ratio . HTM consisted of twice-daily patient self-measurement of weight , blood pressure , heart rate , and rhythm with automated devices linked to a cardiology center . The NTS consisted of specialist nurses who were available to patients by telephone . Primary care physicians delivered UC . The primary end point was days dead or hospitalized with NTS versus HTM at 240 days . RESULTS Of 426 patients r and omly assigned , 48 % were aged > 70 years , mean LVEF was 25 % ( SD , 8) and median plasma N-terminal pro-brain natriuretic peptide was 3,070 pg/ml ( interquartile range 1,285 to 6,749 pg/ml ) . During 240 days of follow-up , 19.5 % , 15.9 % , and 12.7 % of days were lost as the result of death or hospitalization for UC , NTS , and HTM , respectively ( no significant difference ) . The number of admissions and mortality were similar among patients r and omly assigned to NTS or HTM , but the mean duration of admissions was reduced by 6 days ( 95 % confidence interval 1 to 11 ) with HTM . Patients r and omly assigned to receive UC had higher one-year mortality ( 45 % ) than patients assigned to receive NTS ( 27 % ) or HTM ( 29 % ) ( p = 0.032 ) . CONCLUSIONS Further investigation and refinement of the application of HTM are warranted because it may be a valuable role for the management of selected patients with heart failure",
"Objectives : To evaluate the effects of nurse-led secondary prevention clinics for coronary heart disease ( CHD ) in primary care on total mortality and coronary event rates after 10 years . Design : Follow-up of a r and omised controlled trial by review of national data sets . Setting : Stratified r and om sample of 19 general practice s in northeast Scotl and . Participants : Original study cohort of 1343 patients , aged Intervention : Nurse-led secondary prevention clinics promoted medical and lifestyle aspects of secondary prevention and offered regular follow-up for 1 year , Main outcome measures : Total mortality and coronary events ( non-fatal myocardial infa rct ions ( MIs ) and coronary deaths ) . Results : Mean ( SD ) follow-up was at 10.2 ( 0.19 ) years . No significant differences in total mortality or coronary events were found at 10 years . 254 patients in the intervention group and 277 patients in the control group had died : cumulative death rates were 38 % and 41 % , respectively ( p = 0.177 ) . 196 coronary events occurred in the intervention group and 195 in the control group : cumulative event rates were 29.1 % and 29.1 % , respectively ( p = 0.994 ) . When Kaplan – Meier survival analysis , adjusted for age , sex and general practice , was used , proportional hazard ratios were 0.88 ( 0.74 to 1.04 ) for total mortality and 0.96 ( 0.79 to 1.18 ) for coronary death or non-fatal MI . No significant differences in the distribution of cause of death classifications was found at either 4 or 10 years . Conclusions : After 10 years , differences between groups were no longer significant . Total mortality survival curves for the intervention and control groups had not converged , but the coronary event survival curves had . Possibly , therefore , the earlier that secondary prevention is optimised , the less likely a subsequent coronary event is to prove fatal",
"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",
"AIM To assess the feasibility and impact of specialist care in patients with newly diagnosed heart failure in primary and secondary care . METHODS Patients with suspected heart failure referred for open access echocardiography to a hospital-based echocardiography service were assessed from June 2002 through to June 2003 . Patients with confirmed left ventricular systolic dysfunction ( LVSD ) were r and omised to specialist care ( cardiology registrar and heart failure nurses ) or referred back to their general practitioner ( GP ) . R and omisation was stratified for age and sex and both groups were comparable . All patients were followed up for a minimum of 3 months post r and omisation with a mean follow-up time of 10+/-3 months . Specialist care was provided both in the community and in hospital . The primary endpoint was prescription of optimum heart failure medication and secondary endpoint was a composite endpoint of all cause mortality and /or hospital admission . RESULTS 386 patients were screened ; mean age -72+/-10 years . 113 ( 29 % ) had confirmed LVSD on echocardiography and were r and omised to specialist or primary care . The prescription of ACE-inhibitors ( 85 % vs. 64 % ) and beta blockers ( 50 % vs. 2 % ) was higher in patients r and omised to specialist care . No significant differences were noted in mortality or hospitalisation . CONCLUSION Specialist heart failure care results in higher rates of optimal prescribing , in primary and secondary care",
"Context People with chronic conditions may need tailored , practical help for managing their conditions . Contribution This 12-month trial of assistance with managing systolic- dysfunction heart failure r and omly assigned 406 ethnically diverse adults from Harlem , New York , to usual care or nurse management . Nurses counseled nurse management patients about sodium intake , fluid buildup , medication adherence , and self-management of symptoms ; served as a bridge between patients and physicians ; and regularly called patients to discuss problems . Compared with usual care patients , nurse management patients had fewer hospitalizations and better functioning . Implication s Nurse management can improve some outcomes in ethnically diverse patients with systolic-dysfunction heart failure in ambulatory practice s. The Editors Heart failure disproportionately affects black and elderly people and is a leading cause of hospitalization among people 65 years of age or older ( 1 , 2 ) . Although effective therapies can improve functioning and survival in patients with systolic dysfunction , many patients may not be receiving the full benefit of existing knowledge ( 35 ) . Patients play a critical role in managing a chronic condition , such as heart failure . Patients may not realize that specific symptoms are related to heart failure or that adhering to medications and diet can reduce symptoms and life-threatening episodes ( 6 ) . Evidence -based guidelines for systolic dysfunction recommend that physicians not only offer patients effective therapies but also teach them the importance of adherence and self-monitoring ( 3 , 4 ) . Clinicians have fallen short in prescribing angiotensin-converting enzyme inhibitors and -blockers for patients with systolic dysfunction ( 5 , 7 , 8) . When prescribed , the doses have often been lower than those proven to convey greater benefits ( 3 , 9 ) . Clinicians have also documented counseling only a fraction of patients with heart failure about self-management ( 10 , 11 ) . System-related factors may also influence patients ' ability to obtain quality care ( 12 , 13 ) . Systematic review s of clinical behavior change have suggested that interventions targeted to specific problems are more likely to be successful ( 14 , 15 ) . On the basis of shortfalls identified in patient self-management and clinical care in Harlem , New York , a predominately nonwhite area , we tailored a nurse management intervention to address documented problems and evaluated its effectiveness in a r and omized , controlled trial . Our trial among primarily minority patients addresses important gaps in the literature . We targeted problems documented among patients with heart failure in Harlem , enrolled patients from ambulatory care practice s , r and omly assigned patients to either nurse management or usual care , and evaluated the patients ' subsequent health-related outcomes . We hypothesized that patients in the focused nurse management program would have fewer hospitalizations and report better functioning than patients in usual care . Methods Development of the Intervention During interviews with patients with heart failure at Mount Sinai Hospital , New York , New York , patients reported inadequate underst and ing of heart failure and their role in managing it ( 6 ) . Less than half of patients followed a very-low-salt diet , and only about one quarter weighed themselves daily . Regarding clinical management , medical records noted prescriptions for an angiotensin-converting enzyme inhibitor or hydralazinedinitrate combination in 82 % of 322 consecutive black patients with documented systolic dysfunction who were scheduled for visits at the general medicine clinic at Harlem Hospital from February 1995 through February 1997 . The prescribed doses , however , equaled or exceeded those found to be efficacious in clinical trials in only 26 % of these patients ( 3 ) . In design ing a nurse management intervention to address these problems , we built on a Stanford University program that evaluated primarily privately insured patients at Kaiser Permanente in northern California ( 16 , 17 ) . We adapted their question naire on the frequency of foods eaten to incorporate those that are common among African-American and Hispanic people in Harlem . Setting s and Recruitment All 4 hospitals in Harlem , the area 's major providers , collaborated in the trial : 1 large private academic medical center ( 1171 beds ) , 2 medium-sized municipal hospitals ( 286 beds and 363 beds ) , and 1 smaller private community hospital ( 200 beds ) . In 2000 , these hospitals had 521 , 267 , 218 , and 168 discharges for the heart failure diagnosis-related group ( code 127 ) , respectively . All are not-for-profit institutions . The trial had the following inclusion criteria : adults 18 years of age or older ; systolic dysfunction documented on a cardiac test ( echocardiography , radionuclide ventriculography , myocardial stress sestamibi or thallium stress testing , or left-heart catheterization ) ; English- language or Spanish- language speakers ; community-dwelling at enrollment ; and current patient in a general medicine , geriatrics , or cardiology clinic or office at a participating site . Exclusion criteria were medical conditions that prevented interaction with the nurse , including blindness , deafness , or cognitive impairment ; medical conditions requiring individualized management that might differ from st and ard protocol , namely pregnancy , renal dialysis , or terminal illness ; or procedures that corrected systolic dysfunction , such as heart transplantation . Of the 216 clinicians ( 209 physicians and 7 physicians ' assistants or nurse practitioners ) in participating practice s , 1 clinician declined permission to recruit his patients . The institutional review boards for each site approved the study . We identified patients with International Classification of Diseases , Ninth Revision , Clinical Modification ( ICD-9-CM ) , and diagnosis-related group codes on outpatient or inpatient billings for heart failure , March 1999 through February 2001 , who had at least 1 clinician visit to a participating practice and impaired systolic dysfunction . We defined impaired systolic dysfunction as a left ventricular ejection fraction less than 0.40 or moderately or severely reduced systolic dysfunction on echocardiography , radionuclide ventriculography , myocardial stress sestamibi or thallium stress testing , or left-heart catheterization . We obtained clinicians ' permission to recruit specific patients and sent each approved patient a letter from the site 's physician coordinator . Bilingual recruiters telephoned eligible patients or approached them at scheduled clinician appointments . The recruiter confirmed each patient 's eligibility , obtained written informed consent to participate in the study , conducted the baseline survey , and telephoned the project manager for the treatment group assignment . The recruiter conveyed the assignment to the patient and , for each nurse management patient , scheduled the in-person appointment with a nurse . We provided telephone service for 3 patients who did not have it so we could telephone patients in both treatment groups every 3 months for data on end points and so nurse management patients could participate in the intervention . R and omization and Treatment Groups The project 's statistician used a computer-generated , r and om-number sequence without blocking or stratification to central ly determine r and omization assignments and concealed treatment group assignments in sealed , opaque envelopes . Usual care patients received federal consumer guidelines for managing systolic dysfunction but no other intervention ( 18 ) . In the nurse management intervention , 1 of 3 trained registered nurses met once with each patient ( Table 1 ) . In counseling the patient , the nurse stressed the relationship among sodium intake ; fluid buildup ; and symptoms , such as shortness of breath . Nurses mailed patients the reports from the food-frequency question naire after each administration . The nurse also served as a bridge between the patient and the clinician ( Table 1 ) . A local clinical advisory committee implemented national evidence -based guidelines , and a committee of key clinicians from participating sites approved the protocol ( 3 , 4 ) . Nurses contacted patients ' clinicians to discuss specific medications and arranged any prescription changes and examinations ordered ( Table 1 ) . An internist monitored the nurses ' work , initially in weekly and then in biweekly meetings , and a cardiologist provided oversight and substituted for the internist at regular meetings , as necessary . Table 1 . Components of Nurse Management * One nurse who was bilingual in English and Spanish delivered the intervention primarily at the 2 municipal hospitals , a second bilingual nurse delivered the intervention primarily at the small community hospital , and the second and a third English- language speaking nurse delivered the intervention primarily at the academic center . All 3 nurses covered each other , especially for the follow-up telephone calls . Outcomes and Measurement To measure hospitalizations , we used billing data from the 4 participating hospitals . At quarterly telephone surveys , interviewers who were blinded to treatment assignment asked patients about hospitalizations at nonparticipating hospitals ; however , we present the analysis of billing data because they measure hospitalizations independent of possibly socially acceptable responses or survey nonresponse of the patients . For functional status , we used the generic Short Form-12 ( SF-12 ) physical component score and the condition-specific Minnesota Living with Heart Failure ( MLHF ) Question naire , with both scales administered at the quarterly interviews . We measured deaths recorded in the National Death Index plus deaths reported by patients ' families for patients with no subsequent billings . Since both nurse management and usual care involved only services delivered in routine practice , the study did not monitor adverse effects . As required by the",
"Background . The growing number of patients with congestive heart failure has increased both the pressure on hospital re sources and the need for community management of the condition . Improving hospital-to-home transition for this population is a logical step in responding to current practice guidelines ’ recommendations for coordination and education . Positive outcomes have been reported from trials evaluating multiple interventions , enhanced hospital discharge , and follow-up through the addition of a case management role . The question remains if similar gains could be achieved working with usual hospital and community nurses . Methods . A 12-week , prospect i ve , r and omized controlled trial was conducted of the effect of transitional care on health-related quality of life ( disease-specific and generic measures ) , rates of readmission , and emergency room use . The nurse-led intervention focused on the transition from hospital-to-home and supportive care for self-management 2 weeks after hospital discharge . Results . At 6 weeks after hospital discharge , the overall Minnesota Living with Heart Failure Question naire ( MLHFQ ) score was better among the Transitional Care patients ( 27.2 ± 19.1 SD ) than among the Usual Care patients ( 37.5 ± 20.3 SD;P = 0.002 ) . Similar results were found at 12 weeks postdischarge for the overall MLHFQ and at 6- and 12-weeks postdischarge for the MLHFQ ’s Physical Dimension and Emotional Dimension subscales . Differences in generic quality life , as assessed by the SF-36 Physical component , Mental Component , and General Health subscales , were not significantly different between the Transition and Usual Care groups . At 12 weeks postdischarge , 31 % of the Usual Care patients had been readmitted compared with 23 % of the Transitional Care patients ( P = 0.26 ) , and 46 % of the Usual Care group visited the emergency department compared with 29 % in the Transitional Care group ( & khgr;2 = 4.86 , df 1 , P = 0.03 ) . Conclusions . There were significant improvements in health-related quality of life ( HRQL ) associated with Transitional Care and less use of emergency rooms",
"BACKGROUND Outcomes related to chronic heart failure ( HF ) remain relatively poor , despite advances in pharmacological therapy and medical and nursing care . Experts agree that outpatient care may be among the factors that affect HF outcomes . We hypothesized that the method by which outpatient care is delivered may affect outcomes in this patient population . METHODS A prospect i ve , r and omized design was used to compare HF outcomes from 216 patients r and omized to 1 of 2 home health care delivery methods for 3 months after discharge . Care was delivered by the home nurse visit ( HNV ) or the nurse telemanagement ( NTM ) method . In the latter , patients used transtelephonic home monitoring devices to measure their weight , blood pressure , heart rate , and oxygen saturation . These data were transmitted daily to a secure Internet site . An advanced- practice nurse worked collaboratively with a cardiologist and subsequently treated patients via the telephone . Both delivery methods used the same HF-specific clinical guidelines to direct care . Outcomes include HF readmissions and length of stay , anxiety , depression , self-efficacy , and quality of life . Data were primarily tested using a 2-group analysis of variance ( ANOVA ) . We used a repeated- measures ANOVA to conduct preintervention-postintervention analyses . RESULTS After 3 months , patients in the NTM group ( n = 108 ; mean + /- SD age , 62.9 + /- 13.2 years ; 83 % African American ; 64 % female ) had fewer HF readmissions ( 13 vs 24 ; P lengths of stay ( 49.5 vs 105.0 days ; P HNV group ( n = 108 ; mean + /- SD age , 63.2 + /- 12.6 years ; 89 % African American ; 62 % female ) . Hospitalization charges at 3 months were less in the NTM group compared with the HNV group ( $ 65 023 vs $ 177 365 ; P cumulative readmission charges in the NTM group were also less ( $ 223 638 vs $ 500 343 [ P Quality of life was significantly improved for both groups when we compared postintervention and preintervention scores . CONCLUSION The adaptation of state-of-the-art computerized technology to closely monitor patients with HF with advanced- practice nurse care under the guidance of a cardiologist significantly improves HF management while reducing the cost of care",
"BACKGROUND Despite national efforts to improve cholesterol management for patients with coronary artery disease , many patients are not reaching recommended cholesterol target levels . We sought to determine whether a nurse-based educational intervention , design ed to educate patients with confirmed coronary artery disease about personal low-density lipoprotein ( LDL ) cholesterol target levels and encourage partnership with physicians , could increase adherence with National Cholesterol Education Program target levels ( LDL cholesterol level Patients hospitalized with confirmed coronary artery disease were r and omized to undergo a nurse-based educational intervention ( 375 patients ) or usual care ( 381 patients ) for a 12-month period after hospitalization . The primary outcome was the proportion of patients at the LDL cholesterol target level 1 year after hospitalization . The secondary outcome was the proportion of patients with accurate knowledge of LDL cholesterol target levels . RESULTS The groups were similar at baseline in demographic and clinical characteristics , percent at LDL cholesterol target level ( 43.9 % and 41.1 % , respectively ) , and percent with knowledge of LDL cholesterol target levels ( both 5 % ) . The proportion of patients at LDL cholesterol target levels at 1 year did not differ between the intervention ( 70.2 % ) and usual care group ( 67.4 % , P = .46 ) . At the conclusion of the trial , patient knowledge about LDL cholesterol target level was higher for the intervention group than the usual care group ( 19.6 % and 6.7 % , respectively , P = .001 ) , but this was not associated with improved cholesterol management . CONCLUSIONS Our nurse-based educational intervention did not result in a significant increase in the proportion of patients who reached target LDL cholesterol levels 1 year after hospitalization . Although the intervention improved patient knowledge of LDL cholesterol target levels , overall rates of LDL cholesterol knowledge remained low , and it was not associated with improved cholesterol management",
"BACKGROUND Heart failure is a common and important cause of morbidity and mortality . Disease management offers promise in reducing the need for hospitalization and improving quality of life for heart failure patients , but experimental data on the efficacy of such programs are limited . METHODS AND RESULTS A total of 151 patients hospitalized with heart failure were r and omized to usual care or scheduled telephone calls by specially trained nurses promoting self-management and guideline -based therapy as prescribed by primary physicians . Nurses also screened patients for heart failure exacerbations , which they managed with supplemental diuretics or by contacting the primary physician for instructions . Outcomes included time to hospital encounter , mortality , number and cost of hospitalizations , functional status , and satisfaction with care . Intervention patients had a longer time to encounter ( hazard ratio [ HR ] = 0.67 ; 95 % confidence interval [ CI ] 0.47 - 0.96 ; P = .029 ) , hospital readmission ( HR = 0.67 ; CI 0.46 - 0.99 ; P = .045 ) , and heart failure-specific readmission ( HR = 0.62 ; CI 0.38 - 1.03 ; P = .063 ) . The number of admissions , hospital days , and hospital costs were significantly lower during the first 6 months after intervention but not at 1 year . The intervention had little effect on functional status , mortality , and satisfaction with care . CONCLUSION A nurse-administered , telephone-based disease management program delayed subsequent health care encounters , but had minimal impact on other outcomes",
"Objective : To evaluate the effects of a nurse based outpatient management programme for elderly patients discharged with heart failure from a university hospital . Design : Patients with heart failure ( New York Heart Association class II – IV ) and left ventricular systolic dysfunction aged 60 years or more were r and omly assigned to follow up within the management programme or to conventional follow up , usually in primary care . Of the 208 participants , 58 % were men , mean age was 75 years , and mean ejection fraction 34 % . All patients were scheduled for three observational study visits at six month intervals . The primary end point was quality of life ( QoL ) and secondary end points were hospitalisation and mortality . Results : More patients achieved target doses of angiotensin converting enzyme ( ACE ) inhibitors in the intervention group than in the control group ( 82 % v 69 % , 88 % v 69 % , and 88 % v 74 % of recommended target doses at 6 , 12 , and 18 months of follow up , respectively , p low QoL had a poor prognosis . After a mean 1122 days of follow up , 82 % of all patients had been readmitted . There were on average 4.7 readmissions per patient and 66 % were due to non-cardiac diagnoses . There were no differences in QoL or health care consumption between the two study groups during follow up . Conclusion : A nurse based management programme is more effective than follow up in primary care in optimising medication for elderly patients with heart failure . However , such a programme does not seem to have a favourable influence on QoL or readmission rate during long term follow up",
"Background —Although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure , the benefit attributable to patient education alone is not known . We hypothesized that a patient discharge education program would improve clinical outcomes in patients with chronic heart failure . Methods and Results —We conducted a r and omized , controlled trial of 223 systolic heart failure patients and compared the effects of a 1-hour , one-on-one teaching session with a nurse educator to the st and ard discharge process . Subjects were contacted by telephone at 30 , 90 , and 180 days to collect information about clinical events , symptoms , and self-care practice s. The primary end point of the study was the total number of days hospitalized or dead in the 180-day follow-up period . Subjects r and omized to receive the teaching session ( n=107 ) had fewer days hospitalized or dead in the follow-up period ( 0 and 10 days , median and 75th percentiles ) than did controls ( n=116 , 4 and 19 days ; P=0.009 ) . Patients receiving the education intervention had a lower risk of rehospitalization or death ( relative risk , 0.65 ; 95 % confidence interval , 0.45 to 0.93 ; P=0.018 ) . Costs of care , including the cost of the intervention , were lower in patients receiving the education intervention than in control subjects by $ 2823 per patient ( P=0.035 ) . Conclusions —The addition of a 1-hour , nurse educator – delivered teaching session at the time of hospital discharge result ed in improved clinical outcomes , increased self-care measure adherence , and reduced cost of care in patients with systolic heart failure",
"Background Smoking is an important risk factor for cardiovascular disease ( CVD ) , and quitting is highly beneficial . Yet , less than 30 % of CVD patients stop smoking . Relapse-prevention strategies seem most effective when initiated during the exacerbation of the disease . Objective A nurse-delivered inpatient smoking cessation program based on the Transtheoretical Model with telephone follow-up tailored to levels of readiness to quit smoking was evaluated on smoking abstinence and progress to ulterior stages of change . Method Participants ( N = 168 ) were r and omly assigned by cohorts to inpatient counseling with telephone follow-up , inpatient counseling , and usual care . The inpatient intervention consisted of a 1-hr counseling session , and the telephone follow-up included 6 calls during the first 2 months after discharge . The nursing intervention was tailored to the individual 's stage of change . End points at 2 and 6 months included actual and continuous smoking cessation rates ( biochemical markers ) and increased motivation ( progress to ulterior stages of change ) . Results Assuming that surviving patients lost to follow-up were smokers , the 6-month smoking abstinence rate was 41.5 % in the inpatient counseling with telephone follow-up group , compared with 30.2 % and 20 % in the inpatient counseling and usual care groups , respectively ( p = .05 ) . Progress to ulterior stages of change was 43.3 % , 32.1 % , and 18.2 % , respectively ( p = .02 ) . Stage of change at baseline and intervention predicted smoking status at 6 months . Discussion This tailored smoking cessation program with telephone follow-up significantly increased smoking cessation at 6 months , and progression to ulterior stages of change . The telephone follow-up was an important adjunct . It is , therefore , recommended to include such comprehensive smoking cessation programs within hospital setting s for individuals with CVD",
"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",
"Background Providing information is an important part of st and ard care and treatment for acute myocardial infa rct ion in patients . Evidence exists indicating that acute myocardial infa rct ion patients experience an information gap in the period immediately after discharge from the hospital . The aim of this study was to assess the short-term effects of a nurse-led telephone follow-up intervention to provide information and support to patients with acute myocardial infa rct ion after their discharge from hospital . Design and method A prospect i ve r and omized , controlled trial with a 6-month follow-up was conducted . A total of 288 patients were allocated to either an intervention group ( n = 156 ) or a control group ( n = 132 ) . The latter received routine post-discharge care . The primary endpoint measured at 3 and 6 months after discharge was the health-related quality of life using the 36-item Short Form Health Survey . Secondary endpoints included smoking and exercise habits . Results In both groups , health-related quality of life improved significantly over time on most subscales . A statistically significant difference in favour of the intervention group was found on the 36-item Short Form Health Survey Physical Health Component Summary Scale ( P=0.034 ) after 6 months . No difference was found between the groups on the Mental Health Component Summary Scale . We found a significant difference with respect to frequency of physical activity in favour of the intervention group after 6 months ( P=0.004 ) . More participants in the intervention group than the control group had ceased smoking at the 6-month follow-up ( P=0.055 ) . Conclusion A nurse-led systematic telephone follow-up intervention significantly improved the physical dimension of health-related quality of life in patients in the intervention group compared with usual care patients . Participation in this intervention also seemed to promote health behaviour change in patients after acute myocardial infa rct ion",
"Background —Several trials support the usefulness of disease management ( DM ) for improving clinical outcomes in heart failure ( HF ) . Most of these studies are limited by small sample size ; absence of concurrent , r and omized controls ; limited follow-up ; restriction to urban academic centers ; and low baseline use of effective medications . Methods and Results —We performed a prospect i ve , r and omized assessment of the effectiveness of HF DM delivered for 90 days across a diverse provider network in a heterogeneous population of 200 patients with high baseline use of approved HF pharmacotherapy . During a 90-day follow-up , patients r and omized to DM experienced fewer hospitalizations for HF [ primary end point , 0.55±0.15 per patient-year alive versus 1.14±0.22 per patient-year alive in control subjects ; relative risk ( RR ) , 0.48 , P=0.027 ] . Intervention patients experienced reductions in hospital days related to a primary diagnosis of HF ( 4.3±0.4 versus 7.8±0.6 days hospitalized per patient-year ; RR , 0.54 ; P , cardiovascular hospitalizations ( 0.81±0.19 versus 1.43±0.24 per patient-year alive ; RR , 0.57 ; P=0.043 ) , and days in hospital per patient-year alive for cardiovascular cause ( RR , 0.64 ; P reduced all-cause hospitalizations and total hospital days . On long-term ( mean , 283 days ) follow-up , there was substantial attrition of the 3-month gain in outcomes , with sustained significant reduction only in days in hospital for cardiac cause . Conclusions —In a population with high background use of st and ard HF therapy , a DM intervention , uniformly delivered across varied clinical sites , produced significant short-term improvement in HF-related clinical outcomes . Longer-term benefit likely requires more active chronic intervention , even among patients who appear clinical ly stable",
"BACKGROUND The aim of this study was to determine the effects of a home-based exercise program on clinical outcomes . Exercise training improves exercise capacity in patients with heart failure ( HF ) but the long-term effects on clinical outcomes remain unknown . METHODS We r and omized 173 patients with systolic HF to control ( n = 87 ) or home-based exercise ( n = 86 ) . The primary end point was a composite of all-cause hospitalizations , emergency department admissions , urgent transplantation , and death at 12 months . Functional performance ( as assessed by cardiopulmonary exercise testing and the 6-minute walk test ) , quality of life , and psychological states were measured at baseline , 3 months , and 6 months . RESULTS There was no significant difference between experimental and control groups in the combined clinical end point at 12 months and in functional status , quality of life , or psychological states over 6 months . Patients in the exercise group had a lower incidence of multiple ( 2 or more ) hospitalizations compared with the control group : 12.8 % versus 26.6 % , respectively ( P = .018 ) . CONCLUSIONS A home-based walking program that incorporated aerobic and resistance exercise did not result in improved clinical outcomes at 1-year follow-up in this cohort of patients with systolic HF . However , the exercise program result ed in reduced rehospitalization rates",
"Objective : To determine if a disease management programme for patients with coronary heart disease and heart failure represents an efficient use of health services re sources . Methods : We carried out an economic evaluation alongside a cluster r and omised control trial of 1163 patients with coronary heart disease and chronic heart failure in 20 primary care practice s in the United Kingdom . Practice s were r and omised to either a control group , where patients received st and ard general practice care , or an intervention group where patients had access to a specialist nurse-led disease management programme . We estimated costs in both groups for coronary heart disease-related re source use . The main outcome measure used in the economic evaluation was quality adjusted life years ( QALY ) measured using the EuroQol . Results : The disease management programme was associated with an increase in the QALY measured of 0.03 per year and an increase in the total NHS costs of £ 425 ( € 540 ) , of this only £ 83 was directly associated with the provision of the nurse clinics . The clinics generated additional QALY at an incremental cost of £ 13 158 per QALY compared to the control group . Conclusions : The use of a nurse-led disease management programme is associated with increased costs in other coronary heart disease-related services as well as for the costs of the clinics . They are also associated with improvements in health . Even in the short term these disease management programmes may represent a cost-effective service , as additional QALY are generated at an acceptable extra cost",
"OBJECTIVE The purpose of this study was to test the effect of a post-discharge telephone counseling intervention on women 's psychosocial adjustment following a cardiac event . DESIGN The study was a prospect i ve , r and omized , controlled trial . PATIENTS Women ( n = 196 ) were recruited from 4 hospitals in Sydney , Australia , who were hospitalized for coronary artery disease : myocardial infa rct ion , coronary artery bypass grafts , coronary angioplasty , or stable angina . Women were r and omized to usual care ( n = 103 ) or telephone counseling ( n = 93 ) and were 67 years of age ( range 34 - 92 ) . The majority had not completed high school ( 92 % ) and were not employed ( 84 % ) . OUTCOMES Psychosocial adjustment was measured by the Psychosocial Adjustment to Illness Scale and the Hospital Anxiety and Depression Scale the day before hospital discharge and 12 weeks postdischarge . INTERVENTION Individualized information and support , was design ed to promote self-managed recovery and psychosocial adjustment , and began with an evaluation during admission and was followed up by telephone counseling at 1 , 2 , 3 , and 6 weeks after discharge . RESULTS The intervention had no effect on psychosocial adjustment ( F[1,182 ] = 0.06 , P = .8 ) , anxiety ( F[1,182 ] = 0.15 , P = .69 ) or depression ( F[1,182 ] = 0.11 , P = .74 ) at 12 weeks after discharge . Women made significant improvements during the 12 weeks on mean scores for psychosocial adjustment ( F[1,182 ] = 58.37 , P = .00 ) , anxiety ( F [ 1,182 ] = 74.58 , P = .00 ) and depression ( F[1,182 ] = 14.11 , P = .00 ) . The predictors of poor psychosocial outcomes for women included being less than 55 years of age , being unemployed or retired , having poor psychosocial adjustment to illness at baseline , having readmission , or experiencing a stressful , personal event during follow-up . CONCLUSIONS Women at risk for poor outcomes following hospitalization for a cardiac event can be identified ( ie , women less than 55 years of age , unemployed or retired , poorly adjusted to their cardiac illness , or readmitted to hospital within 12 weeks of a previous cardiac admission ) , but an effective intervention to enhance psychosocial outcomes remains to be established",
"Background —Although men hospitalized with cardiovascular disease ( CVD ) show high smoking-cessation rates , similar data for women are lacking . We tested the efficacy of smoking-cessation intervention in women hospitalized for CVD . Methods and Results —In this r and omized controlled trial conducted from 1996 to 2001 , 277 women diagnosed with CVD ( mean age 61±10 years ) were r and omly assigned within 1 of 12 San Francisco Bay Area hospitals to a usual-care group ( UG ; n=135 ) or intervention group ( IG ; n=142 ) . Baseline histories were obtained , and interviews to ascertain self-reported smoking status occurred at 6 , 12 , 24 , and 30 months after hospitalization . The UG received strong physician ’s advice , a self-help pamphlet , and a list of community re sources . The IG received strong physician ’s advice and a nurse-managed cognitive behavioral relapse-prevention intervention at bedside , with telephone contact at intervals after discharge . The groups were similar demographically and had smoked cigarettes for a median of 38 ( IG ) or 40 ( UG ) years . Time to resumption of continuous smoking was assessed by Kaplan-Meier analysis , and risk differences between groups were determined . Time smoke-free was significantly greater for the IG than the UG ( P = 0.038 ) . Point prevalence for nonsmoking at the interviews was somewhat greater for the IG than the UG ( P > 0.15 at all times ) . Conclusions —Cognitive behavioral intervention result ed in longer average times to resumption of smoking , but in these 2 groups of older women with limited social and financial re sources , long-term success rates were similar . Systematic identification of smokers and even the brief intervention afforded the UG yielded a high smoking-cessation rate over time",
"Purpose : To evaluate the cost‐effectiveness of case management by a nurse practitioner ( NP ) to lower blood lipids in patients with coronary heart disease ( CHD ) from a managed care perspective . Data sources : 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 an NP for 1 year after discharge in addition to their usual care ( NURS ) or to receive usual care ( EUC ) enhanced with feedback on lipids to their primary provider and /or cardiologist . A cost‐effectiveness ratio was calculated using incremental costs of the NURS group per unit change and percent change in low‐density lipoprotein cholesterol ( LDL‐C ) for 1 year at 2004 values . Conclusions : The annual incremental cost‐effectiveness of NP case management was $ 26.03 per mg/dL and $ 39.05 per percent reduction in LDL‐C. When costs of NURS care for the second 6 months of management were compared to the first 6 months of management , nursing salary costs were lower as patients were established on cholesterol management regimens , but the reduction in costs was offset by the increase in incremental costs of drug treatment as the NP titrated the patient to higher drug dosages that were more costly . Implication s for practice : The findings suggest that case management by an NP is a cost‐effective approach for a managed care organization to consider in improving the care of patients with cardiovascular disease",
"BACKGROUND There are approximately 1.8 million patients with angina in the United Kingdom , many of whom report a poor quality of life , including raised levels of anxiety and depression . AIM To evaluate the effect of a cognitive behavioural disease management programme , the Angina Plan , on psychological adjustment in patients newly diagnosed with angina pectoris . DESIGN OF STUDY R and omised controlled trial . SETTING Patients from GP practice s in a Northern UK city ( York ) between April 1999 and May 2000 . METHOD Recruited patients were r and omised to receive the Angina Plan or to a routine , practice nurse-led secondary prevention educational session . RESULTS Twenty of the 25 practice s invited to join the study supplied patients ' names ; 142 patients attended an assessment clinic and were r and omised There were no significant differences in any baseline measures . At the six month post-treatment follow-up , 130 ( 91 % ) patients were reassessed . When compared with the educational session patients ( using analysis of covariance adjusted for baseline scores in an intention-to-treat analysis ) Angina Plan patients showed a greater reduction in anxiety ( P = 0.05 ) and depression ( P = 0.01 ) , the frequency of angina ( reduced by three episodes per week , versus a reduction of 0.4 per week , P = 0.016 ) the use of glyceryl trinitrate ( reduced by 4.19 fewer doses per week versus a reduction of 0.59 per week , P = 0.018 ) , and physical limitations ( P changed their diet ( 41 versus 21 , P their daily walking ( 30 versus 2 , P Seattle Angina Question naire or in any of the medical variables measured . CONCLUSION The Angina Plan appears to improve the psychological , symptomatic , and functional status of patients newly diagnosed with angina",
"AIMS To determine the effects of a nurse-led intervention design ed to improve self-management of patients with heart failure in a primary health care setting regarding health-related quality of life and depression . METHODS Patients at eight primary health care centres were screened by the Diagnosis Related Groups registry for the diagnosis of heart failure and eligibility for a cluster r and omised study . A total of 153 patients were included ( n=78 in the intervention group , 54 % males , mean age 79 years , 59 % in New York Heart Association class III-IV ) . The intervention involved patient and family education about heart failure and self-management and monthly telephone follow-up during 12 months by a primary health care nurse . RESULTS The effects of the nurse-led intervention were limited . Significant differences were found in the physical dimension measured by the SF-36 health survey , and in depression measured by the Zung Self-rating Depression Scale . In comparison within groups at the 3 and 12-month follow-up , the intervention group significantly maintained their health-related quality of life measured by the SF-36 health survey , and their experience of depression measured by the Zung Self-rating Depression Scale to a greater extent than in the control group , especially among women . CONCLUSION A nurse-led intervention directed toward patients with heart failure in a primary health care setting result ed in limited effects between the groups , although the physical and mental status were retained during 12 months of follow-up to a greater extent than in the control group",
"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 ",
"Objective Heart failure ( HF ) is a major health problem result ing in a high financial burden for the healthcare system . Many previous HF management programmes reduced adverse clinical outcomes and costs , but they usually involved several professional figures as well as huge investments , requiring re sources and budgets not often available in our healthcare system . We evaluated the effects of our HF management programme , which included patient education and regular outpatient contact with the HF team , on re-hospitalisation and death , optimising the few re sources already available at our hospital . Methods Two hundred consecutive patients admitted to the internal medicine department with a diagnosis of HF were r and omised to the intervention group ( nurse-led education programme , facilitated telephone communication and follow-up visits with an internist at 15 days , 1 and 6 months ) or to the usual care group ( follow-up by their primary care physician ) . The primary endpoints were all-cause readmissions and all-cause deaths during the 6-month post-discharge period . Results There were 81 all-cause hospital readmissions in the intervention group and 82 in the control group ( P = NS ) . Fourteen patients ( 14 % ) in the intervention group and eight patients ( 8 % ) in the control group died during the study period ( P = NS ) . Unplanned outpatient visits were less frequent in the intervention group than in the control group ( 39 [ 28 % ] versus 99 [ 72 % ] , P HF management programme reduced unplanned outpatient visits but proved ineffective in reducing subsequent readmissions and in improving clinical status . More intense follow-up monitoring and more re sources are needed to achieve better results",
"There has been a lack of research regarding nonpharmacologic interventions in heart failure . The objective was to determine the effect of behavioral management on health related quality of life ( HRQL ) in patients with heart failure . Participants ( N = 116 ) were r and omly assigned to one of two groups : usual care for heart failure ( n = 58 ) and the 15-week behavioral management program ( n = 58 ) . Outcomes included exercise performance ( 6-min walk ) , physical and mental functioning ( SF-36 ) , general health perceptions ( SF-36 ) , and disease specific HRQL ( Minnesota Living with Heart Failure Question naire-MLHF ) . Outcomes were assessed at baseline , 4 , 10 and 16 months . Participants were mostly male ( 95 % ) and Caucasian ( 75 % ) , with a mean age of 67 years ( S.D. = 10 ) . Intervention patients showed significantly improved self-reported disease specific HRQL ( MLHF physical dimension scores ) over time compared to control patients . There were no group differences in exercise performance , physical functioning , mental functioning or general health perceptions",
"BACKGROUND Disease management is effective in the general population , but it has not been tested prospect ively in a sample of solely Hispanics with heart failure ( HF ) . We tested the effectiveness of telephone case management in decreasing hospitalizations and improving health-related quality of life ( HRQL ) and depression in Hispanics of Mexican origin with HF . METHODS AND RESULTS Hospitalized Hispanics with chronic HF ( n = 134 ) were enrolled and r and omized to intervention ( n = 69 ) or usual care ( n = 65 ) . The sample was elderly ( 72 + /- 11 years ) , New York Heart Association class III/IV ( 81.3 % ) , and poorly educated ( 78.4 % less than high school education ) . Most ( 55 % ) were unacculturated into US society . Bilingual/bicultural Mexican-American registered nurses provided 6 months of st and ardized telephone case management . Data on hospitalizations were collected from automated systems at 1 , 3 , and 6 months after the index hospital discharge . Health-related quality of life and depression were measured by self-report at enrollment , 3 , and 6 months . Intention to treat analysis was used . No significant group differences were found in HF hospitalizations , the primary outcome variable ( usual care : 0.49 + /- 0.81 [ CI 0.25 - 0.73 ] ; intervention : 0.55 + /- 1.1 [ CI 0.32 - 0.78 ] at 6 months ) . No significant group differences were found in HF readmission rate , HF days in the hospital , HF cost of care , all-cause hospitalizations or cost , mortality , HRQL , or depression . CONCLUSION These results have important implication s because of the current widespread enthusiasm for disease management . Although disease management is effective in the mainstream HF patient population , in Hispanics this ill , elderly , and poorly educated , a different approach may be needed",
"Aim : To determine whether an intensive intervention at a heart failure ( HF ) clinic by a combination of a clinician and a cardiovascular nurse , both trained in HF , reduces the incidence of hospitalisation for worsening HF and /or all-cause mortality ( primary end point ) and improves functional status ( including left ventricular ejection fraction , New York Heart Association ( NYHA ) class and quality of life ) in patients with NYHA class III or IV . Setting : Two regional teaching hospitals in The Netherl and s. Methods : 240 patients were r and omly allocated to the 1-year intervention ( n = 118 ) or usual care ( n = 122 ) . The intervention consisted of 9 scheduled patient contacts — at day 3 by telephone , and at weeks 1 , 3 , 5 , 7 and at months 3 , 6 , 9 and 12 by a visit — to a combined , intensive physician- and -nurse-directed HF outpatient clinic , starting within a week after hospital discharge from the hospital or referral from the outpatient clinic . Verbal and written comprehensive education , optimisation of treatment , easy access to the clinic , recommendations for exercise and rest , and advice for symptom monitoring and self-care were provided . Usual care included outpatient visits initialised by individual cardiologists in the cardiology departments involved and applying the guidelines of the European Society of Cardiology . Results : During the 12-month study period , the number of admissions for worsening HF and /or all-cause deaths in the intervention group was lower than in the control group ( 23 vs 47 ; relative risk ( RR ) 0.49 ; 95 % confidence interval ( CI ) 0.30 to 0.81 ; p = 0.001 ) . There was an improvement in left ventricular ejection fraction ( LVEF ) in the intervention group ( plus 2.6 % ) compared with the usual care group ( minus 3.1 % ; p = 0.004 ) . Patients in the intervention group were hospitalised for a total of 359 days compared with 644 days for those in the usual care group . Beneficial effects were also observed on NYHA classification , prescription of spironolactone , maximally reached dose of β-blockers , quality of life , self-care behaviour and healthcare costs . Conclusion : A heart failure clinic involving an intensive intervention by both a clinician and a cardiovascular nurse substantially reduces hospitalisations for worsening HF and /or all-cause mortality and improves functional status , while decreasing healthcare costs , even in a country with a primary -care-based healthcare system",
"AIM The aim of this study was to examine the effect of a cardiac rehabilitation programme on health behaviours and physiological risk parameters in patients with coronary heart disease in Chengdu , China . BACKGROUND Epidemiological studies indicate a dose- , level- and duration -dependent relationship exists between cardiac behavioural and physiological risks and coronary heart disease incidence as well as subsequent cardiac morbidity and mortality . Cardiac risk factor modification has become the very primary goal of modern cardiac rehabilitation programmes . DESIGN METHODS A r and omized controlled trial was conducted . Coronary heart disease patients ( n = 167 ) who met the sampling criteria in two tertiary medical centres in Chengdu , south-west China , were r and omly assigned to either an intervention group ( the cardiac rehabilitation programme ) or control group ( the routine care ) . The change of health behaviours ( walking performance , step II diet adherence , medication adherence , smoking cessation ) and physiological risk parameters ( serum lipids , blood pressure , body weight ) were assessed to evaluate the programme effect . RESULTS Patients in the intervention group demonstrated a significantly better performance in walking , step II diet adherence , medication adherence ; a significantly greater reduction in serum lipids including triglyceride , total cholesterol , low-density lipoprotein ; and significantly better control of systolic and diastolic blood pressure at three months . The majority of these positive impacts were maintained at six months . The effect of the programme on smoking cessation , body weight , serum high-density lipoprotein , was not confirmed . CONCLUSIONS A cardiac rehabilitation programme led by a nurse can significantly improve the health behaviours and cardiac physiological risk parameters in coronary heart disease patients . Nurses can fill significant treatment gaps in the risk factor management of patients with coronary heart disease . RELEVANCE TO CLINICAL PRACTICE This study raises attention regarding the important roles nurses can play in cardiac rehabilitation and the unique way for nurses to meet the rehabilitative care needs of coronary heart disease patients . Furthermore , the hospital-home bridging nature of the programme also created a model for interfacing the acute care and community rehabilitative care",
"BACKGROUND The long-term effects of disease management programmes for coronary heart disease on health status are unknown . In a r and omized trial of nurse-led secondary prevention clinics , we found significantly improved health status at 1 year . Participants were followed-up again at 4 years to determine if improvements had been sustained . OBJECTIVE Our aim was to evaluate the effects on health of nurse-led clinics for the secondary prevention of coronary heart disease in primary care . METHODS A total of 1343 patients with coronary heart disease were r and omized to nurse-led secondary prevention clinics or usual care , with follow-up at 1 and 4 years by review of medical case notes and national data sets , and postal question naires . The study involved a stratified , r and om sample of 19 general practice s in north-east Scotl and . Health status was 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 . RESULTS At 1 year , there were significant improvements in five of eight SF-36 domains ( all functioning scales , pain and general health ) in patients r and omized to clinics . Role limitations attributed to physical problems improved the most [ adjusted difference 8.52 , 95 % confidence interval ( CI ) 4.16 - 12.9 ] . At 4 years , the intervention group scored higher than control in all domains , but differences were no longer significant . At 1 year , fewer patients in the intervention group reported worsening chest pain ( odds ratio 0.59 , 95 % C1 0.37 - 0.94 ) . At 4 years , there were no significant differences between the proportion of intervention or control group patients who reported chest pain in the last week or who reported worsening chest pain . No significant effects were observed on anxiety or depression at 1 or 4 years . CONCLUSION We have demonstrated previously a significantly greater survival in attendees at nurse-led secondary prevention clinics . Despite this , improvements in health status achieved in the first year of the study were reduced at 4 years . The case for nurse-led clinics remains strong , but further research is required on ways to optimize current health status",
"Cost and accessibility contribute to low participation rates in phase 2 cardiac rehabilitation programs in the United States . In this study , we compared the clinical effectiveness of 2 less costly and potentially more accessible approaches to cardiovascular risk reduction with that of a contemporary phase 2 cardiac rehabilitation program . Low- or moderate-risk patients ( n = 155 ) with coronary artery disease ( CAD ) were r and omly assigned to 12 weeks of participation in a contemporary phase 2 cardiac rehabilitation program ( n = 52 ) , a physician supervised , nurse-case-managed cardiovascular risk reduction program ( n = 54 ) , or a community-based cardiovascular risk reduction program administered by exercise physiologists guided by a computerized participant management system based on national clinical guidelines ( n = 49 ) . In all , 142 patients ( 91.6 % ) completed testing at baseline and after 12 weeks of intervention . For patients with abnormal ( i.e. , not at the goal level ) baseline values , statistically significant ( p multiple CAD risk factors . No statistically significant risk factor differences were observed among the 3 programs . For patients with a baseline maximal oxygen uptake metabolic equivalents , cardiorespiratory fitness increased to a greater degree in patients in the cardiac rehabilitation program and the community-based program versus the physician-supervised , nurse- case-managed program . These data have important implication s for cost containment and increasing accessibility to clinical ly effective comprehensive cardiovascular risk reduction services in low- or moderate-risk patients with CAD",
"BACKGROUND Both r and omized and nonr and omized controlled studies have linked congestive heart failure ( CHF ) case management ( CM ) to decreased readmissions and improved outcomes in mostly homogeneous setting s. The objective of this r and omized controlled trial was to test the effect of CHF CM on the 90-day readmission rate in a more heterogeneous setting . METHODS A total of 287 patients admitted to the hospital with the primary or secondary diagnosis of CHF , left ventricular dysfunction of less than 40 % , or radiologic evidence of pulmonary edema for which they underwent diuresis were r and omized . The intervention consisted of 4 major components : early discharge planning , patient and family CHF education , 12 weeks of telephone follow-up , and promotion of optimal CHF medications . RESULTS The 90-day readmission rates were equal for the CM and usual care groups ( 37 % ) . Total inpatient and outpatient median costs and readmission median cost were reduced 14 % and 26 % , respectively , for the intervention group . Patients in the CM group were more likely to be taking CHF medication at target doses , but dosages did not increase significantly throughout 12 weeks . Although both groups took their medications as prescribed equally well , the rest of the adherence to treatment plan was significantly better in the CM group . Subgroup analysis of patients who lived locally and saw a cardiologist showed a significant decrease in CHF readmissions for the intervention group ( P = .03 ) . CONCLUSIONS These results suggest several limitations to the generalizability of the CHF CM-improved outcome link in a heterogeneous setting . One explanation is that the lack of coordinated system supports and varied accessibility to care in an extended , nonnetworked physician setting limits the effectiveness of the CM",
"OBJECTIVES To examine the effectiveness of a transitional care intervention delivered by advanced practice nurses ( APNs ) to elders hospitalized with heart failure . DESIGN R and omized , controlled trial with follow-up through 52 weeks postindex hospital discharge . SETTING Six Philadelphia academic and community hospitals . PARTICIPANTS Two hundred thirty-nine eligible patients were aged 65 and older and hospitalized with heart failure . INTERVENTION A 3-month APN-directed discharge planning and home follow-up protocol . MEASUREMENTS Time to first rehospitalization or death , number of rehospitalizations , quality of life , functional status , costs , and satisfaction with care . RESULTS Mean age of patients ( control n=121 ; intervention n=118 ) enrolled was 76 ; 43 % were male , and 36 % were African American . Time to first readmission or death was longer in intervention patients ( log rank chi(2)=5.0 , P=.026 ; Cox regression incidence density ratio=1.65 , 95 % confidence interval=1.13 - 2.40 ) . At 52 weeks , intervention group patients had fewer readmissions ( 104 vs 162 , P=.047 ) and lower mean total costs ( $ 7,636 vs $ 12,481 , P=.002 ) . For intervention patients , only short-term improvements were demonstrated in overall quality of life ( 12 weeks , P physical dimension of quality of life ( 2 weeks , P patient satisfaction ( assessed at 2 and 6 weeks , P comprehensive transitional care intervention for elders hospitalized with heart failure increased the length of time between hospital discharge and readmission or death , reduced total number of rehospitalizations , and decreased healthcare costs , thus demonstrating great promise for improving clinical and economic outcomes",
"PURPOSE Despite demonstrated benefits of cardiac rehabilitation and risk factor reduction , only 11 % to 38 % of eligible patients with cardiovascular disease ( CVD ) participate in cardiac rehabilitation programs . Women and older adults are particularly less likely to participate in cardiac rehabilitation . In an effort to broaden access to cardiac rehabilitation , the authors developed an alternative Internet-based program that allows nurse case managers to provide risk factor management training , risk factor education , and monitoring services to patients with CVD . METHODS The evaluation consisted of a r and omized , clinical trial involving 104 patients with CVD , 53 of whom used the program as a special intervention ( SI ) for 6 months and 51 of whom received usual care ( UC ) . RESULTS The results indicate that fewer cardiovascular events occurred among the SI subjects ( 15.7 % ) than among the UC subjects ( 4.1 % ) ( P = .053 ) , result ing in a gross cost savings of $ 1418 US dollars per patient . With a projected program cost of $ 453 USD per patient , the return on investment is estimated at 213 % . More weight loss occurred in the SI group ( -3.68 pounds ) than in the UC group ( + .47 pounds ) ( P = .003 ) . The differences between the two groups in terms of blood pressure , lipid levels , depression scores , minutes of exercise , and dietary habits were not statistically significant . CONCLUSION An Internet-based case management system could be used as a cost-effective intervention for patients with CVD , either independently or in conjunction with traditional cardiac rehabilitation",
"BACKGROUND Heart failure ( HF ) disease management programs are widely implemented , but data about their effect on outcome have been inconsistent . METHODS The Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure ( COACH ) was a multicenter , r and omized , controlled trial in which 1023 patients were enrolled after hospitalization because of HF . Patients were assigned to 1 of 3 groups : a control group ( follow-up by a cardiologist ) and 2 intervention groups with additional basic or intensive support by a nurse specializing in management of patients with HF . Patients were studied for 18 months . Primary end points were time to death or rehospitalization because of HF and the number of days lost to death or hospitalization . RESULTS Mean patient age was 71 years ; 38 % were women ; and 50 % of patients had mild HF and 50 % had moderate to severe HF . During the study , 411 patients ( 40 % ) were readmitted because of HF or died from any cause : 42 % in the control group , and 41 % and 38 % in the basic and intensive support groups , respectively ( hazard ratio , 0.96 and 0.93 , respectively ; P = .73 and P = .52 , respectively ) . The number of days lost to death or hospitalization was 39 960 in the control group , 33 731 days for the basic intervention group ( P = .81 ) , and 34 268 for the intensive support group ( P = .49 ) . All-cause mortality occurred in 29 % of patients in the control group , and there was a trend toward lower mortality in the intervention groups combined ( hazard ratio , 0.85 ; 95 % confidence interval , 0.66 - 1.08 ; P = .18 ) . There were slightly more hospitalizations in the 2 intervention groups ( basic intervention group , P = .89 ; and intensive support group , P = .60 ) . CONCLUSIONS Neither moderate nor intensive disease management by a nurse specializing in management of patients with HF reduced the combined end points of death and hospitalization because of HF compared with st and ard follow-up . There was a nonsignificant , potentially relevant reduction in mortality , accompanied by a slight increase in the number of short hospitalizations in both intervention groups . Clinical Trial Registry http://trialregister.nl Identifier : NCT 98675639",
"Background : After the cardiovascular events of myocardial infa rct ion ( MI ) and coronary artery bypass surgery ( CABS ) , unpartnered older adults are a vulnerable group that may benefit from interventions to improve health outcomes . The purpose of this analysis is to determine if a community-based collaborative peer advisor/advanced practice nurse intervention increased participation in cardiac rehabilitation programs and reduced hospital readmissions after MI and CABS and determine whether the type of cardiovascular event influenced rehospitalization . Subjects and Methods : This study was a r and omized clinical trial that enrolled 247 unpartnered older adults who were single , widowed , or divorced . Subjects were r and omized into 4 groups : st and ard of care group for MI and for CABS and st and ard of care plus the treatment groups for MI and for CABS , for 12 weeks after discharge . There were 163 women/84 men , with a mean age of 76.4 years , who were admitted for MI ( n = 93 ) or CABS ( n = 154 ) and who were enrolled from 5 academic medical centers . The treatment consisted of a community-based intervention of a home visit within 72 hours and telephone calls at 2 , 6 , and 10 weeks from an advanced practice nurse and 12 weekly telephone calls from a peer advisor . Participation in a cardiac rehabilitation program and rehospitalizations were collected at 6 weeks and 3 , 6 , and 12 months by telephone interview . Results and Conclusions : There were significantly more participants in cardiac rehabilitation programs after 3 months in the treatment group , and this increase was seen up to 1 year after MI and CABS . There were no statistical differences , although there were fewer rehospitalizations between 3 and 6 months after MI and CABS in the treatment group compared with the st and ard of care group . Overall , the evidence from this study suggests that a community-based collaborative peer advisor/advanced practice nurse intervention can play a role in promoting active participation in cardiac rehabilitation programs and fewer rehospitalizations in unpartnered older adults after MI and CAGS",
"AIM The aim of this trial was to prospect ively evaluate the effect of follow-up at a nurse-led heart failure clinic on mortality , morbidity and self-care behaviour for patients hospitalised due to heart failure for 12 months after discharge . METHODS A total of 106 patients were r and omly assigned to either follow-up at a nurse-led heart failure clinic or to usual care . The nurse-led heart failure clinic was staffed by specially educated and experienced cardiac nurses , delegated the responsibility for making protocol -led changes in medications . The first follow-up visit was 2 - 3 weeks after discharge . During the visit the nurse evaluated the heart failure status and the treatment , gave education about heart failure and social support to the patient and his family . RESULTS There were fewer patients with events ( death or admission ) after 12 months in the intervention group compared to the control group ( 29 vs 40 , p=0.03 ) and fewer deaths after 12 months ( 7 vs 20 , p=0.005 ) . The intervention group had fewer admissions ( 33 vs 56 , p=0.047 ) and days in hospital ( 350 vs 592 , p=0.045 ) during the first 3 months . After 12 months the intervention was associated with a 55 % decrease in admissions/patient/month ( 0.18 vs 0.40 , p=0.06 ) and fewer days in hospital/patient/month ( 1.4 vs 3.9 , p=0.02 ) . The intervention group had significantly higher self-care scores at 3 and 12 months compared to the control group ( p=0.02 and p=0.01 ) . CONCLUSIONS Follow up after hospitalisation at a nurse-led heart failure clinic can improve survival and self-care behaviour in patients with heart failure as well as reduce the number of events , readmissions and days in hospital",
"The effects of a nurse-managed secondary prevention program for patients after acute cardiac events were examined . Special interest was given to gender-specific results . The design was a prospect i ve , r and omized , controlled trial involving 343 patients following 3 weeks of inpatient cardiac rehabilitation , r and omly assigned to either of two study groups . Patients in the treatment group were contacted monthly by phone over 1 year . The main goals of the intervention were the reduction of behavioural coronary risk factors and enhancing quality of life . The program was conducted by specially trained nurses . The control group received written information only . Primary outcome was the Framingham risk score . Follow-up examination after 12 months was completed by 297 patients . Patients in the intervention group showed lower Framingham risk scores as compared to controls . Separate analyses by sex revealed that this was mostly due to the men in the sample . Women , on the other h and , showed a significant rise of clinical ly relevant anxiety/depressiveness in the control but not in the intervention group ; in males there were no differences between study conditions . In conclusion , telephone counselling by specially trained nurses seems a cost-effective way to achieve a lasting reduction in cardiac risk factors and to maintain the effects of cardiac rehabilitation . Effekte eines von Pflegepersonal durchgefuehrten Nachsorgeprogramms fuer Koronarpatienten wurden untersucht . Besondere Aufmerksamkeit galt moeglichen Gendereffekten . Es h and elt sich um eine prospektive , r and omisierte , kontrollierte Studie . 343 Patienten wurden nach stationaerer kardiologischer Rehabilitation auf eine von zwei Studiengruppen r and omisiert . Patienten in der Interventions gruppe wurden über ein Jahr ca . einmal i m Monat telephonisch kontaktiert . Hauptziele der Intervention waren die effektive und nachhaltige Reduktion verhaltensgebundener Risikofaktoren sowie die Verbesserung der Lebensqualitaet . Das Programm wurde von speziell dafuer fortgebildetem Pflegepersonal durchgefuehrt . Die Kontrollgruppe erhielt nur schriftliches Informations material . Primaerer Endpunkt war das globale koronare Risiko ( Framingham Score ) . Von 297 Patienten wurden komplette Date n bei der Abschlussuntersuchung nach 12 Monaten erhalten . Patienten in der Interventions gruppe zeigten niedrigere Framingham-Scores als Kontrollpatienten . Getrennte Analysen nach Geschlecht ergaben , dass dieser Effekt hauptsaechlich auf die Maenner zurueckzufuehren ist ; bei den Frauen zeigten sich keine Unterschiede zwischen den Studiengruppen . Auf der and eren Seite zeigte sich bei den Frauen in der Kontrollgruppe eine deutliche Zunahme an Angst bzw . Depressivitaet ; ein entsprechender Effekt f and sich bei den Maennern nicht . Telefonische Nachsorge durch speziell fortgebildetes Pflegepersonal scheint ein kostenguenstiger Weg zu sein , koronare Risikofaktoren zu reduzieren und die Effekte von kardiologischer Rehabilitation aufrechtzuerhalten . Se evaluaron los result ados de un programa secundario de prevención dirigido por el personal de enfermería para pacientes que han sufrido un trastorno cardiovascular agudo . Se dio una especial importancia a los result ados específicos para cada sexo . Se trata de un estudio prospect ivo , aleatorizado , comparativo , en el que participaron 343 pacientes tras 3 semanas de haber recibido rehabilitación cardiovascular , a quienes se dividieron en dos grupos , de manera aleatoria . Los pacientes del grupo que recibió tratamiento fueron contactados por teléfono una vez al mes durante 1 año . Los principales objetivos de la intervención fueron reducir los factores de riesgo de las cardiopatías arterioscleróticas relacionados con el actuar de los pacientes , y mejorar la calidad de vida de éstos . La realización del programa estuvo a cargo de un grupo de enfermeras y enfermeros especialmente entrenados para ello . El grupo de referencia recibió información sólo por escrito . Los result ados iniciales se obtuvieron aplic and o la escala de riesgo de Framingham . En las valoraciones de seguimiento , realizadas tras 12 meses , participaron 292 pacientes . Los valores en la escala de riesgo de Framingham fueron más bajos en los pacientes del grupo que recibió la intervención que en el grupo de referencia . Los análisis según el sexo revelaron que el aporte mayor a este result ado provino de los varones de la muestra . Por su parte , las mujeres del grupo de referencia presentaron un aumento importante de la ansiedad/depresión relacionada con el proceso de enfermedad , lo cual no se apreció en el grupo que recibió tratamiento . Entre los varones no se apreciaron diferencias relacionadas con las condiciones del estudio . En conclusión , el apoyo emocional por vía telefónica brindado por el personal de enfermería especialmente entrenado para ello parece ser una manera rentable de disminuir de forma perdurable los factores de riesgo para las cardiopatías arterioscleróticas , así como de perpetuar los result ados de la rehabilitación cardiovascular . Cette étude examine les effets d'un programme de prévention secondaire sous surveillance du personnel infirmier pour les patients ayant souffert d'incidents cardiaques aigus . Une attention toute particulière a été donnée aux résultats selon le sexe . L'essai était de type prospect if , r and omisé et contrôlé , avec la participation de 343 patients après 3 semaines de rééducation cardiaque dans des conditions d'hospitalisation , affectés de manière aléatoire à l'un ou l'autre des deux groupes d'étude . Les patients appartenant au groupe de traitement ont été contactés tous les mois par téléphone sur une période de 1 an . Les principaux objectifs de l'intervention étaient la réduction des facteurs comportementaux de risque coronaire et l'amélioration de la qualité de vie . Le programme était administré par des infirmiers spécialement formés . Le groupe témoin recevait simplement des informations écrites . Le principal résultat était le score de risque de Framingham . 297 patients ont subi des examens de suivi après 12 mois . Les patients appartenant au groupe d'intervention ont affiché des scores de risque de Framingham inférieurs à ceux du groupe témoin . Les analyses séparées par sexe révèlent que la différence porte principalement sur les hommes . Les femmes , par contre , affichent une augmentation significative des tendances dépressives/à l'anxiété , cliniquement pertinente dans le groupe témoin , contrairement au groupe d'intervention ; chez les hommes , on ne note aucune différence entre les conditions d'étude . En conclusion , le conseil téléphonique administré par des infirmiers spécialement formés semble constituer un mode économique et efficace pour parvenir à une réduction durable des facteurs de risques cardiaques et préserver les effets de la rééducation cardiaque",
"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",
"This study determined the effectiveness of a self-efficacy intervention design ed to improve selfefficacy and physical activity in older adults postcardiac event . An experimental three-group design tested the intervention , with treatment groups receiving 1 of 2 supportive telephone protocol s ( theory-based self-efficacy coaching or attention control ) . Outcome variables included selfefficacy expectations for physical activity ( PA ) , self-reported PA , and PA performance ( distance walked in 6 minutes ) . The self-efficacy intervention was effective in demonstrating greater PA performance when compared to the attention control intervention , and PA self-efficacy was significantly correlated with both measures of PA . There were significant main effects of time for PA self-efficacy and distance walked , and a significant interaction effect on the distance walked because of time and treatment condition . Although the self-efficacy intervention did not show a direct effect on level of PA self-efficacy as hypothesized , there was an indirect interaction effect on distance walked and physical activity confidence",
"Patients with chronic conditions are heavy users of the health care system . There are opportunities for significant savings and improvements to patient care if patients can be maintained in their homes . A r and omized control trial tested the impact of 3 months of telehome monitoring on hospital readmission , quality of life , and functional status in patients with heart failure or angina . The intervention consisted of video conferencing and phone line transmission of weight , blood pressure , and electrocardiograms . Telehome monitoring significantly reduced the number of hospital readmissions and days spent in the hospital for patients with angina and improved quality of life and functional status in patients with heart failure or angina . Patients found the technology easy to use and expressed high levels of satisfaction . Telehealth technologies are a viable means of providing home monitoring to patients with heart disease at high risk of hospital readmission to improve their self-care abilities",
"Context Although evidence indicates that nurse-led care management improves clinical outcomes for patients with heart failure , evidence on the economic benefits of these programs is lacking . Contribution Using data on costs from a r and omized trial of 12 months of care management versus usual care for socioeconomically disadvantaged patients with heart failure , the investigators estimated that the cost-effectiveness of case management is less than $ 20000/QALY . Caution The results might not apply to patients in less socioeconomically disadvantaged setting s. The Editors Health care administrators and policymakers are increasingly turning to nurse-led disease management to lessen the economic and health burden of chronic diseases , such as heart failure . Meta-analyses of r and omized , controlled trials ( RCTs ) suggest that nurse management can be effective at reducing rehospitalization and sometimes at improving functioning ( 1 ) . To our knowledge , however , no previous RCT has included a cost-effectiveness analysis sufficient to inform policymakers as to whether nurse management improves quality of life for patients with heart failure at a reasonable cost to society . Studies have not followed recommended cost-effectiveness guidelines or thoroughly calculated intervention costs ( 2 ) . Establishing the cost-effectiveness of nurse management for heart failure may be especially important in minority communities , which have disproportionate rates of hospitalization for heart failure ( 3 ) and shortfalls in the use of proven effective therapies ( 4 ) and in patients ' underst and ing of heart failure ( 5 ) . We aim ed to estimate the cost-effectiveness of a nurse-led disease management intervention that was conducted alongside a r and omized , controlled effectiveness trial . The trial , conducted in Harlem , New York , from 1999 to 2003 , found that patients in the nurse-managed group maintained better physical functioning , as measured by the Short Form-12 ( SF-12 ) physical component score , and had statistically significantly fewer hospitalizations than did patients in the control group ( 6 ) . Methods For the RCT , we recruited patients from outpatient clinics at the 4 hospitals serving East and Central Harlem in New York City . We r and omly assigned 406 patients to usual care ( 203 patients ) or a nurse-led program ( 203 patients ) in which patients had 1 in-person visit with a trained nurse and periodic follow-up telephone calls over 12 months ( 6 ) . The nurses stressed adherence to a low-salt diet and to medications and worked with the patient 's physician to optimize heart failure medications according to published guidelines . Primary outcomes were total hospitalizations and physical functioning as measured by the SF-12 physical component score . Trained surveyors who were blinded to treatment assignment called patients in both groups every 3 months for 18 months to administer the SF-12 and collect information on health care utilization , amount of informal care received , and patients ' estimates of their time engaged in receiving health care over the past 3 months . We measured cost-effectiveness by using the incremental cost-effectiveness ratio ( ICER ) , which is the difference in average costs between the nurse-managed and usual care groups ( CostNCostUC ) divided by the difference in mean quality -adjusted life-years ( QALYs ) ( QALYNQALYUC ) : ICER = (CostNCostUC)/(QALYNQALYUC ) QALYs We estimated QALYs for the 12-month intervention by translating the SF-12 physical and mental component scores into Health Utility Index Mark 3 ( HUI3 ) and EuroQol-5D ( EQ-5D ) quality -of-life scores by using methods described by Franks and colleagues ( 7 ) . We chose these translations over other published methods ( 810 ) because they were vali date d in African-American patients , and most of the patients in our trial were African American or Hispanic . Patients who died were assigned a quality -of-life score of 0 in subsequent periods . We calculated QALYs by connecting the 5 quality -of-life scores for each patient ( baseline and quarterly through 12 months ) by using straight lines and calculating the area of the result ing 4 trapezoids . We estimated adjusted differences in QALYs by the coefficient on treatment from a linear regression of each patient 's QALY on his or her quality -of-life score at baseline and treatment assignment ( 11 ) . Societal Costs We followed guidelines for cost-effectiveness analysis ( 2 ) to estimate costs from a societal perspective and included intervention , medical , and nonmedical costs ( Appendix Table ) . Intervention costs included all intervention material s ( for example , scales ) , telephone service for 2 patients who did not have it , patients ' transportation costs to the initial nurse meeting , nurses ' salaries and fringe benefits , physician time overseeing the nurse activities , and costs for office space and equipment used by the nurses . Appendix Table . Data Sources and Imputations for Cost Items We derived medical costs for inpatient , outpatient , and emergency department use from administrative records from the 4 hospitals that participated in the trial . For inpatient costs , we converted billed charges to costs by using the cost-to-charge ratio for each hospital ( 2 , 12 ) and converted the costs to 2001 U.S. dollars by using the Producer Price Index for general and surgical hospitals ( 13 ) . For outpatient and emergency department cl aims , we applied the 2001 Medicare fee schedule for the New York City region ( 14 ) to billed procedure codes . For medication costs , we obtained medications prescribed from patients ' charts and prices for those medications from the average prices paid by Medicaid ( 15 ) . We used quarterly patient surveys to collect information on inpatient and outpatient utilization at nonparticipating institutions ( to supplement administrative records from participating hospitals ) and information on nonmedical costs , which included nursing home stays ; patient transportation and time costs associated with medical encounters ; and costs of informal care or assistance with household chores provided by friends , family members , or paid housekeepers . Costs are reported in 2001 U.S. dollars . Because of skewed cost data and a high percentage of patients with zero costs for many cost categories , we evaluated the statistical significance of the difference in costs between nurse-managed and usual care groups by using 2-part gamma models ( 16 ) . In the first part , we estimated the probability of costs being greater than 0 by logistic regression , with treatment assignment ; age ; sex ; race ( non-Hispanic black , non-Hispanic white , or other non-Hispanic ) ; Hispanic ethnicity ; recruitment site ; education ; preference for Spanish interview ; New York Heart Association ( NYHA ) heart failure class ; and indicators for diabetes , chronic pulmonary disease , and ischemic heart disease as explanatory variables . In the second part , for patients with costs greater than zero , we modeled costs as a function of the same explanatory variables by using generalized linear models with a gamma distribution and a logarithmic link function . For nursing home costs , which had a very small probability of being greater than 0 , we calculated unadjusted differences in mean costs and bootstrapped SEs by using 500 replicates stratified by treatment . We replaced missing observations for SF-12 scores and self-reported utilization with 10 imputed values found by using imputation by chained equations ( 17 ) as implemented by the ICE comm and in Stata , version 10.0 ( StataCorp , College Station , TX ) ( 18 ) . The previously listed explanatory variables at baseline and administrative data for hospitalizations and outpatient visits at baseline and quarterly follow-up were regressors in these equations . We estimated the 2-part models described previously on each imputed data set and combined the results by using Rubin 's rules ( 19 ) . Uncertainty in the ICER We created 500 bootstrapped replicates ( 50 from each of the 10 imputations ) and plotted the corresponding cost-effectiveness acceptability curves ( 20 ) . We calculated approximate empirical CIs for the ICER by using the bootstrap percentile method ( 21 ) . To explore whether nurse management is more likely to be cost-effective for patients with varying heart failure severity , we computed separate acceptability curves according to baseline NYHA class . Sensitivity Analysis We estimated costs on the basis of national prices for all cost items . We used the national 2001 Medicare fee schedule to calculate costs for outpatient and emergency department use ( 14 ) , deflated costs for hospitalizations and self-reported medical use by the ratio of the United States to New York metropolitan area Consumer Price Index for medical care , and deflated nonmedical costs by the ratio of the United States to New York metropolitan area Consumer Price Index for urban dwellers ( 22 ) . To characterize the cost implication s from the payer 's perspective , we also calculated costs to the Medicare program on the basis of categories and proportions of societal costs that Medicare typically covers . These included intervention costs but excluded costs for nursing home stays , patient time , telephone consultations , nonphysician office visits , and informal care . We decreased payer costs by the deductible and copayment rates for Medicare beneficiaries in 2001 . We included drug costs because Medicare and most insurers now cover medications . We assumed the deductible and copayment rate of the 2006 Medicare prescription drug plan , but no coverage gap . We investigated the influence of imputing missing survey data on the results by reporting the ICER for the observed data only ( available data analysis ) for patients who responded to every quarterly telephone survey until death or 12 months ( complete case analysis ) and for a data set in which a patient 's missing observations were replaced with the mean value of that patient 's observed responses ( patient-specific imputation ) . We conducted all analyses in Stata , version 10 ( 18 ) . The",
"Abstract Objectives : To evaluate the effects of nurse led clinics in primary care on secondary prevention , total mortality , and coronary event rates after four years . Design : Follow up of a r and omised controlled trial by postal question naires and review of case notes and national data sets . Setting : Stratified , r and om sample of 19 general practice s in north east Scotl and . Participants : 1343 patients ( 673 intervention and 670 control ) under 80 years with a working diagnosis of coronary heart disease but without terminal illness or dementia and not housebound . Intervention : Nurse led secondary prevention clinics promoted medical and lifestyle components of secondary prevention and offered regular follow up for one year . Main outcome measures : Components of secondary prevention ( aspirin , blood pressure management , lipid management , healthy diet , exercise , non-smoking ) , total mortality , and coronary events ( non-fatal myocardial infa rct ions and coronary deaths ) . Results : Mean follow up was at 4.7 years . Significant improvements were shown in the intervention group in all components of secondary prevention except smoking at one year , and these were sustained after four years except for exercise . The control group , most of whom attended clinics after the initial year , caught up before final follow up , and differences between groups were no longer significant . At 4.7 years , 100 patients in the intervention group and 128 in the control group had died : cumulative death rates were 14.5 % and 18.9 % , respectively ( P=0.038 ) . 100 coronary events occurred in the intervention group and 125 in the control group : cumulative event rates were 14.2 % and 18.2 % , respectively ( P=0.052 ) . Adjusting for age , sex , general practice , and baseline secondary prevention , proportional hazard ratios were 0.75 for all deaths ( 95 % confidence intervals 0.58 to 0.98 ; P=0.036 ) and 0.76 for coronary events ( 0.58 to 1.00 ; P=0.049 ) Conclusions : Nurse led secondary prevention improved medical and lifestyle components of secondary prevention and this seemed to lead to significantly fewer total deaths and probably fewer coronary events . Secondary prevention clinics should be started sooner rather than later . What is already known on this topic Several effective interventions exist for the secondary prevention of coronary heart disease , but implementing them in practice has proved difficult Secondary prevention programmes for coronary heart disease have improved short term outcomes such as processes of care and quality of life What this study adds Short term improvements in uptake of secondary prevention produced by nurse led clinics are maintained in the longer term Improved medical and lifestyle components of secondary prevention produced by nurse led clinics seem to lead to fewer total deaths and coronary",
"OBJECTIVE The goal of this study was to determine the effects of a supportive educational nursing intervention on self-care abilities , self-care behavior , and quality of life of patients with advanced heart failure . DESIGN The study design was an experimental , r and om assignment . SETTING The study was located at the University Hospital in Maastricht , The Netherl and s. PATIENTS The study included 179 patients ( mean age 73 years , 58 % men , New York Heart Association classification III and IV ) admitted to a university hospital with symptoms of heart failure . OUTCOME MEASURES Outcome measures included self-care abilities ( Appraisal of Self-care Agency Scale ) , self-care behavior ( Heart Failure Self-care Behavior Scale ) , 3 dimensions of quality of life ( functional capabilities , symptoms , and psychosocial adjustment to illness ) , and overall well-being ( Cantril 's ladder of life ) . INTERVENTION The intervention patients received systematic education and support by a nurse in the hospital and at home . Control patients received routine care . RESULTS Self-care abilities did not change as a result of the intervention , but the self-care behavior in the intervention group was higher than the self-care behavior in the control group during follow-up . The effect of the supportive educational intervention on quality of life was limited . The 3 dimensions of quality of life improved after hospitalization in both groups , with no differences between intervention and control group as measured at each follow-up measurement . However , there was a trend indicating differences between the 2 groups in decrease in symptom frequency and symptom distress during the 9 months of follow-up . CONCLUSION A supportive educational nursing intervention is effective in improving self-care behavior in patients with advanced ( New York Heart Association class III-IV ) heart failure ; however , a more intensive intervention is needed to show effectiveness in improving quality of life",
"The time that elapses from the onset of symptoms of acute myocardial infa rct ion ( AMI ) to treatment has a significant effect on mortality and morbidity . This study reports the effectiveness of an education and counselling intervention on knowledge , attitudes and beliefs about AMI symptoms and the appropriate response to symptoms . The intervention was tested in a r and omised controlled trial of 200 people with a history of coronary heart disease ( CHD ) . The groups were equivalent at baseline on study outcomes , clinical history and sociodemographic characteristics with the exception of more women in the intervention group ( 38 % vs. 24 % ) . The results of repeated measures ANOVA showed that the intervention result ed in improved knowledge of CHD , AMI symptoms and the appropriate response to symptoms that was sustained to 12 months ( p = 0.02 ) . There were no differences between groups ' attitudes and beliefs over time . It is concluded that a short individual teaching and counselling intervention result ed in improved knowledge of CHD , AMI symptoms and the appropriate response to symptoms in people at risk of AMI sustained to 12 months",
"abstract Objective To determine whether a nurse led smoking cessation intervention affects smoking cessation rates in patients admitted for coronary heart disease . Design R and omised controlled trial . Setting Cardiac ward of a general hospital , Norway . Participants 240 smokers aged under 76 years admitted for myocardial infa rct ion , unstable angina , or cardiac bypass surgery . 118 were r and omly assigned to the intervention and 122 to usual care ( control group ) . Intervention The intervention was based on a booklet and focused on fear arousal and prevention of relapses . The intervention was delivered by cardiac nurses without special training . The intervention was initiated in hospital , and the participants were contacted regularly for at least five months . Main outcome measure Smoking cessation rates at 12 months determined by self report and biochemical verification . Results 12 months after admission to hospital , 57 % ( n = 57/100)of patients in the intervention group and 37 % ( n = 44/118 ) in the control group had quit smoking ( absolute risk reduction 20 % , 95 % confidence interval 6 % to 33 % ) . The number needed to treat to get one additional person who would quit was 5 ( 3 to 16 ) . Assuming all dropouts relapsed at 12 months , the smoking cessation rates were 50 % in the intervention group and 37 % in the control group ( absolute risk reduction 13 % , 0 % to 26 % ) . Conclusion A smoking cessation programme delivered by cardiac nurses without special training , significantly reduced smoking rates in patients 12 months after admission to hospital for coronary heart disease"
] | 411675d6-06ff-11f0-808a-c43d1ab1c353 |
Inflammatory processes are involved in chronic diseases . It has been suggested that melatonin reduces inflammation by its radical scavenging properties ; however , the results of the previous studies are inconclusive . The objective of the present meta- analysis is to determine the direction and magnitude of melatonin supplementation effect on inflammatory biomarkers . Data bases including PubMed , Scopus , Cochran Library , Embase , and Google Scholar were search ed up to April 2019 . Meta- analysis was performed using r and om-effect model . Subgroup analysis , sensitivity analysis , and meta-regression were also carried out . Thirteen eligible studies with 22 data sets with total sample size of 749 participants were included in the meta- analysis . Melatonin supplementation significantly decreased TNF-α and IL-6 levels [ ( WMD = − 2.24 pg/ml ; 95 % CI − 3.45 , − 1.03 ; P The effect of melatonin on CRP levels was marginal ( WMD = − 0.45 mg/L ; 95 % CI − 0.94 , 0.03 ; P = 0.06 ; I2 = 96.6 % , Pheterogeneity that melatonin supplementation could be effective on ameliorating of inflammatory mediators | [
"Obesity , the global epidemic health problem , results in chronic disorders . Melatonin supplementation may prevent the adverse health consequences of obesity . The aim of this study was to assess the effects of melatonin supplementation on inflammatory and oxidative stress parameters in obese women . In r and omized , double-blind , placebo-controlled trial , 44 obese women were r and omly assigned to melatonin ( n=22 ) and placebo ( n=22 ) groups . Subjects were supplemented with a daily dose of 6 mg melatonin or placebo with low calorie diet for 40 days . Serum TNF-α , IL-6 , hsCRP , TAC , and MDA levels were assessed before and after intervention . In the melatonin group , mean serum TNF-α , IL-6 , hsCRP , and MDA levels decreased significantly ( p significant . Mean TAC level increased slightly ( from 1.11±0.30 to 1.14±0.45 mmol/l ) in the melatonin group whereas it decreased slightly ( from 1.13±0.15 to 1.08±0.21 nmol/l ) in the placebo group . Significant differences were observed only for TNF-α ( p=0.02 ) and IL-6 ( p=0.03 ) between the 2 study groups . Considering the improvements in inflammatory and oxidative stress factors in obese women , it seems that melatonin supplementation may provide beneficial effects in obesity treatment by ameliorating some of its complications . However , further studies are needed to make concise conclusions",
"The objective of the present study was to assess the toxicology of melatonin ( 10 mg ) , administered for 28 days to 40 volunteers r and omly assigned to groups receiving either melatonin ( N = 30 ) or placebo ( N = 10 ) in a double-blind fashion . The following measurements were performed : polysomnography ( PSG ) , laboratory examinations , including complete blood count , urinalysis , sodium , potassium and calcium levels , total protein levels , albumin , blood glucose , triglycerides , total cholesterol , high-density lipoprotein ( HDL ) , low-density lipoprotein ( LDL ) , and very low-density lipoprotein ( VLDL ) , urea , creatinine , uric acid , glutamic-oxalacetic transaminase ( GOT ) , glutamic-pyruvate transaminase ( GPT ) , bilirubin , alkaline phosphatase , gama-glutamic transaminase ( GGT ) , T3 , T4 , TSH , LH/FSH , cortisol , and melatonin serum concentrations . In addition , the Epworth Somnolence Scale ( ESS ) and a sleep diary ( SD ) were also applied to the volunteers 1 wk before each PSG . In addition , the volunteers were asked about possible side effects ( SE ) that appeared during the treatment . The study was carried out according to the following timetable : Visit 0 , filling out the term of consent and inclusion criteria ; Visit 1 , PSG , laboratory examinations , ESS , SD , melatonin serum concentrations ; Visit 2 , SD , melatonin serum concentrations , SE ; Visit 3 , melatonin serum concentrations , PSG , ESS , SE ; Visit 4 , laboratory examinations , SE , melatonin serum concentrations , SD ; and Visit 5 , PSG , ESS , SE . Analysis of the PSG showed a statistically significant reduction of stage 1 of sleep in the melatonin group . No other differences between the placebo and melatonin groups were obtained . In the present study we did not observe , according to the parameters analyzed , any toxicological effect that might compromise the use of melatonin at a dose of 10 mg for the period of time utilized in this study",
"Nonalcoholic fatty liver disease is the most common chronic liver disease and nonalcocholic steatohepatitis ( NASH ) is its advanced form . Oxidative stress and hepatocyte apoptosis may be involved in pathogenesis of NASH and particularly in progress of NASH to liver fibrosis and cirrhosis , which are initiated by the inflammation and which promote the progress of the disease . The aim of this study was to evaluate the effects of melatonin and L-tryptophan on selected biochemical parameters of blood in patients with NASH . Forty five patients with NASH , confirmed by histopathological examination of liver biopsy sample s , were admitted to the study . They were divided into three groups ( I , II and III ) . The first group ( group I , n=15 ) received preparation Essentiale forte 3 times a day and tryptophan 500 mg twice daily for 4 weeks . In the second group ( group II , n=15 ) , Essentiale forte three times a day was administered with melatonin 5 mg applied twice a day for 4 weeks . The third group ( group III , n=15 ) received only Essentiale forte with placebo three times a day for 4 weeks . After four-week treatment we found statistically significant reduction in GGTP , triglycerides and proinflammatory cytokine levels in the melatonin-treated ( group I ) and the L-tryptophan-treated patients ( group II ) . Plasma level of melatonin was significantly elevated in groups treated with tryptophan ( group I ) and melatonin ( group II ) , but remained unchanged in placebo-treated group ( group III ) . Among patients from the third group ( treated with placebo ) no statistically significant differences in the measured biochemical parameters were observed . The present study suggests that melatonin and tryptophan have the significant impact on the reduction in plasma levels of proinflammatory cytokines and may be useful in the treatment of patients with NASH",
"Background : In this study , we investigated the effect of melatonin administration on four markers of endothelial cell function including intercellular adhesion molecule ( ICAM ) , vascular cell adhesion molecule ( VCAM ) , C-reactive protein ( CRP ) , and nitric oxide ( NO ) on patients with three vessels coronary disease . Material s and Methods : This double-blind , r and omized , controlled trial study was conducted on 39 patients ( 32 men and 7 women ) with three vessels coronary disease . The case group included 20 patients who received 10 mg oral melatonin 1 h before sleeping for 1 month . The control group included 19 patients who received placebo 1 h before sleeping for 1 month . The serum levels of CRP , ICAM , VCAM , and NO were compared after 1 month treatment . Results : After 1 month of melatonin treatment , the mean level of ICAM , VCAM , and CRP showed a statistically significant decrease in the case group . On the other h and , the mean level of VCAM increased significantly in the control group . The mean levels of CRP and ICAM were also increased in the control group , but the difference did not reach the significant threshold . With respect to NO , there was a statistically significant increase in the case group , while there was a statistically significant decrease in serum NO in the control group . Conclusions : The results of this study suggested that melatonin may have beneficial effects on endothelial oxidative stress even in patient with severe and advanced atherosclerosis",
"It is known that neoplastic cachexia shows metabolic characteristics different from other common causes of malnutrition , and that it is mainly due to an abnormal secretion of TNF , whose levels are often high in patients with advanced neoplasia . Previous clinical studies have suggested that the pineal hormone melatonin ( MLT ) , which plays an essential role in the neuroendocrine regulation of biological systems , may improve the clinical status of advanced cancer patients and inhibit TNF secretion . To investigate the relationship between MLT , TNF and cancer-related weight loss , 100 untreatable metastatic solid tumour patients entered this study to receive either supportive care alone , or supportive care plus MLT ( 20 mg/day orally in the evening ) . Patients were observed for 3 months , and were considered evaluable when they were observed for at least 2 months . There were 86 evaluable patients , the other 14 patients having died from rapid progression of disease . The per cent of weight loss greater than 10 % was significantly higher in patients treated by supportive care alone than in those concomitantly treated by MLT , with no difference in food intake ( P Mean serum levels of TNF progressively increased in the supportive care group , but to levels that were not significantly different from pretreatment values . In contrast , TNF mean concentrations significantly decreased ( P MLT . These results suggest that the pineal hormone MLT may be effective in the treatment of the neoplastic cachexia by decreasing TNF blood concentrations",
"BACKGROUND The aim of this clinical trial was to determine the effects of melatonin administration on disease severity and sleep quality in children diagnosed with atopic dermatitis ( AD ) . METHODS This r and omized , double-blinded , placebo-controlled trial was conducted by recruiting 70 patients , aged 6 - 12 years , who had been diagnosed with AD . Study participants were r and omly allocated into two intervention groups to receive either 6 mg/d melatonin supplements or placebo ( n = 35 each group ) for 6 weeks . Severity of disease was assessed using the scoring atopic dermatitis ( SCORAD ) and objective SCORAD indices . Sleep quality was evaluated by completing the Children 's Sleep Habits Question naire ( CSHQ ) . RESULTS Following 6 weeks of intervention , melatonin supplementation significantly improved SCORAD index ( β -3.55 ; 95 % CI , -6.11 , -0.98 ; P = 0.007 ) , objective SCORAD index ( β -3.23 ; 95 % CI , -5.08 , -1.38 ; P = 0.001 ) , serum total IgE levels ( β -153.94 ku/L ; 95 % CI , -260.39 , -47.49 ; P = 0.005 ) , and CSHQ scores ( β -2.55 ; 95 % CI , -4.34 , -0.75 ; P = 0.006 ) . However , melatonin had no significant impact on pruritus scores , high-sensitivity C-reactive protein ( hs-CRP ) , sleep-onset latency , total sleep time , weight , and BMI compared with placebo . CONCLUSIONS Overall , melatonin supplementation had beneficial effects on disease severity , serum total IgE levels , and CSHQ among children diagnosed with AD",
"Background Diabetes mellitus ( DM ) and periodontitis are two common chronic diseases with bidirectional relationship . Oxidative stress plays a key role in the pathogenesis of these two diseases . The aim of this study was to investigate the effects of melatonin supplementation in adjunct with non-surgical periodontal therapy on periodontal status , serum melatonin and inflammatory markers in type 2 DM patients with chronic periodontitis ( CP ) . Material s and methods In this double-blind clinical trial study , 50 type 2 DM patients with CP were r and omly allocated to the intervention and control groups . The intervention and control groups received either 6 mg melatonin or placebo ( 2 tablets ) once a day . Serum levels of melatonin , tumor necrosis factor-alpha ( TNF-α ) , interleukin-6 ( IL-6 ) , hs-C-reactive protein ( hs-CRP ) , clinical attachment loss ( CAL ) , pocket depth ( PD ) , bleeding on probing ( BOP ) and plaque index were evaluated in all subjects pre- and post-intervention . Results Melatonin supplementation significantly increased the mean serum levels of melatonin after intervention . The mean changes of melatonin were significantly higher in intervention group compared with control group . IL-6 and hs-CRP levels were significantly ( p = 0.008 and p = 0.017 , respectively ) reduced in the intervention group . The mean changes of IL-6 were significantly lower in the intervention group compared with the control group ( p = 0.04 ) . In the intervention group , PD and CAL were significantly decreased after intervention ( p the mean change of PD and CAL between the intervention and control groups after intervention ( p Conclusions Melatonin supplementation in adjunct with non-surgical periodontal therapy might improve inflammatory and periodontal status in T2DM with CP",
"Multiple sclerosis ( MS ) is a chronic inflammatory disease , which leads to focal plaques of demyelination and tissue injury in the central nervous system ( CNS ) . Neuroinflammation and oxidative stress are involved in the pathogenesis of MS , promoting tissue damage and demielinization . Current research findings suggest that melatonin has antioxidant and neuroprotective effects . The aim of this study was to evaluate the efficacy of melatonin on serum pro-inflammatory cytokines and oxidative stress markers in relapsing-remitting multiple sclerosis ( RRMS ) . 36 patients diagnose with RRMS treated with Interferon β-1b ( IFNβ-1b ) were enrolled in a double bind , r and omized , placebo controlled trial . The experimental group received orally 25 mg/d of melatonin for 6 months . After melatonin administration , we observed a significant decrease in serum concentration of pro-inflammatory cytokines and oxidative stress markers ; 18 % for TNF-α ( p nitric oxide catabolites ( NOC ) levels ( p difference in clinical efficacy outcomes were found between groups . Melatonin treatment was well tolerated and we did not observe significant differences in rates of side effects between the two groups . We concluded that melatonin administration during 6 months period is effective in reducing levels of serum pro-inflammatory cytokines and oxidative stress markers in patients with RRMS . These data support future studies evaluating the safety and effectiveness of melatonin supplementation in RRMS patients"
] | 41167612-06ff-11f0-808a-c43d1ab1c353 |
Background For patients with chronic , non-cancer pain , traditional pain-relieving medications include opioids , which have shown benefits but are associated with increased risks of addiction and adverse effects . Medical cannabis has emerged as a treatment alternative for managing these patients and there has been a rise in the number of r and omized clinical trials in recent years ; therefore , a systematic review of the evidence was warranted . Objective To analyze the evidence surrounding the benefits and harms of medical cannabinoids in the treatment of chronic , non-cancer-related pain . Design Systematic review with meta- analysis . Data sources Medline , Embase , CINAHL , SCOPUS , Google Scholar , and Cochrane Data bases . Eligibility criteria English language r and omized clinical trials of cannabinoids for the treatment of chronic , non-cancer-related pain . Data extraction and synthesis Study quality was assessed using the Cochrane risk of bias tool . All stages were conducted independently by a team of 6 review ers . Data were pooled through meta- analysis with different duration s of treatment ( 2 weeks , 2 months , 6 months ) and stratified by route of administration ( smoked , oromucosal , oral ) , conditions , and type of cannabinoids . Main outcomes and measures Patient-reported pain and adverse events ( AEs ) . Results Thirty-six trials ( 4006 participants ) were included , examining smoked cannabis ( 4 trials ) , oromucosal cannabis sprays ( 14 trials ) , and oral cannabinoids ( 18 trials ) . Compared with placebo , cannabinoids showed a significant reduction in pain which was greatest with treatment duration of 2 to 8 weeks ( weighted mean difference on a 0 - 10 pain visual analogue scale -0.68 , 95 % confidence interval [ CI ] , -0.96 to -0.40 , I 2 = 8 % , P reduction in pain compared with placebo relative to oromucosal and smoked formulations but the difference was not significant ( P[interaction ] > .05 in all the 3 duration s of treatment ) ; cannabinoids had a smaller reduction in pain due to multiple sclerosis compared with placebo relative to other neuropathic pain ( P[interaction ] = .05 ) within 2 weeks and the difference was not significant relative to pain due to rheumatic arthritis ; nabilone had a greater reduction in pain compared with placebo relative to other types of cannabinoids longer than 2 weeks of treatment but the difference was not significant ( P[interaction ] > .05 ) . Serious AEs were rare , and similar across the cannabinoid ( 74 out of 2176 , 3.4 % ) and placebo groups ( 53 out of 1640 , 3.2 % ) . There was an increased risk of non-serious AEs with cannabinoids compared with placebo . Conclusions There was moderate evidence to support cannabinoids in treating chronic , non-cancer pain at 2 weeks . Similar results were observed at later time points , but the confidence in effect is low . There is little evidence that cannabinoids increase the risk of experiencing serious AEs , although non-serious AEs may be common in the short-term period following use | [
"BACKGROUND The Cannabinoid Use in Progressive Inflammatory brain Disease ( CUPID ) trial aim ed to determine whether or not oral Δ(9)-tetrahydrocannabinol ( Δ(9)-THC ) slowed the course of progressive multiple sclerosis ( MS ) ; evaluate safety of cannabinoid administration ; and , improve methods for testing treatments in progressive MS . OBJECTIVES There were three objectives in the CUPID study : ( 1 ) to evaluate whether or not Δ(9)-THC could slow the course of progressive MS ; ( 2 ) to assess the long-term safety of Δ(9)-THC ; and ( 3 ) to explore newer ways of conducting clinical trials in progressive MS . DESIGN The CUPID trial was a r and omised , double-blind , placebo-controlled , parallel-group , multicentre trial . Patients were r and omised in a 2 : 1 ratio to Δ(9)-THC or placebo . R and omisation was balanced according to Exp and ed Disability Status Scale ( EDSS ) score , study site and disease type . Analyses were by intention to treat , following a pre-specified statistical analysis plan . A cranial magnetic resonance imaging ( MRI ) sub study , Rasch measurement theory ( RMT ) analyses and an economic evaluation were undertaken . SETTING Twenty-seven UK sites . PARTICIPANTS Adults aged 18 - 65 years with primary or secondary progressive MS , 1-year evidence of disease progression and baseline EDSS 4.0 - 6.5 . INTERVENTIONS Oral Δ(9)-THC ( maximum 28 mg/day ) or matching placebo . ASSESSMENT VISITS Three and 6 months , and then 6-monthly up to 36 or 42 months . MAIN OUTCOME MEASURES Primary outcomes were time to EDSS progression , and change in Multiple Sclerosis Impact Scale-29 version 2 ( MSIS-29v2 ) 20-point physical subscale ( MSIS-29phys ) score . Various secondary patient- and clinician-reported outcomes and MRI outcomes were assessed . RMT analyses examined performance of MS-specific rating scales as measurement instruments and tested for a symptomatic or disease-modifying treatment effect . Economic evaluation estimated mean incremental costs and quality -adjusted life-years ( QALYs ) . RESULTS Effectiveness - recruitment targets were achieved . Of the 498 r and omised patients ( 332 to active and 166 to placebo ) , 493 ( 329 active and 164 placebo ) were analysed . PRIMARY OUTCOMES no significant treatment effect ; hazard ratio EDSS score progression ( active : placebo ) 0.92 [ 95 % confidence interval ( CI ) 0.68 to 1.23 ] ; and estimated between-group difference in MSIS-29phys score ( active-placebo ) -0.9 points ( 95 % CI -2.0 to 0.2 points ) . Secondary clinical and MRI outcomes : no significant treatment effects . Safety - at least one serious adverse event : 35 % and 28 % of active and placebo patients , respectively . RMT analyses - scale evaluation : MSIS-29 version 2 , MS Walking Scale-12 version 2 and MS Spasticity Scale-88 were robust measurement instruments . There was no clear symptomatic or disease-modifying treatment effect . Economic evaluation - estimated mean incremental cost to NHS over usual care , over 3 years £ 27,443.20 per patient . No between-group difference in QALYs . CONCLUSIONS The CUPID trial failed to demonstrate a significant treatment effect in primary or secondary outcomes . There were no major safety concerns , but unwanted side effects seemed to affect compliance . Participants were more disabled than in previous studies and deteriorated less than expected , possibly reducing our ability to detect treatment effects . RMT analyses supported performance of MS-specific rating scales as measures , enabled group- and individual person-level examination of treatment effects , but did not influence study inferences . The intervention had significant additional costs with no improvement in health outcomes ; therefore , it was dominated by usual care and not cost-effective . Future work should focus on determining further factors to predict clinical deterioration , to inform the development of new studies , and modifying treatments in order to minimise side effects and improve study compliance . The absence of disease-modifying treatments in progressive MS warrants further studies of the cannabinoid pathway in potential neuroprotection . TRIAL REGISTRATION Current Controlled Trials IS RCT N62942668 . FUNDING The National Institute for Health Research Health Technology Assessment programme , the Medical Research Council Efficacy and Mechanism Evaluation programme , Multiple Sclerosis Society and Multiple Sclerosis Trust . The report will be published in full in Health Technology Assessment ; Vol . 19 , No. 12 . See the NIHR Journals Library website for further project information",
"Abstract Objective To evaluate the effect of the oral synthetic δ-9-tetrahydrocannabinol dronabinol on central neuropathic pain in patients with multiple sclerosis . Design R and omised double blind placebo controlled crossovertrial . Setting Outpatient clinic , University Hospital of Aarhus , Denmark . Participants 24 patients aged between 23 and 55 years with multiple sclerosis and central pain . Intervention Orally administered dronabinol at a maximum doseof 10 mg daily or corresponding placebo for three weeks ( 15 - 21days ) , separated by a three week washout period . Main outcome measure Median spontaneous pain intensity ( numericalrating scale ) in the last week of treatment . Results Median spontaneous pain intensity was significantlylower during dronabinol treatment than during placebo treatment(4.0 ( 25th to 75th centiles 2.3 to 6.0 ) v 5.0 ( 4.0 to 6.4),P = 0.02 ) , and median pain relief score ( numerical rating scale)was higher ( 3.0 ( 0 to 6.7 ) v > 0 ( 0 to 2.3 ) , P = 0.035 ) . Thenumber needed to treat for 50 % pain relief was 3.5 ( 95 % confidenceinterval 1.9 to 24.8 ) . On the SF-36 quality of life scale , thetwo items bodily pain and mental health indicated benefits fromactive treatment compared with placebo . The number of patients with adverse events was higher during active treatment , especiallyin the first week of treatment . The functional ability of themultiple sclerosis patients did not change . Conclusions Dronabinol has a modest but clinical ly relevantanalgesic effect on central pain in patients with multiple sclerosis . Adverse events , including dizziness , were more frequent withdronabinol than with placebo during the first week of treatment",
"The objective was to determine whether a cannabis-based medicinal extract ( CBME ) benefits a range of symptoms due to multiple sclerosis ( MS ) . A parallel group , double-blind , r and omized , placebo-controlled study was undertaken in three centres , recruiting 160 out patients with MS experiencing significant problems from at least one of the following : spasticity , spasms , bladder problems , tremor or pain . The interventions were oromucosal sprays of matched placebo , or whole plant CBME containing equal amounts of delta-9- tetrahydrocannabinol ( THC ) and cannabidiol ( CBD ) at a dose of 2.5- 120 mg of each daily , in divided doses . The primary outcome measure was a Visual Analogue Scale ( VAS ) score for each patient ’s most troublesome symptom . Additional measures included VAS scores of other symptoms , and measures of disability , cognition , mood , sleep and fatigue . Following CBME the primary symptom score reduced from mean ( SE ) 74.36 ( 11.1 ) to 48.89 ( 22.0 ) following CBME and from 74.31 ( 12.5 ) to 54.79 ( 26.3 ) following placebo [ ns ] . Spasticity VAS scores were significantly reduced by CBME ( Sativex ) in comparison with placebo ( P- 0.001 ) . There were no significant adverse effects on cognition or mood and intoxication was generally mild",
"Objectives : To determine whether plant-derived cannabis medicinal extracts ( CME ) can alleviate neurogenic symptoms unresponsive to st and ard treatment , and to quantify adverse effects . Design : A consecutive series of double-blind , r and omized , placebo-controlled single-patient cross-over trials with two-week treatment periods . Setting : Patients attended as out patients , but took the CME at home . Subjects : Twenty-four patients with multiple sclerosis ( 18 ) , spinal cord injury ( 4 ) , brachial plexus damage ( 1 ) , and limb amputation due to neurofibromatosis ( 1 ) . Intervention : Whole-plant extracts of delta-9-tetrahydrocannabinol ( THC ) , cannabidiol ( CBD ) , 1:1 CBD : THC , or matched placebo were self-administered by sublingual spray at doses determined by titration against symptom relief or unwanted effects within the range of 2.5–120 mg/24 hours . Measures used : Patients recorded symptom , well-being and intoxication scores on a daily basis using visual analogue scales . At the end of each two-week period an observer rated severity and frequency of symptoms on numerical rating scales , administered st and ard measures of disability ( Barthel Index ) , mood and cognition , and recorded adverse events . Results : Pain relief associated with both THC and CBD was significantly superior to placebo . Impaired bladder control , muscle spasms and spasticity were improved by CME in some patients with these symptoms . Three patients had transient hypotension and intoxication with rapid initial dosing of THC-containing CME . Conclusions : Cannabis medicinal extracts can improve neurogenic symptoms unresponsive to st and ard treatments . Unwanted effects are predictable and generally well tolerated . Larger scale studies are warranted to confirm these findings",
"Objective : To test the effectiveness and long term safety of cannabinoids in multiple sclerosis ( MS ) , in a follow up to the main Cannabinoids in Multiple Sclerosis ( CAMS ) study . Methods : In total , 630 patients with stable MS with muscle spasticity from 33 UK centres were r and omised to receive oral Δ9-tetrahydrocannabinol ( Δ9-THC ) , cannabis extract , or placebo in the main 15 week CAMS study . The primary outcome was change in the Ashworth spasticity scale . Secondary outcomes were the Rivermead Mobility Index , timed 10 metre walk , UK Neurological Disability Score , postal Barthel Index , General Health Question naire-30 , and a series of nine category rating scales . Following the main study , patients were invited to continue medication , double blinded , for up to12 months in the follow up study reported here . Results : Intention to treat analysis of data from the 80 % of patients followed up for 12 months showed evidence of a small treatment effect on muscle spasticity as measured by change in Ashworth score from baseline to 12 months ( Δ9-THC mean reduction 1·82 ( n = 154 , 95 % confidence interval ( CI ) 0.53 to 3.12 ) , cannabis extract 0.10 ( n = 172 , 95 % CI −0.99 to 1.19 ) , placebo −0.23 ( n = 176 , 95 % CI −1.41 to 0.94 ) ; p = 0.04 unadjusted for ambulatory status and centre , p = 0.01 adjusted ) . There was suggestive evidence for treatment effects of Δ9-THC on some aspects of disability . There were no major safety concerns . Overall , patients felt that these drugs were helpful in treating their disease . Conclusions : These data provide limited evidence for a longer term treatment effect of cannabinoids . A long term placebo controlled study is now needed to establish whether cannabinoids may have a role beyond symptom amelioration in MS",
"Background : Central pain in multiple sclerosis ( MS ) is common and often refractory to treatment . Methods : We conducted a single-center , 5-week ( 1-week run-in , 4-week treatment ) , r and omized , double-blind , placebo-controlled , parallel-group trial in 66 patients with MS and central pain states ( 59 dysesthetic , seven painful spasms ) of a whole-plant cannabis-based medicine ( CBM ) , containing delta-9-tetrahydrocannabinol : cannabidiol ( THC : CBD ) delivered via an oromucosal spray , as adjunctive analgesic treatment . Each spray delivered 2.7 mg of THC and 2.5 of CBD , and patients could gradually self-titrate to a maximum of 48 sprays in 24 hours . Results : Sixty-four patients ( 97 % ) completed the trial , 34 received CBM . In week 4 , the mean number of daily sprays taken of CBM ( n = 32 ) was 9.6 ( range 2 to 25 , SD = 6.0 ) and of placebo ( n = 31 ) was 19.1 ( range 1 to 47 , SD = 12.9 ) . Pain and sleep disturbance were recorded daily on an 11-point numerical rating scale . CBM was superior to placebo in reducing the mean intensity of pain ( CBM mean change −2.7 , 95 % CI : −3.4 to −2.0 , placebo –1.4 95 % CI : −2.0 to −0.8 , comparison between groups , p = 0.005 ) and sleep disturbance ( CBM mean change –2.5 , 95 % CI : −3.4 to −1.7 , placebo –0.8 , 95 % CI : −1.5 to −0.1 , comparison between groups , p = 0.003 ) . CBM was generally well tolerated , although more patients on CBM than placebo reported dizziness , dry mouth , and somnolence . Cognitive side effects were limited to long-term memory storage . Conclusions : Cannabis-based medicine is effective in reducing pain and sleep disturbance in patients with multiple sclerosis related central neuropathic pain and is mostly well tolerated",
"BACKGROUND Spasticity is a disabling complication of multiple sclerosis , affecting many patients with the condition . We report the first Phase 3 placebo-controlled study of an oral antispasticity agent to use an enriched study design . METHODS A 19-week follow-up , multicentre , double-blind , r and omized , placebo-controlled , parallel-group study in subjects with multiple sclerosis spasticity not fully relieved with current antispasticity therapy . Subjects were treated with nabiximols , as add-on therapy , in a single-blind manner for 4weeks , after which those achieving an improvement in spasticity of ≥20 % progressed to a 12-week r and omized , placebo-controlled phase . RESULTS Of the 572 subjects enrolled , 272 achieved a ≥20 % improvement after 4weeks of single-blind treatment , and 241 were r and omized . The primary end-point was the difference between treatments in the mean spasticity Numeric Rating Scale ( NRS ) in the r and omized , controlled phase of the study . Intention-to-treat ( ITT ) analysis showed a highly significant difference in favour of nabiximols ( P=0.0002 ) . Secondary end-points of responder analysis , Spasm Frequency Score , Sleep Disturbance NRS Patient , Carer and Clinician Global Impression of Change were all significant in favour of nabiximols . CONCLUSIONS The enriched study design provides a method of determining the efficacy and safety of nabiximols in a way that more closely reflects proposed clinical practice , by limiting exposure to those patients who are likely to benefit from it . Hence , the difference between active and placebo should be a reflection of efficacy and safety in the population intended for treatment",
"Objective : To determine the effect of smoked cannabis on the neuropathic pain of HIV-associated sensory neuropathy and an experimental pain model . Methods : Prospect i ve r and omized placebo-controlled trial conducted in the inpatient General Clinical Research Center between May 2003 and May 2005 involving adults with painful HIV-associated sensory neuropathy . Patients were r and omly assigned to smoke either cannabis ( 3.56 % tetrahydrocannabinol ) or identical placebo cigarettes with the cannabinoids extracted three times daily for 5 days . Primary outcome measures included ratings of chronic pain and the percentage achieving > 30 % reduction in pain intensity . Acute analgesic and anti-hyperalgesic effects of smoked cannabis were assessed using a cutaneous heat stimulation procedure and the heat/capsaicin sensitization model . Results : Fifty patients completed the entire trial . Smoked cannabis reduced daily pain by 34 % ( median reduction ; IQR = −71 , −16 ) vs 17 % ( IQR = −29 , 8) with placebo ( p = 0.03 ) . Greater than 30 % reduction in pain was reported by 52 % in the cannabis group and by 24 % in the placebo group ( p = 0.04 ) . The first cannabis cigarette reduced chronic pain by a median of 72 % vs 15 % with placebo ( p 0.001 ) . Cannabis reduced experimentally induced hyperalgesia to both brush and von Frey hair stimuli ( p ≤ 0.05 ) but appeared to have little effect on the painfulness of noxious heat stimulation . No serious adverse events were reported . Conclusion : Smoked cannabis was well tolerated and effectively relieved chronic neuropathic pain from HIV-associated sensory neuropathy . The findings are comparable to oral drugs used for chronic neuropathic pain",
"Background : Spasticity is a common and poorly controlled symptom of multiple sclerosis . Our objective was to determine the short-term effect of smoked cannabis on this symptom . Methods : We conducted a placebo-controlled , crossover trial involving adult patients with multiple sclerosis and spasticity . We recruited participants from a regional clinic or by referral from specialists . We r and omly assigned participants to either the intervention ( smoked cannabis , once daily for three days ) or control ( identical placebo cigarettes , once daily for three days ) . Each participant was assessed daily before and after treatment . After a washout interval of 11 days , participants crossed over to the opposite group . Our primary outcome was change in spasticity as measured by patient score on the modified Ashworth scale . Our secondary outcomes included patients ’ perception of pain ( as measured using a visual analogue scale ) , a timed walk and changes in cognitive function ( as measured by patient performance on the Paced Auditory Serial Addition Test ) , in addition to ratings of fatigue . Results : Thirty-seven participants were r and omized at the start of the study , 30 of whom completed the trial . Treatment with smoked cannabis result ed in a reduction in patient scores on the modified Ashworth scale by an average of 2.74 points more than placebo ( p reduced pain scores on a visual analogue scale by an average of 5.28 points more than placebo ( p = 0.008 ) . Scores for the timed walk did not differ significantly between treatment and placebo ( p = 0.2 ) . Scores on the Paced Auditory Serial Addition Test decreased by 8.67 points more with treatment than with placebo ( p = 0.003 ) . No serious adverse events occurred during the trial . Interpretation : Smoked cannabis was superior to placebo in symptom and pain reduction in participants with treatment-resistant spasticity . Future studies should examine whether different doses can result in similar beneficial effects with less cognitive impact",
"Background : Chronic neuropathic pain affects 1%–2 % of the adult population and is often refractory to st and ard pharmacologic treatment . Patients with chronic pain have reported using smoked cannabis to relieve pain , improve sleep and improve mood . Methods : Adults with post-traumatic or postsurgical neuropathic pain were r and omly assigned to receive cannabis at four potencies ( 0 % , 2.5 % , 6 % and 9.4 % tetrahydrocannabinol ) over four 14-day periods in a crossover trial . Participants inhaled a single 25-mg dose through a pipe three times daily for the first five days in each cycle , followed by a nine-day washout period . Daily average pain intensity was measured using an 11-point numeric rating scale . We recorded effects on mood , sleep and quality of life , as well as adverse events . Results : We recruited 23 participants ( mean age 45.4 [ st and ard deviation 12.3 ] years , 12 women [ 52 % ] ) , of whom 21 completed the trial . The average daily pain intensity , measured on the 11-point numeric rating scale , was lower on the prespecified primary contrast of 9.4 % v. 0 % tetrahydrocannabinol ( 5.4 v. 6.1 , respectively ; difference = 0.7 , 95 % confidence interval [ CI ] 0.02–1.4 ) . Preparations with intermediate potency yielded intermediate but nonsignificant degrees of relief . Participants receiving 9.4 % tetrahydrocannabinol reported improved ability to fall asleep ( easier , p = 0.001 ; faster , p drowsy , p = 0.003 ) and improved quality of sleep ( less wakefulness , p = 0.01 ) relative to 0 % tetrahydrocannabinol . We found no differences in mood or quality of life . The most common drug-related adverse events during the period when participants received 9.4 % tetrahydrocannabinol were headache , dry eyes , burning sensation in areas of neuropathic pain , dizziness , numbness and cough . Conclusion : A single inhalation of 25 mg of 9.4 % tetrahydrocannabinol herbal cannabis three times daily for five days reduced the intensity of pain , improved sleep and was well tolerated . Further long-term safety and efficacy studies are indicated . ( International St and ard R and omised Controlled Trial Register no. IS RCT N68314063",
"Objective Multiple sclerosis ( MS ) is associated with chronic symptoms , including muscle stiffness , spasms , pain and insomnia . Here we report the results of the Multiple Sclerosis and Extract of Cannabis ( MUSEC ) study that aim ed to substantiate the patient based findings of previous studies . Patients and methods Patients with stable MS at 22 UK centres were r and omised to oral cannabis extract ( CE ) ( N=144 ) or placebo ( N=135 ) , stratified by centre , walking ability and use of antispastic medication . This double blind , placebo controlled , phase III study had a screening period , a 2 week dose titration phase from 5 mg to a maximum of 25 mg of tetrahydrocannabinol daily and a 10 week maintenance phase . The primary outcome measure was a category rating scale ( CRS ) measuring patient reported change in muscle stiffness from baseline . Further CRSs assessed body pain , spasms and sleep quality . Three vali date d MS specific patient reported outcome measures assessed aspects of spasticity , physical and psychological impact , and walking ability . Results The rate of relief from muscle stiffness after 12 weeks was almost twice as high with CE than with placebo ( 29.4 % vs 15.7 % ; OR 2.26 ; 95 % CI 1.24 to 4.13 ; p=0.004 , one sided ) . Similar results were found after 4 weeks and 8 weeks , and also for all further CRSs . Results from the MS scales supported these findings . Conclusion The study met its primary objective to demonstrate the superiority of CE over placebo in the treatment of muscle stiffness in MS . This was supported by results for secondary efficacy variables . Adverse events in participants treated with CE were consistent with the known side effects of cannabinoids . No new safety concerns were observed . Trial registration number NCT00552604",
"& NA ; The objective was to investigate the effectiveness of cannabis‐based medicines for treatment of chronic pain associated with brachial plexus root avulsion . This condition is an excellent human model of central neuropathic pain as it represents an unusually homogenous group in terms of anatomical location of injury , pain descriptions and patient demographics . Forty‐eight patients with at least one avulsed root and baseline pain score of four or more on an 11‐point ordinate scale participated in a r and omised , double‐blind , placebo‐controlled , three period crossover study . All patients had intractable symptoms regardless of current analgesic therapy . Patients entered a baseline period of 2 weeks , followed by three , 2‐week treatment periods during each of which they received one of three oromucosal spray preparations . These were placebo and two whole plant extracts of Cannabis sativa L. : GW‐1000‐02 ( Sativex ® ) , containing Δ9tetrahydrocannabinol (THC):cannabidiol ( CBD ) in an approximate 1:1 ratio and GW‐2000‐02 , containing primarily THC . The primary outcome measure was the mean pain severity score during the last 7 days of treatment . Secondary outcome measures included pain related quality of life assessment s. The primary outcome measure failed to fall by the two points defined in our hypothesis . However , both this measure and measures of sleep showed statistically significant improvements . The study medications were generally well tolerated with the majority of adverse events , including intoxication type reactions , being mild to moderate in severity and resolving spontaneously . Studies of longer duration in neuropathic pain are required to confirm a clinical ly relevant , improvement in the treatment of this condition",
"OBJECTIVES To assess the efficacy of a cannabis-based medicine ( CBM ) in the treatment of pain due to rheumatoid arthritis ( RA ) . METHODS We compared a CBM ( Sativex ) with placebo in a r and omized , double-blind , parallel group study in 58 patients over 5 weeks of treatment . The CBM was administered by oromucosal spray in the evening and assessment s were made the following morning . Efficacy outcomes assessed were pain on movement , pain at rest , morning stiffness and sleep quality measured by a numerical rating scale , the Short-Form McGill Pain Question naire ( SF-MPQ ) and the DAS28 measure of disease activity . RESULTS Seventy-five patients were screened and 58 met the eligibility criteria . Thirty-one were r and omized to the CBM and 27 to placebo . Mean ( S.D. ) daily dose achieved in the final treatment week was 5.4 ( 0.84 ) actuations for the CBM and 5.3 ( 1.18 ) for placebo . In comparison with placebo , the CBM produced statistically significant improvements in pain on movement , pain at rest , quality of sleep , DAS28 and the SF-MPQ pain at present component . There was no effect on morning stiffness but baseline scores were low . The large majority of adverse effects were mild or moderate , and there were no adverse effect-related withdrawals or serious adverse effects in the active treatment group . CONCLUSIONS In the first ever controlled trial of a CBM in RA , a significant analgesic effect was observed and disease activity was significantly suppressed following Sativex treatment . Whilst the differences are small and variable across the population , they represent benefits of clinical relevance and show the need for more detailed investigation in this indication",
"PURPOSE The aim of the present study was to evaluate the efficacy of an oral formulation of Δ9-tetrahydrocannabinol ( ECP002A ) in patients with progressive multiple sclerosis ( MS ) . METHODS This accelerated proof-of-concept study consisted of 2 phases : a crossover challenge ( dose-finding ) phase and a 4-week , parallel , r and omized , placebo-controlled treatment phase . Twenty-four patients with progressive MS and moderate spasticity were enrolled . During the treatment phase , biomarkers for efficacy and secondary pharmacodynamic effects were measured at baseline and after 2 and 4 weeks of treatment . Serum sample s were collected to determine pharmacokinetic properties and perform population modeling . Safety and tolerability profiles were assessed based on adverse events and safety measurements . FINDINGS Pain was significantly reduced when measured directly after administration of ECP002A in the clinic but not when measured in a daily diary . A similar pattern was observed in subjective muscle spasticity . Other clinical outcomes were not significantly different between active treatment and placebo . Cognitive testing indicated that there was no decline in cognition after 2 or 4 weeks of treatment attributable to ECP002A compared with placebo . Implication s This study specifically underlines the added value of thorough investigation of pharmacokinetic and pharmacodynamic associations in the target population . Despite the complex interplay of psychoactive effects and analgesia , the current oral formulation of Δ9-tetrahydrocannabinol may play a role in the treatment of spasticity and pain associated with MS because it was well tolerated and had a stable pharmacokinetic profile",
"BACKGROUND Peripheral neuropathic pain ( PNP ) associated with allodynia poses a significant clinical challenge . The efficacy of Δ(9 ) -tetrahydrocannabinol/cannabidiol ( THC/CBD ) oromucosal spray , a novel cannabinoid formulation , was investigated in this 15-week r and omized , double-blind , placebo-controlled parallel group study . METHODS In total , 303 patients with PNP associated with allodynia were screened ; 128 were r and omized to THC/CBD spray and 118 to placebo , in addition to their current analgesic therapy . The co- primary efficacy endpoints were the 30 % responder rate in PNP 0 - 10 numerical rating scale ( NRS ) score and the mean change from baseline to the end of treatment in this score . Various key secondary measures of pain and functioning were also investigated . RESULTS At the 30 % responder level , there were statistically significant treatment differences in favour of THC/CBD spray in the full analysis ( intention-to-treat ) data set [ p = 0.034 ; 95 % confidence interval ( CI ) : 1.05 - 3.70 ] . There was also a reduction in mean PNP 0 - 10 NRS scores in both treatment groups that was numerically higher in the THC/CBD spray group , but which failed to reach statistical significance . Secondary measures of sleep quality 0 - 10 NRS score ( p = 0.0072 ) and Subject Global Impression of Change ( SGIC ) ( p = 0.023 ) also demonstrated statistically significant treatment differences in favour of THC/CBD spray treatment . CONCLUSIONS These findings demonstrate that , in a meaningful proportion of otherwise treatment-resistant patients , clinical ly important improvements in pain , sleep quality and SGIC of the severity of their condition are obtained with THC/CBD spray . THC/CBD spray was well tolerated and no new safety concerns were identified",
"Three Cannabis Based Medicinal Extracts ( CBMEs ) for sublingual use became available in 2000 . A total of 34 ‘ N of 1 ’ studies were undertaken using this novel therapy for patients with chronic , mainly neuropathic , pain and associated symptoms to explore efficacy , tolerability , safety and dosages . Three CBMEs ( Δ9 Tetrahydrocannabinol ( THC ) , Cannabidiol ( CBD ) and a 1 : 1 mixture of them both ) were given over a 12‐week period . After an initial open‐label period , the CBMEs were used in a r and omised , double‐blind , placebo controlled , crossover trial . Extracts which contained THC proved most effective in symptom control . Regimens for the use of the sublingual spray emerged and a wide range of dosing requirements was observed . Side‐effects were common , reflecting a learning curve for both patient and study team . These were generally acceptable and little different to those seen when other psycho‐active agents are used for chronic pain . These initial experiences with CBME open the way to more detailed and extensive studies",
"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 Many patients with amyotrophic lateral sclerosis ( ALS ) experience cramps during the course of the disease but so far , none of the medications used has been of proven benefit . The objective was to determine the effect of orally administered tetrahydrocannabinol ( THC ) on cramps in ALS patients . Methods The authors conducted a r and omised , double-blind , placebo-controlled crossover trial in 27 ALS patients suffering from moderate to severe ( visual analogue scale ( VAS ) ; VAS≥4 ) daily cramps . There were 7 women and 20 men with a mean age of 57 years and a mean functional ALS score ( ALSFRS-R ) of 38.4 . Patients were r and omly assigned to receive 5 mg THC twice daily followed by placebo or vice versa . Each treatment period lasted for 2 weeks and was preceded by a 2-week drug-free observation period ( run-in , wash-out period respectively ) . The primary outcome measure was change in cramp intensity as assessed by a VAS . Secondary outcome measures included the number of cramps per day , number of cramps during daytime and bedtime , intensity of fasciculations ( VAS ) as well as vali date d measures of quality of life ( ALSAQ-40 ) , quality of sleep ( SDQ ) , appetite ( FAACT ) and depression ( HADS ) . Results Complete data were available from 22 patients . THC was well tolerated . There was no evidence for a treatment effect on cramp intensity , number of cramps , fasciculation intensity or any of the other secondary outcome measures . Conclusions This interventional study with orally administered THC 5 mg twice daily did not demonstrate subjective improvement of cramp intensity in ALS patients",
"Despite management with opioids and other pain modifying therapies , neuropathic pain continues to reduce the quality of life and daily functioning in HIV-infected individuals . Cannabinoid receptors in the central and peripheral nervous systems have been shown to modulate pain perception . We conducted a clinical trial to assess the impact of smoked cannabis on neuropathic pain in HIV . This was a phase II , double-blind , placebo-controlled , crossover trial of analgesia with smoked cannabis in HIV-associated distal sensory predominant polyneuropathy ( DSPN ) . Eligible subjects had neuropathic pain refractory to at least two previous analgesic classes ; they continued on their pre study analgesic regimens throughout the trial . Regulatory considerations dictated that subjects smoke under direct observation in a hospital setting . Treatments were placebo and active cannabis ranging in potency between 1 and 8 % Δ-9-tetrahydrocannabinol , four times daily for 5 consecutive days during each of 2 treatment weeks , separated by a 2-week washout . The primary outcome was change in pain intensity as measured by the Descriptor Differential Scale ( DDS ) from a pretreatment baseline to the end of each treatment week . Secondary measures included assessment s of mood and daily functioning . Of 127 volunteers screened , 34 eligible subjects enrolled and 28 completed both cannabis and placebo treatments . Among the completers , pain relief was greater with cannabis than placebo ( median difference in DDS pain intensity change , 3.3 points , effect size=0.60 ; p=0.016 ) . The proportions of subjects achieving at least 30 % pain relief with cannabis versus placebo were 0.46 ( 95%CI 0.28 , 0.65 ) and 0.18 ( 0.03 , 0.32 ) . Mood and daily functioning improved to a similar extent during both treatment periods . Although most side effects were mild and self-limited , two subjects experienced treatment-limiting toxicities . Smoked cannabis was generally well tolerated and effective when added to concomitant analgesic therapy in patients with medically refractory pain due to HIV DSPN",
"Abstract Cannabinoids are known to have analgesic properties . We evaluated the effect of oro‐mucosal sativex , ( THC : CBD ) , an endocannabinoid system modulator , on pain and allodynia , in 125 patients with neuropathic pain of peripheral origin in a five‐week , r and omised , double‐blind , placebo‐controlled , parallel design trial . Patients remained on their existing stable analgesia . A self‐titrating regimen was used to optimise drug administration . Sixty‐three patients were r and omised to receive sativex and 62 placebo . The mean reduction in pain intensity scores ( primary outcome measure ) was greater in patients receiving sativex than placebo ( mean adjusted scores −1.48 points vs. −0.52 points on a 0–10 Numerical Rating Scale ( p = 0.004 ; 95 % CI : −1.59 , −0.32 ) . Improvements in Neuropathic Pain Scale composite score ( p = 0.007 ) , sleep NRS ( p = 0.001 ) , dynamic allodynia ( p = 0.042 ) , punctate allodynia ( p = 0.021 ) , Pain Disability Index ( p = 0.003 ) and Patient ’s Global Impression of Change ( p vs. placebo . Sedative and gastrointestinal side effects were reported more commonly by patients on active medication . Of all participants , 18 % on sativex and 3 % on placebo withdrew during the study . An open‐label extension study showed that the initial pain relief was maintained without dose escalation or toxicity for 52 weeks",
"CONTEXT 1',1'dimethylheptyl-Delta8-tetrahydrocannabinol-11-oic acid ( CT-3 ) , a potent analog of THC-11-oic acid , produces marked antiallodynic and analgesic effects in animals without evoking the typical effects described in models of cannabinoids . Therefore , CT-3 may be an effective analgesic for poorly controlled resistant neuropathic pain . OBJECTIVE To examine the analgesic efficacy and safety of CT-3 in chronic neuropathic pain in humans . DESIGN AND SETTING R and omized , placebo-controlled , double-blind crossover trial conducted in Germany from May-September 2002 . PARTICIPANTS Twenty-one patients ( 8 women and 13 men ) aged 29 to 65 years ( mean , 51 years ) who had a clinical presentation and examination consistent with chronic neuropathic pain ( for at least 6 months ) with hyperalgesia ( n = 21 ) and allodynia ( n = 7 ) . INTERVENTIONS Patients were r and omized to two 7-day treatment orders in a crossover design . Two daily doses of CT-3 ( four 10-mg capsules per day ) or identical placebo capsules were given during the first 4 days and 8 capsules per day were given in 2 daily doses in the following 3 days . After a washout and baseline period of 1 week each , patients crossed over to the second 7-day treatment period . MAIN OUTCOME MEASURES Visual analog scale ( VAS ) and verbal rating scale scores for pain ; vital sign , hematologic and blood chemistry , and electrocardiogram measurements ; scores on the Trail-Making Test and the Addiction Research Center Inventory-Marijuana scale ; and adverse effects . RESULTS The mean differences over time for the VAS values in the CT-3-placebo sequence measured 3 hours after intake of study drug differed significantly from those in the placebo-CT-3 sequence ( mean [ SD ] , -11.54 [ 14.16 ] vs 9.86 [ 21.43 ] ; P = .02 ) . Eight hours after intake of the drug , the pain scale differences between groups were less marked . No dose response was observed . Adverse effects , mainly transient dry mouth and tiredness , were reported significantly more often during CT-3 treatment ( mean [ SD ] difference , -0.67 [ 0.50 ] for CT-3-placebo sequence vs 0.10 [ 0.74 ] for placebo-CT-3 sequence ; P = .02 ) . There were no significant differences with respect to vital signs , blood tests , electrocardiogram , Trail-Making Test , and Addiction Research Center Inventory-Marijuana scale . No carryover or period effects were observed except on the Trail-Making Test . CONCLUSIONS In this preliminary study , CT-3 was effective in reducing chronic neuropathic pain compared with placebo . No major adverse effects were observed",
"Despite the proven efficacy of Sativex ® ( 9-delta-tetrahydrocannabinol plus cannabidiol ) oromucosal spray in reducing spasticity symptoms in multiple sclerosis ( MS ) , little is known about the neurophysiological correlates of such effects . The aim of the study was to investigate the effects of Sativex on neurophysiological measures of spasticity ( H/M ratio ) and corticospinal excitability in patients with progressive MS . This was a r and omized , double-blind , placebo-controlled , crossover study . Consecutive subjects with progressive MS and lower limb spasticity referred to our center were r and omized to 4 weeks ’ treatment ( including 2 weeks ’ titration ) with Sativex or placebo , with crossover after a 2-week washout . Clinical and neurophysiological measures ( H/M ratio and cortical excitability ) of spasticity were assessed . The H/M ratio was the primary outcome , with sample size calculation of 40 patients . Of 44 recruited patients , 34 were analyzed due to 6 drop-outs and 4 exclusions , which lowered the power of the study to show differences between treatments . Neurophysiological measures did not differ significantly according to treatment and did not correlate significantly with clinical response . Response on the modified Ashworth scale ( at least 20 % improvement ) was significantly more frequent after Sativex than placebo ( 50 vs 23.5 % ; p = 0.041 ; McNemar ) . Side effects did not differ significantly according to treatment . Our findings confirm the clinical benefit of Sativex on MS spasticity . The lack of corresponding changes in corticospinal excitability and on the monosynaptic component , of the stretch reflex , although in a limited sample size , points to the involvement of other spinal and supraspinal mechanisms in the physiopathology of spasticity in progressive MS",
"TOC summary This enriched‐enrollment , r and omized , double‐blind , placebo‐controlled , flexible‐dose adjuvant study demonstrated that nabilone provided improvements in pain , anxiety , quality of life and patient satisfaction for patients with diabetic neuropathic pain . ABSTRACT Cannabinoids are emerging as potential options for neuropathic pain treatment . This study evaluated an oral cannabinoid , nabilone , in the treatment of refractory human diabetic peripheral neuropathic pain ( DPN ) . We performed a single‐center , r and omized , double‐blind , placebo‐controlled , flexible‐dose study with an enriched enrolment r and omized withdrawal design . DPN subjects with a pain score ⩾4 ( 0‐10 scale ) continued regular pain medications and were administered single‐blinded adjuvant nabilone for 4 weeks . Subjects achieving ⩾30 % pain relief ( 26/37 ) were then r and omized and treated with either flexible‐dose nabilone 1‐4 mg/day ( n = 13 ) or placebo ( n = 13 ) in a further 5‐week double‐blind treatment period , with 30 % ( 11/37 ) of subjects deemed run‐in‐phase nabilone nonresponders . For nabilone run‐in‐phase responders , there was an improvement in the change in mean end‐point neuropathic pain vs placebo ( mean treatment reduction of 1.27 ; 95 % confidence interval 2.29‐0.25 , P = 0.02 ) , with an average nabilone dose at end point of 2.9 ± 1.1 mg/day , and improvements from baseline for the anxiety subscale of the Hospital Anxiety and Depression Scale , the Medical Outcomes Study sleep scale problems index , and the European Quality of Life‐5‐Domains index score ( each P greater global end‐point improvement with nabilone than with placebo ( 100 % vs 31 % ; P 0.05 ) . Medication‐related confusion led to discontinuation in 2/37 subjects during single‐blind nabilone treatment . Potential unmasking occurred in 62 % of both groups . Flexible‐dose nabilone 1‐4 mg/day was effective in relieving DPN symptoms , improving disturbed sleep , quality of life , and overall patient status . Nabilone was well tolerated and successful as adjuvant in patients with DPN",
"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",
"BACKGROUND Sativex ( ® ) , a cannabis extract oromucosal spray containing Δ(9)-tetrahydrocannabinol ( THC ) and cannabidiol ( CBD ) , is currently in phase III trials as an adjunct to opioids for cancer pain treatment , and recently received United Kingdom approval for treatment of spasticity . There are indications that CBD modulates THC 's effects , but it is unclear if this is due to a pharmacokinetic and /or pharmacodynamic interaction . METHODS Cannabis smokers provided written informed consent to participate in this r and omized , controlled , double-blind , double-dummy institutional review board-approved study . Participants received 5 and 15 mg synthetic oral THC , low-dose ( 5.4 mg THC and 5.0 mg CBD ) and high-dose ( 16.2 mg THC and 15.0 mg CBD ) Sativex , and placebo over 5 sessions . CBD , THC , 11-hydroxy-THC , and 11-nor- 9-carboxy-THC were quantified in plasma by 2-dimensional GC-MS . Lower limits of quantification were ≤0.25 μg/L. RESULTS Nine cannabis smokers completed all 5 dosing sessions . Significant differences ( P in maximum plasma concentrations ( C(max ) ) and areas under the curve from 0 - 10.5 h postdose ( AUC(0→10.5 ) ) for all analytes were found between low and high doses of synthetic THC and Sativex . There were no statistically significant differences in C(max ) , time to maximum concentration or in the AUC(0→10.5 ) between similar oral THC and Sativex doses . Relative bioavailability was calculated to determine the relative rate and extent of THC absorption ; 5 and 15 mg oral THC bioavailability was 92.6 % ( 13.1 % ) and 98.8 % ( 11.0 % ) of low- and high-dose Sativex , respectively . CONCLUSION These data suggest that CBD modulation of THC 's effects is not due to a pharmacokinetic interaction at these therapeutic doses",
"UNLABELLED A r and omized , double-blind , placebo-controlled trial was conducted to determine the benefit of nabilone in pain management and quality of life improvement in 40 patients with fibromyalgia . After a baseline assessment , subjects were titrated up on nabilone , from 0.5 mg PO at bedtime to 1 mg BID over 4 weeks or received a corresponding placebo . At the 2- and 4-week visits , the primary outcome measure , visual analog scale ( VAS ) for pain , and the secondary outcome measures , number of tender points , the average tender point pain threshold , and the Fibromyalgia Impact Question naire ( FIQ ) , were evaluated . After a 4-week washout period , subjects returned for re assessment of the outcome measures . There were no significant differences in population demographics between groups at baseline . There were significant decreases in the VAS ( -2.04 , P FIQ ( -12.07 , P anxiety ( -1.67 , P side effects per person at 2 and 4 weeks ( 1.58 , P beneficial , well-tolerated treatment option for fibromyalgia patients , with significant benefits in pain relief and functional improvement . PERSPECTIVE To our knowledge , this is the first r and omized , controlled trial to assess the benefit of nabilone , a synthetic cannabinoid , on pain reduction and quality of life improvement in patients with fibromyalgia . As nabilone improved symptoms and was well-tolerated , it may be a useful adjunct for pain management in fibromyalgia",
"BACKGROUND Neuropathic pain ( NPP ) is a chronic syndrome suffered by patients with multiple sclerosis ( MS ) , for which there is no cure . Underlying cellular mechanisms involved in its pathogenesis are multifaceted , presenting significant challenges in its management . METHODS A r and omized , double-blind , placebo-controlled study involving 15 relapsing-remitting MS patients with MS-induced NPP was conducted to evaluate nabilone combined with gabapentin ( GBP ) . Eligible patients stabilized on GBP ( ≥1,800 mg/day ) with inadequate pain relief were recruited . Nabilone or placebo was titrated over 4 weeks ( 0.5 mg/week increase ) followed by 5-week maintenance of 1 mg oral nabilone ( placebo ) twice daily . Primary outcomes included two daily patient-reported measures using a 100-mm visual analog scale ( VAS ) , pain intensity ( VASpain ) , and impact of pain on daily activities ( VASimpact ) . Hierarchical regression modeling was conducted on each outcome to determine if within-person pain trajectory differed across study groups , during 63-day follow-up . RESULTS After adjustment for key patient-level covariates ( e.g. , age , sex , Exp and ed Disability Status Scale , duration of MS , baseline pain ) , a significant group × time(2 ) interaction term was reported for both the VASpain ( P and VASimpact score ( P dizziness/drowsiness most frequently reported . CONCLUSION Nabilone as an adjunctive to GBP is an effective , well-tolerated combination for MS-induced NPP . The results of this study identify a novel therapeutic combination for use in this population of patients predisposed to tolerability issues that may otherwise prevent effective pain management",
"Noncardiac chest pain is associated with poor quality of life and high care expenditure . The majority of noncardiac chest pain is either gastresophageal reflux disease related or due to esophageal motility disorders , and the rest are considered functional chest pain ( FCP ) due to central and peripheral hypersensitivity . Current treatment of FCP improves 40 - 50 % of patients . Cannabinoid receptors 1 ( CB1 ) and 2 ( CB2 ) modulate release of neurotransmitters ; CB1 is located in the esophageal epithelium and reduces excitatory enteric transmission and potentially could reduce esophageal hypersensitivity . We performed a prospect i ve study to evaluate its effects on pain threshold , frequency , and intensity in FCP . Subjects with FCP received dronabinol ( 5 mg , twice daily ; n = 7 ; average age , 44 years ; mean body mass index , 26.7 ) or placebo ( n = 6 ; average age , 42 years ; mean body mass index , 25.9 ) for 28 days ( 4 weeks ) . Chest pain , general health , and anxiety/depression question naires were assessed at baseline and at 4 weeks . Subjects underwent an esophageal balloon distention test prior to treatment and on last day of the study . Dronabinol increased pain thresholds significantly ( 3.0 vs. 1.0 ; P = 0.03 ) and reduced pain intensity and odynophagia compared to placebo ( 0.18 vs. 0.01 and 0.12 vs. 0.01 , respectively , P = 0.04 ) . Depression and anxiety scores did not differ between the groups at baseline or after treatment . No significant adverse effects were observed . In this novel study , dronabinol increased pain threshold and reduced frequency and intensity of pain in FCP . Further , large scale studies are needed to substantiate these findings",
"Abstract Background : Muscle spasticity is common in multiple sclerosis ( MS ) , occurring in more than 60 % of patients . Objective : To compare Sativex with placebo in relieving symptoms of spasticity due to MS . Methods : A 15-week , multicenter , double-blind , r and omized , placebo-controlled , parallel-group study in 337 subjects with MS spasticity not fully relieved with current anti-spasticity therapy . Results : The primary endpoint was a spasticity 0–10 numeric rating scale ( NRS ) . Intention-to-treat ( ITT ) analysis showed a non-significant improvement in NRS score , in favor of Sativex . The per protocol ( PP ) population ( 79 % of subjects ) change in NRS score and responder analyses ( ≥30 % improvement from baseline ) were both significantly superior for Sativex , compared with placebo : −1·3 versus −0·8 points ( change from baseline , p=0·035 ) ; and 36 % versus 24 % ( responders , p=0·040 ) . These were supported by the time to response ( ITT : p=0·068 ; PP : p=0·025 ) analyses , carer global impression of change assessment ( p=0·013 ) and timed 10-meter walk ( p=0·042 ) . Among the subjects who achieved a ≥30 % response in spasticity with Sativex , 98 , 94 and 73 % reported improvements of 10 , 20 and 30 % , respectively , at least once during the first 4 weeks of treatment . Sativex was generally well tolerated , with most adverse events reported being mild-to-moderate in severity . Discussion and conclusions : The 0–10 NRS and responder PP analyses demonstrated that Sativex treatment result ed in a significant reduction in treatment-resistant spasticity , in subjects with advanced MS and severe spasticity . The response observed within the first 4 weeks of treatment appears to be a useful aid to prediction of responder/non-responder status",
"Abstract Purpose / aim : To evaluate the efficacy of tetrahydrocannabinol (THC):cannabidiol ( CBD ) oromucosal spray ( Sativex ® ) as add-on therapy to optimised st and ard antispasticity treatment in patients with moderate to severe multiple sclerosis ( MS ) spasticity . Methods : Sativex ® as add-on therapy vs. further optimised first-line ANTispastics ( SAVANT ) was a two-phase trial . In Phase A , eligible patients received add-on THC : CBD spray for 4 weeks to identify initial responders [ ≥20 % improvement from baseline in spasticity 0–10 numerical rating scale ( NRS ) score ] . Following washout , eligible initial responders were r and omised to receive THC : CBD spray or placebo for 12 weeks ( double-blinded , Phase B ) . Optimisation of underlying antispasticity medications was permitted in both groups across all study periods . Results : Of 191 patients who entered Phase A , 106 were r and omised in Phase B to receive add-on THC : CBD spray ( n = 53 ) or placebo ( n = 53 ) . The proportion of clinical ly relevant responders after 12 weeks ( ≥30 % NRS improvement ; primary efficacy endpoint ) was significantly greater with THC : CBD spray than placebo ( 77.4 vs. 32.1 % ; p , THC : CBD spray also significantly improved key secondary endpoints : changes in mean spasticity NRS ( p ) , mean pain NRS ( p = 0.0013 ) , and mean modified Ashworth ’s scale ( p = 0.0007 ) scores from Phase B baseline to week 12 . Adverse events , when present , were mild/moderate and without new safety concerns . Conclusions : Add-on THC : CBD oromucosal spray provided better and clinical ly relevant improvement of resistant MS spasticity compared with adjusting first-line antispasticity medication alone",
"Treatment of neuropathic pain ( NP ) symptoms associated with multiple sclerosis ( MS ) is frequently insufficient . Yet , cannabis is still rarely offered for treatment of pain . This clinical trial aim ed at showing the positive benefit-risk ratio of dronabinol . Two hundred forty MS patients with central NP entered a 16-weeks placebo-controlled phase-III study followed by a 32-weeks open-label period . One hundred patients continued therapy for overall up to 119 weeks . Primary endpoint was change of pain intensity on the 11-point Numerical Rating Scale over a 16-weeks treatment period . Safety was assessed on the basis of adverse reactions ( ARs ) , signs of dependency and abuse . Pain intensity during 16-weeks dronabinol and placebo treatment was reduced by 1.92 and 1.81 points without significant difference in between ( p = 0.676 ) . Although the proportion of patients with ARs was higher under dronabinol compared to placebo ( 50.0 vs. 25.9 % ) , it decreased during long-term use of dronabinol ( 26 % ) . No signs of drug abuse and only one possible case of dependency occurred . The trial results demonstrate that dronabinol is a safe long-term treatment option"
] | 4116764e-06ff-11f0-808a-c43d1ab1c353 |
& NA ; Complementary and alternative medicine ( CAM ) treatments have been used for thous and s of years around the world . There has been increased interest in utilizing CAM for menopausal symptoms since the release of results of the Women 's Health Initiative eluci date d long‐term adverse effects associated with hormone therapy . Women looking for more natural or safer means to treat hot flushes , night sweats , and other menopausal symptoms often turn to CAM such as yoga , phytoestrogens , or black cohosh . Yet there have been few well‐conducted studies looking at the efficacy of these treatments . This review examines r and omized clinical trials , systematic review s , and meta‐analyses evaluating the effectiveness of commonly used CAM for the treatment of menopausal symptoms | [
"Objective This study aims to determine the efficacy of yoga in alleviating vasomotor symptoms ( VMS ) frequency and bother . Methods This study was a three-by-two factorial , r and omized controlled trial . Eligible women were r and omized to yoga ( n = 107 ) , exercise ( n = 106 ) , or usual activity ( n = 142 ) , and were simultaneously r and omized to a double-blind comparison of & ohgr;-3 fatty acid ( n = 177 ) or placebo ( n = 178 ) capsules . Yoga intervention consisted of 12 weekly 90-minute yoga classes with daily home practice . Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline , 6 weeks , and 12 weeks . Secondary outcomes included insomnia symptoms ( Insomnia Severity Index ) at baseline and 12 weeks . Results Among 249 r and omized women , 237 ( 95 % ) completed 12-week assessment s. The mean baseline VMS frequency was 7.4 per day ( 95 % CI , 6.6 to 8.1 ) in the yoga group and 8.0 per day ( 95 % CI , 7.3 to 8.7 ) in the usual activity group . Intent-to-treat analyses included all participants with response data ( n = 237 ) . There was no difference between intervention groups in the change in VMS frequency from baseline to 6 and 12 weeks ( mean difference [ yoga − usual activity ] from baseline at 6 wk , −0.3 [ 95 % CI , −1.1 to 0.5 ] ; mean difference [ yoga − usual activity ] from baseline at 12 wk , −0.3 [ 95 % CI , −1.2 to 0.6 ] ; P = 0.119 across both time points ) . Results were similar for VMS bother . At week 12 , yoga was associated with an improvement in insomnia symptoms ( mean difference [ yoga − usual activity ] in the change in Insomnia Severity Index , 1.3 [ 95 % CI , −2.5 to −0.1 ] ; P = 0.007 ) . Conclusions Among healthy women , 12 weeks of yoga class plus home practice , compared with usual activity , do not improve VMS frequency or bother but reduce insomnia symptoms",
"Objective The practice of yoga has been proven to have positive effects on reducing insomnia . Studies have also shown its effects on reducing climacteric symptoms . To date , however , no studies that evaluate the effects of yoga on postmenopausal women with a diagnosis of insomnia in a r and omized clinical trial have been conducted . The aim of this study was to evaluate the effect of yoga practice on the physical and mental health and climacteric symptoms of postmenopausal women with a diagnosis of insomnia . Methods Postmenopausal women not undergoing hormone therapy , who were 50 to 65 years old , who had an apnea-hypopnea index less than 15 , and who had a diagnosis of insomnia were r and omly assigned to one of three groups , as follows : control , passive stretching , and yoga . Question naires were administered before and 4 months after the intervention to evaluate quality of life , anxiety and depression symptoms , climacteric symptoms , insomnia severity , daytime sleepiness , and stress . The volunteers also underwent polysomnography . The study lasted 4 months . Results There were 44 volunteers at the end of the study . When compared with the control group , the yoga group had significantly lower posttreatment scores for climacteric symptoms and insomnia severity and higher scores for quality of life and resistance phase of stress . The reduction in insomnia severity in the yoga group was significantly higher than that in the control and passive-stretching groups . Conclusions This study showed that a specific sequence of yoga might be effective in reducing insomnia and menopausal symptoms as well as improving quality of life in postmenopausal women with insomnia",
"Abstract The cardinal climacteric symptoms of hot flushes and night sweats affect 24 - 93 % of all women during the physiological transition from reproductive to post-reproductive life . Though efficacious , hormonal therapy and partial oestrogenic compounds are linked to a significant increase in breast cancer . Non-hormonal treatments are thus greatly appreciated . This systematic review of published hormonal and non-hormonal treatments for climacteric , and breast and prostate cancer-associated hot flushes , examines clinical efficacy and therapy-related cancer risk modulation . A PubMed search included literature up to June 19 , 2014 without limits for initial date s or language , with the search terms , ( hot flush * OR hot flash * ) AND ( clinical trial * OR clinical stud * ) AND ( r and omi * OR observational ) NOT review ) . Retrieved references identified further papers . The focus was on hot flushes ; other symptoms ( night sweats , irritability , etc . ) were not specifically screened . Included were some 610 clinical studies where a measured effect of the intervention , intensity and severity were documented , and where patients received treatment of pharmaceutical quality . Only 147 of these references described studies with alternative non-hormonal treatments in post-menopausal women and in breast and prostate cancer survivors ; these results are presented in Additional file 1.The most effective hot flush treatment is oestrogenic hormones , or a combination of oestrogen and progestins , though benefits are partially outweighed by a significantly increased risk for breast cancer development . This review illustrates that certain non-hormonal treatments , including selective serotonin reuptake inhibitors , gabapentin/pregabalin , and Cimicifuga racemosa extracts , show a positive risk-benefit ratio . Key pointsSeveral non-hormonal alternatives to hormonal therapy have been established and registered for the treatment of vasomotor climacteric symptoms in peri- and post-menopausal women . There are indications that non-hormonal treatments are useful alternatives in patients with a history of breast and prostate cancer . However , confirmation by larger clinical trials is required",
"OBJECTIVES Yoga practice includes a group of specific psychophysical techniques . Although previous studies showed beneficial effects of yoga for health and rehabilitation , improving quality of life , there are few studies on the possible therapeutic application of yoga during the climacteric period . The purpose of this study was to investigate the psychophysiological effects of Hatha Yoga regular practice in post-menopausal women . METHODS Eighty-eight post-menopausal women volunteered for this 12-week trial . They were r and omly assigned to one of three groups : control ( no intervention ) , exercise , and yoga . Question naires were applied in order to evaluate climacteric syndrome ( Menopause Rating Scale ) , stress ( Lipp Stress Symptom Inventory ) , quality of life ( Brief World Health Organization Quality of Life ) , depression ( Beck Depression Inventory ) and anxiety ( State/Trait Anxiety Inventories ) . Physiological changes were evaluated through hormone levels ( cortisol , FSH , LH , progesterone and estradiol ) . RESULTS At 12 weeks , yoga practitioners showed statistically lower scores for menopausal symptoms , stress levels and depression symptoms , as well as significantly higher scores in quality of life when compared to control and exercise groups . Only control group presented a significant increase in cortisol levels . The yoga and exercise groups showed decreased levels of FSH and LH when compared to control group . CONCLUSIONS These results suggest that yoga promotes positive psychophysiological changes in post-menopausal women and may be applied as a complementary therapy towards this population",
"OBJECTIVE To determine the feasibility and acceptability of a restorative yoga intervention for the treatment of hot flushes in postmenopausal women . METHODS A pilot trial in 14 postmenopausal women experiencing > or = 4 moderate to severe hot flushes per day or > or = 30 moderate to severe hot flushes per week . The intervention consisted of eight restorative yoga poses taught in a 3-h introductory session and 8 weekly 90-min sessions . Feasibility was measured by recruitment rates , subject retention and adherence . Acceptability was assessed by subject interview and question naires . Efficacy measures included change in frequency and severity of hot flushes as recorded on a 7-day diary . RESULTS Recruitment was accomplished as planned . The majority of study subjects ( 93 % ) completed the trial . Of those who completed the trial , 92 % attended seven or more of the eight yoga sessions . The majority of the subjects were satisfied with the study and 75 % continued to practice yoga 3 months after the study . Mean number of hot flushes per week decreased by 30.8 % ( 95 % CI 15.6 - 45.9 % ) and mean hot flush score decreased 34.2 % ( 95 % CI 16.0 - 52.5 % ) from baseline to week 8 . No adverse events were observed . CONCLUSIONS This pilot trial demonstrates that it is feasible to teach restorative yoga to middle-aged women without prior yoga experience . The high rates of subject retention and satisfaction suggest that yoga is an acceptable intervention in this population . Our results indicate that a larger , r and omized controlled trial to explore the efficacy of restorative yoga for treatment of menopausal symptoms would be safe and feasible",
"Objective This study aims to determine the efficacy of exercise training for alleviating vasomotor and other menopausal symptoms . Methods Late perimenopausal and postmenopausal sedentary women with frequent vasomotor symptoms ( VMS ) participated in a r and omized controlled trial conducted in three sites : 106 women r and omized to exercise and 142 women r and omized to usual activity . The exercise intervention consisted of individual facility-based aerobic exercise training three times per week for 12 weeks . VMS frequency and bother were recorded on daily diaries at baseline and on weeks 6 and 12 . Intent-to-treat analyses compared between-group differences in changes in VMS frequency and bother , sleep symptoms ( Insomnia Severity Index and Pittsburgh Sleep Quality Index ) , and mood ( Patient Health Question naire-8 and Generalized Anxiety Disorder-7 question naire ) . Results At the end of week 12 , changes in VMS frequency in the exercise group ( mean change , −2.4 VMS/d ; 95 % CI , −3.0 to −1.7 ) and VMS bother ( mean change on a four-point scale , −0.5 ; 95 % CI , −0.6 to −0.4 ) were not significantly different from those in the control group ( −2.6 VMS/d ; 95 % CI , −3.2 to −2.0 ; P = 0.43 ; −0.5 points ; 95 % CI , −0.6 to −0.4 ; P = 0.75 ) . The exercise group reported greater improvement in insomnia symptoms ( P = 0.03 ) , subjective sleep quality ( P = 0.01 ) , and depressive symptoms ( P = 0.04 ) , but differences were small and not statistically significant when P values were adjusted for multiple comparisons . Results were similar when considering treatment-adherent women only . Conclusions These findings provide strong evidence that 12 weeks of moderate-intensity aerobic exercise do not alleviate VMS but may result in small improvements in sleep quality , insomnia , and depression in midlife sedentary women",
"Extracts from Cimicifuga racemosa ( CR , synonym Actaea racemosa ) have shown efficacy in trials in women with menopausal symptoms . Yet , dose dependency remains unclear . Therefore , 180 female out patients with climacteric complaints were treated for 12 weeks in a r and omized , double-blind , placebo-controlled , 3-armed trial ( CR extract Ze 450 in 6.5 mg or 13.0 mg , or placebo ) . Primary outcome was the difference in menopausal symptoms ( vasomotor , psychological , and somatic ) , assessed by the Kupperman Menopausal Index between baseline and week 12 . Secondary efficacy variables were patients ' self- assessment s of general quality of life ( QoL ) , responder rates , and safety . Compared to placebo , patients receiving Ze 450 showed a significant reduction in the severity of menopausal symptoms in a dose-dependent manner from baseline to endpoint ( mean absolute differences 17.0 ( 95 % CI 14.65–19.35 ) score points , P QoL and responder rates corresponded with the main endpoint . Changes in menopausal symptoms and QoL were inversely correlated . Reported adverse events and clinical laboratory testing did not raise safety concerns . The CR extract Ze 450 is an effective and well-tolerated nonhormonal alternative to hormone treatment for symptom relief in menopausal women",
"Background This study aims to evaluate the efficacy of Black cohosh ( Cimicifuga racemosa L. ) in treating early menopausal symptoms . Methods This r and omized , double-blind , placebo-controlled clinical trial was conducted on 84 early post-menopausal participants with Greene climacteric scale ( GCS ) scores of 15 to 42 , who were referred to two public health care centers in Tehran , Iran , in 2011–2012 . The participants were r and omly allocated into treatment ( 6.5 mg of dried extract of Black cohosh roots daily ) and control ( placebo ) groups with a ratio of 1:1 . The participants took one tablet per day for 8 weeks . The GCS scores were recorded at baseline , and after 4 and 8 weeks of treatment . Data analysis was carried out using a general linear model with repeated measures with SPSS software . The level of significance was set at P The GCS total score ( primary outcome ) in the treatment group was significantly lower than that in the control group at both week 4 [ adjusted mean difference : -7.8 ( 95 % confidence interval : -11.1 to -4.4 ) ] and week 8 [ -12.9 ( -16.2 to -9.3 ) ] . The treatment group showed significantly more improvement than the control group in all GCS subscale scores ( vasomotor , psychiatric , physical , and sexual symptoms ; secondary outcomes ) . The differences between the treatment and control groups at week 8 were significantly higher ( P the total scores and the vasomotor and psychiatric subscale scores . No side effects were reported . Conclusions Black cohosh reduced the GCS total score and all GCS subscale scores ( vasomotor , psychiatric , physical , and sexual symptoms ) during 4 and 8 weeks of treatment . Clinical trial registration This study was approved ( Code 9061 ) by the Ethics Committee of Tabriz University of Medical Sciences and registered at the Iranian Registry of Clinical Trials withI RCT 201107186709N4 on 15 January 2012",
"Hot flash is among the most common complaints of menopausal women , affecting their career , social activities and quality of life . This study aim ed to investigate the effects of Valerian on hot flashes in menopausal women . In this double blind clinical trial , 68 menopausal women with the chief complaint of hot flash were enrolled using sampling at h and and were r and omly divided into drug and placebo groups . The women in the drug group were prescribed 255 mg Valerian capsules 3 times a day for 8 weeks . The women in the placebo group were prescribed identical capsules filled with starch . Then , severity and frequency of hot flashes were measured and recorded through question naires and information forms in three levels ( 2 weeks before , four and eight weeks after the treatment ) . The Severity of hot flashes revealed a meaningful statistical difference pre- and post- Valerian treatment ( p severity of hot flash after the treatment showed a meaningful statistical difference ( p hot flash frequencies 4 and 8 weeks after the treatment ( p menopausal hot flash and that it can be considered as a treatment of choice for reduction of hot flashes among the women who are reluctant to receive hormone therapy due to fear or any other reason",
"OBJECTIVE The objective of this clinical trial was to examine the efficacy of a supplement containing natural S-(-)equol , a daidzein metabolite , in reducing menopausal symptoms . METHODS In this multicenter , double-blind placebo-controlled trial , 160 equol nonproducing , postmenopausal Japanese women who experienced at least 1 hot flush/day were r and omly assigned to consume 10 mg/day S-(-)equol ( n=77 women ) or placebo ( n=83 women ) for 12 weeks . Participants completed a st and ardized menopausal symptom checklist and rated five common menopause symptoms by a visual analog scale at baseline , week 12 , and week 18 ( 6-week postintervention ) . Physical , blood , and urine examinations were conducted . One hundred twenty-six women completed the study . RESULTS At baseline , daily hot flush frequency was 2.9±2.1 for the S-(-)equol group and 3.2±2.4 for the placebo group . After the 12-week intervention , the S-(-)equol group had a greater decrease from baseline in hot flush frequency compared with the placebo group ( -1.9±1.8/day , -58.7 % , vs. -1.0±2.0/day , -34.5 % , p=0.009 ) . The severity of hot flushes and neck or shoulder muscle stiffness significantly decreased in the S-(-)equol group compared with the placebo group . No changes in clinical parameters or serious adverse effects were reported . CONCLUSIONS This is the first trial to show beneficial effects of a 10-mg natural S-(-)equol supplement consumed daily for 12 weeks on major menopausal symptoms , specifically , hot flushes and neck or shoulder muscle stiffness , in postmenopausal Japanese women . This supplement offers a promising alternative for management of menopausal symptoms ",
"OBJECTIVES To develop the 1996 MENQOL question naire further with advice regarding summary score computation , missing- data management , readability , recall period and assessment of the vasomotor domain reliability and construct validity . To develop a modified version , the MENQOL-Intervention question naire , for use where certain treatment side effects could negatively impact the quality of life . METHODS MENQOL-Intervention modifications involved the addition of three items to the physical domain . For both question naires , psychometric property assessment was embedded in two r and omized controlled trials of menopause interventions . Test-retest reliability and Cronbach 's alpha were computed for all domains as was construct validity of the vasomotor domain for both question naires . RESULTS The vasomotor intraclass correlation coefficient was 0.73 for the MENQOL-Intervention over 1 week and 0.78 for the MENQOL over 1 month . The altered physical domain of the MENQOL-Intervention question naire continued to show strong test-retest reliability and Cronbach 's alpha consistent with the MENQOL . The MENQOL-Intervention demonstrated excellent face validity with high construct validity for the vasomotor domain of 0.78 - 0.80 . For both instruments , comparisons of the vasomotor domains to hot flash scores , although statistically significant , were only moderate at 0.56 and 0.49 . CONCLUSIONS Both the MENQOL and the MENQOL-Intervention question naires show strong psychometric properties . We recommend using the MENQOL-Intervention question naire where intervention side effects might negatively impact a woman 's quality of life . For both question naires , a summary score can be calculated",
"OBJECTIVE To assess the feasibility and efficacy of a yoga treatment for menopausal symptoms . Both physiologic and self-reported measures of hot flashes were included . METHODS A prospect i ve within-group pilot study was conducted . Participants were 12 peri- and post-menopausal women experiencing at least 4 menopausal hot flashes per day , at least 4 days per week . Assessment s were administered before and after completion of a 10-week yoga program . Pre- and post-treatment measures included : Severity of question naire-rated menopausal symptoms ( Wiklund Symptom Check List ) , frequency , duration , and severity of hot flashes ( 24-h ambulatory skin-conductance monitoring ; hot-flash diary ) , interference of hot flashes with daily life ( Hot Flash Related Daily Interference Scale ) , and subjective sleep quality ( Pittsburgh Sleep Quality Index ) . Yoga classes included breathing techniques , postures , and relaxation poses design ed specifically for menopausal symptoms . Participants were asked to practice at home 15 min each day in addition to weekly classes . RESULTS Eleven women completed the study and attended a mean of 7.45 ( S.D. 1.63 ) classes . Significant pre- to post-treatment improvements were found for severity of question naire-rated total menopausal symptoms , hot-flash daily interference ; and sleep efficiency , disturbances , and quality . Neither 24-h monitoring nor accompanying diaries yielded significant changes in hot flashes . CONCLUSIONS The yoga treatment and study procedures were feasible for midlife women . Improvement in symptom perceptions and well being warrant further study of yoga for menopausal symptoms , with a larger number of women and including a control group",
"Objective Preliminary data suggest that flaxseed , a rich source of dietary lignans , may be a potentially effective treatment of hot flashes . A phase III , r and omized , placebo , controlled trial was conducted to evaluate the efficacy of flaxseed in reducing hot flashes . Methods Postmenopausal women with or without breast cancer were r and omly assigned to a flaxseed bar ( providing 410 mg of lignans ) for 6 weeks versus a placebo bar . Participants completed daily , prospect i ve , hot flash diaries during the baseline week , and then ate one study bar per day for 6 weeks while recording their daily hot flashes . The intraparticipant difference in hot flash activity between baseline and the last treatment week was the primary endpoint . Adverse effects were evaluated through a self-report and the Common Terminology Criteria assessment . Results A total of 188 women were enrolled in this trial . The mean hot flash score was reduced 4.9 in the flaxseed group and 3.5 in the placebo group ( P = 0.29 ) . In both groups , slightly more than a third of the women received a 50 % reduction in their hot flash score . Only one adverse effect was significantly different between groups , grade 1 pruritus , which was more common in the placebo group ( 8 % vs 1 % ) . Both groups reported abdominal distension , flatulence , diarrhea , and nausea . Adherence and ability to detect treatment assignment did not differ between groups . Conclusions The results of this trial do not support the use of 410 mg of lignans for the reduction of hot flashes . The bars were fairly well tolerated , with both groups reporting gastrointestinal effects , probably due to the fiber content",
"BACKGROUND Root extracts of Cimicifuga racemosa ( L. ) Nutt . have been successfully used in the treatment of climacteric complaints . METHOD In this observational study , Cimicifuga racemosa ( CR ) extract Ze 450 was studied in 442 unselected ambulatory female out patients with menopausal complaints under daily practice conditions . Physicians were suggested to treat patients for the first 3 months with 13 mg/d CR ( high dose , HD ) and to continue over additional 6 months either with this treatment or to switch to 6.5mg/d CR ( low dose , LD ) . The choice of treatment and its dose , however , was fully at the discretion of the physician . RESULTS After 3-months treatment with HD , symptom severity ( Kupperman Menopause Index , KMI ) decreased significantly ( p total KMI and its sub-item scores further ( HD , LD : p unselected patients with climacteric complaints under the conditions of daily practice result ed in a significant improvement of menopausal symptoms assessed by the total KMI score and its sub-item scores with an effect size similar to that in a previous r and omized , controlled clinical trial",
"Abstract Objectives To evaluate the effectiveness of black cohosh extract 40 mg/day for relieving moderate to severe menopausal symptoms and improving quality of life in Thai women . Methods A r and omized , double-blind , placebo-controlled clinical trial was conducted in a menopause clinic of a tertiary-care university hospital during 2011–2013 . Participants were peri- or postmenopausal Thai women aged at least 40 years , who have moderate to severe menopausal symptoms evaluated using the Kupperman index ( KI ) . Outcome measures included KI , frequency of hot flushes , Menopause-Specific Quality of Life ( MENQOL ) score , participants ’ global satisfaction and safety outcomes . Results There were 54 participants assigned to treatment ( black cohosh extract 40 mg/day , n = 27 ) or placebo group ( n = 27 ) . Both the treatment and placebo groups had comparable baseline KI scores ( 33.9 ± 7.9 vs. 31.3 ± 6.8 ) , frequency of hot flushes ( 3.1 ± 2.0 vs. 2.8 ± 2.1 ) , and MENQOL scores , all of which improved with time . Neither the improvements nor the global satisfaction were significantly different between the two groups ; but the proportion of participants with moderate to severe symptoms seemed to be lower in the treatment group than in the placebo group ( 40 % vs. 60 % , p = 0.174 ) . There was no serious adverse event or significant change in liver function tests . Conclusions A black cohosh extract of 40 mg/day is not superior to a placebo for relieving moderate to severe menopausal symptoms or improving quality -of-life scores in Thai women",
"Objective : Sleep disturbances reduce the quality of life . About 50 % of postmenopausal women experience sleep disturbances such as insomnia . Complementary and alternative medical therapies may be useful for the management of sleep disturbances among postmenopausal women . The aim of the present study was to evaluate the effects of valerian extract taken nightly on the improvement of sleep quality in postmenopausal women experiencing insomnia . Methods : A r and omized , triple-blind , controlled trial design was used for this study . Participants consisted of 100 postmenopausal women aged 50 to 60 years who were experiencing insomnia . A demographic data form and the Pittsburgh Sleep Quality Index were used to collect data . The women were r and omly divided into two groups . Each group received either 530 mg of concentrated valerian extract or a placebo twice a day for 4 weeks . Descriptive and inferential statistics were used to analyze the data . Results : A statistically significant change was reported in the quality of sleep of the intervention group in comparison with the placebo group ( P placebo group showed an improvement in the quality of sleep ( P Valerian improves the quality of sleep in women with menopause who are experiencing insomnia . Findings from this study add support to the reported effectiveness of valerian in the clinical management of insomnia",
"OBJECTIVE The purpose of this study was to determine the efficacy of 3 nonhormonal therapies for the improvement of menopause-related quality of life in women with vasomotor symptoms . STUDY DESIGN We conducted a 12-week 3 × 2 r and omized , controlled , factorial design trial . Peri- and postmenopausal women , 40 - 62 years old , were assigned r and omly to yoga ( n = 107 ) , exercise ( n = 106 ) , or usual activity ( n = 142 ) and also assigned r and omly to a double-blind comparison of omega-3 ( n = 177 ) or placebo ( n = 178 ) capsules . We performed the following interventions : ( 1 ) weekly 90-minute yoga classes with daily at-home practice , ( 2 ) individualized facility-based aerobic exercise training 3 times/week , and ( 3 ) 0.615 g omega-3 supplement , 3 times/day . The outcomes were assessed with the following scores : Menopausal Quality of Life Question naire ( MENQOL ) total and domain ( vasomotor symptoms , psychosocial , physical and sexual ) . RESULTS Among 355 r and omly assigned women who average age was 54.7 years , 338 women ( 95 % ) completed 12-week assessment s. Mean baseline vasomotor symptoms frequency was 7.6/day , and the mean baseline total MENQOL score was 3.8 ( range , 1 - 8 from better to worse ) with no between-group differences . For yoga compared to usual activity , baseline to 12-week improvements were seen for MENQOL total -0.3 ( 95 % confidence interval , -0.6 to 0 ; P = .02 ) , vasomotor symptom domain ( P = .02 ) , and sexuality domain ( P = .03 ) scores . For women who underwent exercise and omega-3 therapy compared with control subjects , improvements in baseline to 12-week total MENQOL scores were not observed . Exercise showed benefit in the MENQOL physical domain score at 12 weeks ( P = .02 ) . CONCLUSION All women become menopausal , and many of them seek medical advice on ways to improve quality of life ; little evidence -based information exists . We found that , among healthy sedentary menopausal women , yoga appears to improve menopausal quality of life ; the clinical significance of our finding is uncertain because of the modest effect",
"OBJECTIVE To assess the effect of low-dose conjugated equine estrogens ( E ) on circulating neurotransmitters and the efficacy for the treatment of psychological symptoms . DESIGN Controlled comparative clinical study . SETTING Endocrine Research Unit , Instituto Mexicano del Seguro Social , Mexico . PATIENT(S ) Thirty postmenopausal women received conjugated equine E. Ten women acted as a comparison group . INTERVENTION(S ) Conjugated equine E , 0.312 mg/day , for 21 days per cycle during six cycles and added chlormadinone acetate , 2 mg/day , for the last 5 days of each cycle . Green scale for climateric women and Blatt-Kupperman Menopausal Index were used for measuring psychological well-being . MAIN OUTCOME MEASURE(S ) Serum levels of dopamine ( DA ) , noradrenaline , serotonin , and beta-endorphin were quantified by specific assays at baseline and at the end of treatment . RESULT ( S ) Low baseline levels of DA , serotonin , and beta-endorphin increased significantly ( P conjugated equine E. In parallel , augmented baseline noradrenaline levels diminished significantly ( P neurotransmitter levels had a significant correlation with 17beta-E(2 ) concentrations at the end of the study . Alleviation of psychological symptoms was observed in all but eight treated women . CONCLUSION ( S ) Low-dose conjugated equine E associated with periodic administration of chlormadinone acetate elicited favorable changes in neurotransmitters and relieved psychological symptoms",
"Background It is now recognized that Cimicifuga foetida extract is effective in alleviating menopausal symptoms . But the duration s reported were usually short . This paper compares the clinical effects of different regimens of three‐month course on climacteric symptoms in Chinese women , so as to evaluate the efficacy and safety of Cimicifuga foetida extract . Methods This was a prospect i ve , r and omized trial . Ninety‐six early menopausal women were recruited and r and omly assigned into 3 groups to take different kinds of medicine for 3 months ; participants were given Cimicifuga foetida extract daily in group A ( n=32 ) , given estradiol valerate and progesterone capsule cycle sequentially in group B ( n=32 ) , and given estradiol valerate and medroxyprogesterone acetate cycle sequentially in group C ( n=32 ) . The question naires of Kupperman menopause index , Menopause‐Specific Quality of Life , and Hospital Anxiety and Depression Scale were finished before and after the treatment . The status of vaginal bleeding and breast tenderness was recorded every day . Results Eighty‐nine participants ( 89/96 , 92.7 % ) completed the treatment . Kupperman menopause index decreased after taking the medicine for 3 months in each group ( with all P the score of sexual domain in group A ( P=0.103 ) , the scores of all domains of the Menopause‐Specific Quality of Life decreased significantly after the treatment in all groups ( with all P≤0.01 ) . Score of anxity decreased significantly in group A ( P=0.015 ) and B ( P=0.003 ) . Incidence of breast tenderness was 12.9 % ( 4/31 ) in group A , 36.7 % ( 11/30 ) in group B , and 14.3 % ( 4/28 ) in group C. Incidence of vaginal bleeding was 6.5 % ( 2/31 ) in group A , 26.7 % ( 8/30 ) in group B , and 82.1 % ( 23/28 ) in group C. Conclusions Cimicifuga foetida extract is effective and safe in the treatment of menopausal syndrome . It is worth extending its use in the treatment of climacteric complaints , especially among those having contradiction for hormone replacement therapy",
"INTRODUCTION Hot flash is considered to be an early and common symptom of menopause . The present study aim ed to determine the impact of black cohosh ( Cimicifuga racemosa ) on vasomotor symptoms in postmenopausal women . METHODS This was a r and omized , double-blind , placebo-controlled clinical trial . This study was performed on 84 postmenopausal women . The participants were r and omly divided into control and intervention groups . The participants of the intervention group received one black cohosh tablet per day and the control group received one placebo tablet per day for eight weeks . The severity of vasomotor symptoms and number of hot flashes were recorded during the pre-intervention phase , and 4 and 8 weeks after the intervention . The data were analyzed using repeated measures ANOVA and ANCOVA tests . The level of significance was considered lower than 0.05 . RESULTS There was a significant difference between the two groups in terms of severity and number of hot flashes in weeks 4 and 8 by controlling the intensity of vasomotor symptoms and number of hot flashes before the intervention . Moreover , using repeated measures ANOVA , the intergroup comparison indicated a significant difference in bothgroups ( the test and control groups ) in terms of severity of vasomotor symptoms and number of hot flashes . CONCLUSION According to the findings of the study , it seems that black cohosh can be used as an effective alternative medicine in relieving menopausal vasomotor symptoms"
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IMPORTANCE Mobility limitations are common in older adults , affecting the physical , psychological , and social aspects of an older adult 's life . OBJECTIVE To identify mobility risk factors , screening tools , medical management , need for physical therapy , and efficacy of exercise interventions for older primary care patients with limited mobility . EVIDENCE ACQUISITION Search of PubMed and PEDro from January 1985 to March 31 , 2013 , using the search terms mobility limitation , walking difficulty , and ambulatory difficulty to identify English- language , peer- review ed systematic review s , meta-analyses , and Cochrane review s assessing mobility limitation and interventions in community-dwelling older adults . Articles not appearing in the search referenced by review ed articles were also evaluated . FINDINGS The most common risk factors for mobility impairment are older age , low physical activity , obesity , strength or balance impairment , and chronic diseases such as diabetes or arthritis . Several tools are available to assess mobility in the ambulatory setting . Referral to physical therapy is appropriate , because physical therapists can assess mobility limitations and devise curative or function-enhancing interventions . Relatively few studies support therapeutic exercise to improve mobility limitation . Strong evidence supports resistance and balance exercises for improving mobility-limiting physical weakness and balance disorders . Assessing a patient 's physical environment and the patient 's ability to adapt to it using mobility devices is critical . CONCLUSIONS AND RELEVANCE Identification of older adults at risk for mobility limitation can be accomplished through routine screening in the ambulatory setting . Addressing functional deficits and environmental barriers with exercise and mobility devices can lead to improved function , safety , and quality of life for patients with mobility limitations | [
"BACKGROUND A major obstacle to screening for early mobility disability ( ie , mobility difficulty ) , a major public health concern , is the lack of a method that identifies those who are at high risk . The goal of this study was to develop easy-to-use clinical nomograms for estimation of the probability of incident mobility difficulty . METHODS We conducted a population -based prospect i ve study using data from 266 high physically and cognitively functioning older women , aged 70 to 80 years , who were free of mobility disability at the baseline evaluation of the Women 's Health and Aging Study II . The outcome measure was incident mobility disability within 18 months , defined as self-reported difficulty walking 0.8 km , climbing 10 steps , or transferring from or into a car or bus . Logistic regression and receiver operating characteristic curve analyses were used for evaluation of the optimal combination of self-reported and performance-based mobility measures . Bootstrap sampling and estimation was used for validation . RESULTS Predictive nomograms were developed based on a final model that included 3 simple-to-obtain measures of pre clinical disability : self-report of modification in mobility tasks without having difficulty with them , one-leg stance balance , and time to walk 1 m at a usual pace . Final model accuracy ( as estimated by the area under the receiver operating characteristic curve ) was 73 % ( SE = 0.04 ) . Validation analysis confirmed the high accuracy of these nomograms . CONCLUSIONS An original tool was developed for assessment of the risk of mobility difficulty in older women that can be used to assist physicians and research ers in deciding which women to target for preventive interventions",
"OBJECTIVES To evaluate the effectiveness of an enhanced balance training program in improving mobility and well-being of elderly people with balance problems . DESIGN Prospect i ve , single-blind , r and omized , controlled trial . SETTING District general hospital . PARTICIPANTS One hundred ninety-nine patients aged 60 and older with a Berg Balance Scale ( BBS ) score of less than 45 . INTERVENTIONS Six weeks enhanced balance training consisting of a series of repetitive tasks of increasing difficulty specific to functional balance . The control group received physiotherapy conforming to existing practice in elderly patients with mobility problems . MEASUREMENTS Ten-meter timed walk test ( TWT ) , BBS , Frenchay Activities Index ( FAI ) , Falls H and icap Inventory ( FHI ) , and European Quality of Life question naire ( Euroqol ) measured at 6 , 12 , and 24 weeks after intervention . RESULTS The mean age + /- st and ard deviation of subjects was 82.7 + /- 5.6 , and baseline characteristics were comparable between the groups . Both groups showed improvements in TWT ( intervention : 22.5 - 16.5 seconds , P = .001 ; control : 20.5 - 15.8 seconds , P = .054 ) , BBS ( intervention : 33.3 - 42.7 , P = .001 ; control : 33.4 - 42.0 , P FAI ( 18 - 21 , P = .02 in both groups ) , FHI score ( intervention : 31 - 17 , P = .0001 ; control : 33 - 17 , P = .0001 ) and Euroqol score ( intervention : 58 - 65 , P = .04 ; control : 60 - 65 , P = .07 ) . There were no intergroup differences at any time . More patients reported increased confidence in walking indoors ( 36 % vs 28 % ; P = .04 ) and outdoors ( 27 % vs 18 % ; P = .02 ) in the enhanced balance-training group . CONCLUSION Exercise programs significantly improve balance and mobility in patients with balance problems , independent of strategy . Enhanced balance training may , in addition , improve confidence and quality of life but needs further investigation",
"The purpose of this study was to determine whether a walking program supplemented by tasks design ed to challenge balance and mobility ( WALK+ ) could improve physical function more than a traditional walking program ( WALK ) in older adults at risk for mobility disability . 31 community-dwelling older adults ( M + /- SD age = 76 + /- 5 yr ; Short Physical Performance Battery [ SPPB ] score = 8.4 + /- 1.7 ) were r and omized to treatment . Both interventions were 18 sessions ( 1 hr , 3x/wk ) and progressive in intensity and duration . Physical function was assessed using the SPPB and the 400-m-walk time . A subset of participants in the WALK group who had relatively lower baseline function showed only small improvement in their SPPB scores after the intervention ( 0.3 + /- 0.5 ) , whereas a subset of participants in the WALK+ group with low baseline function showed substantial improvement in their SPPB scores ( 2.2 + /- 0.7 ) . These preliminary data underscore the potential importance of tailoring interventions for older adults based on baseline levels of physical function",
"Abstract Objective : To evaluate the effect of intensive geriatric rehabilitation on demented patients with hip fracture . Design : Preplanned sub analysis of r and omised intervention study . Settting : Jyväskylä Central Hospital , Finl and . Participants : 243 independently living patients aged 65 years or older admitted to hospital with hip fracture . Intervention : After surgery patients in the intervention group ( n=120 ) were referred to the geriatric ward whereas those in the control group were discharged to local hospitals . Main outcome measures : Length of hospital stay , mortality , and place of residence three months and one year after surgery for hip fracture . Results : The median length of hospital stay of hip fracture patients with moderate dementia ( mini mental state examination score 12 - 17 ) was 47 days in the intervention group ( n=24 ) and 147 days in the control group ( n=12 , P=0.04 ) . The corresponding figures for patients with mild dementia ( score 18 - 23 ) were 29 days in the intervention group ( n=35 ) and 46.5 days in the control group ( n=42 , P=0.002 ) . Three months after the operation , in the intervention group 91 % ( 32 ) of the patients with mild dementia and 63 % ( 15 ) of the patients with moderate dementia were living independently . In the control group , the corresponding figures were 67 % ( 28 ) and 17 % ( 2 ) . There were no significant differences in mortality or in the lengths of hospital stay of severely demented patients and patients with normal mini mental state examination scores . Conclusions : Hip fracture patients with mild or moderate dementia can often return to the community if they are provided with active geriatric rehabilitation",
"OBJECTIVES To vali date self-reported pre clinical mobility limitation concept and self-report assessment method against muscle power and walking speed , and to study the predictive validity of pre clinical mobility limitation with respect to future risk of manifest mobility limitation . DESIGN Observational prospect i ve cohort study and cross-sectional analysis . SETTING Research laboratory and community . PARTICIPANTS A total of 632 community-living ( age range , 75 - 81 y ) women and men took part in the baseline assessment s and 302 persons in the semi-annual interviews on mobility limitation over 2 years . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Walking speed , muscle power , and self-reported pre clinical and manifest mobility limitation . Pre clinical mobility limitation was defined as self-reported tiredness or modification of task performance without task difficulty . At baseline , 4 subgroups were created according to self-reported pre clinical mobility limitation in any of 3 mobility tasks ( walking 2 km , walking 0.5 km , climbing up stairs ) : no limitation , pre clinical limitation , and minor and major manifest limitation . RESULTS At baseline , participants with pre clinical mobility limitation showed intermediate levels of walking speed and muscle power , compared with those with no limitation or manifest mobility limitation . Participants reporting baseline pre clinical mobility limitation had 3- to 6-fold higher age- and sex-adjusted risk of progressing to major manifest mobility limitation during the 2-year follow-up compared with participants with no limitation at baseline , whereas the risk among those with minor limitation at baseline was 14- to 18-fold higher compared with those with no limitation . CONCLUSIONS The self-report assessment tool proved to be a valid measure to capture the early signs of disability and may serve as an inexpensive tool for identifying those nondisabled persons at high risk for future disability",
"BACKGROUND The number of older adults living in the United States continues to increase , and recent research has begun to target interventions to older adults who have mobility limitations and are at risk for disability . The objective of this study is to describe and examine correlates of health-related quality of life in this population subgroup using baseline data from a larger intervention study . METHODS The Lifestyle Interventions and Independence for Elders-Pilot study ( LIFE-P ) was a r and omized controlled trial that compared a physical activity intervention to a non-exercise educational intervention among 424 older adults at risk for disability . Baseline data ( collected in April-December 2004 , analyzed in 2006 ) included demographics , medical history , the Quality of Well-Being Scale ( QWB-SA ) , a timed 400-m walk , and the Short Physical Performance Battery ( SPPB ) . Descriptive health-related quality of life ( HRQOL ) data are presented . Hierarchical linear regression models were used to examine correlates of HRQOL . RESULTS The mean QWB-SA score for the sample was 0.630 on an interval scale ranging from 0.0 ( death ) to 1.0 ( asymptomatic , optimal functioning ) . The mean of 0.630 is 0.070 lower than a comparison group of healthy older adults . The variables associated with lower HRQOL included white ethnicity , more comorbid conditions , slower 400-m walk times , and lower SPPB balance and chair st and scores . CONCLUSIONS Older adults who are at risk for disability had reduced HRQOL . Surprisingly , however , mobility was a stronger correlate of HRQOL than an index of comorbidity , suggesting that interventions addressing mobility limitations may provide significant health benefits to this population",
"BACKGROUND Little is known about the effect of diabetes mellitus on subsequent lower body disability in older Mexican Americans , one of the fastest growing ethnic groups in the United States . The aim of this study is to examine the relationship between diabetes mellitus and incident lower body disability over a 7-year follow-up period . METHODS Ours was a 7-year prospect i ve cohort study of 1835 Mexican-American individuals > or = 65 years old , nondisabled at baseline , and residing in five Southwestern states . Measures included self-reported physician diagnosis of diabetes , stroke , heart attack , hip fracture , arthritis , or cancer . Disability measures included activities of daily living ( ADLs ) , mobility tasks , and an 8-foot walk test . Body mass index , depressive symptoms , and vision function were also measured . RESULTS At 7-year follow-up , 48.7 % of diabetic participants nondisabled at baseline developed limitations in one or more measures of lower body function . Cox proportional regression analyses showed that diabetic participants were more likely to report any limitation in lower body ADL function ( hazard ratio [ HR ] = 2.05 , 95 % confidence interval [ CI ] , 1.58 - 2.67 ) , mobility tasks ( HR = 1.69 , 95 % CI , 1.39 - 2.04 ) , and 8-foot walk ( HR = 1.46 , 95 % CI , 1.15 - 1.85 ) compared with nondiabetic participants , after controlling for relevant factors . Older age and having one or more diabetic complications were significantly associated with increased risk of limitations in any lower body ADL and mobility task at follow-up . CONCLUSION Older Mexican Americans with diabetes mellitus are at high risk for development of lower body disability over time . Awareness of disability as a potentially modifiable complication and use of interventions to reduce disability should become health priorities for older Mexican Americans with diabetes",
"Background and aims : This study investigated whether high-velocity high-power training ( POW ) improved lower extremity muscle power and quality in functionally-limited elders greater than traditional slow-velocity progressive resistance training ( STR ) . Methods : Fifty-seven community-dwelling older adults aged 74.2±7 ( range 65–94 yrs ) , Short Physical Performance Battery score 7.7±1.4 , were r and omized to either POW ( n=23 ) ( 12 females ) , STR ( n=22 ) ( 13 females ) or a control group of lower extremity stretching ( CON ) ( n=12 ) ( 6 females ) . Training was performed three times per week for 12 weeks and subjects completed three sets of double leg press and knee extension exercises at 70 % of the one repetition maximum ( 1RM ) . Outcome measures included 1RM strength and peak power ( PP ) . Total leg lean mass was determined using dual-energy X-ray absorptiometry to estimate specific strength and specific PP . Results : During training , power output was consistently higher in POW compared to STR for knee extension ( ∼2.3-fold ) and leg press ( ∼2.8-fold ) exercises ( p this , PP and specific PP of the knee extensors increased similarly from baseline in POW and STR compared to CON ( p for PP of the leg extensors . However , gains in leg press specific PP were significantly greater in POW compared to both STR and CON ( p did not change within any group . Conclusions : A short-term intervention of high-velocity power training and traditional slow-velocity progressive resistance training yielded similar increases of lower extremity power in the mobility-impaired elderly . Neuromuscular adaptations to power training , rather than skeletal muscle hypertrophy , may have facilitated the improvements in muscle quality . Additional studies are warranted to test the efficacy of power training in older individuals with compromised physical functioning",
"STUDY DESIGN R and omized multicenter retrospective chart review of medical referral diagnoses and corresponding referral , patient , and physician demographic data . OBJECTIVE To examine the information content of medical referral diagnoses provided to outpatient physical therapists with respect to physician and patient characteristics . BACKGROUND Previous studies indicate that physicians commonly provide nonspecific referral diagnoses to physical therapists . The effects of patient and physician characteristics on information contained in referral diagnoses are not well eluci date d. METHODS AND MEASURES A team of blinded raters categorized the information content of referral diagnoses ( n = 2183 ) using a classification system adapted from a previous study . RESULTS One third ( 32 % ) of analyzed diagnoses were anatomically oriented and reported specific pathology . These specific diagnoses were provided significantly more commonly by specialist physicians ( odds ratio [ OR ] , 3.4 ; 95 % confidence interval [ CI ] , 2.7 - 4.2 ; P male physicians ( OR , 2.2 ; 95 % CI , 1.6 - 3.1 ; P early- and late-career physicians ( P for male patients ( OR , 1.3 ; 95 % CI , 1.1 - 1.6 ; P physicians . The practice of evidence -based physical therapy seems challenged by the high rate of nonspecific referral diagnoses . Physical therapists may also have the responsibility to conduct differential diagnosis of pathology more commonly than formally recognized by many state practice acts and third-party payers",
"BACKGROUND The Short Physical Performance Battery ( SPPB ) , which includes walking , balance , and chair st and s tests , independently predicts mobility disability and activities of daily living disability . To date , however , there is no definitive evidence from r and omized controlled trials that SPPB scores can be improved . Our objective was to assess the effect of a comprehensive physical activity ( PA ) intervention on the SPPB and other physical performance measures . METHODS A total of 424 sedentary persons at risk for disability ( ages 70 - 89 years ) were r and omized to a moderate-intensity PA intervention or a successful aging ( SA ) health education intervention and were followed for an average of 1.2 years . RESULTS The mean baseline SPPB score on a scale of 0 - 12 , with 12 corresponding to highest performance , was 7.5 . At 6 and 12 months , the PA versus SA group adjusted SPPB ( + /- st and ard error ) scores were 8.7 + /- 0.1 versus 8.0 + /- 0.1 , and 8.5 + /- 0.1 versus 7.9 + /- 0.2 , respectively ( p 400-meter walking speed was also significantly improved in the PA group . The PA group had a lower incidence of major mobility disability defined as incapacity to complete a 400-meter walk ( hazard ratio = 0.71 , 95 % confidence interval = 0.44 - 1.20 ) . CONCLUSIONS A structured PA intervention improved the SPPB score and other measures of physical performance . An intervention that improves the SPPB performance may also offer benefit on more distal health outcomes , such as mobility disability",
"OBJECTIVE To evaluate , in terms of function and mobility , the predictive value of commonly adopted anthropometric ' definitions ' used in the nutritional assessment of older adults , in a cohort of older Australians . DESIGN Prospect i ve cohort study - Australian Longitudinal Study of Ageing ( ALSA ) . SETTING Adelaide , South Australia ( 1992 - 1994 ) . SUBJECTS Data were analysed from 1272 non-institutionalised ( 685 males , 587 females ) older adults > or = 70 years old in South Australia . Seven ' definitions ' commonly used in the anthropometric assessment of both under- and overnutrition ( including four using body mass index ( BMI ) , waist-to-hip ratio , waist circumference and percentage weight change ) were evaluated at baseline , for their ability to predict functional and mobility limitation assessed ( by self-report question naire ) at two years follow-up . All question naires were administered and anthropometry performed by trained investigators . The associations between the definitions and decline in mobility and physical function were evaluated over two years using multiple logistic regression . RESULTS A BMI > 85th percentile or > 30 kg m-2 or a waist circumference of > 102 cm in males and > 88 cm in females increased risk of functional and mobility limitations . Over two years , a loss of 10 % body weight significantly increased the risk of functional and mobility limitations . CONCLUSION Maintaining weight within older adults , irrespective of initial body weight , may be important in preventing functional and mobility limitations . Excessive weight is associated with an increased risk of limitation in function and mobility , both key components of health-related quality of life",
"BACKGROUND Decreased muscle strength impedes elders ' functional performance in daily activities such as gait . The mechanisms whereby increased strength improves gait are unknown . METHODS A prospect i ve , blinded , r and omized trial of moderate intensity strength exercise was conducted and its impact was measured on functional mobility during gait in 132 functionally limited elders . Lower extremity strength was measured , including hip abductor , hip extensor , and knee extensor strength . Of the 132 subjects , 120 subjects ( mean age , 75.1 yrs ) completed 6 months of elastic b and resistance training at least 3 times a week or served as no-exercise controls . RESULTS Subjects increased their lower extremity strength in the exercise and control groups , by 17.6 % and 7.3 % ( p Gait stability improved significantly more in the exercise group than in the control group ( p forward gait velocity were not significantly different between groups . Peak mediolateral velocity and base of support improved in the exercise group , but not in the control group . Change in lower extremity strength correlated significantly but weakly with many of the gait variables . CONCLUSIONS Gait stability , especially mediolateral steadiness , improved in the exercise group but not in the control group . These results show that even moderate strength gains benefit gait performance in elders and thus provide a sound basis for encouraging low-intensity strength training for elders with functional limitations",
"OBJECTIVES To evaluate the validity and reliability of a st and ardized approach for assessing life-space mobility ( the University of Alabama at Birmingham Study of Aging Life-Space Assessment ( LSA ) ) and its ability to detect changes in life-space over time in community-dwelling older adults . DESIGN Prospect i ve , observational cohort study . SETTING Five counties ( three rural and two urban ) in central Alabama . PARTICIPANTS Community-dwelling Medicare beneficiaries ( N=306 ; 46 % male , 43 % African American ) who completed in-home baseline interviews and 2-week and 6-month telephone follow-up interviews . MEASUREMENTS The LSA assessed the range , independence , and frequency of movement over the 4 weeks preceding assessment s. Correlations between the baseline LSA and measures of physical and mental health ( physical performance , activities of daily living , instrumental activities of daily living , a global measure of health ( the short form-12 question survey ) , the Geriatric Depression Scale , and comorbidities ) established validity . Follow-up LSA scores established short-term test-retest reliability and the ability of the LSA to detect change . RESULTS For all LSA scoring methods , baseline and 2-week follow-up LSA correlations were greater than 0.86 ( 95 % confidence interval=0.82 - 0.97 ) . Highest correlations with measures of physical performance and function were noted for the LSA scoring method considering all attributes of mobility . The LSA showed both increases and decreases at 6 months . DISCUSSION Life-space correlated with observed physical performance and self-reported function . It was stable over a 2-week period yet showed changes at 6 months",
"OBJECTIVES To evaluate weighted stair climbing exercise ( SCE ) as a means of increasing lower extremity muscle power in mobility-limited older people . DESIGN Single-blinded , r and omized controlled pilot study . SETTING Human physiology laboratory of a metropolitan university . PARTICIPANTS Forty-five community-dwelling people aged 65 and older who had baseline mobility limitations manifested by scores of 11 or lower on the Short Physical Performance Battery ( SPPB ) . INTERVENTIONS Subjects were r and omized into one of two 12-week exercise programs . The intervention group ( SCE ) ( n = 23 ) ascended and descended stairs , at a set pace , while wearing a weighted vest . The control group ( WALK ) ( n = 22 ) participated in a st and ardized walking program . MEASUREMENTS Primary and secondary outcomes included measures of muscle power and strength , submaximal aerobic capacity , and physical performance . RESULTS SCE produced 17 % improvement in double leg press peak power in comparison with WALK ( P = .013 ) and significant improvement in stair climbing power from baseline ( 12 % ) . Improvement in submaximal aerobic performance was equivalent for both groups . Although not statistically significant , effect size estimates suggest that SCE can potentially influence knee extension power and strength . Stair climb time was improved in both groups , whereas SCE produced significant improvements from baseline SPPB score in a subcohort of participants . CONCLUSIONS These findings suggest that SCE maybe a useful component of a home exercise program design ed to enhance lower extremity muscle power , aerobic capacity , and functional performance . Further investigation is needed involving larger sample sizes and direct comparisons with other forms of resistance training",
"BACKGROUND AND PURPOSE The University of Alabama at Birmingham ( UAB ) Study of Aging Life-Space Assessment ( LSA ) is a relatively new instrument to measure mobility . The purpose of this report is to describe the relationships between LSA and traditional measures of physical function , sociodemographic characteristics , depression , and cognitive status . SUBJECTS Subjects were a stratified r and om sample of 998 Medicare beneficiaries aged > or = 65 years . The sample was 50 % African American , 50 % male , and 50 % from rural ( versus urban ) counties . METHODS In-home interviews were conducted . Mobility was measured using the LSA , which documents where and how often subjects travel and any assistance needed during the 4 weeks prior to the assessment . Basic activities of daily living ( ADL ) and instrumental activities of daily living ( IADL ) , cognitive status , income level , presence of depressive symptoms , and transportation re sources were determined . The Short Physical Performance Battery ( SPPB ) was used to assess physical performance . RESULTS Simple bivariate correlations indicated a significant relationship between LSA and all variables except residence ( rural versus urban ) . In a regression model , physical function ( ADL , IADL ) and physical performance ( SPPB ) accounted for 45.5 % of the variance in LSA scores . An additional 12.7 % of the variance was explained by sociodemographic variables , and less than 1 % was explained by cognition and depressive symptoms . DISCUSSION AND CONCLUSION The LSA can be used to document patients ' mobility within their home and community . The LSA scores are associated with a person 's physical capacity and other factors that may limit mobility . These scores can be used in combination with other tests and measures to generate clinical hypotheses to explain mobility deficits and to plan appropriate interventions to address these deficits",
"OBJECTIVES To test whether accelerated sarcopenia in older persons with high interleukin (IL)-6 serum levels plays a role in the prospect i ve association between inflammation and disability found in many studies . DESIGN Cohort study of older women with moderate to severe disability . PARTICIPANTS Six hundred twenty older women from the Women 's Health and Aging Study in whom information on baseline IL-6 serum level was available . MEASUREMENTS Self-report of functional status , objective measures of walking performance , and knee extensor strength were assessed at baseline and over six semiannual follow-up visits . Potential confounders were baseline age , race , body mass index , smoking , depression , and medical conditions . RESULTS At baseline , women with high IL-6 were more often disabled and had lower walking speed . After adjusting for confounders , women in the highest IL-6 tertile ( IL-6>3.10 pg/mL ) were at higher risk of developing incident mobility disability ( risk ratio ( RR ) = 1.50 , 95 % confidence interval ( CI ) = 1.01 - 2.27 ) , disability in activities of daily living ( RR = 1.41 , 95 % CI = 1.01 - 1.98 ) , and severe limitation in walking ( RR = 1.61 , 95 % CI = 1.09 - 2.38 ) and experienced steeper declines in walking speed ( P in knee extensor strength was also steeper , but differences across IL-6 tertiles were not significant . After adjusting for change over time in knee extensor strength , the association between high IL-6 and accelerated decline of physical function was no longer statistically significant . CONCLUSIONS Older women with high IL-6 serum levels have a higher risk of developing physical disability and experience a steeper decline in walking ability than those with lower levels , which are partially explained by a parallel decline in muscle strength",
"Elderly participants experiencing difficulty in chair rising and with a maximum knee-extensor torque below 87.5 N . m were r and omized to different versions of a strength-training program for the knee-extensors : to a high-guidance group ( HG ; two group sessions supervised by a physical therapist and one unsupervised home session per week , n = 17 ) , a medium-guidance group ( MG ; one supervised group session and two unsupervised home sessions per week , n = 16 ) , or a control group ( C ; no exercise , n = 16 ) . Maximal isometric knee strength increased more in HG than in C ( p = .03 ) and with increasing guidance ( p = .03 ) . The effect was mainly the result of participants with low initial strength . Walking speed increased more for HG than for C ( p = .02 ) and than for MG ( p = .06 ) . No statistically significant improvements were seen on other functional tests . In summary , the study shows a trend toward better results with more supervision , but more and larger studies are needed to confirm this",
"OBJECTIVES To examine joint associations of physical activity and adiposity measures ( body mass index ( BMI ) , waist circumference , percentage body fat ) with incident mobility limitation . DESIGN Prospect i ve observational cohort study . SETTING Memphis , Tennessee and Pittsburgh , Pennsylvania . PARTICIPANTS Two thous and nine hundred and eighty-two black and white men and women aged 70 to 79 participating in the Health , Aging and Body Composition ( Health ABC ) study . MEASUREMENTS Mobility limitation was defined as reported difficulty walking one-quarter of a mile or climbing 10 steps during two consecutive semiannual assessment s over 6.5 years . Three measures of adiposity were included in this study : BMI , total percentage body fat , and waist circumference . Physical activity was assessed using a modified leisure-time physical activity question naire . RESULTS Forty-six percent of the cohort developed mobility limitation . White and black men with a high BMI ( > or = 30 kg/m(2 ) ) , high total percentage body fat ( > 31.3 % ) , or high waist circumference ( > or = 102 cm ) had an approximately 60 % , 40 % , and 40 % , respectively , higher risk of incident mobility limitation than those with low adiposity . In women , high adiposity was also associated with a significantly higher mobility limitation risk than in those with low adiposity . Low physical activity ( lowest quartile ) was associated with a 70 % higher risk of mobility limitation in all groups . Persons with high adiposity and low physical activity were at particularly high risk of mobility limitation . People with high adiposity who were physically active had an equally high risk of mobility limitation as inactive people with low adiposity . CONCLUSION High adiposity and low self-reported physical activity predicted the onset of mobility limitation in well-functioning older persons . Preventing weight gain in old age and promoting physical activity in obese and non-obese older persons may therefore be effective strategies to prevent mobility loss and future disability",
"Objective : To establish the effects of group exercise on mobility and strength . Design : R and omized controlled trial . Setting : Two public hospital outpatient rehabilitation services . Participants : One hundred and seventy-three people ( mean age 74.9 years , SD 10.8 ) with impaired mobility were r and omized and 159 people ( 92 % ) completed the trial . Interventions : Five-week , twice-weekly ` circuit-style ' group exercise programme run by a physiotherapist ( n = 85 ) and a no-intervention waiting list control group ( n = 88 ) . Main outcome measures : Three aspects of mobility : balance while st and ing and stepping ( Step Test , semi-t and em and t and em stance times ) ; sit-to-st and ability ( rate and minimum height ) and gait ( 6-metre and 6-minute walk tests ) . Lower limb muscle strength ( knee flexion and extension ) . Results : At retest , exercise participants had improved significantly more than their control counterparts on measures of balance while stepping , sit to st and and gait . Exercise participants averaged 1.6 more steps on the 15-second Step Test ( 95 % confidence interval ( CI ) 0.5 to 2.8 , P=0.005 ) , walked an average of 0.12 m/s faster ( 95 % CI 0.05 to 0.2 , P=0.002 ) and took 2.5 fewer steps in 6 metres ( 95 % CI —4.2 to —0.8 , P=0.004 ) . Exercise participants also averaged 0.04 more sit-to-st and s/second , ( 95 % CI 0.003 to 0.08 , P=0.037 ) and walked an average of 30.9 metres further in 6 minutes ( 95 % CI 9.4 to 52.4 , P=0.005 ) . There were no clinical ly important or statistically significant between-group differences at retest for the measures of strength ( knee extension and flexion ) , balance while st and ing or minimal sit-to-st and height . Conclusion : This short- duration circuit class programme improved mobility , but not strength",
"PURPOSE To compare the effects of functional home exercise of repeated sit-to-st and s with low-intensity progressive resistance training , on performance measures in mobility-limited adults over 80 years of age . SETTING Participants ' homes . DESIGN Community-dwelling older adults > or = 80 years of age were invited to participate in a r and omised controlled clinical trial . Baseline and outcome measures were : comfortable gait velocity , 30-s chair-st and test , 15-s step test , Berg Balance Scale , Modified Falls Efficacy Scale and the Late-Life Function and Disability Instrument-function component . Participants r and omised to the intervention group performed repeated sit-to-st and s using a Gr and St and System ; a biofeedback device that recorded and displayed the number of repetitions performed . Participants r and omised to the control group performed knee extensions using ankle cuff weights . Both groups performed the exercises daily for 6 weeks . RESULTS Sixty-six older adults took part . The intervention group had a statistically significant improvement in Berg Balance Scale mean score , 1.67 + /- 2.64 points , P = 0.001 ( control group 0.73 + /- 3.63 points , P = 0.258 ) , indicating an improvement in balance over the 6-week exercise period . There was no statistically significant effect of either intervention on the other outcome measures . CONCLUSIONS In a highly variable population of older adults with mobility limitations , low-intensity functional home exercise of repeated sit-to-st and s using the Gr and St and System improved Berg Balance Scale score while low-intensity progressive resistance training did not . While statistically significant , the improvement in Berg Balance Scale score was modest raising the issue of what extent of change in score is clinical ly significant in this population",
"BACKGROUND Physical disability and dependency are serious , and frequent , adverse health outcomes associated with aging and result ing from chronic disease . Reasoning has suggested that there might be a pre clinical , intermediate phase of disablement which might develop in parallel with progression of underlying disease and precede and predict disability . Definition of this stage could provide a basis for screening and early intervention to prevent disability . The objective of this study was to determine pre clinical functional predictors of incident mobility difficulty and provide evidence for a pre clinical stage of disability . METHODS A prospect i ve , population -based cohort study was carried out in Baltimore , Maryl and , with two evaluations 18 months apart . The participants were 436 community-dwelling women , 70 - 80 years of age at baseline , not cognitively impaired , and reporting difficulty in no areas , or only one area , of physical function ( primarily mobility ) , who were participating in the Women 's Health and Aging Study II . Participants were recruited from a population -based , age-stratified r and om sample . Incident mobility disability was studied in the subset without such disability at baseline . The main outcome measure was self-reported incident difficulty walking 1/2 mile or climbing up 10 steps . RESULTS At baseline , 69.3 % of the cohort reported no difficulty with mobility . After 18 months , 16.0 and 11.7 % of this group reported incident difficulty walking 1/2 mile or climbing up 10 steps , respectively . Those reporting baseline task modification due to underlying health problems , our measure of pre clinical disability , were at three- to fourfold higher odds of progressing to difficulty than were those without such modification . In multivariate logistic regression analyses , this self-report measure , task modification without difficulty , and objective measures of performance were independently and jointly predictive of incident mobility difficulty . Specifically , for incident difficulty walking 1/2 mile , self-reported task modification odds ratio ( OR ) = 3.67 , walking speed ( .5 m/s difference ) OR = 2.16 ; for incident difficulty climbing up 10 stairs , OR for task modification = 3.84 , for stair climb speed ( 1/3 step/s difference ) = 2.08 ( 95 % CI did not include 1 for any ) . Covariates , age , living alone , number of chronic diseases , depression score , knee strength , and balance by functional reach , were not significant predictors in either model . CONCLUSIONS Two indicators of functional changes in older women without mobility difficulty , self-report of modification of method of doing a task in the absence of difficulty and performance measures , are independent and strong predictors of risk of incident mobility disability . The self-report measure provides substantial strength in predicting risk of incident disability across the full range of performance , and may identify a vulnerable point at which other risk factors act to cause transitions to disability . Together , the pre clinical indicators identify a subset of high-functioning older women who are at high risk of mobility disability , and provide a potential basis for screening for disability risk and targeting interventions to prevent mobility disability",
"Background Due to the many problems associated with reduced balance and mobility , providing an effective and engaging rehabilitation regimen is essential to progress recovery from impairments and to help prevent further degradation of motor skills . Objectives The purpose of this study was to examine the feasibility and benefits of physical therapy based on a task-oriented approach delivered via an engaging , interactive video game paradigm . The intervention focused on performing targeted dynamic tasks , which included reactive balance controls and environmental interaction . Design This study was a r and omized controlled trial . Setting The study was conducted in a geriatric day hospital . Participants Thirty community-dwelling and ambulatory older adults attending the day hospital for treatment of balance and mobility limitations participated in the study . Interventions Participants were r and omly assigned to either a control group or an experimental group . The control group received the typical rehabilitation program consisting of strengthening and balance exercises provided at the day hospital . The experimental group received a program of dynamic balance exercises coupled with video game play , using a center-of-pressure position signal as the computer mouse . The tasks were performed while st and ing on a fixed floor surface , with progression to a compliant sponge pad . Each group received 16 sessions , scheduled 2 per week , with each session lasting 45 minutes . Measurements Data for the following measures were obtained before and after treatment : Berg Balance Scale , Timed “ Up & Go ” Test , Activities-specific Balance Confidence Scale , modified Clinical Test of Sensory Interaction and Balance , and spatiotemporal gait variables assessed in an instrumented carpet system test . Results Findings demonstrated significant improvements in posttreatment balance performance scores for both groups , and change scores were significantly greater in the experimental group compared with the control group . No significant treatment effect was observed in either group for the Timed “ Up & Go ” Test or spatiotemporal gait variables . Limitations The sample size was small , and there were group differences at baseline in some performance measures . Conclusion Dynamic balance exercises on fixed and compliant sponge surfaces were feasibly coupled to interactive game-based exercise . This coupling , in turn , result ed in a greater improvement in dynamic st and ing balance control compared with the typical exercise program . However , there was no transfer of effect to gait function",
"Background Definitive evidence that exercise interventions that improve gait also reduce disability is lacking . A task-oriented , motor sequence learning exercise intervention has been shown to reduce the energy cost of walking and improve gait speed , but whether the intervention also improves activity and participation has not been demonstrated . Objective The objective of this study was to compare the impact of a task-oriented , motor sequence learning exercise ( TO ) intervention and the impact of an impairment-oriented , multicomponent exercise ( IO ) intervention on activity and participation outcomes in older adults with mobility limitations . The mediating effects of a change in the energy cost of walking on changes in activity and participation also were determined . Design This study was a single-blind , r and omized controlled trial . Setting The study was conducted in an ambulatory clinical research training center . Participants The study participants were 47 older adults ( mean age=77.2 years , SD=5.5 ) with slow and variable gait . Intervention The intervention was a 12-week , physical therapist – guided program of TO or IO . Measurements Measures of activity ( gait speed over an instrumented walkway ; daily physical activity measured with an accelerometer ; confidence in walking determined with the Gait Efficacy Scale ; and physical function determined with the total , basic lower-extremity , and advanced lower-extremity components of the Late-Life Function and Disability Instrument [ Late-Life FDI ] ) and participation ( disability limitation dimension and instrumental role [ home and community task performance ] domain components of the Late-Life FDI ) were recorded before and after the intervention . The energy cost of walking was determined from the rate of oxygen consumption during self-paced treadmill walking at the physiological steady state st and ardized by walking speed . An adjusted comparison of activity and participation outcomes in the treatment arms was made by use of an analysis of covariance model , with baseline and change in energy cost of walking added to the model to test for mediation . Tests were used to determine the significance of the mediating effects . Results Activity improved in TO but not in IO for confidence in walking ( Gait Efficacy Scale ; mean adjusted difference=9.8 [ SD=3.5 ] ) and physical function ( Late-Life FDI basic lower-extremity component ; mean adjusted difference=3.5 [ SD=1.7 ] ) . Improvements in TO were marginally greater than those in IO for gait speed , physical activity , and total physical function . Participation improved marginally more in TO than in IO for disability limitations and instrumental role . Limitations The older adults were r and omized to the intervention group , but differences in baseline measures had to be accounted for in the analyses . Conclusions A TO intervention that improved gait also led to improvements in some activity and participation outcomes in older adults with mobility limitations",
"BACKGROUND Relatively little is known about why older persons develop long-term disability in community mobility . OBJECTIVE To identify the risk factors and precipitants for long-term disability in walking a quarter mile and driving a car . DESIGN Prospect i ve cohort study from March 1998 to December 2009 . SETTING Greater New Haven , Connecticut . PARTICIPANTS 641 persons , aged 70 years or older , who were active drivers or nondisabled in walking a quarter mile . Persons who were physically frail were over sample d. MEASUREMENTS C and i date risk factors were assessed every 18 months . Disability in community mobility and exposure to potential precipitants , including illnesses or injuries leading to hospitalization or restricted activity , were assessed every month . Disability that lasted 6 or more consecutive months was considered long-term . RESULTS 318 ( 56.0 % ) and 269 ( 53.1 % ) participants developed long-term disability in walking and driving , respectively . Seven risk factors were independently associated with walking disability and 8 were associated with driving disability ; the strongest associations for each outcome were found for older age and lower score on the Short Physical Performance Battery . The precipitants had a large effect on long-term disability , with multivariate hazard ratios for each outcome greater than 6.2 for hospitalization and greater than 2.4 for restricted activity . The largest differences in absolute risk were generally observed in participants with a specific risk factor who were subsequently hospitalized . LIMITATIONS The observed associations may not be causal . The severity of precipitants was not assessed . The effect of the precipitants may have been underestimated because their exposure after the initial onset of disability was not evaluated . CONCLUSION Long-term disability in community mobility is common among older persons . Multiple risk factors , together with subsequent precipitants , greatly increase the likelihood of long-term mobility disability . PRIMARY FUNDING SOURCE National Institute on Aging , National Institutes of Health"
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CONTEXT Less than 5 % of U.S. adults accumulate the required dose of exercise to maintain health . Behavioral economics has stimulated renewed interest in economic-based , population -level health interventions to address this issue . Despite widespread implementation of financial incentive-based public health and workplace wellness policies , the effects of financial incentives on exercise initiation and maintenance in adults remain unclear . EVIDENCE ACQUISITION A systematic search of 15 electronic data bases for RCTs reporting the impact of financial incentives on exercise-related behaviors and outcomes was conducted in June 2012 . A meta- analysis of exercise session attendance among included studies was conducted in April 2013 . A qualitative analysis was conducted in February 2013 and structured along eight features of financial incentive design . EVIDENCE SYNTHESIS Eleven studies were included ( N=1453 ; ages 18 - 85 years and 50 % female ) . Pooled results favored the incentive condition ( z=3.81 , p Incentives also exhibited significant , positive effects on exercise in eight of the 11 included studies . One study determined that incentives can sustain exercise for longer periods ( > 1 year ) , and two studies found exercise adherence persisted after the incentive was withdrawn . Promising incentive design feature attributes were noted . Assured , or " sure thing , " incentives and objective behavioral assessment in particular appear to moderate incentive effectiveness . Previously sedentary adults responded favorably to incentives 100 % of the time ( n=4 ) . CONCLUSIONS The effect estimate from the meta- analysis suggests that financial incentives increase exercise session attendance for interventions up to 6 months in duration . Similarly , a simple count of positive ( n=8 ) and None ( n=3 ) effect studies suggests that financial incentives can increase exercise adherence in adults in the short term ( < 6 months ) | [
"OBJECTIVE To examine the viability of monetary incentives to increase fitness-center use and maintain/improve the Body Mass Indexes ( BMI s ) of first-year students over the fall semester . METHOD R and omized-controlled trial with no-treatment and incentive conditions involving 117 first-year students . For 12 weeks , students in the incentive condition received monetary payments ranging from $ 10 to $ 38.75 for meeting research er-set fitness-center use goals that were identical across conditions . Fitness-center use was monitored through electronic ID-card check-in and check-out records at the campus fitness center . RESULTS 63 % of incentive-condition participants met the weekly fitness-center use goals on average compared to only 13 % of control-condition participants , a significant difference , p Goal achievement significantly decreased over time , p incentive conditions , p=0.23 . Average BMI increases over the fall semester in the control ( 24.2 ( 0.6 ) to 24.6 (0.6)kg/m(2 ) ) versus incentive condition ( 23.1 ( 0.4 ) to 23.5 (0.4)kg/m(2 ) ) were not significantly different ( p=0.70 ) . CONCLUSION Weekly monetary incentives result ed in significantly more first-year students meeting weekly fitness-center use goals . However , the increased fitness-center use by the incentive condition did not prevent an increase in BMI during fall semester",
"Exercise is the best predictor of long-term weight loss . This study evaluated two strategies for improving exercise adherence and long-term weight loss in obese out patients . Obese men and women ( N = 193 ) were r and omized to 1 of 5 treatment groups for 18 months : st and ard behavior therapy ( SBT ) ; SBT with supervised walks ( SW ) 3 times per week ; SBT + SW with personal trainers ( PT ) , who walked with participants , made phone reminders , and did make-up SW ; SBT + SW with monetary incentives ( I ) for completing SW ; and SBT + SW + PT + I. Both PT and I enhanced attendance at SWs , the combination producing the best adherence . Increased walk attendance did not result in higher overall energy expenditure , however , and long-term weight loss was also not improved . Post hoc analyses suggest that the level of exercise needed for successful long-term weight loss is much higher than that usually recommended in behavioral treatment programs",
"Behavioral treatments for obesity seek to modify eating and exercise behaviors by a change in their antecedents and consequences . More direct modification of antecedents and consequences by ( a ) the provision of food to patients and ( b ) the provision of financial rewards for weight loss was hypothesized to improve treatment outcomes . Two hundred two men and women were r and omly assigned to no treatment , st and ard behavioral treatment ( SBT ) , SBT plus food provision , SBT plus incentives , or SBT plus food provision and incentives . The major finding was that food provision significantly enhanced weight loss . Weight losses with SBT averaged 7.7 , 4.5 , and 4.1 kg at 6 , 12 , and 18 months , respectively , compared with 10.1 , 9.1 , and 6.4 kg , respectively , at the same intervals with the addition of food . Food provision also enhanced attendance , completion of food records , quality of diet , and nutrition knowledge . We conclude that the provision of food to weight-loss patients is a promising methodology that deserves further exploration",
"Two behavioral techniques were assessed to determine their effects on subjects ' adherence to unsupervised exercise . The subjects were 35 moderately fit persons who had just completed an adult fitness program ( AF group ) and 42 sedentary individuals who were recruited through the campus newspaper ( NEWS group ) . Participants were r and omly assigned to one of three conditions : ( a ) self-monitoring , ( b ) reinforcement supplied by another person , or ( c ) control . All subjects were given instructions on how to exercise and asked to exercise on their own for 18 weeks . Self-monitoring subjects kept written records of their exercise behavior , while reinforcement subjects verbally reported their exercise behavior to another person who periodically administered rewards . Pre- and posttreatment tests on the NEWS group revealed no significant treatment or interaction effects . However , the reinforcement group had an 11 % improvement in predicted max VO2 and a 9 bpm improvement in exercise heart rate compared to 7.8 % , 5 bpm for the self-monitoring ( SM ) group and 5.3 % , 6 bpm for the control group . T-tests indicated that reward and SM groups improved significantly on these variables , whereas the control group did not . SM ( M = 2.07 ) and reinforcement ( M = 2.29 ) groups reported a significantly higher frequency of exercise per week than the control ( M = 1.36 ) group . The AF subjects were able to maintain their fitness level ( with the exception of a small increase in body fat ) over the 18-week period . The behavioral interventions had little differential effect on adherence by AF subjects who were already regular exercisers",
"Exercise is important for long-term weight loss , but few studies have examined ways to improve exercise adherence in overweight subjects participating in a behavioral weight loss program . This paper presents two studies , one conducted at the University of Pittsburgh and one at the University of Minnesota , that sought to improve exercise adherence by exerting more direct control over the environmental antecedents and consequences controlling exercise . Study 1 investigated the use of a personal trainer who called participants regularly and met them at their home or office at scheduled times for a walk . Study 2 investigated the effect of a lottery incentive for exercise adherence . In both studies , the effect of these manipulations was examined in the context of a 24-week st and ard behavioral weight control program with three supervised exercise sessions per week . Neither intervention achieved statistically significant improvements in exercise adherence compared to control conditions , perhaps due in part to the limited statistical power of the studies . Future studies should focus on better underst and ing the barriers to exercise and design ing behavioral interventions that address these barriers",
"The purpose of the present study was to examine the effect of a previously untested reinforcement strategy ( i.e. , 1 month 's free membership ) on attendance at a fitness facility . Participants were paying members of a fitness facility r and omly assigned to control ( n = 100 ) , placebo ( n = 100 ) , and reinforcement ( n = 100 ) conditions . The control condition received no intervention ; the placebo condition received a letter by mail ; and the reinforcement condition received the same letter by mail , except that it included an additional paragraph instructing them that they could earn 1 month 's free membership if they attended the fitness facility at least 12 times in the next month . Attendance was monitored for I month baseline and postintervention by using the facility 's computer system . Analysis of variance , t tests , and chi-square analysis all revealed that the reinforcement condition had the best attendance record during the intervention period . These preliminary results shed some light on increasing attendance at a fitness facility . Discussion highlighted the practical implication s of the findings and offered directions for future research",
"OBJECTIVES This study examined whether weight gain with age could be prevented through the use of a low-intensity intervention . METHODS Participants , 228 men and 998 women recruited from diverse sources , were r and omized to one of the following groups : ( 1 ) no-contact control , ( 2 ) education through monthly newsletters , or ( 3 ) education plus incentives for participation . All participants were weighed and completed question naires about behaviors and attitudes related to weight at baseline and annually for 3 years thereafter . RESULTS Individuals in intervention groups reported favorable changes over time in frequency of weighting and healthy dieting practice s relative to those in the control group . These behavior changes were in turn related to a reduced rate of weight gain over time . However , weight gain over 3 years did not differ significantly by treatment group . CONCLUSIONS This low-intensity educational approach to weight gain prevention sustained interest over a lengthy time period and was associated positively with behavior change , but it was not strong enough to significantly reduce weight gain with age",
"OBJECTIVES This study reports an efficacy trial of four work-site health promotion programs . It was predicted that strategies making use of behavioral counseling would produce a greater reduction in cardiovascular disease risk factors than screening and educational strategies . METHODS Twenty-eight work sites were r and omly allocated to a health risk assessment , risk factor education , behavioral counseling , or behavioral counseling plus incentives intervention . Participants were assessed before the intervention and at 3 , 6 , and 12 months . RESULTS Compared with the average of the health risk assessment and risk factor education conditions , there were significantly higher vali date d continuous smoking cessation rates and smaller increases in body mass index and estimated percentage of body fat in the two behavioral counseling conditions . The behavioral counseling condition was associated with a greater reduction in mean blood pressure than was the behavioral counseling plus incentives condition . On average among all groups , there was a short-term increase in aerobic capacity followed by a return to baseline levels . CONCLUSIONS Work-site interventions that use behavioral approaches can produce lasting changes in some cardiovascular risk factors and , if implemented routinely , can have a significant public health impact",
"OBJECTIVE Less than half of all U.S. adults meet public health recommendations for physical activity , and even fewer older adults ( aged 50 years and over ) are sufficiently active . Because inactivity increases the risk of costly medical complications , successful efforts to increase physical activity among older adults may potentially be cost-effective . We sought to test if financial incentives for walking could increase physical activity among sedentary older adults . METHODS We conducted a 4-week r and omized controlled study using pedometers . A total of 51 adults age 50 + from the Raleigh-Durham area of North Carolina participated in the study in April-May 2007 . Individuals were r and omized into one of two arms . The control group received a fixed payment of $ 75 ; the intervention group received a fixed payment of $ 50 plus up to $ 25 more per week depending on the number of weekly aerobic minutes , defined as 10 + minutes of continuous walking or jogging . RESULTS The control group logged 2.3 h per week , on average . The intervention group logged 4.1 h per week and received an additional weekly payment of $ 17.50 , on average . CONCLUSION Modest financial incentives tied to aerobic minutes are an effective , and potentially cost-effective , approach for increasing physical activity among sedentary older adults ",
"OBJECTIVE The aim of this study was to assess the efficacy of a behavioral treatment program for achieving initial cocaine abstinence in individuals enrolled in outpatient treatment for cocaine dependence . METHOD Thirteen consecutively admitted out patients were offered behavioral treatment consisting of contingency management procedures and the community reinforcement approach . Fifteen consecutively admitted out patients were offered treatment with 12-step counseling . All 13 of the patients who were offered the behavioral treatment accepted it ; 12 of the patients offered 12-step counseling accepted it . RESULTS Eleven of the 13 patients in the behavioral treatment were retained for 12 weeks of treatment , compared with five of the 12 patients given 12-step counseling . Ten of the patients given behavioral therapy achieved 4 weeks of continuous cocaine abstinence , compared with only three of those given 12-step counseling . Six of the patients in the behavioral treatment group achieved 8 weeks , and three achieved 12 weeks ; none of the patients in the 12-step counseling program achieved 8 weeks . CONCLUSIONS The behavioral treatment described in this paper offers promise as an effective intervention for achieving initial cocaine abstinence . A r and omized trial is underway to assess the generality of these findings"
] | 41167702-06ff-11f0-808a-c43d1ab1c353 |
Study question Is methylpheni date beneficial or harmful for the treatment of attention-deficit/hyperactivity disorder ( ADHD ) in children and adolescents ? Methods Electronic data bases were search ed up to February 2015 for parallel and crossover r and omised clinical trials comparing methylpheni date with placebo or no intervention in children and adolescents with ADHD . Meta-analyses and trial sequential analyses ( TSA ) were conducted . Quality was assessed using GRADE . Teachers , parents , and observers rated ADHD symptoms and general behaviour . Study answer and limitations The analyses included 38 parallel group trials ( n=5111 , median treatment duration 49 days ) and 147 crossover trials ( n=7134 , 14 days ) . The average age across all studies was 9.7 years . The analysis suggested a beneficial effect of methylpheni date on teacher rated symptoms in 19 parallel group trials ( st and ardised mean difference ( SMD ) −0.77 , n=1698 ) , corresponding to a mean difference of −9.6 points on the ADHD rating scale . There was no evidence that methylpheni date was associated with an increase in serious adverse events ( risk ratio 0.98 , nine trials , n=1532 ; TSA adjusted intervention effect RR 0.91 ) . Methylpheni date was associated with an increased risk of non-serious adverse events ( 1.29 , 21 trials , n=3132 ; TSA adjusted RR 1.29 ) . Teacher rated general behaviour seemed to improve with methylpheni date ( SMD −0.87 , five trials , n=668 ) A change of 7 points on the child health question naire ( CHQ ) has been deemed a minimal clinical ly relevant difference . The change reported in a meta- analysis of three trials corresponds to a mean difference of 8.0 points on the CHQ ( range 0 - 100 points ) , which suggests that methylpheni date may improve parent reported quality of life ( SMD 0.61 , three trials , n=514 ) . 96.8 % of trials were considered high risk of bias trials according to the Cochrane guidelines . All outcomes were assessed very low quality according to GRADE . What this study adds The results suggest that among children and adolescents with a diagnosis of ADHD , methylpheni date may improve teacher reported symptoms of ADHD and general behaviour and parent reported quality of life . However , given the risk of bias in the included studies , and the very low quality of outcomes , the magnitude of the effects is uncertain . Methylpheni date is associated with an increased risk of non-serious but not serious adverse events . Funding , competing interests , data sharing Region Zeal and Research Foundation and Copenhagen Trial Unit . Competing interests are given in the full paper on bmj.com . Full data are available in the version of this review published in The Cochrane Library | [
"Background This study examined augmenting atomoxetine with extended-release methylpheni date in children whose attention-deficit/hyperactivity disorder ( ADHD ) previously failed to respond adequately to stimulant medication . Methods Children with ADHD and prior stimulant treatment ( N = 25 ) received atomoxetine ( 1.2 mg/kg/day ) plus placebo . After 4 weeks , patients who were responders ( n = 4 ) were continued on atomoxetine/placebo while remaining patients were r and omly assigned to either methylpheni date ( ATX/MPH ) ( 1.1 mg/kg/day ) or placebo augmentation ( ATX/PB ) for another 6 weeks . Patients and sites were blind to timing of active augmentation . Safety measures included vital signs , weight , and adverse events . Efficacy was assessed by ADHD rating scales . Results Categorical increases in vital signs occurred for 5 patients ( 3 patients in ATX/MPH , 2 patients in ATX/PBO ) . Sixteen percent discontinued the study due to AE , but no difference between augmentation groups . Atomoxetine treatment was efficacious on outcome measures ( P ≤ .001 ) , but methylpheni date did not enhance response . Conclusion Methylpheni date appears to be safely combined with atomoxetine , but conclusions limited by small sample . With atomoxetine treatment , 43 % of patients achieved normalization on ADHD ratings ",
" Research participants were 46 adolescents ( mean age = 13.8 years ) who completed an intensive summer treatment program including a placebo-controlled , double-blind , crossover trial of 3 doses of methylpheni date ( MPH ) totaling 25 , 50 , or 75 mg per day . Dependent measures focused on social behavior and included observed behavior frequencies and ratings completed by counselors and parents , including side effects . Multiple data analytic methods were used with the goal of ( a ) describing the shape of the dose-response curves across multiple measures of social functioning , ( b ) determining the percentage of adolescents whose social behavior improved in response to MPH , and ( c ) assessing the incremental gains that result from increases in dose . The results show that ( a ) the shape of the dose-response curve is influenced by the measurement method , ( b ) the majority of adolescents exhibited improved social behavior when treated with MPH , ( c ) the bulk of the positive effects of MPH were achieved at the lowest dose , and ( d ) there appear to be diminishing positive effects and an increased risk of negative effects with successively higher doses",
"OBJECTIVE Response to atomoxetine , a nonstimulant norepinephrine-specific reuptake inhibitor , was compared with the effect of osmotic-release oral methylpheni date , a long-acting methylpheni date preparation , in patients with attention deficit hyperactivity disorder ( ADHD ) . METHOD In a large placebo-controlled , double-blind study , patients ages 6 - 16 with ADHD , any subtype , were r and omly assigned to receive 0.8 - 1.8 mg/kg per day of atomoxetine ( N=222 ) , 18 - 54 mg/day of osmotically released methylpheni date ( N=220 ) , or placebo ( N=74 ) for 6 weeks . The a priori specified primary analysis compared response ( at least 40 % decrease in ADHD Rating Scale total score ) to osmotically released methylpheni date with response to atomoxetine and placebo . After 6 weeks , patients treated with methylpheni date were switched to atomoxetine under double-blind conditions . RESULTS The response rates for both atomoxetine ( 45 % ) and methylpheni date ( 56 % ) were markedly superior to that for placebo ( 24 % ) , but the response to osmotically released methylpheni date was superior to that for atomoxetine . Each medication was well tolerated , with completion rates and discontinuations for adverse events not significantly different from those for placebo . Of the 70 subjects who did not respond to methylpheni date , 30 ( 43 % ) subsequently responded to atomoxetine . Likewise , 29 ( 42 % ) of the 69 patients who did not respond to atomoxetine had previously responded to osmotically released methylpheni date . CONCLUSION Response was significantly greater with osmotically released methylpheni date than with atomoxetine . One-third of patients who received methylpheni date followed by atomoxetine responded better to one or the other , suggesting that there may be preferential responders",
"Our objective was to evaluate the effectiveness of a long-acting formulation of methylpheni date ( MPH-SODAS ) on attention-deficit/hyperactivity disorder ( ADHD ) symptoms in an outpatient sample of adolescents with ADHD and substance use disorders ( SUD ) . Secondary goals were to evaluate the tolerability and impact on drug use of MPH-SODAS . This was a 6-week , single-blind , placebo-controlled crossover study assessing efficacy of escalated doses of MPH-SODAS on ADHD symptoms in 16 adolescents with ADHD/SUD . Participants were r and omly allocated to either group A ( weeks 1 - 3 on MPH-SODAS , weeks 4 - 6 on placebo ) or group B ( reverse order ) . The primary outcome measures were the Swanson , Nolan and Pelham Scale , version IV ( SNAP-IV ) and the Clinical Global Impression Scale ( CGI ) . We also evaluated the adverse effects of MPH-SODAS using the Barkley Side Effect Rating Scale and subject reports of drug use during the study . The sample consisted of marijuana ( N = 16 ; 100 % ) and cocaine users ( N = 7 ; 43.8 % ) . Subjects had a significantly greater reduction in SNAP-IV and CGI scores ( P MPH-SODAS treatment compared to placebo . No significant effects for period or sequence were found in analyses with the SNAP-IV and CGI scales . There was no significant effect on drug use . MPH-SODAS was well tolerated but was associated with more severe appetite reduction than placebo ( P MPH-SODAS was more effective than placebo in reducing ADHD symptoms in a non-abstinent outpatient sample of adolescents with comorbid SUD . R and omized clinical trials , with larger sample s and SUD intervention , are recommended",
"OBJECTIVE To examine the short-term efficacy of methylpheni date in the treatment of youths with bipolar disorder ( BD ) and comorbid attention deficit/hyperactivity disorder ( ADHD ) . METHOD A 4-week double-blind , placebo-controlled trial in youths ages 5 to 17 years was conducted . Subjects met DSM-IV criteria for bipolar disorder and ADHD , were currently receiving a stable dose of at least one thymoleptic , and while euthymic continued to have clinical ly significant symptoms of ADHD . Patients received 1 week each of placebo , methylpheni date 5 mg twice daily , methylpheni date 10 mg twice daily , and methylpheni date 15 mg twice daily using a crossover design . Subjects were r and omly assigned to receive one of six possible dosing orders . At study 's end , and before the blind being broken , a \" best dose week \" for each subject was determined . The primary outcome measure was the total score on the parent-completed ADHD Rating Scale-IV . RESULTS Sixteen patients , with a mean age of 10.43 ( SD 3.14 ) years completed the trial . Lower scores during best dose treatment compared to the week of placebo treatment were found on the ADHD Rating Scale-IV ( p methylpheni date . Treatment was generally well tolerated . CONCLUSIONS Euthymic youths with bipolar disorder and ADHD may benefit from short-term concomitant treatment with methylpheni date",
"Objective : While American Academy of Pediatrics guidelines recommend obtaining symptom reports from both parents and teachers when treating children with attention-deficit hyperactivity disorder ( ADHD ) , information from parents is easier to obtain and practitioners may prefer to rely solely on parent report when managing medications . There are , however , few empirical data on the relationship between parent and teacher reports during medication management of ADHD . This study examined the relationship between parent and teacher reports of symptoms of ADHD during a clinical trial . Methods : A study to improve medication management of ADHD was conducted in 24 pediatric practice s with 270 children . Children meeting criteria for ADHD were r and omized by practice to treatment-as-usual or specialized care groups , with data combined from the groups to examine parent-teacher agreement . Parent and teacher reports on the ADHD Rating Scale-IV were obtained at pretreatment , 4 months , and 12 months follow-up . Results : At each assessment , correlations between parent and teacher ratings were statistically significant , but the magnitudes of the correlations were low , accounting for no more than approximately 17 % of the variance between measures . Correlations between change scores on parent and teacher ratings were statistically significant but low for Total and Inattentive scales and not significant for the Hyperactive-Impulsive scale . For agreement on extreme scores , 6 of 9 kappas were statistically significant but all were unacceptably low . Conclusions : Agreement between parent and teacher ratings of symptoms of ADHD is too low for clinicians to rely on parent reports while managing medications . Teacher reports are still needed to ensure optimal management",
"This pilot study was design ed to assess the short-term effectiveness and side effects of methylpheni date in treating symptoms of attention deficit hyperactivity disorder ( ADHD ) in Native American children ( 5 to 12 years old ) with documented fetal alcohol syndrome ( FAS ) or partial fetal alcohol syndrome . Using strict criteria for the diagnosis of FAS and ADHD , a r and omized double-blind cross-over study of two placebos and a fixed dose of methylpheni date was completed in 4 Native American children in a residential school . Each treatment condition lasted 5 days , and daily observational outcome measures , the Conners Parent Rating Scale ( CPRS-48 ) , and the Conners Teacher Rating Scale ( CTRS-39 ) , were employed . Methylpheni date significantly improved scores of the Hyperactivity Index Scale on the CPRS-48 and the CTRS-39 but not the Daydreaming-Attention score on the CTRS-39 . Side effects were similar to those traditionally found in other population s. The promising preliminary results suggest that a more definitive study of methylpheni date in Native and non-Native children with FAS and ADHD is warranted",
" Thirty-eight boys , referred for psychiatric treatment because of serious problems of behaviour , underwent a double-blind , placebo-controlled , crossover trial of methylpheni date and placebo . Methylpheni date was an effective treatment over a 3-week period . A good response to methylpheni date was predicted by higher levels of inattentive and restless behaviour , impaired performance on tests of attention , clumsiness , younger age and by the absence of symptoms of overt emotional disorder . DSM-III and ICD-9 diagnoses of ' hyperactivity ' were not good predictors . The results support the validity of a construct of hyperactivity in describing childhood psychopathology , but emphasize the need for a refinement of diagnostic criteria",
"OBJECTIVE Methylpheni date ( MPH ) is commonly used to treat attention-deficit/hyperactivity disorder ( ADHD ) in all children , including those with velocardiofacial syndrome ( VCFS ) . Yet concerns have been raised regarding its safety and efficacy in VCFS . The goal of this study was to examine the safety and efficacy of MPH in children with VCFS . METHODS Thirty-four children and adolescents with VCFS and ADHD participated in a r and omized , controlled trial with a 2:1 ratio of MPH versus placebo . All subjects underwent a cardiological evaluation before and after MPH administration . The primary outcome measure was prefrontal cognitive performance following a single dose of MPH or placebo . A follow-up assessment was conducted after a 6-month treatment with MPH . RESULTS Compared with placebo , single MPH administration was associated with a more robust improvement in prefrontal cognitive performance , including achievements in the Hearts and Flowers executive function task and the visual continuous performance task . After 6 months of treatment , a 40 % reduction in severity of ADHD symptoms was reported by parents on the Revised Conners Rating Scale . All subjects treated with MPH reported at least one side effect , but it did not necessitate discontinuation of treatment . MPH induced an increase in heart rate and blood pressure that was usually minor , but was clinical ly significant in two cases . No differences in response to MPH were observed between catechol-O-methyltransferase Met versus Val carriers . CONCLUSION The use of MPH in children with VCFS appears to be effective and relatively safe . A comprehensive cardiovascular evaluation for children with VCFS before and during stimulant treatment is recommended",
"OBJECTIVE To determine the efficacy and safety of clonidine , used alone or in combination with methylpheni date , in treating attention-deficit/hyperactivity disorder ( ADHD ) . METHOD A 16-week , r and omized , double-blind , placebo-controlled clinical trial was conducted in 122 children , ages 7 to 12 , with any subtype of ADHD , r and omly assigned to clonidine , methylpheni date , clonidine in combination with methylpheni date , or placebo according to a 2 x 2 factorial design . In two successive 4-week titration periods , clonidine ( or matching placebo ) and added methylpheni date ( or matching placebo ) were adjusted to optimal doses and then continued for 8 weeks . The primary efficacy outcome was changed from baseline to week 16 on the Conners Teachers Abbreviated Symptom Question naire . Secondary outcomes included the Conners Abbreviated Symptom Question naire for Parents and the Children 's Global Assessment Scale . RESULTS On the Conners Teachers Abbreviated Symptom Question naire , clonidine was not found to improve ADHD symptoms , whereas subjects treated with methylpheni date showed significant improvement compared to those not treated with methylpheni date . Subjects treated with clonidine had greater improvements on the Conners Abbreviated Symptom Question naire for Parents and Children 's Global Assessment Scale , but also a higher rate of sedation compared with subjects not treated with clonidine . CONCLUSIONS Based on the Conners Teachers Abbreviated Symptom Question naire , methylpheni date offers the best combination of efficacy and tolerability for ADHD . Clonidine was well tolerated despite the frequency of sedation and did offer some benefit",
"Objective : The study examined the concordance among rating sources on attention problems of elementary school – aged children . Method : A r and omly selected sample ( N = 841 ) of children was rated by the physical educators , the teachers , and the parents , using the Attention Scales of the Motor Behavior Checklist ( MBC ) , the Teacher Report Form , the Child Behavior Checklist , and the ADHD – Rating Scale – IV ( ADHD-RS-IV ) . Results : Convergent validity of the Lack of Attention Scale of the MBC with the corresponding subscales was supported . Correlations were higher between teachers ’ ratings and between physical educators ’ and teachers ’ ratings than between physical educators ’ and parents ’ ratings or between teachers ’ and parents ’ ratings . Conclusion : Findings underscore the importance of taking the child ’s setting s and observer influences into account and suggest that MBC is a new promising instrument for screening attention problems in school setting",
"Methylpheni date ( MPH , Ritalin ) , has been prescribed to treat attention deficit/hyperactivity disorder ( ADHD ) since its approval by the FDA over 50 years ago . Diagnoses of pediatric patients with ADHD and the administration of MPH to treat the symptoms have increased in prevalence in recent years . A 2005 study by El-Zein et al. reported statistically significant increases in cytogenetic anomalies including chromosomal aberrations ( CA ) , micronuclei ( MN ) and sister chromatid exchanges ( SCEs ) in peripheral blood lymphocytes cultured from pediatric patients treated for 3 months with MPH . These findings led to wide-spread concern regarding the potential for genotoxic risks associated with prolonged administration of MPH . The study described in the present paper was design ed to repeat the El-Zein effort with a much larger sample size . The subjects ( N = 109 ) were r and omized into two groups : one treated with MPH as well as behavior therapy , the other was a control group that received behavior therapy only . We evaluated CAs , MN , and SCEs in peripheral blood lymphocytes in sample s obtained prior to therapy and after 3 months of treatment with MPH . The data were analyzed using a Poisson regression model with a generalized estimating equation method adjusted for several covariates including time , treatment-by-time interaction , sex , and age group . The log(e ) rate ratios of the MPH plus behavior therapy and behavior therapy groups were compared . The frequencies of CAs , MN , and SCEs were not increased in the MPH plus behavior therapy group when compared to the behavior therapy group only ( p = 0.53 , 0.28 , 0.81 , respectively ) . These results provide evidence in a large cohort that MPH does not induce cytogenetic anomalies in children , in contrast to the findings of the El-Zein study",
"Published evidence suggests that aspects of trial design lead to biased intervention effect estimates , but findings from different studies are inconsistent . This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses containing 1973 trials . Outcome measures were classified as \" mortality , \" \" other objective , \" \" or subjective , \" and Bayesian hierarchical models were used to estimate associations of trial characteristics with average bias and between-trial heterogeneity . Intervention effect estimates seemed to be exaggerated in trials with inadequate or unclear ( vs. adequate ) r and om-sequence generation ( ratio of odds ratios , 0.89 [ 95 % credible interval { CrI } , 0.82 to 0.96 ] ) and with inadequate or unclear ( vs. adequate ) allocation concealment ( ratio of odds ratios , 0.93 [ CrI , 0.87 to 0.99 ] ) . Lack of or unclear double-blinding ( vs. double-blinding ) was associated with an average of 13 % exaggeration of intervention effects ( ratio of odds ratios , 0.87 [ CrI , 0.79 to 0.96 ] ) , and between-trial heterogeneity was increased for such studies ( SD increase in heterogeneity , 0.14 [ CrI , 0.02 to 0.30 ] ) . For each characteristic , average bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes , with little evidence of bias in trials with objective and mortality outcomes . This study is limited by incomplete trial reporting , and findings may be confounded by other study design characteristics . Bias associated with study design characteristics may lead to exaggeration of intervention effect estimates and increases in between-trial heterogeneity in trials reporting subjectively assessed outcomes"
] | 4116773e-06ff-11f0-808a-c43d1ab1c353 |
Electronic diaries are increasingly used to assess daily pain in many different forms and population s. This systematic review aims to survey the characteristics of studies using electronic pain diaries and to examine how these characteristics affect compliance . A literature search of 11 electronic data bases was conducted . Studies were evaluated on the basis of predetermined inclusion criteria by two independent review ers . Study characteristics were grouped into four categories : general , population , electronic diary , and sampling procedure ( i.e. , response , attrition , and compliance rates ) including strategies to enhance compliance . The 62 included publications reported from 43 different data sets . Papers were usually written in English and published as from 2000 . Sample s mostly consisted of female chronic pain patients aged 19 - 65 years from western countries . Most diaries held less than 20 items and were completed up to 6 times daily at fixed or prompted times for 1 month at most . Less than 25 % of the studies reported both response and attrition rates ; however , a majority reported compliance . Compliance was generally high , and positively associated with shorter diaries , age , having a user 's manual , financial compensation and using an alarm . It is important that the various study characteristics are catalogued carefully , especially response and attrition rates , because they can affect compliance . Measures of momentary pain are often developed for the purpose of a certain study ; st and ardisation and validation of these measures is recommended . Finally , authors should mention whether they report on data that has also been used in previous studies | [
"1 . The objective of this study was to investigate the efficacy of home-medicated non-steroidal anti-inflammatory ( NSAID ) analgesics , using an electronic patient diary . Single doses of ketoprofen 25 mg and ketoprofen 50 mg were compared with ibuprofen 200 mg and placebo in the treatment of a single occasion of episodic tension-type headache , using a double-blind , r and omized , parallel group design . 2 . A total of 166 patients with headache compatible with episodic tension-type headache and no refractory headaches or contraindications to NSAIDs were contacted by advertisements and selected by question naires . Patients performed the study at home , using an electronic diary for headache assessment , with a form to allow comments and corrections . Visual analogue scales ( VAS 10 cm ) of headache severity , five-item headache relief rating ( HRR ) scales , and time of intake of ' escape ' analgesics were scored regularly , for 4 h following intake of trial medication . 3 . VAS-scores ( n = 1407 ) and HRRs ( n = 452 ) were returned by 159 patients . Of these scores , 1.5 % were inadvertently omitted from the electronic diary or modified on the comment forms . 4 . Headache ( VAS and HRR ) improved more with all three NSAIDs than with placebo , although the effect of ibuprofen was significant for HRR only . After 2 and 4 h respectively , the reduction in VAS-ratios was 17 and 19 % with placebo , 18 and 53 % with ibuprofen 200 mg , 41 and 61 % with ketoprofen 25 mg , and 47 and 59 % with ketoprofen 50 mg . After 4 h , headache improved strongly ( highest HRR ) in 18 % of patients on placebo , 39 % on ibuprofen 200 mg , 62 % on ketoprofen 25 mg , and 55 % on ketoprofen 50 mg . Headache disappeared completely ( VAS-score = 0 ) in one patient ( 3 % ) with placebo ( after 180 min ) , 10 % with ibuprofen 200 mg ( average 211 min ) , 18 % with ketoprofen 25 mg ( 159 min ) , and 28 % with ketoprofen 50 mg ( 146 min ) . 5 . The effects of ketoprofen 50 mg were more pronounced than those of ibuprofen 200 mg , which seemed to start later . Ketoprofen 25 mg and 50 mg were very similar , suggesting a maximal effect of the lower dose . Mild to moderate adverse events were reported by 9 % of the patients , half of which occurred with ketoprofen 50 mg . Treatment of headache with ketoprofen can start with 25 mg , and possibly less . 6 . Although a direct comparative study would be necessary to determine the relative benefits of the novel electronic patient diaries over traditional paper- and -pencil methods , this study has shown the usefulness of this newer technique to detect differences in efficacy between low doses of analgesics under ambulant conditions , with very limited loss of data . Electronic patient diaries appear to be an important new attribute for the efficacy assessment of self-medicated drugs",
"UNLABELLED Reactive measures ( measures that change the phenomenon assessed ) cause problems in interpreting any changes observed . This study examined whether electronic daily diary measures of pain , activity interference , mood , and pain beliefs were reactive in terms of both observable data and patient-reported effects . Patients with chronic temporom and ibular disorder pain ( N = 71 , 86 % female ) completed electronic diaries 3 times daily for approximately 2 weeks and subsequently reported perceived effects on symptom-related variables . Seventy-three percent of patients reported that the assessment affected their pain , whereas 51 % , 45 % , and 39 % thought that it affected their daily activities , mood , and beliefs , respectively . In contrast , there was little objective evidence of reactivity as observed in the electronic diary ratings ; changes over 14 days were small ( eg , predicted changes on 0 to 10 scales : positive mood , .1 ; pain , -.3 ; perceived control , -.5 ) and not statistically significant . Subjective reactivity was generally not significantly related to objective reactivity . The data suggest that patients view daily assessment as having positive and negative effects on pain-related variables , but pain-related measures do not show reactive effects . PERSPECTIVE Electronic daily diary assessment methods hold the potential to increase knowledge concerning patients ' experiences with pain and sequential relations between pain-related variables , but only if the measurement process is nonreactive . This study provides evidence that electronic diary assessment of pain-related variables is nonreactive",
"Objective : This study was design ed to compare 3 commonly used method ologies for assessing clinical pain during trials involving patients diagnosed with fibromyalgia syndrome . Baseline characteristics , characteristics over time , and compliance were evaluated for each of the methods . Methods : Fourteen patients diagnosed with fibromyalgia syndrome were asked to monitor their symptoms of pain using 3 different strategies over a 12-week period : 1 ) real-time pain reports were collected on an electronic diary using r and omly-scheduled audible prompts ; 2 ) end-of-week reports asked patients to rate their mean pain over the past week on the electronic diary ; and 3 ) monthly in-clinic reports asked patients to rate their mean pain for the week using a traditional paper and pencil diary . Results : Significantly different baseline values were obtained for the 3 methods . Paper and pencil produced the highest values , and real-time pain reports produced the lowest baseline values . Pain ratings were more likely to reflect decreases in the 2 methods relying on recall than the real-time strategy . The average adherence with pain monitoring using the electronic diary was 85 % , which was superior to the adherence for the recall measures completed during the clinic visits . Conclusion : Pain assessment methods relying on recall might contribute to an apparent improvement in clinical trials in the absence of an intervention ; such an effect has been considered a “ placebo response . ” Future clinical trials might consider using a real-time approach to pain assessment , which in this study appeared to mitigate against seeing improvement in the absence of an intervention and demonstrated higher levels of patient adherence",
"In an open three-center pilot study , 17 patients suffering from chronic persistent pain syndrome , due to osteoarthritis of the hip and knee or spondylarthrosis , were treated orally with 1800 - 2400 mg Ibuprofen per day for 3 weeks . The chronic pain syndrome and joint status were assessed by the physician at the beginning , and after 7 , 14 and 21 days . Self- assessment s were made by the patients six times daily during the full study period by means of battery-driven electronic diaries ( E.D. ) . The data entered by the patients were stored in the E.D. and after online transfer , processed and evaluated in a PC using appropriate software programs . E.D. were returned by 16 of 17 patients for evaluation . The technical functioning of the instrument was perfect ; its use was accepted by patients and physicians . The closely-meshed real-time recording of pain course and other subjective data , such as adverse events or medication , etc . , enables the physician to calculate more exactly and reliably improvement rates , as well as to carry out prognostic trend analyses and individual benefit-risk-ratio estimates . By comparing different kinds of data , each entered at the same time , plausibility checks are possible . The procedure presented here is considered to be a new valuable tool for review ing subjective data from clinical drug trials",
"Background : Therapy processes are complex dynamical systems where several variables are constantly interacting with each other . In general , the underlying mechanisms are difficult to assess . Our approach is to identify the dependency structure of relevant variables within the therapy process using interaction graphs . These are instruments for multivariate time series which are based on the analysis of partial spectral coherences . We used interaction graphs in order to investigate the therapy process of a multimodal therapy concept for fibromyalgia patients . Our main hypothesis was that self-efficacy plays a central role in the therapy process . Methods : Patients kept an electronic diary for 13 weeks . Pain intensity , depression , sleep quality , anxiety and self-efficacy were assessed via visual analogue scales . The result ing multivariate time series were aggregated over individuals , and partial spectral coherences between each pair of the variables were calculated . From the partial coherences , interaction graphs were plotted . Results : Within the result ing graphical model , self-efficacy was strongly related to pain intensity , depression and sleep quality . All other relations were substantially weaker . There was no direct relationship between pain intensity and sleep quality . Conclusions : The relations between two variables within the therapy process are mainly induced by self-efficacy . Interaction graphs can be used to pool time series data of several patients and thus to assess the common underlying dependency structure of a group of patients . The graphical representation is easily comprehensible and allows to distinguish between direct and indirect relationships",
"A new type of electronic pain diary was vali date d in an open , r and omized , crossover study . The main target variables were the comparison of the correctly realized pain assessment entries as well as the recording of the number of adverse events . Selected for the study were 20 patients , who were either hospitalized , partially-hospitalized or treated on an out-patient basis , with painful spondylogenic spinal syndrome or osteoarthritis of the trunk-proximal large joints . The patients were r and omly-assigned to the two groups . The first group initially received the conventional diary and thereafter the electronic diary ; the sequence was reversed for the second group . The drug therapy consisted of the NSAID , Ibuprofen , at an individually-adjusted dosage . Additional therapeutic measures were carried out by all the patients . The electronic pain diary proved to be equivalent to the conventional diary with regard to adherence of the pain assessment entry times . At a defined equivalence range of + /- 20 % , the statistical comparison showed that the limits were never exceeded . The equivalence test of And erson-Hauck showed a significance level of p less than 0.0001 . The minimum equivalence range was + /- 2 % . It therefore follows , that the conventional method of data recording can indeed be fully replaced by the electronic method . Comparing the individual data of the 16 patients , from whom entries with both the electronic as well as the conventional pain diaries were su bmi tted , a clear tendency for increased entries on adverse events in the electronic diary ( C.D. 6.4 + /- 10.5/E.D. 36.4 + /- 44.1 ) was demonstrated . No significant difference , however , was shown for the number of patients making data entries on adverse events in the electronic pain diary compared to those patients , who made their entries on adverse events in the conventional diary . According to the data from the physicians and patients , the Ibuprofen treatment results in an improvement in 90%/75 % of cases , respectively . Likewise , the functional impairment of the affected joints as well as the swelling decreased markedly . The advantages of the electronic data recording system , i.e. closely-meshed controls can be carried out , transcriptional errors are minimized , data can be processed on-line , no possibility to subsequently change an entry , st and in contrast to the feature that there is no possibility to make free-style entries . The employment of the electronic system in the recording of individual data and subjective data represents a substantial improvement with regard to the quantity and quality of the data",
"OBJECTIVE A growing body of evidence suggests that real-time electronic assessment s of pain are preferable to traditional paper- and -pencil measures . We used electronic assessment data derived from a study of patients with fibromyalgia ( FM ) to examine variability of pain over time and to investigate the implication s of pain fluctuation in the context of a clinical trial . METHODS The study group comprised 125 patients with FM who were enrolled in a r and omized , placebo-controlled trial of milnacipran . Pain intensity levels were captured in real time by participants using electronic diaries . Variability in pain was assessed as the st and ard deviation of pain entries over time ( pain variability index [ PVI ] ) . RESULTS Substantial between-subject differences in pain variability were observed ( mean + /- SD PVI 1.61 + /- 0.656 [ range 0.27 - 4.05 ] ) . The fluctuation in pain report was constant over time within individuals ( r = 0.664 , P pain scores in individuals receiving placebo ( r = 0.460 , P = 0.02 ) rather than active drug ( r = 0.09 , P > 0.10 ) . CONCLUSION Among individuals with FM , there were large between-subject differences in real-time pain reports . Pain variability was relatively constant over time within individuals . Perhaps the most important finding is that individuals with larger pain fluctuations were more likely to respond to placebo . It is not clear whether these findings are applicable only to patients with FM or whether they may also be seen in patients with other chronic pain conditions",
"& NA ; We used patient daily electronic ratings of outcome ( activity interference , pain intensity , jaw use limitations , negative mood ) and process ( pain‐related beliefs , catastrophizing , and coping ) variables to evaluate a brief cognitive‐behavioral ( CB ) treatment for chronic temporom and ibular disorder ( TMD ) pain . TMD clinic patients ( N=158 ) were assigned r and omly to four biweekly sessions of either CB pain management training ( PMT ) or an education/attention control condition [ self‐care management ( SCM ) ] and were asked to complete electronic interviews three times daily for the 8‐week treatment . We analyzed diary data from 126 participants who completed > 50 % of requested interviews for > 6 weeks . Multilevel regression analyses indicated no statistically significant difference between the study groups in rate of within‐subject change over time on the daily outcome measures , but consistently greater within‐subject improvement in the PMT group on the daily process measures . Significantly ( P proportions of PMT than of SCM patients showed clinical ly important ( > 50 % ) improvement from weeks 1 to 8 in daily activity interference and jaw use limitations . This study is novel in its application of electronic diary methods for assessing outcome and process variables in a chronic pain treatment trial , and supports the feasibility and utility of such methods . The brief CB treatment was efficacious in decreasing catastrophizing and increasing perceived control over pain , and in improving activity interference and jaw use limitations for a subgroup of patients . Longer‐term follow‐ups are ongoing to determine if there is an impact on outcomes over time",
"BACKGROUND The gastric stasis that commonly accompanies migraine headache may impair absorption of conventional oral tablets in the stomach . A fast-disintegrating/rapid-release formulation of sumatriptan has been developed to enhance tablet disintegration and drug dispersion and potentially improve absorption . OBJECTIVE Two studies were conducted comparing the time to onset of relief from moderate or severe migraine pain with the fast-disintegrating/rapid-release formulation of sumatriptan tablets 50 and 100 mg and placebo . METHODS These were 2 identically design ed r and omized , double-blind , parallel-group studies . Sumatriptan 50 or 100 mg or placebo was taken on an outpatient basis to treat a single moderate or severe migraine attack . Using a personal digital assistant , patients recorded the time of dosing and the time at which pain severity reached none or mild ( ie , pain relief ) or none ( ie , pain free ) in real time so that the time to onset of relief could be measured as a continuous variable . Onset of relief was defined as the earliest time point at which a statistically significant difference in pain relief compared with placebo was achieved and maintained through 2 hours after dosing . Before dosing and at pre-determined time points after dosing , patients also provided an assessment of migraine pain as none , mild , moderate , or severe . At a clinic visit within 1 week after treatment of the migraine attack , patients were queried about adverse events . For each adverse event , investigators recorded whether study medication was considered the cause . Data analyses were undertaken for each study individually and , in post hoc analyses of the primary and key secondary end points , on pooled data from both studies . RESULTS The 2 studies comprised 2696 patients : 902 received sumatriptan 50 mg , 902 received sumatriptan 100 mg , and 892 received placebo . Patients ' mean age ranged from 40.2 to 40.8 years across treatment groups , and most patients were female ( 83%-87 % ) and white ( 92%-93 % ) . In the analysis of pooled data , sumatriptan tablets provided significantly more effective pain relief compared with placebo as early as 20 minutes after dosing with the 100-mg dose and as early as 30 minutes after dosing with the 50-mg dose ( P sumatriptan tablets were significantly more effective than placebo at 25 minutes with the 100-mg dose and at 50 minutes with the 50-mg dose ; in study 2 , sumatriptan tablets were significantly more effective than placebo at 17 minutes for the 100-mg dose and at 30 minutes for the 50-mg dose ( P pain relief by 2 hours after dosing were 72 % for the 100-mg dose and 67 % for the 50-mg dose , compared with 42 % for placebo ( P a pain-free response by 2 hours were 47 % for the 100-mg dose , 40 % for the 50-mg dose , and 15 % for placebo ( P migraine free 2 hours after dosing and had sustained pain relief and a sustained pain-free response over 24 hours compared with placebo ( P adverse events reported in > 2 % of patients in any treatment group in either study were nausea ( both studies : 3 % sumatriptan 100 mg , 2 % sumatriptan 50 mg , 1 % placebo ) and paresthesia ( study 1 : < 1 % sumatriptan 100 mg , < 1 % sumatriptan 50 mg , 0 % placebo ; study 2 : 3 % sumatriptan 100 mg , 1 % sumatriptan 50 mg , < 1 % placebo ) . CONCLUSIONS In these studies , sumatriptan tablets in a fast-disintegrating/rapid-release formulation were effective for the acute treatment of moderate to severe migraine pain , were generally well tolerated , and achieved an onset of pain relief as early as 20 minutes for 100 mg and as early as 30 minutes for 50 mg",
"& NA ; Patient self‐reports are the primary method for capturing the experience of pain , and diaries are often used to collect patient self‐reports . This study was design ed to determine if momentary monitoring of pain with an electronic diary affected pain levels over time , if it affected weekly recall of pain , and if daily sampling density affected compliance rates and patients ’ reactions to the study . Ninety‐one patients with chronic pain were r and omized into four groups with differing levels of momentary monitoring over 2 weeks . Little support was found for reactivity defined as temporal shifts in pain over the study or as changes in recalled weekly pain due to momentary monitoring . Compliance with the electronic diary protocol was 94 % or better , and was not related to sampling density . Patients reported little difficulty with the diary procedures and were not unduly burdened by the protocol",
"Background : Migraine is frequently associated with nonheadache symptoms before , during , and after the headache . Premonitory symptoms occurring before the attack have not been rigorously studied . Should these symptoms accurately predict headache , there are considerable implication s for the pathophysiology and management of migraine . Methods : Electronic diaries were used in a 3-month multicenter study to record nonheadache symptoms before , during , and after migraine . The authors recruited subjects who reported nonheadache symptoms in at least two of three attacks that they believed predicted headache . Symptoms were entered in the diaries by patient initiation and through prompted entries at r and om times daily . Entries could not be altered retrospectively . Data recorded included nonheadache symptoms occurring during all three phases of the migraine , prediction of the attack from premonitory symptoms , general state of health , and action taken to prevent the headache . Results : One hundred twenty patients were recruited : 97 provided usable data . Patients correctly predicted migraine headaches from 72 % of diary entries with premonitory symptoms . A range of cognitive and physical symptoms was reported at a similar rate through all three phases of the migraine . The most common premonitory symptoms were feeling tired and weary ( 72 % of attacks with warning features ) , having difficulty concentrating ( 51 % ) , and a stiff neck ( 50 % ) . Subjects who functioned poorly in the premonitory phase were the most likely to correctly predict headache . Conclusions : Using an electronic diary system , the authors show that migraineurs who report premonitory symptoms can accurately predict the full-blown headache",
"& NA ; Fifty women with fibromyalgia syndrome ( FS ) recorded their sleep quality , pain intensity , and attention to pain for 30 days , using palm‐top computers programmed as electronic interviewers . They described their previous night 's sleep quality within one‐half hour of awakening each day , and at r and omly selected times in the morning , afternoon , and evening rated their present pain in 14 regions and attention to pain during the last 30 min . We analyzed the 30‐day aggregates cross‐sectionally at the across‐persons level and the pooled data set of 1500 person‐days at the within‐persons level after adjusting for between‐persons variation and autocorrelation . Poorer sleepers tended to report significantly more pain . A night of poorer sleep was followed by a significantly more painful day , and a more painful day was followed by a night of poorer sleep . Pain attention and sleep were unrelated at the across‐persons level of analysis . But there was a significant bi‐directional within‐person association between pain attention and sleep quality that was not explained by changes in pain intensity "
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The aim of this systematic review was to address the question : Do different irrigating protocol s have an impact on the dislocation resistance of mineral trioxide aggregate (MTA)-based material s ? The review was performed using a well-defined search strategy in three data bases ( PubMed , Scopus , Web of Science ) to include laboratory studies performed between January 1995 and May 2017 , in accordance with PRISMA guidelines . Two review ers analysed the papers , assessed the risk of bias and extracted data on teeth used , sample size , size of root canal preparation , type of MTA-based material , irrigants , canal filling method , storage method and duration , region of roots and the parameters of push-out testing ( slice thickness , plunger dimensions and plunger loading direction ) , the main results and dislocation resistance values ( in MPa ) . From 255 studies , 27 were included for full-text analysis . Eight papers that met the inclusion criteria were included in this review . There was a wide variation in dislocation resistance due to differences in irrigation sequence , time and concentration of irrigants , storage method and duration , and the parameters of push-out bond strength testing . A meta- analysis was not done but qualitative synthesis of the included studies was performed . No definitive conclusion could be drawn to evaluate the effect of irrigation protocol s on dislocation resistance of MTA-based material s. Recommendations have been provided for st and ardized testing methods and reporting of future studies , so as to obtain clinical ly relevant information and to underst and the effects of irrigating protocol s on root canal sealers and their interactions with the dentine walls of root canals | [
"Introduction : The aim of this in vitro study was to evaluate the bond strength of Photo-Activated Disinfection ( PAD ) system to dentin with different root canal sealers by using a push-out test design . Material s and Methods : A total of 30 extracted m and ibular premolar teeth with single and straight roots were used . The crowns were removed and the root canals were prepared by using ProTaper rotary files . The smear layer was removed and the roots were r and omly divided into two groups ( n = 15 ) according to the use of PAD system as the final disinfecting agent . Each group was then divided into 6 ( n = 5 ) subgroups and obturated with gutta-percha and 3 different root canal sealers . The groups were Group 1 : Sodium hypochlorite ( NaOCl ) + ethylenediaminetetraacetic acid (EDTA)-AH Plus sealer ; Group 2 : NaOCl + EDTA + PAD-AH Plus ; Group 3 : NaOCl + EDTA-Sealapex ; Group 4 : NaOCl + EDTA + PAD-Sealapex ; Group 5 : NaOCl + EDTA-mineral trioxide aggregate (MTA)-Fiallapex ; and Group 6 : NaOCl + EDTA + PAD-MTA-Fillapex . 1-mm thickness horizontal sections ( n : 5 × 4 = 20 ) were sliced for the push-out bond strength measurement . Results : Group 3 and 4 showed significantly lower bond strengths compared with all the other groups ( P that the PAD system adversely affected the bond strength of the MTA Fillapex root canal sealer",
"INTRODUCTION Recently , it was shown that the interaction of each of mineral trioxide aggregate ( MTA ) and Portl and cement with dentin in phosphate-buffered saline ( PBS ) promotes a biomineralization process that leads to the formation of an interfacial layer with tag-like structures at the cement-dentin interface . This study analyzes the influence of the biomineralization process on the push-out strength of ProRoot MTA ( Dentsply Tulsa Dental , Tulsa , OK ) , MTA Branco ( Angelus Soluções Odontológicas , Londrina , PR , Brazil ) , MTA BIO ( Angelus Soluções Odontológicas ) , or Portl and cement with and without calcium chloride . METHODS Dentin discs with st and ardized cavities were filled with ProRoot MTA , MTA Branco , MTA BIO , white Portl and cement + 20 % bismuth oxide ( PC1 ) , or PC1 + 10 % of calcium chloride ( PC2 ) . The specimens were r and omly divided into two groups : cement in contact with a wet cotton pellet for 72 hours or immersed in PBS for 2 months . The bond strengths were measured with the Instron Testing machine ( Model 4444 ; Instron Corp , Canton , MA ) , and the fractured surfaces on the root walls were observed by scanning electron microscopy . RESULTS All sample s immersed in PBS displayed a significantly greater resistance to displacement than that observed for the sample s in contact with a wet cotton pellet for 72 hours ( p greater resistance to displacement than Portl and cements . CONCLUSION It was concluded that the biomineralization process positively influenced the push-out bond strength of the cements , particularly the MTA groups",
"Introduction The purpose of this study was to assess the effect of different irrigation protocol s for smear layer removal on the bond strength of EndoSequence BC Sealer , a new bioceramic sealer , to root canal dentin . Material s and Methods The middle third of forty-four extracted human teeth were sectioned horizontally to obtain 128 dentin disks . After st and ardization of canal spaces , dentin disks were immersed in 5.25 % NaOCl for 20 min . The specimens were then r and omly assigned to four groups ( n=32 ) according to dentin treatment procedure : group 1 , 17 % EDTA ( 1 min ) ; group 2 , 17 % EDTA ( 1 min ) + 5.25 % NaOCl ( 5 min ) ; group 3 , 17 % EDTA ( 1 min ) + 2 % chlorhexidine ( CHX ) ( 5 min ) ; and group 4 , 17 % EDTA ( 1 min ) + saline ( 5 min ) . After dentin treatment , two specimens of each group were prepared for investigation with scanning electron microscopy ( SEM ) . Surface of root canal wall was assessed in each specimen . Then the canal spaces were filled with EndoSequence BC Sealer in the remaining specimens . Push-out bond-strength and failure modes were assessed . The data on push-out test were analyzed using one-way ANOVA test . The significance level was set at P=0.05 . Results There was no significant difference between the bond strengths of test groups ( P=0.203 ) . The bond failure was mainly cohesive for all groups . Conclusion Under the conditions of this ex vivo study , it could be concluded that the application of 17 % EDTA alone or followed by 5.25 % NaOCl , 2 % CHX , or saline result ed in similar bond strength of EndoSequence BC Sealer to dentinal walls",
"INTRODUCTION The aim of this in vitro study was to evaluate the effect of various irrigants on the push-out bond strength of calcium-enriched mixture ( CEM ) cement and mineral trioxide aggregate ( MTA ) . METHODS AND MATERIAL S A total of 140 dentin disks with a thickness of 1.5±0.2 mm and lumen size of 1.3 mm , were r and omly divided into 12 groups ( n=10 ) and 4 control groups ( n=5 ) . The lumen of disks in groups 1 , 2 , 3 , 7 , 8 , 9 were filled with CEM and groups 4 , 5 , 6 , 10 , 11 , 12 were filled with MTA . Control groups were filled with CEM and MTA . Specimens were incubated at 37 ° C for one day in groups 1 to 6 and seven days in groups 7 to 12 . After incubation the sample s were divided into three subgroups ( n=10 ) that were either immersed for 30 min in 5.5 % sodium hypochlorite ( NaOCl ) , 2 % chlorhexidine ( CHX ) or saline solution . The push-out bond strength values were measured by using a universal testing machine . The nature of the failures were determined by light microscope . Data was analyzed using the three-way ANOVA to evaluate the effect of material type , different irrigants and time intervals . Post hoc Tukey 's test was used for two-by-two comparison of the groups . RESULTS CEM cement significantly showed a higher push-out bond strength in comparison with MTA ( P=0.001 ) . The elapse of time significantly increased the bond strength ( P=0.001 ) . There was no significant difference between the irrigants used in this study ( P=0.441 ) . Bond failure was predominantly of mixed type in MTA and of cohesive type in CEM sample s. CONCLUSION Based on this study , endodontic irrigants did not influence the push-out bond strength of MTA and CEM cement",
"OBJECTIVE The objective of the present study was to assess the effect of erbium , chromium : yttrium-sc and ium-gallium-garnet ( Er , Cr : YSGG ) laser-activated irrigation ( LAI ) of NaOCl on the push-out bond strength of furcal perforations repaired with ProRoot mineral trioxide aggregate ( MTA ) and Biodentine . BACKGROUND DATA Several studies investigated the adhesion of calcium silicate-based cements after exposure to endodontic irrigants , while effect of LAI on bond strength remains to be eluci date d. MATERIAL S AND METHODS Bur-cut furcal perforations with st and ard dimensions were created in 100 extracted human m and ibular molars . Teeth were r and omly distributed into two groups ( n = 50/group ) according to the repair material applied : ( 1 ) ProRoot MTA or ( 2 ) Biodentine . The specimens were further assigned into five subgroups according to the irrigation regimens used over the set material s : ( a ) distilled water with needle irrigation ; ( b ) 5.25 % NaOCl with needle irrigation ; ( c ) distilled water with LAI ; ( d ) 5.25 % NaOCl with LAI ; and ( e ) no irrigation ( control ) . Bond strengths of the test material s were assessed by using push-out bond strength test . RESULTS Biodentine showed significantly higher dislocation resistance than ProRoot MTA ( p NaOCl and distilled water did not significantly affect the push-out bond strength results ( p > 0.05 ) . CONCLUSIONS Biodentine showed higher dislocation resistance than ProRoot MTA as a perforation repair material . Er , Cr : YSGG laser activation of irrigation aqueous solutions had no adverse effect on push-out bond strength of Biodentine and ProRoot MTA",
"Background This study aim ed to assess the push-out bond strength of mineral trioxide aggregate ( MTA ) to root canal dentin after irrigation with Smear Clear in comparison with 2.5 % sodium hypochlorite ( NaOCl ) , 2 % chlorhexidine ( CHX ) and saline as commonly used root canal irrigants . Material and Methods The coronal and mid-root areas of maxillary anterior teeth were horizontally sectioned into one-millimeter thick slices . The root canal lumen of dentinal slices was dilated using a diamond bur with 1.3 mm diameter . After the application of MTA , the sample s were incubated in 100 % humidity for 10 minutes and were then r and omly divided into four groups ( n=20 ) and immersed in Smear Clear , 2.5 % NaOCl , 2 % CHX and saline for 30 minutes . No irrigant was used for the control group ( n=20 ) . A wet cotton pellet was placed on the sample s and after 48 hours of incubation , push-out bond strength was measured using a universal testing machine . The sample s were evaluated under a stereomicroscope to determine the mode of failure . One-way ANOVA was used to assess statistical differences among the groups . Results The control group showed the highest bond strength with significant differences with other groups ( P Smear Clear and NaOCl groups ( P bond strength to MTA was noted after irrigation with Smear Clear , CHX and NaOCl ( P>0.05 ) . Other pairwise comparisons showed no significant difference ( P>0.05 ) . Conclusions Irrigation with Smear Clear , CHX and NaOCl did not cause a significant change in bond strength of MTA to dentin . Key words : Root Canal Irrigants , push-out , Mineral Trioxide Aggregate , dentin",
"INTRODUCTION The aim of this study was to evaluate the bond strength of various root canal sealers after various irrigation solutions and Er : YAG laser irradiation were used on root canal dentin . METHODS One hundred fifty freshly extracted human maxillary single-rooted teeth were used in this study . Teeth were sectioned transversally 4 mm below the cementoenamel junction . The root canal of each specimen was prepared using a tapered bur . Teeth were divided into 3 main groups by sealer ( AH Plus Jet [ Dentsply DeTrey , Konstanz , Germany ] , EndoSequence BC Sealer [ Brasseler , Savannah , GA ] , and Real Seal [ SybronEndo , Orange , CA ] ) and then divided into 5 subgroups by dentin treatment ( distilled water , calcium hydroxide , sodium hypochlorite , EDTA , and Er : YAG laser ) . The specimens were placed immediately at 37 ° C and 100 % humidity for 1 week . Then , the push-out test was applied . The maximum failure load was recorded in newtons and was used to calculate the push-out bond strength in MPa . Then , 3 r and om specimens from each group were examined under scanning electron microscopy . RESULTS The resin root canal sealers had higher push-out bond strength than the bioceramic sealer , and the differences were statistically significant ( P The EDTA and Er : YAG laser applications removed the smear layer and increased the bond strength . The highest adhesion was observed in EDTA groups when each sealer was evaluated in itself . CONCLUSIONS The bonding strength of root canal sealers is influenced by their properties and various dentin surface treatments . The scanning electron microscopic study showed that although the dentinal tubules were open , at the profile examination the sealers did not penetrate into the dentin canals in all specimens",
"The purpose of this study was to compare the bond strength of a new bioceramic sealer ( EndoSequence BC Sealer ) and AH Plus in the presence or absence of smear layer . Extracted single-rooted human teeth were prepared and r and omly divided into four groups . In groups 1 and 3 , the root canals were finally irrigated with 5.25 % NaOCl and smear layer was not removed , but in groups 2 and 4 , the root canals were finally irrigated with 17 % EDTA followed by 5.25 % NaOCl in order to remove the smear layer . In groups 1 and 2 , the root canals were obturated with gutta-percha/AH Plus , but in groups 3 and 4 , obturation was performed with gutta-percha/EndoSequence BC Sealer . Push-out bond strength and failure modes were evaluated . The bond strength of gutta-percha/AH Plus and gutta-percha/EndoSequence BC Sealer was not significantly different ( P = 0.89 ) . The presence or absence of smear layer did not significantly affect the bond strength of filling material s ( P = 0.69 ) . The mode of bond failure was mainly cohesive for all groups . In conclusion , the bond strength of the new bioceramic sealer was equal to that of AH Plus with or without the smear layer",
"The purpose of this study was to evaluate the effects of sodium hypochlorite ( 5.25 % ) , chlorhexidine ( 2 % ) , and Glyde File Prep on the bond strengths of MTA-dentin in vitro . St and ardized dentin disks were prepared and the central hole in each disk was filled with mineral trioxide aggregate ( MTA ) . The specimens were r and omly divided into four groups to be immersed in saline , 5.25 % NaOCl , 2 % chlorhexidine , and Glyde File Prep for 2 hours . The bond strengths of MTA-dentin were measured with a material testing system ( MTS ) and the fractured surfaces on the root walls were observed by scanning electron microscopy . Compared with the control group , the bond strengths were significantly lower in Glyde File Prep group ( p chlorhexidine group or in the NaOCl group ( p > 0.05 ) . This study suggested that Glyde File Prep could negatively affect the bond strengths of MTA-dentin",
"AIM The aim of this study was to evaluate the effectiveness of final decontamination protocol s against Enterococcus faecalis and their influence on bond strength of filling material to root canal dentin . MATERIAL AND METHODS Ninety root canals were enlarged with ProTaper system and inoculated with E. faecalis for 15days . Sixty sample s were r and omly divided into six groups ( n=10 ) and subjected to following protocol s : G1-distilled water(control ) , G2 - 2 % chlorhexidine , G3-QMix , G4 - 6.5 % grape seed extract , G5-photodynamic therapy with optical fiber and G6-photodynamic therapy without optical fiber . The percentage of bacterial reduction was checked by counting of CFUs . The remaining 30 sample s were subjected to the same decontamination protocol s ( n=5 ) and filled with gutta-percha and AH Plus sealer in order to perform the push-out test . Data from both tests were subjected to one-way ANOVA followed by Tukey 's post hoc procedure ( α=0.05 ) . RESULTS The greatest bacterial reduction was observed for 2 % chlorhexidine , QMix and 6.5 % grape seed extract , with no statistically significant difference between them . Photodynamic therapy , with and without optical fiber , demonstrated a significantly higher reduction than distilled water , with no statistically significant difference between them ( p similar bond strength values ( p highest incidence of cohesive failure in all groups . CONCLUSIONS The tested final decontamination protocol s showed effectiveness against E. faecalis and did not interfere with the bond strength of filling material to root canal dentin",
"INTRODUCTION The aim of this study was to evaluate the effect of smear layer removal on the push-out bond strength between radicular dentin and three calcium silicate cements ( CSC ) in comparison with gutta percha and sealer . METHODS Eighty human anterior extracted teeth were decoronated , cleaned and shaped to size 50/0.05 apically and r and omly divided into 2 major groups : ( A ) smear layer preserved , and ( B ) smear layer removed using irrigation with 17 % EDTA . Roots within each major group were further divided into 4 subgroups according to the obturation material used : ( 1 ) ProRoot MTA , ( 2 ) Biodentine , ( 3 ) Harvard MTA , ( 4 ) Gutta percha and AH-plus sealer . Obturated roots were stored in synthetic tissue fluid for 7 days to allow maximum setting of the root filling material s. Three 2-mm-thick slices were obtained from each root at different section levels ( coronal , middle , apical ) . The canal diameters and slice thickness were measured , and the adhesion surface area for each slice was calculated . Push-out bond strength test was carried out using a universal testing machine . The bond failure mode was assessed under an optical microscope at 40 × . RESULTS The mean push-out bond strength in groups 1A , 2A and 3A were 7.54 ( ±1.11 ) , 7.64 ( ±1.08 ) and 8.79 (±1.55)MPa respectively , while those for groups 1B , 2B and 3B were 6.58 ( ±1.13 ) , 6.47 ( ±1.08 ) , 7.71 (±1.81)MPa , respectively . In the gutta percha and sealer groups the push-out bond strength means were : 1.98 ( ±0.48 ) and 2.09 (±0.51)MPa in the preserved and removed smear layer groups respectively . The push-out strength values were significantly reduced when the smear layer was removed in the CSC groups ( P<0.05 ) while no significant difference was detected in the gutta percha and sealer groups . CONCLUSIONS Based on the conditions of this ex vivo study , it can be concluded that smear layer removal is detrimental to the bond strength between calcium silicate cements and dentin",
"AIM To assess the push-out bond strength of two new calcium silicate-based endodontic sealers in the root canals of extracted teeth . METHODOLOGY Thirty extracted single-rooted central incisors of similar sizes were selected r and omly and distributed to three groups ( n = 10 ) . All canals were instrumented using ProTaper rotary instruments to achieve tapered canal walls . Irrigation was performed using 5 mL 2.5 % NaOCl between each instrument , and the smear layer was removed using 5 mL 17 % EDTA . The canals were filled with three different sealers using a cold lateral compaction technique : group 1 : AH Plus + gutta-percha , group 2 : I Root SP + gutta-percha and group 3 : MTA Fillapex + gutta-percha . Three horizontal sections were prepared at a thickness of 1 mm ± 0.1 in the apical , middle and coronal parts of each root . The test specimens were subjected to the push-out test method using a Universal Test Machine ( Instron , Canton , MA , USA ) that carried 1-mm , 0.5-mm and 0.3-mm plungers for coronal , middle and apical specimens , respectively . The loading speed was 1 mm min(-1 ) . The push-out data were analysed by two-way analysis of variance ( anova ) and the post hoc Holm-Sidak test , with significance set at P was no significant difference between the sealers . In the middle and apical segments , there was no significant difference between I Root SP and AH Plus groups . However , the I Root SP and AH Plus had significantly higher bond strength values than the MTA Fillapex ( P , the bond strengths in the middle specimens and the apical specimens were higher compared with the bond strengths in the coronal specimens ( P differences between the bond strengths in the middle and apical specimens . CONCLUSION MTA Fillapex had the lowest push-out bond values to root dentine compared with other sealers"
] | 411677ca-06ff-11f0-808a-c43d1ab1c353 |
PURPOSE To quantify effectiveness of lifestyle interventions for hypertension . DATA SOURCES Electronic bibliographic data bases from 1998 onwards , existing guidelines , systematic review s. STUDY SELECTION AND DATA ABSTRACT ION We included r and omized , controlled trials with at least 8 weeks ' follow-up , comparing lifestyle with control interventions , enrolling adults with blood pressure at least 140/85 mmHg . Primary outcome measures were systolic and diastolic blood pressure . Two independent review ers selected trials and abstract ed data ; differences were resolved by discussion . RESULTS We categorized trials by type of intervention and used r and om effects meta- analysis to combine mean differences between endpoint blood pressure in treatment and control groups in 105 trials r and omizing 6805 participants . Robust statistically significant effects were found for improved diet , aerobic exercise , alcohol and sodium restriction , and fish oil supplements : mean reductions in systolic blood pressure of 5.0 mmHg [ 95 % confidence interval ( CI ) : 3.1 - 7.0 ] , 4.6 mmHg ( 95 % CI : 2.0 - 7.1 ) , 3.8 mmHg ( 95 % CI : 1.4 - 6.1 ) , 3.6 mmHg ( 95 % CI : 2.5 - 4.6 ) and 2.3 mmHg ( 95 % CI : 0.2 - 4.3 ) , respectively , with corresponding reductions in diastolic blood pressure . Relaxation significantly reduced blood pressure only when compared with non-intervention controls . We found no robust evidence of any important effect on blood pressure of potassium , magnesium or calcium supplements . CONCLUSIONS Patients with elevated blood pressure should follow a weight-reducing diet , take regular exercise , and restrict alcohol and salt intake . Available evidence does not support relaxation therapies , calcium , magnesium or potassium supplements to reduce blood pressure | [
"Weight reduction was compared with metoprolol ( 200 mg daily ) in a r and omised placebo-controlled trial of first-line treatment of mild hypertension ( diastolic blood pressure 90 - 109 mm Hg ) in 56 overweight patients aged under 55 years . After 21 weeks of follow up the weight-reduction group had lost an average of 7.4 kg . The fall in their systolic pressure of 13 mm Hg was significantly greater than that in the placebo group ( 7 mm Hg ) but not different from that in the metoprolol group ( 10 mm Hg ) . Their fall in diastolic pressure ( 10 mm Hg ) was greater than that in both the metoprolol ( 6 mm Hg ) and placebo ( 3 mm Hg ) groups . At the end of the follow-up period 50 % of patients in the weight-reduction group had a diastolic pressure of less than 90 mm Hg . In the metoprolol group there was a decrease in high density lipoprotein (HDL)-cholesterol and an increase in the ratio of total to HDL-cholesterol ; in the weight-reduction group there was a decrease both in total cholesterol and in the ratio of total to HDL-cholesterol . Thus in this study population weight reduction produced significant and clinical ly important reductions in blood pressure but not the adverse effects on plasma lipids commonly associated with antihypertensive drug therapy",
"We have examined the independent and combined effects on blood pressure and blood lipids of alcohol restriction and weight loss in overweight male drinkers with a view to assessing overall effects on cardiovascular risk of two widely promoted nonpharmacological approaches for hypertension . Eighty-six men with a mean age of 44.3 years , a mean regular alcohol intake of 440 ml/wk ( five or six st and ard drinks per day ) , a mean blood pressure of 137.4 mm Hg systolic and 84.8 mm Hg diastolic , and a mean body mass of 92.5 kg entered a controlled two-way factorial study . The subjects were r and omly assigned to four groups for an 18-week intervention in which members of two groups drank only low-alcohol beer , thereby reducing their alcohol intake by 374 ml/wk , while those of the other two groups continued their normal alcohol intake . Within the low and normal alcohol intake groups subjects either continued their usual diet or reduced their caloric intake by 4,200 - 6,300 kJ/day ( 1,000 - 1,500 kcal/day ) ( with protein , fat , and carbohydrate provided as 15 % , 30 % , and 55 % of total calories , respectively ) . Calorie reduction and alcohol restriction caused weight losses of 7.5 ( p less than 0.001 ) and 2.1 ( p less than 0.01 ) kg , respectively . Calorie reduction and alcohol restriction were associated with decreases in systolic blood pressure of 5.4 ( p less than 0.001 ) and 4.8 ( p less than 0.01 ) mm Hg , respectively , and in diastolic blood pressure of 4.2 ( p less than 0.001 ) and 3.3 ( p less than 0.01 ) mm Hg , respectively . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The blood pressure responses of 19 mildly hypertensive ( diastolic blood pressure 90–104 mmHg ) individuals to treatment with either 1200 mg of elemental calcium supplementation or placebo were assessed weekly in a 6-month r and omized , double-blind , placebo-controlled crossover study . Both groups showed a decrease in blood pressure ( calcium treated : 6 ± 12 mmHg systolic , 7 ± 7 mmHg diastolic ; and placebo controlled : 9 ± 14 mmHg systolic , 9 ± 8 mmHg diastolic ) . Differences between the two groups were not significant ( P > 0.1 ) . There were no adverse effects to either treatment . This study does not support the hypothesis that dietary calcium supplementation is more effective than placebo in reducing blood pressure in mildly hypertensive individuals",
"BACKGROUND Several nonpharmacological interventions , including exercise , are recommended in primary prevention of hypertension and other cardiovascular diseases in which the pathogenetic role of endothelial dysfunction has been suggested . We studied the effects of long-term aerobic exercise on endothelial function in patients with essential hypertension . METHODS AND RESULTS The forearm blood flow was measured by strain-gauge plethysmography . The responses of forearm vasculature to acetylcholine were smaller in the hypertensive patients than in the normotensive subjects . There was no significant difference in forearm vascular responses to isosorbide dinitrate in the normotensive and hypertensive subjects . We evaluated the effects of physical exercise for 12 weeks on forearm hemodynamics in untreated patients with mild essential hypertension who were divided r and omly into an exercise group ( n=10 ) and a control group ( n=7 ) . After 12 weeks , the forearm blood flow response to acetylcholine increased significantly , from 25.8+/-9.8 to 32.3+/-11.2 mL. min(-1 ) . 100 mL tissue(-1 ) ( P forearm blood flow after isosorbide dinitrate was similar before and after 12 weeks of follow-up in both groups . The infusion of N(G)-monomethyl-L-arginine abolished the exercise-induced enhancement of forearm vasorelaxation evoked by acetylcholine in the exercising group . In normotensive subjects also , long-term aerobic exercise augmented acetylcholine-stimulated nitric oxide release . CONCLUSIONS These findings suggest that long-term physical exercise improves endothelium-dependent vasorelaxation through an increase in the release of nitric oxide in normotensive as well as hypertensive subjects",
"Meditation training appears to be a promising psychological approach to the control of hypertension . However , most studies to date have had serious deficiencies . This study attempted to correct many of these deficiencies . Forty-one unmedicated hypertensives referred by general practitioners were r and omly allocated to three groups . The treatment group ( SRELAX ) underwent training procedures based on Transcendental Meditation ; a placebo control group ( NSRELAX ) underwent identical training but without a mantra . Both procedures were compared with a no-treatment control group . The results showed modest reductions in blood pressure in both SRELAX and NSRELAX groups , compared with the no-treatment controls , with diastolic percentage reductions reaching significance ( p diastolic blood pressure of 8–10 % on 3-month follow-up . Possible indicators to predict the response of subjects are considered and reasons for the similarity in the effectiveness of the SRELAX and NSRELAX conditions are discussed",
"OBJECTIVE To determine the feasibility of conducting a r and omized clinical trial in the private practice setting examining short- and long-term effects of chiropractic adjustments for subjects with essential hypertension compared with a brief soft tissue massage , as well as a nontreatment control group . DESIGN R and omized controlled-comparison trial with 3 parallel groups . SETTING Private practice outpatient chiropractic clinic . PATIENTS Twenty-three subjects , aged 24 to 50 years with systolic or diastolic essential hypertension . INTERVENTIONS Two months of full-spine chiropractic care ( ie , Gonstead ) consisting primarily of specific-contact , short-lever-arm adjustments delivered at motion segments exhibiting signs of subluxation . The massage group had a brief effleurage procedure delivered at localized regions of the spine believed to be exhibiting signs of subluxation . The nontreatment control group rested alone for a period of approximately 5 minutes in an adjustment room . MAIN OUTCOME MEASURES Cost per enrolled subject , as well as systolic and diastolic blood pressure ( BP ) measured with a r and om-0 sphygmomanometer and patient reported health status ( SF-36 ) . Pilot study outcome measures also included an assessment of cooperation of subjects to r and omization procedures and drop-out rates , recruitment effectiveness , analysis of temporal stability of BPs at the beginning of care , and the effects of inclusion /exclusion criteria on the subject pool . RESULTS Thirty subjects enrolled , yielding a cost of $ 161 per enrolled subject . One subject was later determined to be ineligible , and 6 others dropped out . In both the chiropractic and massage therapy groups , all subjects were classified as either overweight or obese ; in the control group there were only 2 classified as such . SF-36 profiles for the groups were similar to that of a normal population . The mean change in diastolic BP was -4 ( 95 % confidence interval [ CI ] : -8.6 , 0.5 ) in the chiropractic care group , 0.5 ( 95 % CI : -3.5 , 4.5 ) in the brief massage treatment group , and -4.9 ( 95 % CI : -9.7 , -0.1 ) in the no treatment control group . At the end of the study period , this change was -6.3 ( 95 % CI : 13.1 , 0.4 ) , -1.0 ( 95 % CI : -7.5 , 15.6 ) , -7.2 ( 95 % CI : -13.3 , -1.1 ) in the 3 study groups . The mean improvements in the chiropractic care and no treatment control groups remained consistent over the follow-up period . CONCLUSIONS This pilot study eluci date d several procedural issues that should be addressed before undertaking a full-scale clinical trial on the effects of chiropractic adjustments in patients with essential hypertension . A multidisciplinary approach to recruitment may need to be used in any future efforts because of the limited subject pool of patients who have hypertensive disease but are not taking medications for its control . Measures need to be used to assure comparable groups regarding prognostic variables such as weight . Studies such as these demonstrate the feasibility of conducting a full-scale 3-group r and omized clinical trial in the private practice setting",
"To determine the antihypertensive efficacy of aerobic exercise training in mild essential hypertension , a prospect i ve r and omized controlled trial was conducted comparing an aerobic exercise regimen to a placebo exercise regimen , with a crossover replication of the aerobic regimen in the placebo exercise group . The study took place in an outpatient research clinic in a university-affiliated Veterans Administration medical center . Twenty-seven men with untreated diastolic blood pressure ( DBP ) of 90 - 104 mm Hg were r and omized to the two exercise regimens . Ten patients completed the aerobic regimen . Nine patients completed the control regimen , seven of whom subsequently entered and completed the aerobic regimen . The aerobic regimen consisted of walking , jogging , stationary bicycling , or any combination of these activities for 30 minutes , four times a week , at 65 - 80 % maximal heart rate . The control regimen consisted of slow calisthenics and stretching for the same duration and frequency but maintaining less than 60 % maximal heart rate . DBP decreased 9.6 + /- 4.7 mm Hg in the aerobic exercise group but increased 0.8 + /- 6.2 mm Hg in the placebo control exercise group ( p = 0.02 ) . Systolic blood pressure ( SBP ) decreased 6.4 + /- 9.1 mm Hg in the aerobic group and increased 0.9 + /- 9.7 mm Hg in the control group ( p = 0.11 ) . Subsequently , seven of the nine controls entered a treatment crossover and completed the aerobic regimen with significant reductions in both DBP ( -6.1 + /- 3.2 mm Hg , p less than 0.01 ) and SBP ( -8.1 + /- 5.7 mm Hg , p less than 0.01 ) . BP changes were not associated with any significant changes in weight , body fat , urinary electrolytes , or resting heart rate . This r and omized controlled trial provides evidence for the independent BP lowering effect of aerobic exercise in unmedicated mildly hypertensive men",
"Dietary intakes of potassium , calcium , and magnesium have each been reported to lower blood pressure , but the extent of blood pressure reduction in epidemiological studies and clinical trials has tended to be small and inconsistent . We hypothesized that combinations of these mineral supplements would lower blood pressure and that the reductions would be greater than that usually reported in studies of each cation alone . One hundred twenty-five patients 82 men and 43 women ) with untreated mild or borderline hypertension were r and omly assigned to daily treatment with one of the following four regimens : 60 mmol potassium and 25 mmol ( 1000 mg ) calcium , 60 mmol potassium and 15 mmol ( 360 mg ) magnesium , calcium and magnesium , or placebo . St and ardized clinic blood pressure measurements were obtained on 3 days at baseline and after 3 and 6 months of treatment . At baseline , systolic and diastolic blood pressures ( mean + /- SD ) were 139 + /- 12 and 90 + /- 4 mm Hg , respectively , and dietary intakes of potassium , calcium , and magnesium were 77 + /- 32 , 19 + /- 13 , and 12 + /- 52 mmol/d , respectively . The mean differences ( with 95 % confidence intervals ) of the changes in systolic and diastolic blood pressures between the treatment and placebo groups were not significant : -0.7 ( -4.3 to + 2.9 ) and -0.4 ( -2.9 to + 2.1 ) for potassium and calcium , -1.3 ( -4.4 to + 1.8 ) and 0.4 ( -2.5 to + 3.3 ) for potassium and magnesium , and + 2.1 ( -1.8 to + 6.0 ) and + 2.2 ( -1.0 to + 5.4 ) for calcium and magnesium . In conclusion , this trial provides little evidence of an important role of combinations of cation supplements in the treatment of mild or borderline hypertension",
"The main objective of this clinical trial was to evaluate the effects of magnesium pidolate ( 15 mmol/day ) on blood pressure at rest and during sympathetic stimulation induced by cold , isometric and tilt test ; peripheral blood flow has been evaluated by strain-gauge plethysmography . Fourteen mild to moderate hypertensives ( 8 males , 6 females , age range 40 - 60 years ) were r and omly given magnesium or placebo in a double-blind parallel clinical trial for 6 months . In the actively treated group magnesium urinary excretion increased from 5.3 + /- 2 to 7.7 + /- 2 mmol/24 h , and serum magnesium changed from 0.9 + /- 0.1 to 1.0 + /- 0.2 mmol/l . On magnesium , BP changed at rest from 156/97 + /- 12/4 to 149/90 + /- 8/3 mm Hg , during cold pressor test from 169/105 + /- 9/6 to 174/105 + /- 15/4 , during isometric exercise from 170/107 + /- 13/9 to 170/105 + /- 20/6 , and during tilt test from 149/96 + /- 11/6 to 153/96 + /- 17/7 mm Hg . Similar changes were observed in the placebo group . Peripheral resistances were 14.7 + /- 4 and 9.8 + /- 2 PRU before and after magnesium , respectively . These data indicate that long-term magnesium pidolate supplementation does not affect blood pressure at rest and during sympathetic stimulation , despite a slight , nonsignificant reduction in forearm peripheral resistance",
"The Oslo Diet and Exercise Study ( ODES ) is an unmasked r and omized 2 x 2 factorial trial of 1-year duration for each participant . During 1990 - 1991 219 participants ( 198 males and 21 females ) aged 41 - 50 were r and omized into one of four treatment groups ; no treatment ( control ) , dietary changes alone , exercise alone , or a combination of the two treatments . At inclusion , the participants had no overt heart disease , but they had increased body weight ; slightly increased blood pressure , serum triglycerides , and total cholesterol , and they had decreased HDL cholesterol . Further , they were all inactive at leisure time . The primary aim of the trial is to compare the isolated and combined effects of the four treatments on the variables fibrinogen , fibrinolytic capacity , coagulation factor VII , and platelet volume . A series of secondary hypotheses will also be tested , such as the effects on other coagulation and fibrinolytic components and activities ; lipids and lipoproteins ; fatty acids ; glucose and insulin response to a glucose load ; clinical , physiological , and anthropometric variables ; and quality of life . The dietary treatments are adapted according to each participant 's risk profile ( level of total cholesterol , HDL cholesterol , triglycerides , blood pressure , and body weight ) . Fish and fish products are recommended . Special emphasis is put on caloric restriction in those who are overweight and those with elevated blood pressure . Exercise sessions take place three times a week under the guidance of highly qualified instructors . The aim is to increase peak oxygen uptake through aerobic endurance training . Adherence to the exercise program is monitored closely",
"In 46 elderly ( aged greater than or equal to 60 y ) hypertensive subjects with entry systolic blood pressure ( SBP ) greater than or equal to 160 or diastolic blood pressure ( DBP ) greater than or equal to 90 mm Hg , our specific aim in a r and omized , double-blind , crossover study ( two 8-wk treatment periods separated by a 3-wk washout ) was to compare blood pressure-lowering effects of 9 g fish oil/d [ omega-3 ( n-3 ) fatty acid ] vs 9 g corn oil/d [ omega-6 ( n-6 ) fatty acid ] . After a 4-wk baseline period , 22 subjects were r and omly assigned to receive fish oil and 24 to receive corn oil . For both 8-wk treatments there were no between-group differences in the change in blood pressure . There was a treatment difference for st and ing DBP when baseline values were compared with those after treatment 2 ; DBP decreased by 5.1 mm Hg in the fish-oil group vs 0.72 mm Hg in the corn-oil group ( P = 0.024 ) . Within groups during the first treatment , both fish oil and corn oil lowered all four blood pressure measures ( P less than 0.05 ) ; blood pressures were not further lowered during the second treatment compared with the washout period . There were no significant between-group differences in laboratory safety tests or categorical side effects . Fish oil lowered triglycerides by 0.47 mmol/L ( P less than 0.001 ) . In elderly subjects , diet plus both omega-3 and omega-6 supplements ( 9 g/d ) safely and effectively lower SBP and DBP",
"In a double-blind controlled trial , 91 middle-aged and elderly women with mild to moderate hypertension who were not on antihypertensive medication were r and omly assigned to treatment with magnesium aspartate-HCl ( 20 mmol Mg/d ) or placebo for 6 mo . Magnesium aspartate-HCl in the given dose was well-tolerated and was not associated with an increased frequency of diarrhea compared with placebo . At the end of the study , systolic blood pressure had fallen by 2.7 mm Hg ( 95 % CI -1.2 , 6.7 ; P = 0.18 ) and diastolic blood pressure by 3.4 mm Hg ( 1.3 , 5.6 ; P = 0.003 ) more in the magnesium group than in the placebo group . Blood pressure response was not associated with baseline magnesium status , as measured by dietary magnesium intake and urinary magnesium excretion . Urinary magnesium excretion in the magnesium group increased by 50 % during the intervention period . No changes were seen in other biochemical indexes , including serum concentrations of total and high-density-lipoprotein cholesterol . The findings suggest that oral supplementation with magnesium aspartate-HCl may lower blood pressure in subjects with mild to moderate hypertension",
"Tests of behavioral interventions seldom examine changes in health beliefs and behaviors thought to be prerequisites of improved outcome health states and they do not attempt to specify how patient characteristics or pretest measures influence responses to the intervention . In this study an experimental nursing intervention , its impact on hypertensive patients ' beliefs about their disease , efficacy of medications and diet , as well as blood pressure and weight are described . Among patients from the experimental group , the ability of selected pretest variables to predict clinical outcomes and changes in clinical health states was evaluated . The intervention was successful in lowering diastolic blood pressure and altering certain beliefs held by the patients . The pretest characteristics were not successful in explaining hypertensive patients ' responses to the intervention . Explanations for this are pursued through remarks from the content analysis of the intervention protocol . From these observations , the original health belief model was revised . The discussion concludes with a set of research questions that may prove promising for future research",
"Epidemiological and experimental data suggest blood pressure-lowering effects of dietary potassium . A r and omized , double-blind clinical trial was used to assess blood pressure response to orally administered potassium , 120 mEq/day , and to placebo in 101 adults with mild hypertension . Blood pressure was measured with a r and om-zero sphygmomanometer every 2 weeks of this 8-week trial . Systolic blood pressure in the potassium-treated group decreased by 6.4 + /- 13.7 ( SD ) mm Hg ( p less than or equal to 0.025 ) compared with 0.11 + /- 13.0 mm Hg in the placebo-treated group ( p = 0.96 ) . Diastolic blood pressure in the potassium-treated group decreased by 4.1 + /- 8.3 mm Hg ( p less than or equal to 0.05 ) compared with a 1.6 + /- 6.5 mm Hg decrease in placebo-treated subjects ( p = 0.09 ) . Baseline blood pressure of potassium-treated subjects was unexpectedly higher than that of controls . After correcting for baseline variation , blood pressure still decreased 3.4/1.8 mm Hg more in potassium recipients than in placebo recipients ( p = 0.14 and 0.24 , respectively ) . Blood pressure decreased by 19/13 mm Hg in five blacks taking potassium versus a 1/0 mm Hg increase in seven blacks taking placebo . Compliance with the potassium regimen was 91.5 % by pill count ; only one subject discontinued treatment because of side effects . In conclusion , 120 mEq/day of microencapsulated potassium chloride was well tolerated in adults with mild hypertension . An antihypertensive effect of potassium can not be ruled out despite the fact that there was no statistically significant difference between potassium-treated and placebo-treated subjects after adjustment for differences in baseline blood pressure . ( ABSTRACT TRUNCATED AT 250 WORDS",
"We compared the effects of nonpharmacologic therapy , propranolol monotherapy , and placebo on blood pressure , metabolic , exercise , and quality of life variables in a 12-week , r and omized , placebo-controlled trial of 79 male patients with hypertension . A significant reduction in diastolic blood pressure was observed with both nondrug therapy ( -8.0 + /- 1.08 mm Hg ) and propranolol ( -9.5 + /- 1.46 mm Hg ) compared to placebo ( -0.1 + /- 2.01 mm Hg ) . However , only patients receiving nonpharmacologic therapy showed a reduced body mass index , lower total and low-density lipoprotein serum cholesterol levels , and increased exercise tolerance compared to both propranolol and placebo . Patients receiving propranolol felt less anxious and unsure but showed a significant decrement in nocturnal penile tumescence compared to both placebo and nondrug therapy . Patients receiving nondrug therapy felt more energetic and reported improved sexual arousal and greater sexual satisfaction after treatment . Reductions in blood pressure in the nondrug treatment group were related to both weight reduction and improved fitness . We conclude that nondrug therapy is effective in controlling blood pressure in men with mild hypertension and is associated with improvements in weight , lipoprotein levels , and exercise tolerance compared to both propranolol and placebo . Quality of life assessment s further support the use of nondrug therapy in this context",
"STUDY OBJECTIVE : To study the clinical and cost outcomes of providing nutritional counselling to patients with one or more of the following conditions : overweight , hypertension and type 2 diabetes . DESIGN : The study was design ed as a r and om controlled trial . Consecutive patients were screened opportunistically for one or more of the above conditions and r and omly allocated to one of two intervention groups ( doctor/dietitian or dietitian ) or a control group . Both intervention groups received six counselling sessions over 12 months from a dietitian . However , in the doctor/dietitian group it was the doctor and not the dietitian who invited the patient to join the study and the same doctor also review ed progress at two of the six counselling sessions . SETTING : The study was conducted in a university group general practice set in a lower socioeconomic outer suburb of Perth , Western Australia . PATIENTS : Of the 273 patients r and omly allocated to a study group , 198 were women . Age ranged from 25 to 65 years . Seventy eight per cent of patients resided in the lower two socioecnomic quartiles , 56 per cent described their occupation as home duties and 78 per cent were partnered . RESULTS : Both intervention groups reduced weight and blood pressure compared with the control group . Patients in the doctor/dietitian group were more likely to complete the 12 month programme than those in the dietitian group . Patients in the doctor/dietitian group lost an average of 6.7 kg at a cost of $ A9.76 per kilogram , while the dietitian group lost 5.6 kg at a cost of $ A7.30 per kilogram . CONCLUSION : General practitioners , in conjunction with a dietitian , can produce significant weight and blood pressure improvement by health promotion methods",
"A r and omized , double-blind , placebo-controlled crossover trial of oral calcium supplementation was carried out in 18 patients with uncomplicated essential hypertension . After 15 weeks of oral calcium supplementation , 1 g/day , of the patients ' habitual diet , the only blood pressure change ( compared with the results of placebo treatment ) was in the average st and ing systolic blood pressure , which was significantly reduced ( -8.6 mm Hg ; p less than 0.01 ) . The 24-hour urinary calcium excretion and the total serum calcium concentration increased significantly during calcium supplementation ( p less than 0.05 ) , indicating good compliance with the treatment . The individual blood pressure changes with high calcium intake were found to be inversely related to basal 24-hour urinary calcium excretion ( r = -0.69 , p less than 0.001 for st and ing systolic pressure ; r = -0.55 , p less than 0.002 for st and ing diastolic pressure ) . This correlation was independent of age , basal blood pressure , serum calcium concentration , basal 24-hour urinary sodium excretion , and body weight changes during the trial . In particular , a subgroup of six patients , who had a basal 24-hour urinary calcium excretion higher than the mean + 2 SD of a reference healthy population previously described , showed a substantial average blood pressure fall at variance with the other patients in the study . These results do not support the usefulness of an oral calcium supplement in the majority of subjects with mild essential hypertension ; however , they suggest that a group of patients with a previously reported abnormality of calcium metabolism may be responsive to this therapeutic measure",
"BACKGROUND Although nonpharmacologic interventions are widely recommended in the therapy of high blood pressure in older adults , surprisingly little data exist to confirm the efficacy of these interventions in older persons . METHODS We conducted a r and omized , controlled clinical trial in persons aged 60 to 85 years with a diastolic blood pressure of 85 to 100 mm Hg . The experimental arm was a nonpharmacologic intervention combining weight reduction , sodium restriction , and increased physical activity . The nonpharmacologic intervention consisted of eight weekly group and two individual sessions during the intensive phase , followed by four monthly group sessions during the maintenance phase . The control group received no treatment during the study . Blood pressure was assessed by certified technicians ( blinded to group assignment ) using r and om zero sphygmomanometers . RESULTS Of 56 participants r and omized , 47 completed the entire 6-month trial ( 21 in the intervention group and 26 in the control group ) . Attendance at the intervention sessions was excellent . The intervention group lost more weight ( -2.1 kg ) over 6 months than the control group ( + 0.3 kg ) . Trends for decreasing 24-hour urine sodium excretion in both the intervention and control groups , with greater trend in the intervention group , were not statistically significant . The intervention group experienced more reduction in systolic and diastolic blood pressure than did the control group ( mean differences between groups at 6 months , 4.2/4.9 mm Hg , respectively ) . CONCLUSIONS Our data indicate that a nonpharmacologic intervention will lower systolic and diastolic blood pressure levels in older people with borderline or mild elevations of diastolic blood pressure",
"Obesity , especially central , increases the risk of hypertension , hypertriglyceridaemia and diabetes to a significant extent . To determine whether dietary weight reduction can reduce blood pressure ( BP ) and other cardiovascular risk factors , 217 hypertensives were r and omised to receive either 1600 Kcal/day diet ( group A , n = 108 ) or the usual 2100 Kcal/day diet ( group B , n = 109 ) . Sodium intake and physical activity were kept similar in both groups . After 16 weeks of follow-up , patients in group A received significantly less energy leading to a 2.8 kg net reduction in mean weight in association with a significant net decrease in mean SBP and DBP ( 7.5/6.5 mm Hg ) compared with nonsignificant changes in group B. There was a significant net decrease in mean total cholesterol ( 7.0 % ) , low-density lipoprotein (LDL)-cholesterol ( 7.9 % ) and triglycerides ( 8.0 % ) , with a significant net increase in high-density lipoprotein (HDL)-cholesterol ( 4.0 % ) in group A compared with group B. New risk factors such as glucose intolerance ( 8.0 % ) and central obesity ( waist-hip girth ratio , 0.021 ) showed a significant net reduction compared with group B. Patients with central obesity and other associated disturbances showed maximal reduction in BP and other cardiovascular risk factors with a significantly greater increase in HDL-cholesterol . Mean doses of drugs were similar at entry to the study as well as after 16 weeks in both groups . It is possible that weight reduction due to a low caloric diet can moderate central obesity and associated disturbances in hypertensive subjects",
"A group of previously untreated obese hypertensive patients were started on a weight reduction programme supervised by two dietitians working in a general practice surgery . It was stressed from the beginning of the programme that reducing blood pressure was the purpose of the diet . The results of follow-up after six months are presented together with results for a control group of obese hypertensive patients not receiving dietary advice or drug therapy , but being followed by the general practitioner . The weight , systolic blood pressure and diastolic blood pressure of the dieting hypertensive group were significantly lower than those of the non-dieting group after six months . However , the drop-out rate was significantly higher for the dieting group than for the non-dieting group . The results of a separate comparison between a control group of obese normotensive patients following the same dietary programme and the group of dieting obese hypertensive patients are also presented . Attendance rates and weight loss achieved were significantly better for the hypertensive group than for the normotensive group after 12 months . Weight reduction appears to be an effective first-line therapy for approximately 50 % of obese patients with mild to moderate hypertension , and raised blood pressure appears to provide motivation for such patients to attend a dietitian 's clinic and to lose weight",
"The contribution of training procedures design ed to alter individuals ' psychological responses to stressful life stimuli to the reduction of blood-pressure levels of hypertensives was evaluated . The treatment consisted of a set of coping skill-building experiences . Forty-one black males , mildly to moderately hypertensive and under medical supervision in an outpatient cardiovascular unit of a veterans ' hospital , participated . Subjects were r and omly assigned to one of three groups : Cognitive Self-Management Training ( CSM ) , Attention Placebo Control , and Current Clinic Conditions Control . The dependent measures were the State Anxiety Scale , Trait Anxiety Scale , Coping Strategic Inventory , systolic blood pressure , and diastolic blood pressure . Subjects in the CSM group reported significant increases in the use of cognitive coping strategies in their lives and demonstrated significant decreases in measured levels of state anxiety and systolic blood pressure . Promising reductions of diastolic blood pressure ratings were obtained as well",
"Fish and fish oils have been reported to reduce blood pressure in normotensives and untreated hypertensives . The present study examined the effect of dietary supplementation with fish oil on blood pressure in 20 treated hypertensives with controlled blood pressures who continued their usual antihypertensive drug treatment throughout . A double-blind , r and omized crossover design was used , with two phases , each of 8 weeks ' duration . In one phase , subjects took fifteen 1 g fish oil capsules ( Lipitac ; Reckitt and Colman Pharmaceuticals , Sydney , Australia ) daily , and in the other , 15 capsules of identical appearance containing 1 g olive oil daily . There was no difference between the treatment phases for any blood pressure parameter , heart rate or body weight , but blood pressure was lower in both phases compared with pretreatment values . The fasting plasma triglyceride concentration was 30 % lower in the fish oil phase ( P less than 0.001 ) , but there was no difference between the phases for plasma concentrations of total or high-density lipoprotein ( HDL ) cholesterol . We conclude that , in treated hypertensives with controlled blood pressures , any additional fall in blood pressure produced by dietary supplementation with fish oil is so small that the requirement for antihypertensive drug therapy is unlikely to be reduced",
"In order to assess the effects of a Behavioral Treatment Program in the control of primary hypertension , twenty one unmedicated hypertensives were r and omly allocated to three groups : first , a treatment group ( BHG ) receiving a Behavioral Treatment which included : deep muscle relaxation , peripheral temperature Biofeedback and anxiety management training ; second , the placebo attention control group ( PHG ) and third , a control group of hypertensives too ( CHG ) . Additionally , were compared with seven normotensives subjects ( CNG ) . The post-treatment measures showed a significant reduction ( p in systolic and diastolic values only in the ( BHG ) . In a six months follow-up the ( BHG ) group still showed a significant reduction in the systolic and diastolic BP ( p < 0.02 ; p < 0.01 ) . Moreover individual variations in response to treatment were observed in this group , ( BHG )",
"This study examined the effect of a relaxation technique on plasma lipids , weight , blood pressure , and blood glucose . Sixteen outpatient males were r and omly assigned to control or experimental groups . The experimental group was taught a relaxation technique that they used throughout the study . The control group was started in a reading program . Subjects were followed by a nurse practitioner and dietitian for eight weeks . Results revealed a significant reduction in systolic blood pressure and a marginally significant reduction in low density lipoprotein ( LDL ) cholesterol in the experimental group . Both control and experimental groups self-reported high compliance with diet and adherence to prescribed intervention . State anxiety was found to be inversely related to changes in total cholesterol and LDL cholesterol",
"Forty-seven patients with mild hypertension and 48 normotensive patients entered a blinded , parallel study in which they received a placebo , 10 mmol/day calcium carbonate ( CaCO3 ) , or 20 mmol/day CaCO3 . There were no significant differences in blood pressure changes among the groups . In the hypertensive group and in patients with the highest blood pressure there were individual falls in systolic pressure , particularly in the group receiving 10 mmol daily CaCO3 . In the hypertensive group the changes were : with placebo , −3±2/− 2±2 mm Hg ; with CaCO3 ( 10 mmol ) , −7±3/− 2±2 mm Hg ; and with CaCO3 ( 20 mmol ) , −2±3/l±2 mm Hg . No change was significant , and no pressure changes of patients taking CaCO3 differed significantly from changes of patients taking placebo . Ten of 33 patients taking placebo , 11 of 31 taking 10 mmol/ day CaCO3 , and nine of 31 taking 20 mmol/day CaCO3 were classified as responders from their systolic blood pressure fall . These response rates did not differ . Eight patients had falls of systolic blood pressure greater than 15 mm Hg . Five were on 10 mmol/day CaCO3 and three on 20 mmol/day CaCO3 . This response was significantly different from that with placebo . Univariate analyses failed to reveal any predictive dietary or biochemical parameter . After 3 months of not taking CaCO3 , 12 patients classified as responders , including six of the eight with a fall of 15 mm Hg or more , were rer and omized to placebo or to 20 mmol/day CaCO3 . In the rechallenge , responses to CaCO3 and placebo were similar , neither causing a significant pressure fall . Calcium carbonate did not reduce blood pressure . The apparent response hi a few patients was not verified by rechallenge . The present study does not support calcium supplementation as a useful nonpharmacological measure for reducing elevated blood pressure",
"The aim of the study was to clarify the feasibility of physical training for middle-aged borderline-hypertensive males . Blood pressure of 59 subjects was followed for nine months , whereafter 25 persons were classified as borderline-hypertensive and 34 persons as normotensive . Both groups were r and omly allocated into training and control groups . Training lasted for four months , of which the first two included supervised bicycle ergometer exercise . During the last two months training was unsupervised . After training estimated maximal oxygen consumption increased significantly both in borderline-hypertensive and normotensive men . After training resting diastolic blood pressure decreased significantly both in training and control groups . This finding supports the importance of sufficiently long follow-up of blood pressure before eventual drug therapy when blood pressure is mildly elevated . Diastolic blood pressure during 50-minute ergometer exercise was decreased after four months of training in borderline-hypertensives and did not any longer differ from that of normotensives . Individually prescribed physical training is worth regarding as one treatment modality for middle-aged borderline-hypertensive patients",
"The effects of long-term sodium restriction on plasma atrial natriuretic factor ( ANF ) concentrations , and the role of baseline plasma ANF concentration as an indicator of changes in haemodynamics and left ventricular hypertrophy during this treatment were studied in 40 middle-aged previously untreated mildly to moderately hypertensive men and women in a 6-month controlled r and omized study . The main emphasis of the treatment programme was to reduce daily sodium intake to less than 70 mmol . Mean sodium excretion decreased from 148 + /- 74 mmol 24 h-1 to 79 + /- 71 mmol 24 h-1 in the treatment group , but remained unchanged in the control group ( 173 + /- 68 mmol 24 h-1 vs. 186 + /- 62 mmol 24 h-1 ; P less than 0.01 for the difference in changes between the groups ) . Mean plasma ANF concentrations in the treatment group were 52.4 + /- 20.7 ( median 50 ) pg ml-1 at baseline and 38.7 + /- 26.3 ( median 42 ) pg ml-1 at 6 months , and the corresponding values in the control group were 55.5 + /- 20.5 ( median 50 ) pg ml-1 and 46.1 + /- 32.4 ( median 50 ) pg ml-1 , respectively ( P = NS for the difference in changes ) . The ANF concentration decreased from 70 + /- 14 pg ml-1 to 32 + /- 26 pg ml-1 in treated subjects with a high baseline plasma ANF concentration ( greater than 50 pg ml-1 ) , but increased from 37 + /- 11 pg ml-1 to 45 + /- 27 pg ml-1 in subjects with a low baseline plasma ANF concentration ( less than or equal to 50 pg ml-1 ) ( difference in changes P less than 0.001 ) . Compared with treated subjects with low baseline plasma ANF levels and with controls , treated subjects with high baseline plasma ANF levels showed a decrease ( P less than 0.05 ) in interventricular septal and left posterior wall thicknesses , in relative wall thickness , and in peripheral resistance . These results suggest that in mildly to moderately hypertensive subjects long-term sodium restriction decreases high plasma ANF concentrations concomitantly with regression of concentric left ventricular hypertrophy , probably as a result of changes in haemodynamics",
"Objective : To examine the efficacy of a new device , which slows and regularises breathing , as a non-pharmacological treatment of hypertension and thus to evaluate the contribution of breathing modulation in the blood pressure ( BP ) reduction . Design and setting : R and omised , double-blind controlled study , carried out in three urban family practice clinics in Israel . Patients : Sixty-five male and female hypertensives , either receiving antihypertensive drug therapy or unmedicated . Four patients dropped out at the beginning of the study .Intervention : Self treatment at home , 10 minutes daily for 8 consecutive weeks , using either the device ( n = 32 ) , which guides the user towards slow and regular breathing using musical sound patterns , or a Walkman , with which patients listened to quiet music ( n = 29 ) . Medication was unchanged 2 months prior to and during the study period . Main outcome measures : Systolic BP , diastolic BP and mean arterial pressure ( MAP ) changes from baseline . Results : BP reduction in the device group was significantly greater than a predetermined ‘ clinical ly meaningful threshold ’ of 10.0 , 5.0 and 6.7 mm Hg for the systolic BP , diastolic BP and MAP respectively ( P = 0.035 , P = 0.0002 and P = 0.001 ) . Treatment with the device reduced systolic BP , diastolic BP and MAP by 15.2 , 10.0 and 11.7 mm Hg respectively , as compared to 11.3 , 5.6 and 7.5 mm Hg ( P = 0.14 , P = 0.008 , P = 0.03 ) with the Walkman . Six months after treatment had stopped , diastolic BP reduction in the device group remained greater than the ‘ threshold ’ ( P high BP during 2 months of self-treatment by patients at home . Breathing pattern modification appears to be an important component in this reduction",
"After a general clinical observation period of over 4 weeks , 20 essential hypertensive subjects ( Japanese ) were r and omly divided into two groups . One group ( n = 10 ; 4 men and 6 women ; 51.4 + /- 2.8 years of age ) agreed to physical training using bicycle ergometer exercise with the intensity at blood lactate threshold for 60 minutes three times a week for 10 weeks , while the other group ( n = 10 ; 4 men and 6 women ; 51.0 + /- 2.9 years of age ) did no particular physical training and was followed once a week as the control . Changes in blood pressure , hemodynamics , and humoral factors of the exercised group were compared with values in the controls . The following significant changes were found only in the exercised group . Blood pressure was significantly ( p less than 0.01 ) reduced . Whole blood and plasma volume indices were significantly reduced ( p less than 0.05 , p less than 0.01 , respectively ) . The change in ratio of serum sodium to potassium positively correlated with the change in systolic blood pressure ( r = 0.76 , p less than 0.02 ) . Plasma norepinephrine concentrations both at rest and at the workload of blood lactate threshold during grade d exercise tests were significantly reduced ( p less than 0.05 , p less than 0.02 respectively ) after 10 weeks of exercise training . The change in the resting level of plasma norepinephrine positively correlated with that in the mean blood pressure . No such changes were observed in the control group . In both groups , body weight and urinary sodium excretion showed no statistically significant changes . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The aim of this study was to evaluate if a nutritional dose of magnesium given orally changes the blood pressure in untreated hypertensive patients and if orally-given magnesium had any influence on serum and muscle magnesium and potassium . A r and omized , double-blind crossover study design was followed with magnesium 15 mmol/day or placebo treatment for two months . Thirty-nine patients aged 20 - 59 years , were treated . Sample s for magnesium and potassium in blood , muscle and urine were taken at entry time , after two months ( crossover time ) and after four months ( end of study ) . Systolic and diastolic supine and st and ing blood pressures were measured at the same times . No significant change in blood pressure , serum or muscle concentrations of electrolytes were observed on magnesium treatment . Urine magnesium rose significantly on magnesium , and it decreased significantly on placebo . Therefore results suggest that 15 mmol magnesium/day , given to untreated mild-to-moderate hypertensives does not alter blood pressure nor the concentrations of magnesium and potassium in serum and muscle , in patients with normal magnesium turnover",
"To determine the impact of dietary patterns on the control of hypertension we studied the subgroup of 133 participants with systolic blood pressure ( BP ) of 140 to 159 mm Hg and /or diastolic BP of 90 to 95 mm Hg enrolled in the Dietary Approaches to Stop Hypertension ( DASH ) study . Participants were fed a control diet for a 3-week period and were then r and omized to receive for 8 weeks either the control diet ; a diet rich in fruits and vegetables , but otherwise similar to control ; or a combination diet rich in fruits , vegetables , and low-fat dairy products , including whole grains , fish , poultry , and nuts , and reduced in fats , red meats , sweets , and sugar-containing beverages . Sodium intake and body weight were held constant throughout the study . The combination diet significantly reduced systolic BP ( -11.4 mm Hg , P diastolic BP ( -5.5 mm Hg , P fruits- and -vegetables diet also significantly reduced systolic BP ( -7.2 mm Hg , P diastolic BP ( -2.8 mm Hg , P = .013 ) . The combination diet produced significantly greater BP effects ( P fruits- and -vegetables diet . Blood pressure changes were evident within 2 weeks of starting the intervention feeding . After the 8-week intervention period , 70 % of participants eating the combination diet had a normal BP ( systolic BP -vegetables diet and 23 % on the control diet . In patients with hypertension , the DASH combination diet effectively lowers BP and may be useful in achieving control of Stage 1 hypertension",
"This pilot study was aim ed at investigating the hypotensive potential of hawthorn extract and magnesium dietary supplements individually and in combination , compared with a placebo . Thirty-six mildly hypertensive subjects completed the study . At baseline , anthropometric and dietary assessment , as well as blood pressure measurements were taken at rest , after exercise and after a computer ' stress ' test . Volunteers were then r and omly assigned to a daily supplement for 10 weeks of either : ( a ) 600 mg Mg , ( b ) 500 mg hawthorn extract , ( c ) a combination of ( a ) and ( b ) , ( d ) placebo . Measurements were repeated at 5 and 10 weeks of intervention . There was a decline in both systolic and diastolic blood pressure in all treatment groups , including placebo , but ANOVA provided no evidence of difference between treatments . However , factorial contrast analysis in ANOVA showed a promising reduction ( p = 0.081 ) in the resting diastolic blood pressure at week 10 in the 19 subjects who were assigned to the hawthorn extract , compared with the other groups . Furthermore , a trend towards a reduction in anxiety ( p = 0.094 ) was also observed in those taking hawthorn compared with the other groups . These findings warrant further study , particularly in view of the low dose of hawthorn extract used",
"A 5-year trial involving 201 men and women with high-normal blood pressure at baseline demonstrated the ability to reduce the incidence of hypertension in participants r and omized to nutritional-hygienic intervention compared with a control group . The incidence of hypertension was 8.8 % among 102 intervention group participants vs 19.2 % among 99 control group members . The odds ratio for the incidence of hypertension in the control group was 2.4 . Mean trial blood pressure also was lower in the intervention compared with the control group ( -1.2 and -1.9 mm Hg , respectively , for diastolic blood pressure at work-site and office visits and -1.3 and -2.0 mm Hg , respectively , for systolic blood pressure at the two sites ) . Net weight loss in the intervention group averaged 2.7 kg during the trial ; sodium intake was reduced by 25 % and reported alcohol intake decreased by 30 % . The majority of intervention participants also reported an increase in physical activity . Effect on blood pressure was related particularly to degree of weight loss . Results indicate that even a moderate reduction in risk factors for hypertension among hypertension-prone individuals contributes to the primary prevention of the disease",
"OBJECTIVE --To assess the effects of physical exercise training on blood pressure in patients with mild hypertension . DESIGN --R and omized controlled trial . SETTING --Hospital-based cardiac rehabilitation program . PATIENTS --Ninety-nine men and women with untreated mild hypertension ( systolic blood pressure , 140 to 180 mm Hg ; diastolic blood pressure , 90 to 105 mm Hg ) were included in the volunteer sample . INTERVENTIONS --Subjects were r and omly assigned to a 4-month program of aerobic exercise training , strength and flexibility training , or to a waiting list control group . MAIN OUTCOME MEASURES --The main outcome measures were systolic and diastolic blood pressures measured four times with a r and om zero sphygmomanometer on 3 separate days in a clinic setting . RESULTS --After 4 months of exercise training , subjects in the aerobic exercise group did not exhibit greater reductions in blood pressure than subjects in the control group . We expected a differential decline of 5 mm Hg between the aerobic exercise and waiting list control groups and found a difference of -1.0 + /- 16 mm Hg and -1.2 + /- 10 mm Hg at alpha = .05 for systolic and diastolic blood pressure , respectively . CONCLUSIONS --Moderate aerobic exercise alone should not be considered a replacement for pharmacologic therapy in nonobese patients with mild hypertension",
" 28 patients who had a sustained diastolic blood pressure of 95 to 104 mm Hg and who had no treatment for it for at least 13 months before the trial , but who were otherwise unselected , took part in a r and omised controlled trial in which the effect of a restricted sodium diet was compared with that of a general health package . The general health package did not include any specific hypotensive procedures . Changes in blood pressure were measured at predetermined intervals over the course of a year . Within each group both systolic and diastolic blood pressure fell to a highly significant extent after a year , but there was no significant difference between the groups . It would thus seem that the antihypertensive effect of a restricted sodium diet may be related to the increased consultation and monitoring activity of such intervention rather than to the dietary manipulation itself",
"& NA ; We determined the effect of relaxation therapy for hypertension in patients whose blood pressure remained elevated despite the use of antihypertensive medication . The effect was assessed in multiple setting s , including the relaxation therapist 's office , the Hypertension Clinic , and the patient 's natural environment , the latter using 24‐hour automated ambulatory blood pressure measures . Nineteen patients were r and omized either to temperature biofeedback‐assisted relaxation or to an attention control , “ stress education . ” Antihypertensive medication was kept constant . In the behavioral therapist 's office , blood pressure decreased in equivalent amounts with both treatments . Hypertension Clinic nurse blood pressure remained stable or increased with both treatments , but again there was no difference between treatments . Ambulatory blood pressure increased with relaxation therapy and decreased with stress education , the effect being significant for diastolic pressure . The effects on ambulatory blood pressure were limited to the waking hours . The only variable that showed superior effects for relaxation therapy was physician‐determined blood pressure . These results call into question the generalizability of the effects of relaxation therapy from one setting to another",
"OBJECTIVE To determine whether blood pressure is reduced for at least 6 months with an intervention to lower alcohol intake in moderate to heavy drinkers with above optimal to slightly elevated diastolic blood pressure , and whether reduction of alcohol intake can be maintained for 2 years . DESIGN A r and omized controlled trial . METHODS Six hundred forty-one outpatient veterans with an average intake of 3 or more alcoholic drinks per day in the 6 months before entry into the study and with diastolic blood pressure 80 to 99 mm Hg were r and omly assigned to a cognitive-behavioral alcohol reduction intervention program or a control observation group for 15 to 24 months . The goal of the intervention was the lower of 2 or fewer drinks daily or a 50 % reduction in intake . A subgroup with hypertension was defined as having a diastolic blood pressure of 90 to 99 mm Hg , or 80 to 99 mm Hg if recently taking medication for hypertension . RESULTS Reduction in average weekly self-reported alcohol intake was significantly greater ( P blood pressure than the control group ( for each , P = .17 and P = .18 ) for the 6-month primary end point ; for the hypertensive stratum the difference was 0.9/0.7 mm Hg ( for each , P = .58 and P = .44 ) . CONCLUSIONS The 1.3 drinks per day average difference between changes in self-reported alcohol intake observed in this trial produced only small nonsignificant effects on blood pressure . The results from the Prevention and Treatment of Hypertension Study ( PATHS ) do not provide strong support for reducing alcohol consumption in nondependent moderate drinkers as a sole method for the prevention or treatment of hypertension",
"National guidelines for the prevention and treatment of hypertension recommend sodium reduction , weight loss , the Dietary Approach to Stop Hypertension ( DASH ) diet , and regular aerobic exercise . However , no trial has assessed the efficacy of simultaneously implementing all of these recommendations . The objective of this study was to determine the effects on blood pressure and other cardiovascular disease risk factors of a comprehensive lifestyle intervention . We conducted a r and omized controlled trial of 44 hypertensive , overweight adults on a single blood pressure medication . Participants were r and omized to a lifestyle or control group . For 9 weeks , the lifestyle group was fed a hypocaloric version of the DASH diet that provided 100 mmol/d of sodium . This group also participated in a supervised , moderate-intensity exercise program 3 times per week . The control group received no intervention . Outcomes were ambulatory blood pressure , serum lipids , weight , and fitness . At the end of the intervention , mean weight loss in the lifestyle group , net of control , was 4.9 kilograms . In the lifestyle group mean net reductions in 24-hour ambulatory systolic and diastolic blood pressures were 9.5 mm Hg ( P daytime systolic and diastolic blood pressures were 12.1 mm Hg ( P total cholesterol ( -25 mg/dL , P low-density lipoprotein cholesterol ( -18 mg/dL , P=0.005 ) , high-density lipoprotein cholesterol ( -5 mg/dL , P hypertensive overweight adults already on antihypertensive medication , a comprehensive lifestyle intervention can substantially lower blood pressure and improve blood pressure control",
"A 15 week r and omised double blind placebo controlled trial of oral potassium supplements ( 48 mmol daily ) was conducted in 37 patients who had mildly increased blood pressure and a normal dietary intake of sodium . After a two month run in and a one week baseline period the patients were r and omly assigned to receive either potassium supplements ( n = 18 ) or placebo ( n = 19 ) . By the third week of treatment blood pressure in the actively treated group had decreased significantly compared with that in the placebo group , though the decrease reached its maximum after 15 weeks . Urinary potassium excretion increased significantly in the group who received potassium supplements , but no significant changes were found in plasma sodium and potassium concentrations or in urinary sodium excretion . In a subgroup of 13 patients who underwent a further nine weeks of treatment with oral potassium supplements at half of the previous dose ( 24 mmol daily ) their blood pressure , at the end of this second study period , was still significantly lower compared with their baseline value but not with that of the placebo group . These results show that moderate oral potassium supplements are associated with a long term reduction in blood pressure in patients who have mild hypertension",
"We evaluated the effect of oral calcium supplementation on blood pressure , calcium metabolism , and insulin resistance in essential hypertension . After receiving a st and ard diet with 500 mg of calcium per day during a 4-week period , 20 nondiabetic , essential hypertensive patients were r and omized in a double-blind fashion to receive oral calcium supplementation ( 1500 mg of calcium per day ) or placebo for 8 weeks . At the end of the 4-week period of low-calcium diet and after the 8-week period of intervention , we measured blood pressure ( by both office and 24-hour ambulatory blood pressure monitoring ) , calcium-regulating hormones [ urinary hydroxyproline and serum osteocalcin , parathormone , and 1,25(OH)2-vitamin D3 ] , intraplatelet free calcium concentration , fasting plasma glucose and insulin levels , and the insulin-sensitivity index ( euglycemic-hyperinsulinemic clamp ) . Compared with patients maintained at low calcium intake , essential hypertensive patients under oral calcium supplementation significantly reduced serum osteocalcin ( from 22.2 + /- 1.9 to 17.9 + /- 2.0 micrograms/L ; P = .0015 ) , parathormone ( from 4.20 + /- 0.38 to 3.30 + /- 0.36 pmol/L ; P = .0003 ) , and 1,25(OH)2-vitamin D3 ( from 98.0 + /- 11.0 to 61.6 + /- 5.7 pmol/L ; P = .0062 ) . Likewise , we found a significant reduction in intraplatelet free calcium concentration ( from 35.9 + /- 1.2 to 26.5 + /- 0.8 nmol/L ; P = .0005 ) and fasting plasma insulin levels ( from 71.8 + /- 5.9 to 64.6 + /- 6.2 pmol/L ; P = .05 ) and a significant increase in the insulin-sensitivity index ( from 2.89 + /- 0.77 to 4.00 + /- 0.95 mg.kg-1.min-1 ; P = .0007 ) . None of these parameters were significantly modified in patients maintained at low calcium intake . Office and 24-hour mean values of systolic and diastolic blood pressure did not change after 8 weeks of oral calcium supplementation or placebo",
"The relation between alcohol consumption and blood pressure is well recognized , and advice to reduce alcohol plays an important part in the management of hypertensive patients . We have evaluated the effectiveness of this advice in a r and omized , controlled , single-blind clinical study . After a 2-week run-in period , hypertensive men regularly consuming more than 20 units/wk ( 1 unit = 10 g ) of alcohol were r and omly assigned either to the \" advice \" or control group and were seen at 2-week intervals over an 8-week study period . The outcome measures were : reported alcohol consumption ( 1-week retrospective diary ) , markers of alcohol consumption ( serum gamma-glutamyl transpeptidase , aspartate aminotransferase , uric acid , mean corpuscular volume ) , and blood pressure ( sitting and st and ing ) . Over 18 months , 67 men who drank more than 20 units/wk of alcohol were seen . Twenty-six either were excluded , refused to participate , or dropped out due to nonattendance . Forty-one patients completed the study . After intervention , reported alcohol consumption fell from 60 units/wk to around 30 units/wk in the advice group , whereas it remained between 50 and 60 units/wk in the control group ( analysis of variance [ ANOVA ] F = 7.1 , p less than 0.05 ) . This was accompanied by falls in gamma-glutamyl transpeptidase ( 20.9 % ) and aspartate aminotransferase ( 18.1 % ) , but no significant changes were seen in the control group . St and ing diastolic blood pressure fell significantly in the advice group ( from 101.5 mm Hg to 96.3 mm Hg ) compared with the control group ( ANOVA F = 4.8 , p less than 0.05 ) . The results suggest that advice to reduce alcohol consumption is a useful form of treatment for hypertensive patients who drink excessively",
"An increase in magnesium intake has been suggested to lower blood pressure ( BP ) . However , the results of clinical studies are inconsistent . We studied the effects of magnesium supplementation on office , home , and ambulatory BPs in patients with essential hypertension . Sixty untreated or treated patients ( 34 men and 26 women , aged 33 to 74 years ) with office BP > 140/90 mm Hg were assigned to an 8-week magnesium supplementation period or an 8-week control period in a r and omized crossover design . The subjects were given 20 mmol/d magnesium in the form of magnesium oxide during the intervention period . In the control period , office , home , and average 24-hour BPs ( mean+/-SE ) were 148.6+/-1.6/90.0+/-0.9 , 136.4+/-1.3/86.8+/-0.9 , and 133.7+/-1.3/81.0+/-0.8 mmHg , respectively . All of these BPs were significantly lower in the magnesium supplementation period than in the control period , although the differences were small ( office , 3.7+/-1.3/1.7+/-0.7 mmHg ; home , 2.0+/-0.8/1.4+/-0.6 mmHg ; 24-hour , 2.5+/-1.0/1.4+/-0.6 mm Hg ) . Serum concentration and urinary excretion of magnesium increased significantly with magnesium supplementation . Changes in 24-hour systolic and diastolic BPs were correlated negatively with baseline BP or changes in serum magnesium concentration . These results indicate that magnesium supplementation lowers BP in hypertensive subjects and this effect is greater in subjects with higher BP . Our study supports the usefulness of increasing magnesium intake as a lifestyle modification in the management of hypertension , although its antihypertensive effect may be small",
" Forty-eight black patients with mildly increased blood pressure ( BP ) that had not yet been subjected to treatment took part in a double-blind clinical trial of the efficacy and tolerability of oral potassium supplements ( 64 mmol daily ) versus a matching placebo ( made of starch with coating ) in a 16-week study . Potassium supplements produced a significant decrease in mean supine and st and ing BP within 4 weeks after treatment inception . Urinary potassium excretion increased significantly in the 24 patients who received potassium supplements ( p plasma sodium and potassium concentrations or in urinary excretion of sodium during the study . All patients completed the trial without experiencing any notable untoward effects . These results are consistent with the premise that oral potassium supplements may exert hypotensive effects of clinical ly significant degree in patients with mild hypertension",
"& NA ; The efficacy and the mechanisms of action of two behavioral treatments for essential hypertension were compared : cognitive group therapy for anger control and biofeedback for heart rate control . The cognitive therapy aim ed at lowering the “ general anger ” level and helping overt expression of “ anger out ; ” heart rate biofeedback aim ed at slowing heart rate in stress situations . Ninety‐seven essential hypertensive patients were r and omly assigned to three groups ; after 20 dropouts , 77 patients fully participated in the study : cognitive treatment ( N = 30 ) , biofeedback ( N = 27 ) , and control ( no treatment , N = 20 ) . The treatments were held in 17 weekly sessions ; during treatment , blood pressure was measured once a month , and during follow‐up after 1 and 6 months . The anger level and heart rate control were assessed at the beginning and the end of treatment . The main results were : 1 ) a significant decrease of blood pressure for both treatments as compared with control , 2 ) a significant decrease of blood pressure with heart rate biofeedback as compared with cognitive therapy , and 3 ) a better control in anger achieved with cognitive therapy and a lesser control in heart rate as compared with biofeedback",
"OBJECTIVE To determine whether dietary supplementation with fish oil adversely affects glycemic control in patients with hypertension . DESIGN R and omized , double-blind , placebo-controlled study . PATIENTS 78 persons with untreated hypertension recruited from a population survey . INTERVENTION Participants were r and omly assigned to receive eicosapentaenoic and docosahexaenoic acids , 4 g/d , or corn oil placebo , 4 g/d , for 16 weeks . MEASUREMENTS An oral glucose tolerance test ; assessment s of insulin release , glucose disposal , and insulin sensitivity done using the hyperglycemic clamp technique to keep plasma glucose levels at 10 mmol/L for 180 minutes ; assessment of insulin sensitivity done using a euglycemic hyperinsulinemic clamp technique ( infusing insulin and glucose to keep plasma glucose levels at 5 mmol/L ) ; assessment s of lipid levels and blood pressure . Measurements were done before and after intervention . RESULTS Changes in integrated glucose and insulin response after the oral glucose challenge did not differ between the fish oil and corn oil groups after intervention ( -0.6 + /- 0.7 compared with -1.0 + /- 0.6 mmol/L [ P > 0.3 ] for integrated glucose and 143 + /- 76 compared with 169 + /- 84 pmol/L [ P > 0.3 ] for insulin response ) . Changes in first-phase insulin release ( 34 + /- 72 pmol/L in the fish oil group compared with 191 + /- 112 pmol/L in the corn oil group [ P > 0.3 ] ) , second-phase insulin release ( 179 + /- 66 pmol/L compared with 257 + /- 122 pmol/L [ P > 0.3 ] ) , and insulin sensitivity index ( -0.03 + /- 0.01 compared with -0.01 + /- 0.01 [ mumol/kg.min divided by pmol/L ] ; P > 0.3 ) were also similar in both groups after treatment . Fish oil lowered systolic blood pressure by 3.8 mm Hg more than control ( P = 0.04 ) and lowered diastolic blood pressure by 2.0 mm Hg more than control ( P = 0.10 ) . After fish oil treatment , triglyceride levels decreased by 0.28 + /- 0.08 mmol/L more than control ( P = 0.01 ) , and very-low-density lipoprotein cholesterol levels decreased by 0.13 + /- 0.04 mmol/L more than control ( P = 0.01 ) . CONCLUSION Fish oil , in doses that reduce blood pressure and lipid levels in hypertensive persons , does not adversely affect glucose metabolism",
"On screening 192 men and women aged 35 - 64 were identified as having two or more of the following risk factors : blood pressure greater than or equal to 140/90 mm Hg , plasma cholesterol concentration greater than or equal to 6.3 mmol/l ( 243.6 mg/100 ml ) , and current smoking habit greater than or equal to 10 cigarettes a day . They were r and omly allocated to a group for modification of behaviour or to serve as controls . Both groups were given health education leaflets containing advice to stop smoking , to reduce animal fats in the diet , and on the importance of reducing blood pressure . In addition , the treatment group had group sessions of one hour a week for eight weeks in which they were taught breathing exercises , relaxation , and meditation and about managing stress . It had previously been found that after eight weeks and eight months there was a significantly greater reduction in both systolic and diastolic blood pressures in the group taught to relax compared with the control group . After four years of follow up these differences in blood pressure were maintained . Plasma cholesterol concentration and the number of cigarettes smoked were lower in the treatment group at eight weeks and eight months but not at the four year follow up . At four years more subjects in the control group reported having had angina and treatment for hypertension and its complications . Incidence of ischaemic heart disease , fatal myocardial infa rct ion , or electrocardiographic evidence of ischaemia was significantly greater in the control group . If the results of this study could be obtained in a larger study the financial and health care implication s would be enormous",
"Objective To study the effects of a high calcium intake in hypertensive patients by blood pressure monitoring . Design In a r and omized crossover study , patients were assigned to an 8-week calcium supplementation period and an 8-week control period . The subjects were given 25 mmol/day ( 1 g/day ) of calcium as calcium carbonate during the intervention period . Setting A hypertension clinic in a tertiary teaching hospital . Patients Sixty untreated or treated hypertensive patients ( 35 men and 25 women , mean age 58 years ) with office systolic/diastolic blood pressure ≥ 140/90 mmHg . Main outcome measures Office blood pressure , home blood pressure ( last 7 days ) , and ambulatory 24 h blood pressure ( every 30 min using TM-2421 ) . Results The serum calcium concentration and urinary calcium excretion increased significantly with calcium supplementation . Office , home and 24 h blood pressure were lower in the calcium period than in the control period , although the differences were small ( mean ± SEM office blood pressure : 1.2 ± 1.2/1.1 ± 0.7 mmHg ; home blood pressure : 1.9 ± 0.7/1.3 ± 0.6 mmHg ; 24 h blood pressure : 1.2 ± 0.8/0.9 ± 0.5 mmHg , ) , and significant only for home systolic and diastolic blood pressures . The difference in home systolic blood pressure was inversely correlated with the level of home blood pressure in the control period and with the difference in urinary calcium . The difference in 24 h systolic blood pressure was positively correlated with the control level of urinary calcium . Age , sex , antihypertensive medication , drinking habit , sodium intake or order of treatment did not significantly influence the effects of calcium supplementation . Conclusions An increase in calcium intake tends to lower office , home and ambulatory blood pressure in hypertensive patients . However , the antihypertensive effect is too small to support the general application of a high calcium intake in the treatment of hypertension",
"& NA ; This industry‐based r and omized study compared the effects of behavioral treatment ( BT ) and blood pressure monitoring ( BPM ) on blood pressure ( BP ) change in 158 unmedicated persons with mild hypertension ( diastolic blood pressure 90 to 104 mm Hg ) . Participants recruited by a three‐stage screening were r and omly assigned to BT or BPM groups and stratified by entry diastolic blood pressure ( DBP ) , age , and sex . BT participants received relaxation training , with or without the addition of biofeedback , cognitive restructuring , and health behavior change components . During the study , all participants were followed by their usual care physicians and received medical advice . At 18 weeks into the study , after the BT groups completed training , both the BT and BPM groups showed significant reductions in systolic blood pressure ( SBP ) and DBP assessed in the company medical clinic ( 7.4 and 9.0 mm Hg SBP and 4.5 and 5.9 mm Hg DBP , respectively ) . These reductions were maintained throughout the 36‐week follow‐up period . Reductions in BP assessed at the participants ' worksite were similar for BT and BPM participants throughout most of the trial , indicating little advantage to the inclusion of behavioral interventions over monitoring alone . Differences in BP changes observed among participants receiving various combinations of behavioral treatment components indicated that the cognitive restructuring component reduced SBP in the worksite by an additional 5.4 mm Hg ( p less than 0.05 ) . Possible explanations for the BP changes observed in the BPM group and implication s of the results for the treatment of unmedicated mild hypertensives are discussed",
"OBJECTIVES To evaluate if magnesium alters blood pressure in hypertensive patients treated with beta blockers and if such effect can be coupled to a change in potassium and magnesium levels in muscle , serum and urine . DESIGN A r and omized double-blind , cross-over study with magnesium and placebo taken orally , each for 8 weeks . SETTING Outpatient clinic , University Hospital , Umeå , Sweden . SUBJECTS Thirty-nine patients aged 26 - 69 years with moderate essential hypertension , treated before entry and during the study with continuous , unchanged beta blockers completed the study . INTERVENTIONS R and om allocation to receive magnesium aspartate or placebo . Daily magnesium dose was 15 mmol ( 365 mg ) distributed three times a day over 8 weeks . MAIN OUTCOME MEASURES Blood pressure , serum , urine and muscle magnesium and potassium . Measurements performed at the start , after 8 and 16 weeks . RESULTS Systolic supine and st and ing blood pressure significantly decreased when magnesium was supplemented following placebo but not when magnesium was given at start . When magnesium and placebo groups were independently compared there was no significant change in supine and st and ing systolic and diastolic pressure . Serum and urine magnesium and serum potassium were significantly higher after magnesium treatment , whilst no change was present in urine potassium or in muscle magnesium and potassium . CONCLUSIONS This study showed that 15 mmol magnesium day-1 given to mild to moderate hypertensive patients treated with beta blockers could be the cause of a significant decrease in supine and st and ing systolic blood pressure",
"Both experimental and epidemiological studies support the idea of magnesium supplementation in essential hypertension . We added 15 mmol Mg to a free diet in 71 subjects with mild essential hypertension or a high-normal blood pressure in a double-blind , placebo-controlled study over 6 months . The treatment , which raised urinary magnesium excretion 30 % , induced no general effects on the blood pressure . However , when the changes in blood pressure in the actively treated group were related to the pretreatment magnesium status , a correlation was found between pretreatment urinary magnesium excretion and the induced change in supine blood pressure ( P less than .05 ) with a blood pressure reduction in subjects with a low pretreatment urinary excretion of magnesium , and a pressor effect in the subjects with the highest pretreatment levels of urinary magnesium . The induced change in blood pressure was furthermore found to be inversely correlated to the changes in serum magnesium and urinary excretion of sodium ( P less than .03 ) induced by treatment indicating that both a direct calcium antagonist action of magnesium at the cellular level as well as a diuretic effect of the increased magnesium load might be involved in the blood pressure effects of magnesium . Pretreatment serum potassium concentration also appeared to be a predictor of the induced change in st and ing blood pressure ( P less than .03 ) . In conclusion , magnesium supplementation does not seem to be effective in unselected mild hypertensive subjects or in subjects with a high-normal blood pressure and can therefore not be generally recommended . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Overweight patients with uncomplicated essential hypertension were followed up biweekly for six months : 24 not receiving antihypertensive-drug therapy ( Group I ) and 83 on regular but inadequate ( despite drug manipulation ) antihypertensive-drug therapy ( Group II ) . All patients in Group I and 57 r and omly selected patients from group II ( IIa ) participated in a weight-reduction program . The remaining 26 from Group II ( IIb ) did not receive a dietary program . Salt intake was in the normal range in all three groups . All patients on the dietary program lost at least 3 kg ( mean , 10.5 kg ) , and all but two showed a meaningful reduction in blood pressure ; 75 per cent of Group I and 61 per cent of Group IIa returned to normal blood pressure . The weight and blood-pressure reductions were highly significant ( P less than 0.001 ) , were present in both sexes and all ages , and were directly associated . In Group IIb , no significant change in blood pressure or weight occurred ( P greater than 0.30 )",
"Few studies of psychological interventions for essential hypertension have incorporated comprehensive coping skills treatment programs , evaluated the efficacy of such programs against credible , minimally effective controls , examined the effects of these interventions on pressor responses , or clarified the nature of person by treatment interactions . The present study examined the relative effectiveness of multimodal stress management training and a minimally effective treatment control ( i.e. GSR biofeedback training ) in the treatment of essential hypertensives ' blood pressure at rest and in response to simulated stressful interpersonal situations . At the conclusion of an 8 week training period , stress management participants exhibited reliably lower resting diastolic blood pressure and tended to exhibit lower systolic pressure than controls . The former condition maintained their lower pressures through a 6-month follow-up period , but decreases in controls over follow-up rendered the conditions equivalent in blood pressure . No differences between conditions emerged in analyses on pressor responses . Stress management training was somewhat more effective for individuals scoring low rather than high on measures of trait anxiety and irritability",
"OBJECTIVE To assess the long-term effects of a prepackaged , nutritionally complete , prepared meal plan compared with a usual-care diet ( UCD ) on weight loss and cardiovascular risk factors in overweight and obese persons . DESIGN In this r and omized multicenter study , 302 persons with hypertension and dyslipidemia ( n = 183 ) or with type 2 diabetes mellitus ( n = 119 ) were r and omized to the nutrient-fortified prepared meal plan ( approximately 22 % energy from fat , 58 % from carbohydrate , and 20 % from protein ) or to a macronutrient-equivalent UCD . MAIN OUTCOME MEASURES The primary outcome measure was weight change . Secondary measures were changes in blood pressure or plasma lipid , lipoprotein , glucose , or glycosylated hemoglobin levels ; quality of life ; nutrient intake ; and dietary compliance . RESULTS After 1 year , weight change in the hypertension/dyslipidemia group was -5.8+/-6.8 kg with the prepared meal plan vs -1.7+/-6.5 kg with the UCD plan ( P type 2 diabetes mellitus group , the change was -3.0+/-5.4 kg with the prepared meal plan vs -1.0+/-3.8 kg with the UCD plan ( P blood pressure , total and low-density lipoprotein cholesterol levels , glycosylated hemoglobin level , and quality of life ( P glucose level was reduced ( P UCD group , participants with hypertension/dyslipidemia in the prepared meal plan group showed greater improvements in total ( P high-density lipoprotein ( P cholesterol levels , systolic blood pressure ( P and glucose level ( P participants with type 2 diabetes mellitus , there were greater improvements in glucose ( P = .046 ) and glycosylated hemoglobin ( P quality of life ( P compliance ( P UCD group . CONCLUSIONS Long-term dietary interventions induced significant weight loss and improved cardiovascular risk in high-risk patients . The prepared meal plan simultaneously provided the simplicity and nutrient composition necessary to maintain long-term compliance and to reduce cardiovascular risk ",
"There is evidence that inclusion of high fiber foods such as oats , fruits and vegetables in the diet can decrease fat intake and modulate blood lipids . To test this hypothesis , 61 group A and 59 group B patients with essential hypertension were administered guava fruit preferably before meals in a foods-to-eat approach rather than foods-to-restrict , in a r and omized and single-blind fashion for 12 weeks . At entry into the study , mean age , male sex , mean body mass index , percentages of risk factors and mean levels of blood lipids were comparable between groups A and B. Adherence to guava consumption was assessed by question naires and weighing of guava intake by 24-hour recall after 12 weeks of follow-up . Nutrient intakes including saturated and total fat were significantly decreased ; carbohydrates , total and soluble fiber and vitamins and mineral intakes were significantly higher in group A than in group B at 12 weeks . There was a significant net decrease in serum total cholesterol ( 9.9 % ) , triglycerides ( 7.7 % ) and blood pressures ( 9.0/8.0 mm Hg ) with a significant net increase in high-density lipoprotein cholesterol ( 8.0 % ) after 12 weeks of guava fruit substitution in group A than in group B. By adding moderate amounts of guava fruit in the usual diet , changes in dietary fatty acids and carbohydrates may occur , providing significant amounts of soluble dietary fiber and antioxidant vitamins and minerals without any adverse effects . There is a greater decrease in lipoprotein metabolism and blood pressures",
"Background Psychologic stress has been associated with the development of hypertension . Aerobic exercise training appears to decrease cardiovascular responses to psychologic stress . Objective To determine the efficacy of low-intensity and moderate-intensity exercise training in reducing blood pressure and cardiovascular responses to stress . Design We sought to compare the cardiovascular responses to a psychologic stressor , the Stroop Color Word Task ( Stroop ) , before and after 12 weeks of low-intensity ( about 45 % maximal oxygen uptake ) and moderate-intensity ( about 75 % maximal oxygen uptake ) aerobic exercise training . Methods Eighteen borderline hypertensive subjects ( resting blood pressure 139 ± 9/92 ± 9 mmHg ) were divided r and omly into three groups : control ( no exercise ) , low-intensity exercise ( 40 - 50 % maximal oxygen uptake ) , and moderate-intensity exercise ( 70 - 80 % maximal oxygen uptake ) . Training groups exercised three times per week at the prescribed exercise intensity . Heart rate and blood pressure were recorded during the Stroop before , and after 4 and 8 weeks of exercise training . Results In the low-intensity exercise group , exercise training attenuated mean blood pressure , systolic blood pressure , and diastolic blood pressure responses to the Stroop and decreased resting blood pressure . The moderate-intensity exercise group demonstrated a reduced diastolic blood pressure response to the Stroop . Conclusions These results suggest that , in borderline hypertensive humans , 12 weeks of aerobic exercise training attenuates the cardiovascular responses to the Stroop . Furthermore , low-intensity exercise training appears to a more effective stimulus than moderate-intensity exercise training in reducing resting blood pressure and blood pressure responses to stress",
"Alcohol consumption has been recognized as an important correlate of blood pressure in many epidemiologic studies , but few interventional studies have been conducted to examine the effect of a reduction in alcohol intake on blood pressure . Because these studies have usually included few subjects and been of short duration , the National Heart , Lung , and Blood Institute ( NHLBI ) , the National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) , and the Veterans Affairs ( VA ) Cooperative Studies Program have initiated a r and omized , controlled , multicenter trial to determine whether blood pressure and left ventricular mass are lowered over 6 months of alcohol moderation in non-dependent moderate to heavy drinkers ( three or more drinks per day average but not alcohol dependent ) with above-average normal ( 80 to 89 mm Hg ) and mildly hypertensive ( 90 to 99 mm Hg ) levels of diastolic blood pressure , and whether a reduction in alcohol intake can be maintained for 2 years . Eligible veterans are r and omized to either an alcohol reduction intervention or a control observation group at seven clinical sites . The projected sample size is 580 participants . Alcohol intake is assessed by self-report using a retrospective diary ( Chronological Drinking Record ) and by various biochemical markers , including apolipoproteins , HDL cholesterol ( and subfractions ) , and carbohydrate deficient transferrin , analyzed at a central laboratory . The alcohol intervention technique is a cognitive-behavioral program , the intensive phase of which consists of six counseling sessions over 3 months . Echocardiograms are obtained at baseline and 6 months after r and omization . This trial has important implication s for both the prevention and treatment of hypertension",
"In several trials , a blood pressure lowering effect of potassium chloride could be demonstrated . However , it is not known if other potassium salts are also effective . In a r and omized cross-over trial , 12 patients with essential hypertension were treated for 8 weeks with placebo and 120 mmol potassium per day . Potassium was given together with 50 % citrate and 50 % bicarbonate as anions . Urinary potassium excretion rose from 61.8 + /- 8.1 to 166.7 + /- 21.2 mmol/24 hours during potassium supplementation . However , blood pressure and heart rate remained unchanged when compared to placebo . Non-chloride potassium salts may not be effective in lowering blood pressure in essential hypertension . Since potassium rich foods like fruits and vegetables contain potassium mostly as non-chloride salts , it appears to be premature to recommend a high dietary potassium intake as a mean to treat elevated blood pressure",
"BACKGROUND Even though the effectiveness of mediation and relaxation skills is controversial in blood pressure control , extensive field studies are limited . A national study targeting 50 communities r and omly selected from northern Taiwan was conducted to test and compare the effectiveness of hypertension control incorporating three strategies . METHODS Five hundred ninety hypertensives identified from 3,128 adults at a screening survey among the 50 communities were invited to participate in the study and were r and omly assigned to three treatment modalities , ( a ) relaxation techniques training at home , ( b ) routine blood pressure measurement by a health professional , and ( c ) reading self-learning packages , or to a control group . RESULTS After a 2-month intervention period , the three treatment groups showed a significant reduction in systolic blood pressure levels compared with the control group ( 11.0 mm Hg for group 1 , 9.2 mm Hg for group 2 , and 5.1 mm Hg for group 3 ) . The relaxation group had the most significant reduction in systolic blood pressure levels , followed by the routine blood pressure monitoring group and the self-learning group . However , the effect of relaxation training at home was not significantly greater than routine blood pressure measurement by a health professional",
"OBJECTIVES To evaluate the effects on blood pressure , lipid profile , and anxiety status on subjects received a 12-week Tai Chi Chuan exercise program . DESIGN R and omized controlled study of a Tai Chi Chuan group and a group of sedentary life controls . SETTING Taipei Medical University Hospitals and University campus in the Taipei , Taiwan , area . SUBJECTS Two ( 2 ) selected groups of 76 healthy subjects with blood pressure at high-normal or stage I hypertension . INTERVENTION A 12-week Tai Chi Chuan exercise training program was practice d regularly with a frequency of 3 times per week . Each session included 10-minute warm-up , 30-minute Tai Chi exercise , 10-minute cool-down . Exercise intensity was estimated to be approximately 64 % of maximal heart rate . OUTCOME MEASURES Blood pressure , lipid profile and anxiety status ( State-Trait Anxiety Inventory ; STAI ) were evaluated . RESULTS After 12-weeks of Tai Chi training , the treatment group showed significant decrease in systolic blood pressure of 15.6 mm Hg and diastolic blood pressure 8.8 mm Hg . The serum total cholesterol level decreased 15.2 mg/dL and high-density lipoprotein cholesterol increased 4.7 mg/dL. By using STAI evaluation , both trait anxiety and state anxiety were decreased . CONCLUSIONS This study shows that under well- design ed conditions , Tai Chi exercise training could decrease blood pressure and results in favorable lipid profile changes and improve subjects ' anxiety status . Therefore , Tai Chi could be used as an alternative modality in treating patients with mild hypertension , with a promising economic effect",
"Although aerobic exercise training and diet-induced weight loss each have been shown to individually lower elevated blood pressure ( BP ) , it is currently not known whether their combined use produces an additive antihypertensive effect . In this r and omized clinical trial we therefore compared the effect on resting BP of exercise training only and dietary modification only with that of exercise training plus dietary modification in 55 sedentary , overweight patients with high normal BP or stage 1 or 2 hypertension . After baseline testing , patients were r and omized to 1 of the following 3 interventions for 12 weeks : exercise training only ( aerobic exercise ; 30 to 45 minutes ; 3 to 5 days/week ; 60 % to 85 % of maximal heart rate ) , dietary modification only ( aim ed primarily at weight loss via restriction of energy intake and dietary fat ) , or exercise training plus dietary modification . Forty-eight patients completed the study . In these patients , exercise training plus dietary modification elicited a greater reduction ( p body weight ( -7.1 + /- 2.9 vs -1.0 + /- 1.8 kg ) than exercise training only , and a greater increase ( p maximal oxygen uptake ( 4.3 + /- 2.6 vs 1.9 + /- 2.0 ml/kg/min ) versus dietary modification only . However , the reduction in BP with exercise training plus dietary modification ( -12.5 + /- 6.3/7.9 + /- 4.3 mm Hg ) did not differ significantly from that with exercise training only ( -9.9 + /- 6.4/5.9 + /- 4.6 mm Hg ) or dietary modification only ( -11.3 + /- 12.1/7.5 + /- 4.3 mm Hg ) . These data indicate that the antihypertensive effects of exercise training and diet-induced weight loss are not additive . This finding has important public health and clinical implication s for the millions of overweight persons with high normal BP or stage 1 or 2 hypertension ",
"Objective To assess whether lifestyle counselling is effective in non-pharmacological treatment of hypertension in primary health care . Design Open r and omized controlled trial . Setting Ten municipal primary health care centres in eastern Finl and . Patients Seven hundred and fifteen subjects aged 25–74 years with systolic blood pressure 140–179 mmHg and /or diastolic blood pressure 90–109 mmHg or antihypertensive drug treatment . Interventions Systematic health counselling given by local public health nurses for 2 years . Main outcome measures Blood pressure , lipids and lifestyle data were collected annually . Results Among participants with no antihypertensive drug treatment , the net reductions after 1 year both in systolic blood pressure [ −2.6 mmHg ; 95 % confidence interval ( CI ) , −4.7 to −0.5 mmHg ] and in diastolic blood pressure ( −2.7 mmHg ; 95 % CI , −4.0 to −1.4 mmHg ) were significant in favour of the intervention group . This difference in blood pressure change was maintained during the second year . In participants with antihypertensive drug treatment , no significant difference in blood pressure reduction was seen between the groups during the study . Conclusions A relatively modest , but systematic counselling in primary health care can , at least among untreated hypertensive subjects , produce reductions in blood pressure levels that are modest for the individual , but very important from the public health point of view",
"One hundred and one patients , 70 experimental and 31 controls , with a diagnosis of essential hypertension , were examined for the effects of group relaxation training and thermal biofeedback on blood pressure and on other psychophysiologic measures : heart rate , forehead muscle tension , finger temperature , depression , anxiety , plasma aldosterone , plasma renin activity , and plasma and urinary cortisol . Eighty percent of the participants were medicated . Treatment yielded a short-term success rate , defined as a decrease in mean arterial pressure of 5 mm Hg , of 49 % in the experimental group . Other significant short-term changes included a reduction of forehead muscle tension , state anxiety , plasma aldosterone , and increased finger temperature . Follow-up measurements were made approximately 10 months after treatment in 36 patients , 51 % of the treatment completers . Twenty of the 36 were short-term treatment failures , while 16 were treatment succeeders . Thirty-seven percent of the short-term succeeders continued to meet blood pressure criterion at follow-up . In short-term succeeders , continued practice of relaxation may influence long-term maintenance of decreased blood pressure . It is suggested that group relaxation training can be beneficial for short-term and long-term adjunctive treatment of essential hypertension in selected individuals",
"Mild essential hypertensive patients comprise a large portion of the hypertensive population . Previous reports have shown that moderate-intensity regular exercise training in these patients usually reduces blood pressure . By design ing programmed exercise to evaluate whether it is effective in reducing blood pressure in mild hypertensive patients and also has beneficial effects on other biochemical parameters . Twenty-three mild hypertensive Taiwanese patients ( resting blood pressure 139.1±11.4/99.5±8.0 mmHg ) were divided r and omly into two groups : control ( no exercise ) and moderate-intensity exercise ( average 6.4±0.7 METs ) . The training group exercised three times per week at the prescribed exercise intensity by using the Treadmill exercise test . Blood pressure , heart rate and other biochemical parameters were monitored regularly every 4 weeks for 12 weeks . After 12 weeks regular exercise training , the exercise group showed for significant resting blood pressure reduction . Mean maximal reduction of systolic pressure was 18 mmHg . Significant reduction of total cholesterol , low-density lipoprotein cholesterol ( LDL-C ) and triglyceride were found ; elevation of high-density lipoprotein cholesterol ( HDL-C ) was also noted . These data suggest that after 12 weeks of exercise training in mild hypertensive patients , successful reduction of blood pressure and favorable changes of lipid profile will be noted",
"The aim of the study was to test the effect of a non-pharmacological weight reduction program on cardiovascular risk factors among overweight hypertensives in a primary health care setting . Forty-nine overweight hypertensive patients completed the 12-month program . The patients were r and omly allocated into either intervention or control groups . The examinations included interviews by a nutritionist , pertinent laboratory tests , and a medical examination . The intervention involved an individually planned energy-restricted diet of 1000 - 1500 kcal per day , weekly discussion s , and various leaflets on diet modification and on increase of physical activity . The mean body weight was reduced by 5 kg in the intervention group , but remained unchanged in the control group . The intervention group reduced their fat intake by 14 g/day while the control group increased it by 9 g/day on the average . In the intervention group , the total serum cholesterol decreased , HDL-cholesterol increased and triglycerides decreased significantly . The systolic blood pressure fell by 8 mm Hg and 15 mm Hg in the intervention and control groups , respectively . The diastolic blood pressure fell on average by 11 mm Hg in both groups . The results demonstrate the comprehensive weight reduction program to be effective in the control of cardiovascular risk factors",
"To study the effects of long-term , home-based exercise on physical fitness and cardiovascular risk factors of middle-aged nonsmoking males , a controlled study was conducted in 61 sedentary Swiss men . Thirty-nine men were r and omly allocated to jog 2 h/week for 4 months on an individually prescribed and heart-rate-controlled basis , whereas 22 men served as controls . Despite varying adherence to the exercise regimen , the 4-month net change ( effect in exercise group minus effect in control group ) in estimated endurance capacity was significant and positive . Net changes in arterial blood pressure , measured with a r and om-zero device , were nonsignificant , but after exclusion of low-normotensive men ( n = 19 ) from analysis , a significant net effect of exercise on diastolic blood pressure was seen ( -4.3 mmHg ; p = .048 ) . The following net changes in serum lipid levels occurred : HDL cholesterol + 0.12 mmol/l ( p = .028 ) , total triglycerides -0.21 mmol/l ( ns ) , HDL-C/total cholesterol ratio + 0.02 ( p = .047 ) . Exploratory analyses revealed that an increase in estimated endurance capacity was associated with a rise in systolic and diastolic blood pressure ( r = 0.49 and 0.43 , respectively ; p less than 0.01 both ) . Changes in the waist-hip ratio were directly related to the change in diastolic blood pressure ( r = 0.27 ; p less than 0.05 ) . Multivariable analysis indicated that much of the beneficial effect of exercise on diastolic blood pressure was apparently mediated through a decrease in body fat . This study confirms that individually prescribed jogging can reduce cardiovascular risk factors in self-selected nonsmoking males . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Two-hundred- and -twelve untreated subjects ( mean age 52.3 + /- 0.8 years ; 181 males and 31 females ) with a diastolic blood pressure between 90 and 100 mmHg were recruited to the study . Subjects were seen fortnightly and , after 4 pre-diet visits , were r and omized into a normal diet group ( A , 55 subjects ) , a high-potassium diet group ( B , 52 subjects receiving greater than 100 mmol K+/day ) a reduced-sodium diet group ( C , 52 subjects receiving 50 - 75 mmol Na+/day ) or a high-potassium and low-sodium diet group ( D , 53 subjects receiving same Na+ and K+ as groups B and C ) . Two-hundred subjects completed the diet phase of 12 weeks . Urine sodium fell to 86 + /- 7 mmol/day in group C and 73 + /- 6 mmol/day in group D , while daily potassium excretion rose to 96 + /- 5 mmol in group B and 87 + /- 4 mmol in group C. Systolic and diastolic blood pressure fell by 3.8 + /- 1.0 and 1.6 + /- 0.6 mmHg respectively in the normal diet group . The falls in systolic and diastolic blood pressures ( mmHg ) in the diet phase were 7.7 + /- 1.1 and 4.7 + /- 0.7 ( B ) , 8.9 + /- 1.0 and 5.8 + /- 0.6 ( C ) and 7.9 + /- 0.9 and 4.2 + /- 0.7 ( D ) . These falls were all greater than those in the control group on an intention-to-treat analysis ( P less than 0.005 ) but did not differ from each other . Factorial analysis confirmed that the falls in pressure attributable to the low-sodium diet and high-potassium diet were not additive . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE --To establish whether stress management had a larger effect than a control treatment on resting blood pressure , ambulatory blood pressure , and left ventricular mass . DESIGN --A 12 week baseline period of habituation to measurement of blood pressure was followed by r and omisation to either stress management or mild exercise for six months and follow up six months later . SETTING --General practice , district general hospital , and medical school . PATIENTS --Of the 184 patients aged under 60 with mild primary hypertension who entered the baseline habituation period , 88 were excluded because they failed to meet the entry criteria or they withdrew from the study . The remaining 46 men and 50 women underwent treatment . INTERVENTIONS --10 clinical sessions and daily practice at home of either stress management based on relaxation or non-aerobic stretching exercises . Mildly stressful 15 minute interviews before and after treatment . MAIN OUTCOME MEASURES --Diastolic and systolic blood pressure in the clinic and during 12 hours of ambulatory recording , and left ventricular mass measured by echocardiography . RESULTS --The patients ' blood pressure fell during habituation ( systolic pressure from 152 mmHg to 140 mmHg , diastolic pressure from 98 to 93 mm Hg ) , but neither resting nor ambulatory blood pressure was changed by the treatments . Left ventricular mass was also unchanged . Blood pressure rose during the stressful interview , but this rise was reduced by stress management ( systolic pressure rose by 7.4 mmHg before treatment and by 3.7 mmHg after treatment ) . CONCLUSION --Stress management of a type advocated for treating mild primary hypertension is ineffective in lowering blood pressure in patients who are well habituated to measuring blood pressure",
"We examined the interactions between sodium and calcium responsiveness of blood pressure by study ing the effects of calcium supplementation in 46 normotensive and hypertensive subjects who had been previously characterized as salt sensitive or salt resistant on the basis of their blood pressure responses to rapid sodium and extracellular volume expansion and contraction . The calcium supplementation study utilized a placebo-controlled , double-blind , r and omized crossover design . Subjects received calcium carbonate supplementation ( 1.5 g/day ) for 8 weeks or matching placebo , with 2-week placebo lead-in and crossover periods . For the entire group , no significant blood pressure changes were seen with calcium supplementation . When the subjects were separated on the basis of race or prior salt sensitivity , significant differences were seen . Blacks and salt sensitive subjects exhibited a significant ( P blood pressure decrease when compared to their counterparts . Calcium sensitive subjects had significantly ( P plasma renin activity than those not demonstrating a decrease in blood pressure with added calcium . When urinary calcium excretion of subjects previously defined as salt sensitive or salt resistant were compared , the former had significantly ( P calcium excretion values at baseline as well as during the placebo and calcium supplementation periods than did the latter . There were no known differences in dietary calcium intake to account for the striking urinary findings . These observations confirm the heterogeneity of blood pressure response to calcium supplementation and demonstrate congruity between sodium and calcium responsiveness of blood pressure in normal and hypertensive humans . ( ABSTRACT TRUNCATED AT 250 WORDS",
"In a double-blind trial 90 mildly hypertensive subjects aged 16 - 29 years were r and omly assigned to 1 g calcium per day or placebo . Calcium supplementation did not affect systolic blood pressure , but at six and twelve weeks diastolic blood pressure had fallen by 3.1 ( p = 0.04 ) and 2.4 ( p = 0.11 ) mm Hg , respectively , more in the calcium group than it had in the placebo group . Subjects with a baseline plasma parathyroid hormone ( PTH ) higher than the median showed a 6.1 mm Hg ( p = 0.01 ) greater fall in diastolic blood pressure after six weeks and 5.4 mm Hg ( p = 0.01 ) after twelve than in the placebo group . The fall in diastolic blood pressure was greater in the calcium group than in the placebo group in subjects with a lower than median serum total calcium and in those with a large bodyweight . Calcium supplementation may lower blood pressure in young people with mildly raised blood pressure , particularly in those with high plasma PTH and /or low serum total calcium",
"51 patients with mild essential hypertension ( EH ) were r and omly divided into two groups ; the first group ( 31 patients ) was treated with 1 g. of oral calcium during a period of 8 weeks ; the second group received a placebo . The treated with calcium showed a significant decrease in blood pressure ( BP ) , the maximal reduction being of 6 mm Hg in the systolic pressure ( SBP ) and 3 mm in the diastolic ( DBP ) at the end of the 8th week . We found a substantial positive relationship between the decrease in SBP and seric renin activity ( p less than 0.05 ) , as well as a significant negative relationship ( p less than 0.05 ) between DBP and the seric level of parathyroid hormone ( PTH ) . During the administration of the oral calcium supplement , the BP decreased in an inverse proportion to the plasmatic renin and seric level of PTH",
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Influence of populaion sreening on morbidity and mortality of cancr of the uterine cervixin Maribo Amt . DanMd BMBl 1979;26:91 - 100 . 15 Lyage E , Poll P. Incdence of cevical following neptie smear . A cohort study from Manibocounty , Denmark . AmEpideasidin p .s ) . 16 Berget A , Mailer KA , Ol1sen JL Poll P. esrnigfor cervical crioain Maribo Amt 1971 - 1975 . DaxnMedBull 1978;2S:232 - 4 . 17 Norwegian Cancer Society . Mass saenmg fr canwff of sinetaramn cervixmi Oszfold cmmxgy 19591965 . Report No 1 . Oslo : Norwegian Cancer Society , 1967 . 18 Pedersen E , Hoeg K , Kolstad P. Mmassceeningforcanceroftheuterinecervix in Ostfold county , Norway : an experiment . Second report of the Norwegian Cancer Society . Acta Obstea Gynecol Sc and [ Suppl ] 11 , 1971 . 19 Ho'ugen A. Mms screening for cafice of the uternDe cervix in the county of Ostfold , Norway . In : Nieburgs HE , ed . Prevention and desecion ofcancer . New York : Marcel Dekker , 1980:1875 - 84 . 20 Stenkvist B , BergstromR , Ekhund G , FoxCH . Papanicolaou smnearscreening and cervical cancer . What can you expect?_JAmMedAssw 1984;252:1423 - 6 . 21 Pettersaon F , Bj6ekbhol E , Nislund I. Evaluatio of the effect of Papnmcolaou screening in Sweden.2 . Trends in incidence and mmortalt for cancer of the uterine cervix in Sweden 1958 - 1980 . IntyjEpikdeaia(inpress ) : 22 Raymond L , Obradovic M , Riotton G. Une 6tude csa-tenxina pour 1'6valuation du depistag cytologique du cancer du col uterin . RevEpidemiolSantePubique 1984;32:10 - 5 . 23 Berrino F , GattaG , D'alto M , Crosignani P , Riboli E. Efficacy fsreeningimpreventinginvasive cervical cancer . A case-control study carried outin Milan , Italy . In : HakamoaM , MiIIerAB , Day NE , eds . Screexingfor cervical cancer . Lyon : International Agency for Research on Cancer ( in press ) . ( IARC Scientific Publications , No 76 . ) 24 Clarke EA , And erson TW . Does screeningby \" Pop \" smearshelp prevent cervsia cancer ? Acasecontrol study . Lances 1979;ii:14 . 25 Hakama M , Day NE , MilkerAB , eds . Sreenmgfor cervi ~ cawaner.-Lyon : International Agencyfor Research on Cancer(inprea ) . ( LARC Scientific Publicanons , No. 76 . ) 26 Day NE , Walter SD . Siniplsfied modelsforscreening : estimation procedures fiommass screening programmres . Biometrics 1984;40:1 - 14 . 27 Brookmeyer R , Day NE , Mosa S. Case-contrxotatuidies for the estimation of the natural history of precdinicaf disease from screening data . StauMed IM8S:127 - 38 .28 Store BE , Wachoklder 5 , BreslowNE . Maximum likelihood flttingofgeneralrelative risk models to stratified data . AppliedStastst 1983;32:172 - 81 . 29 LaVecchia C , Franceschi5 , Decali A , FasoliM , GentileA , TognoniG. \" Pap \" smear and the risk of cervical neoplasia : quantitative estimates from a case-control study . Lances 1984ssi779 - 82 . 30 Aristizabal N , Cuello C , Correa P , Collaxos T , Haenszel W. The impact of vaginal cytology on cervical cancer rinks in Cali , Colombia . I1u4 Cancer 1984;34:5 - 9 . 31 Hakama M. Trends in theincidenceofcervica cancerin the Nordic cotunties . In : Magnus K , ed . Trends in cancer inciene . Washington : Hemisphere , 1982:279 - 92",
" Fifty-two pharmacologically treated hypertensive patients were r and omized to one of four treatment groups : ( 1 ) diastolic blood pressure biofeedback , ( 2 ) progressive deep muscle relaxation training , ( 3 ) self-directed relaxation training , or ( 4 ) medication alone . Data collection occurred during baseline , treatment , and 1-year follow-up phases in a laboratory , a medical clinic , and the patient 's own home . Patients from all four groups combined showed mean blood pressure reductions of −10.2/−5.5 mm Hg on clinic recordings and −2.4/−.7 mm Hg on home recordings , which were maintained throughout the follow-up period . There were no significant differences among the four groups in terms of blood pressure reduction . Patients given adjunctive behavioral treatment showed significantly larger reductions in medication usage compared to patients treated with medication alone , but there were no significant differences among the three behaviorally treated groups . Patients who showed medication reductions did not show subsequent blood pressure elevation . The results suggest that combined behavioral and pharmacological therapy may be superior to pharmacological therapy alone in the treatment of essential hypertension",
"The present study set out to assess the feasibility of long-term moderate dietary sodium restriction in patients with mild hypertension in general practice . After screening and a run-in phase of 6 - 8 weeks , a total of 77 previously undiagnosed mildly hypertensive patients were identified . Half of them were r and omized to receive a few simple dietary instructions from their general practitioners in order to reduce salt usage ; the others were r and omized to receive no advice . The patients were followed up for 12 months with quarterly visits . A total of 56 patients ( 72.7 % ) completed the study , 26 on a low-sodium diet ( LD ) and 30 on their usual diet ( UD ) . At each visit in the diet phase , patients provided 24h urine , which was analysed for volume and sodium concentration in order to assess their sodium intake . Blood pressure , heart the rate and body weight were recorded . The mean urinary sodium excretion for all diet phase visits overlapped in the two groups ( 177.0 + /- 32.9 vs. 169.3 + /- 49.4 mEq/24h respectively in the LD and UD groups ) . Nevertheless the mean systolic and diastolic blood pressures for all diet phase visits were significantly lower in the LD than in UD group ( 144.2 + /- 11.1/91.6 + /- 6.4 and 148.0 + /- 13.7/95.6 + /- 4.7 mmHg respectively , P less than 0.01 ) . Our data suggest that it is not feasible at present to reduce sodium intake in mild hypertensives with simple and inexpensive dietary instructions , the only ones suitable for widespread application in general practice",
"& NA ; In this industrial‐based study we compared the blood pressure (BP)‐lowering effectiveness of relaxation , a beta blocker , and the combined use of these two treatments in 47 untreated , mildly hypertensive blue collar steel workers . Using a r and omized two by two factorial design , patients received either nadolol or placebo drug daily , and either a relaxation training or an education program , each lasting 8 weeks . A pre‐intervention and post‐intervention stress test measured response of heart rate and BP to mental and physical tasks . BP assessment s were done at baseline , post‐intervention , 1 month , and 3 month follow‐up . Change in several self‐report measures was determined . Results showed that beta blocker was more effective in lowering BP than placebo , but relaxation was not more effective in lowering BP than health education . The combined effect of beta blocker and relaxation was not superior to beta blocker alone . Compliance with relaxation practice was not superior to compliance with medication . We conclude that pharmacologic treatment is superior to the relaxation therapy tested",
"In a double-blind , r and omized , placebo-controlled , crossover trial , 23 middle-aged patients with mild to moderate essential hypertension were given an oral calcium supplement ( 1 g/day ) for 8 weeks . At the end of this period , eight patients continued with this treatment for an additional 2 weeks but were also given 0.5 micrograms/day of 1,25-(OH)2 vitamin D3 . In the 21 patients who completed the study , arterial pressure during the calcium-supplemented phase was almost identical to that of the placebo phase . In eight patients , mean arterial pressure ( MAP ) had changed by greater than 5 mmHg at the end of the calcium-supplemented period , compared with the end of the placebo phase ( six patients showed an increase in MAP and two a decrease ) . Changes in arterial pressure were unrelated to age , plasma ionized calcium , parathyroid hormone ( PTH ) , plasma renin activity ( PRA ) , plasma aldosterone , 24-h urinary calcium , sodium and potassium and were only weakly related to body weight . In the eight patients who continued with the treatment of calcium plus 1,25-(OH)2 vitamin D3 after the 8-week study period , arterial pressure changed very little and not significantly . These results do not support the suggestion that calcium supplements lower arterial pressure in middle-aged subjects with mild to moderate essential hypertension",
" Thirty-two male and female hypertensives , 34 to 65 yr of age , systolic blood pressure ( SBP ) less than 200 mmHg and diastolic blood pressure ( DBP ) between 90 and 109 mmHg , were r and omly allocated to receive either relaxation and stress management ( experimental condition ) or mild physical exercise ( control condition ) . Half the participants were taking antihypertensive drugs , which were constant for six months prior to the study and controlled during the study . Outcome measures included various measures of blood pressure in the clinic and at home , cardiovascular responsiveness , moods and 24-hr urinary adrenaline and noradrenaline . The study schedule consisted of 3-months baseline , 10 weeks treatment and 3-months follow-up . Relaxation was superior to the control procedure in reducing blood pressure as assessed by nurses blind to the participants ' treatment at post-treatment for DBP and at follow-up for DBP and SBP",
"Abstract Objective : To examine the effect of a reduced sodium and increased potassium and magnesium intake on blood pressure . Design : R and omised double blind placebo controlled trial . Setting : General population of a suburb of Rotterdam . Subjects : 100 men and women between 55 and 75 years of age with untreated mild to moderate hypertension . Interventions : During 24 weeks the intervention group received a mineral salt ( sodium : potassium : magnesium 8:6:1 ) and foods prepared with the mineral salt . Controls received common salt and foods . Main outcome measure : Change in blood pressure . Results - Complete follow up was achieved for 97 of the 100 r and omised subjects . Systolic blood pressure ( mean of measurements at weeks 8 , 16 , and 24 ) fell by 7.6 mm Hg ( 95 % confidence interval 4.0 to 11.2 ) and diastolic blood pressure by 3.3 mm Hg ( 0.8 to 5.8 ) in the mineral salt group compared with the controls , with a 28 % decrease in urinary sodium excretion and a 22 % increase in urinary potassium excretion . Twenty five weeks after the study the difference in blood pressure between the groups was no longer detectable . Conclusion : Replacing common sodium salt by a low sodium , high potassium , high magnesium mineral salt could offer a valuable non -pharmacological approach to lowering blood pressure in older people with mild to moderate hypertension",
" Thirty-five patients with mild to moderate hypertension were r and omised into a three months ' dietary advised and a three months ' control group . The diet was of a composition currently considered to be appropriate , and was monitored by a dietitian . Statistically significant decreases in diastolic blood pressure , mean arterial pressure , sodium excretion , and low density lipoprotein (LDL)-cholesterol occurred in the intervention group , although differences in change between the intervention and the control group were , except for LDL-cholesterol , not statistically significant . Thus , it did not become clear whether and to what extent change in diet was responsible for the lowering of the blood pressure in the intervention group",
"On the basis of medical officers diagnosis , thirty three ( N = 33 ) hypertensives , aged 35 - 65 years , from Govt . General Hospital , Pondicherry , were examined with four variables viz , systolic and diastolic blood pressure , pulse rate and body weight . The subjects were r and omly assigned into three groups . The exp . group-I underwent selected yoga practice s , exp . group-II received medical treatment by the physician of the said hospital and the control group did not participate in any of the treatment stimuli . Yoga imparted in the morning and in the evening with 1 hr/session . day-1 for a total period of 11-weeks . Medical treatment comprised drug intake every day for the whole experimental period . The result of pre-post test with ANCOVA revealed that both the treatment stimuli ( i.e. , yoga and drug ) were effective in controlling the variables of hypertension",
"OBJECTIVE : To examine the effects of a GP exercise referral programme on modifiable coronary heart disease risk factors . DESIGN : R and omised controlled trial . A battery of vali date d measures were carried out at 0 , 8 , 16 , 26 , and 37 weeks . SETTING : Two community health centres and a leisure centre in Hailsham , East Sussex . SUBJECTS : 389 patients ( smokers , hypertensive or overweight ) were selected from medical records , screened for contraindications to exercise and 345 were invited into the study . Of 142 patients r and omly allocated , 40 ( 41 % ) completed the study in the exercise group and 31 ( 69 % ) in the control group . Sixty ( 35 % ) invited smokers ( 48 % of non-smokers ) , 71 ( 38 % ) invited hypertensive patients ( 45 % of non-hypertensive patients ) , and 107 ( 45 % ) overweight patients ( 33 % of non-overweight patients ) were r and omised . Of those r and omised , 27 ( 45 % ) smokers , 52 ( 48 % ) overweight , and 43 ( 61 % ) hypertensive patients completed the study . INTERVENTION : The exercise group was offered 20 , half price sessions over 10 weeks at a leisure centre . Patients engaged in moderate and vigorous aerobic type activity on various exercise machines , in a semi-supervised , informal environment . RESULTS : 87 % of those referred used the prescription and 28 % ( high adherers)(45 % of obese patients ) did at least 15 sessions . The exercise group reduced sum of skinfolds by 8.1 % ( 2.9 to 13.3 , 95 % confidence intervals ) more than the control group , up to 16 weeks after baseline . High adherers reduced sum of skinfolds by 9.2 % ( 0.9 to 17.5 ) more than the control group , up to 26 weeks . High adherers reduced systolic blood pressure by 7.2 % ( -0.7 to 14.9 ) ( that is , 9 mm Hg ) more than low adherers , up to 37 weeks . Non-smokers and obese patients attended more prescribed sessions than smokers and non-overweight patients . CONCLUSIONS : Reduction in sum of skinfolds was maintained up to 26 weeks , among high adherers compared with controls . Reduction in systolic blood pressure was evident up to 37 weeks among high adherers , but only in comparison with low adherers . Selection of appropriate referees and use of other strategies to improve exercise adherence will help to maximise the benefits from GP exercise prescription schemes",
"We conducted a double-blind , placebo-controlled crossover study to determine the effects of fish oil supplementation on blood pressure in middle-aged men . Subjects were r and omly assigned to consume either 20 g of fish oil or safflower oil for 12 weeks and then consume the other oil for an additional 12 weeks after a 4-week washout period . We found no significant changes from the pretreatment value in systolic or diastolic blood pressure with the use of fish oil supplements . In addition , there were no significant differences in the posttreatment blood pressures comparing the fish and safflower oil phases of the study",
"A controlled prospect i ve study compared two groups of obese hypertensive subjects during 12 weeks of a hypocaloric protein-supplemented fast containing 40 mEq of sodium daily . One group received additional sodium chloride sufficient to maintain baseline sodium intake measured prior to the fast ( 210 m/Eq/day ) . Sodium restriction result ed in greater weight loss and slightly greater BP reduction only during the initial week of fasting . Thereafter , despite sodium equilibrium , further substantial weight loss and BP reduction were identical in both groups , the decrement in weight being linear ( 1.89 kg/wk ) and the BP reduction asymptotic . Although the initial reduction in BP during the first week of supplemented fast may be attributable to negative salt and water balance , the further reduction in BP during a period of constant sodium balance must be caused by weight loss per se or by the triggering of other antihypertensive mechanisms associated with weight reduction",
"Thirty-one patients receiving medical treatment for essential hypertension were r and omly distributed into three groups : ( 1 ) relaxation therapy , ( 2 ) nonspecific therapy , and ( 3 ) medical treatment only . The nonspecific therapy group spent the same amount of time with the therapists as the relaxation group but was not given a specific therapy . Blood pressures were measured at a different time and in a different place from the behavioral treatments . The relaxation therapy group showed a significant reduction in blood pressure postreatment compared with the nonspecific therapy and medical treatment only groups , even when those patients whose medication was increased were excluded from the data analysis . At follow-up six months post-treatment , the relaxation group showed a slight decrement in treatment effects , while both the nonspecific therapy and medical treatment only groups showed continued improvement ; thus , there was not a significant difference between groups",
"& NA ; The present study describes a 16‐week trial of the use of a combination of biofeedback and relaxation techniques for the treatment of hypertension . Twenty‐two hypertensive patients were r and omly allocated to one of three groups : ( 1 ) diastolic blood pressure feedback , electromyographic feedback , and verbal relaxation ; ( 2 ) sham blood pressure feedback ; and ( 3 ) no treatment . For the 14 patients completing active treatment during an initial or crossover period , the average changes in blood pressure as measured outside the laboratory were minimal ( 0/−1 and + 1/0 mm Hg , supine and st and ing , respectively ) . Average blood pressure reduction in the laboratory was no greater with active than with sham blood pressure feedback ( −3/−2 vs. −5/−2 mm Hg ) . One subject , however , after showing no change in blood pressure during sham feedback , achieved pronounced and prolonged improvement following active treatment . Overall results do not support the usefulness of these techniques as primary therapy in most hypertensives ",
"STUDY OBJECTIVE To evaluate the effects of omega-3 fatty acids on blood pressure control and lipid levels . DESIGN Double-blind , placebo-controlled , r and omized study . SETTING Veterans Affairs Medical Center teaching hospital . PATIENTS Twenty-one men whose blood pressure was not optimally controlled with antihypertensive agents , who met the inclusion criteria . INTERVENTIONS Patients were r and omized to receive either fish oil ( 4.5 g omega-3 fatty acids/day ) or placebo . MEASUREMENTS AND MAIN RESULTS Blood pressure readings were taken at baseline , and 4 and 8 weeks . Sitting systolic and diastolic blood pressures were significantly reduced in the fish oil group at both week 4 ( 148/97 to 132/90 , p Sitting diastolic blood pressure was significantly reduced in the placebo group at week 8 ( 94 to 88 , p sitting systolic and diastolic pressures at week 8 comparing the placebo group ( -6.4 % and -6.3 % , respectively ) and the fish oil group ( -8.8 % and -6.6 % , respectively ) . Triglyceride levels ( -40.9 % , p platelet counts ( -8.7 % , p low-density lipoprotein ( LDL ) cholesterol levels were significantly increased both at 4 and 8 weeks ( 13.5 % and 19.1 % , respectively ) in the fish oil group . CONCLUSION Adjunctive fish oil supplementation did not substantially augment blood pressure lowering in treated hypertensive men with suboptimally controlled blood pressure . Effects on plasma lipid values were mixed , with an increase in LDL cholesterol and a decrease in plasma triglyceride levels",
"Eighty patients with essential hypertension , stages IIA-IIB , were examined three times : on admission to hospital , and 1 and 12 months later . All patients were subjected to clinical , psychological ( brief multifactorial question naire for examination of a personality and the interpersonal relationships test ) and psychophysiological investigation . The patients were allocated to 3 groups by r and om selection : 30 patients practicing autogenic training ( group 1 ) , 30 patients on relaxation therapy making use of biological feedback ( BFB ) ( group 2 ) , and 20 patients exposed to no psychological influences ( group 3 , or the controls ) . In the presence of psychological treatment , the BP decline , the increase in stress tolerance and the improvement of the psychological status were significantly more marked in the former two groups , as compared to the controls . Comparative assessment of the efficiency of autogenic training and BFB showed no basic differences between the two treatment methods . In cases where treatment proved inefficient , the patients exhibited a negative attitude to treatment and markedly demonstrative character",
"The blood pressure response of 48 hypertensive persons and 32 normotensive persons to elemental calcium ( as the carbonate or citrate salt ) , 1000 mg/d for 8 weeks , was assessed in a r and omized , double-blind , placebo-controlled , crossover trial . Compared with placebo , Ca2 + significantly lowered supine systolic blood pressure by 3.8 mm Hg , st and ing systolic blood pressure by 5.6 mm Hg ( p less than 0.02 ) , and supine diastolic blood pressure by 2.3 mm Hg ( p less than 0.05 ) in hypertensive persons . The response in normotensive persons differed significantly from that in hypertensives ( p less than 0.03 ) as their blood pressure was unchanged . Twenty-one ( 44 % ) hypertensive and 6 ( 19 % ) normotensive persons achieved a reduction in st and ing systolic arterial pressure of 10 mm Hg or greater . Reported adverse effects were similar between calcium and placebo phases and did not necessitate withdrawal of any patient from the trial . Treatment with 1000 mg/d of oral Ca2 + for 8 weeks represents a safe , well-tolerated , nonpharmacologic intervention that lowers blood pressure in selected patients with mild to moderate hypertension",
"BACKGROUND Diet is an essential part of the nonpharmacological management of hypertension . The aim of this study was to investigate in a primary health care setting the effect of intensified diet counseling on the diet of hypertensive subjects . METHODS A total of 715 free-living subjects , ages 25 - 74 years , with systolic blood pressure 140 - 179 mm Hg and /or diastolic blood pressure 90 - 109 mm Hg and /or drug treatment for hypertension participated in an open r and omized trial with a 2-year follow-up at health centers in eastern Finl and . The intervention group ( n = 360 ) was advised to reduce their total fat , saturated fat , and salt intake and to increase monounsaturated and polyunsaturated fat intake as well as to reduce weight and to use alcohol in moderation if at all . The usual care group ( n = 355 ) continued with their usual primary health care . The subjects filled out a 4-day food record , and 24-h urine sample s were collected at baseline and at 1- and 2-year examinations . RESULTS The 2-year net changes ( change in intervention minus change occurring in usual care group ) in total fat intake [ -2.7 E% ( 95 % CI -4.0 , -1.6 ; P saturated fatty acid intake [ -1.7 E% ( 95 % CI -2.3 , -1.1 ; P body weight [ -1.4 kg ( 95 % CI -2.0 , -0.8 ; P daily sodium intake was significant , -9 mmol ( 95 % CI -17 , -2 ; P = 0.021 ) , but the 24-h urinary sodium excretion showed no difference between the study groups . CONCLUSION The intensified diet counseling in primary health care result ed in dietary changes interpreted as being of benefit in the long-term treatment of hypertension and prevention of atherosclerotic vascular diseases",
"OBJECTIVES : Evaluate whether weight-loss diets are more effective than regular diets or other antihypertensive therapies in controlling blood pressure and preventing morbidity and mortality in hypertensive adults . SEARCH STRATEGY : MEDLINE and The Cochrane Library were search ed through November 1997 . Trials known to experts in the field were included through June 1998 . SELECTION CRITERIA : For inclusion in the review , trials were required to meet each of the following criteria : 1 ) r and omized controlled trials with one group assigned to a weight-loss diet and the other group assigned to either normal diet or antihypertensive therapy ; 2 ) ambulatory adults with a mean blood pressure of at least 140 mm Hg systolic and /or 90 mm Hg diastolic ; 3 ) active intervention consisting of a calorie-restricted diet intended to produce weight loss ( excluded studies simultaneously implementing multiple lifestyle interventions where the effects of weight loss could not be disaggregated ) ; and 4 ) outcome measures included weight loss and blood pressure . DATA COLLECTION AND ANALYSIS : Studies were dual abstract ed by two independent review ers using a st and ardized form design ed specifically for this review . The primary mode of analysis was qualitative ; graphs of effect sizes for individual studies were also used . MAIN RESULTS : Eighteen trials were found . Only one small study of inadequate power reported morbidity and mortality outcomes . None addressed quality of life or general well being issues . In general , participants assigned to weight-reduction groups lost weight compared to control groups . Six trials involving 361 participants assessed a weight-reducing diet versus a normal diet . The data suggested weight loss in the range of 4 % to 8 % of body weight was associated with a decrease in blood pressure in the range of 3 mm Hg systolic and diastolic . Three trials involving 363 participants assessed a weight-reducing diet versus treatment with antihypertensive medications . These suggested that a stepped-care approach with antihypertensive medications produced greater decreases in blood pressure ( in the range of 6/5 mm Hg systolic/diastolic ) than did a weight-loss diet . Trials that allowed adjustment of participants ' antihypertensive regimens suggested that patients required less intensive antihypertensive drug therapy if they followed a weight-reducing diet . Data was insufficient to determine the relative efficacy of weight-reduction versus changes in sodium or potassium intake or exercise . REVIEW ER 'S CONCLUSIONS : Weight-reducing diets in overweight hypertensive persons can affect modest weight loss in the range of 3 - 9 % of body weight and are probably associated with modest blood pressure decreases of roughly 3 mm Hg systolic and diastolic . Weight-reducing diets may decrease dosage requirements of persons taking antihypertensive medications",
"OBJECTIVES --To improve blood pressure control among hypertensive ( > 140/90 mmHg ) excessive alcohol drinkers . DESIGN --Fourteen worksite physicians were r and omised onto an intervention group and a control group . The intervention was based on training the worksite physicians and follow up of those hypertensive subjects defined as excessive drinkers . Follow up was based on self monitoring of alcohol consumption by the subject , in view of the results of their gamma glutamyl transferase ( GGT ) activity determination . SETTING --Fourteen workplaces in France - mainly in the industrial sector . SUBJECTS -- Altogether 15 301 subjects were screened by the 14 physicians : 129 of these were included in the study . MAIN OUTCOME MEASURES --This was the difference between the initial systolic blood pressure ( SBP ) and the SBP one year later ( delta BP ) . Secondary criteria were the difference between the initial and final diastolic blood pressure ( delta DBP ) and delta BP at two years ; antihypertensive treatment ; state alcohol consumption ( delta AC ) ; delta GGT ; and body mass index ( delta BMI ) . RESULTS --The decrease in SBP levels was significantly larger in the intervention group than in the control group : at one year , delta SBP values were -11.9 ( 15.6 ) mmHg and -4.6 ( 13.8 ) respectively ( p DBP . The percentage of treated subjects did not differ between groups . At one year , delta AC was larger in the intervention group ( -2.8 ( 5.2 ) U/d ) than in the control group ( -1.6 ( 3.4 ) ( p delta GGT and delta BMI did not differ between the two groups . A weak positive correlation was observed between delta AC and delta SBP ( r = 0.16 ) . CONCLUSION --An intervention aim ed at the hypertensive excessive drinkers in a working population was found to be effective in reducing SBP on a long term basis ( two years ) . The mechanisms of reduction in alcohol consumption and improved drug compliance can not be ascertained in this pragmatic study . From a public health point of view , reducing the excess cardiovascular risk among a \" hard to reach \" population seems feasible with a strategy specifically design ed for this high risk group",
"The potential antihypertensive effects after prolonged use of small doses of fish oils remain undefined . Therefore , we conducted a r and omized , double-blind , controlled crossover study comparing low doses of n-3 fatty acid supplementation with n-6 fatty acids on blood pressure in 33 subjects with mild hypertension . After a 6-week stabilization period , subjects ingested either 2.04 g/d of n-3 fatty acids or safflower oil ( 4.8 g/d of linoleic acid ) for 12 weeks , then crossed over to the alternative encapsulated oil for another 12 weeks , after a 4-week washout period . All antihypertensive drug therapy had been discontinued . For the combined data , there were significant reductions from pretreatment values for supine diastolic ( -2.4 mm Hg ) and sitting systolic ( -4.1 mm Hg ) blood pressure after fish oil ; no significant changes occurred after safflower oil control . Compared with safflower oil , fish oil supplementation was associated with a statistically significant reduction in mean supine diastolic blood pressure of 3.7 mm Hg ( 95 % confidence interval , -7.3 and 0.1 ) . Sitting diastolic and mean arterial pressures showed a sequence effect ; therefore , only the initial period was used in an analysis of their responses . There were significant decreases from pretreatment values for sitting diastolic ( -4.4 mm Hg ) , mean arterial ( -5.1 mm Hg ) , and systolic ( -6.5 mm Hg ) blood pressure after fish oil . The differences between groups after the 12-week period remained statistically significant for sitting diastolic and sitting mean arterial blood pressures . No adverse changes were noted in plasma levels of lipid-related measures",
"Effects of progressive muscle relaxation ( PMR ) and of attention control were investigated in a prospect i ve r and omized trial of borderline or mild hypertensive patients . Both groups received placebo and had the same number of clinic return visits . After 22 weeks the average mean home BP in PMR decreased 3 mm Hg , whereas in controls BP increased 2 mm Hg . Progressive muscle relaxation had no significant effect on the clinic BP . The response to PMR was not uniform . Responders were characterized by faster heart rates and higher plasma norepinephrine levels . The responders also showed a decrease of anxiety scores during the trial . Progressive muscle relaxation is a time-consuming procedure . Blood pressure responses do not substantially exceed the placebo effects in unselected patients . However , relaxation may be suitable for young , anxious patients with mild hypertension who have a high resting sympathetic tone ",
"Twenty-one patients with essential hypertension were r and omly allocated to eight 1-hour sessions of meditation training , meditation plus biofeedback-aided relaxation , or a no-treatment control group . Statistically significant falls in systolic and diastolic blood pressure occurred after both training programs , although overall reductions in blood pressure were not significantly greater in either program than in the control group . Meditation plus biofeedback-aided relaxation produced falls in diastolic blood pressure earlier in the training program than did meditation alone . All patients practice d meditation regularly between training sessions : The amount of practice did not correlate with the amount of blood pressure reduction after training . On question naire measures of psychological symptoms and personality , sex differences emerged , with females showing significant abnormalities in hostility scores and males showing significantly raised levels of somatopsychic symptoms . In females , outward-directed hostility fell significantly and assertiveness increased after training , but in males , somatopsychic symptoms were unchanged",
"A prospect i ve r and omised trial was carried out to see whether paranormal healing by laying on of h and s might reduce blood pressure in essential hypertension and whether such an effect might be due to a paranormal , psychological , or placebo factor . Patients were r and omised to three treatment groups : paranormal healing by laying on of h and s ( n=40 ) , paranormal healing at a distance ( n=37 ) , and no paranormal healing ( controls ; n=38 ) . Healing at a distance and no paranormal healing were investigated double blind . Systolic and diastolic blood pressures were significantly reduced in all three groups at week 15 ( mean reduction ( 95 % confidence interval ) 17·1 ( 14·0 to 20·2)/8·3 ( 6·6 to 10·0 ) mm Hg ) . Only the successive reductions in diastolic blood pressures among the groups from week to week were significantly different . Each week diastolic pressure was consistently lower ( average 1·9 mm Hg ) after healing at a distance compared with control , but on paired comparison these differences were not significant . Probably week to week variations among the groups accounted for any differences noted . In this study no treatment was consistently better than another and the data can not therefore be taken as evidence of a paranormal effect on blood pressure . Probably the fall in blood pressure in all three groups either was caused by the psychosocial approach or was a placebo effect of the trial itself",
"Ninety patients with essential hypertension were followed for 5 years . Initially the patients were r and omized into two groups : ( a ) an experimental group consisting of 44 patients who received autogenic training and ( b ) a control group of 46 patients who did not receive any behavioral intervention . By the end of the follow-up period , the experimental group was significantly different from the control group , with reduced blood pressure ( by 5.8 mm Hg systolic and 3.2 mm Hg diastolic vs. 4.3 mm Hg systolic and 2.0 mm Hg diastolic ) , a smaller increase in left-ventricular myocardial mass ( 14.6 g vs. 38.2 g ) , improved psychological indices , and a decrease in the number of sick days of leave . Autogenic training appeared to be more effective in patients with mild hypertension than in those with moderate hypertension and the results were comparable with those obtained with regular medication",
"To see whether general practitioners could effectively carry out training in relaxation and management of stress to reduce mild hypertension a study was carried out with a sub sample of phase 2 of the Medical Research Council 's treatment of mild hypertension trial.1 In the main mild hypertension trial patients had been receiving either an active drug or placebo for six years . In phase 2 a sub sample of these patients were r and omly allocated either to continue or to stop receiving the active drug or placebo . In a further sub sample patients were again r and omised to receive or not to receive relaxation therapy . This factorial design presented an additional opportunity to assess whether patients controlled with active drugs might have their blood pressure maintained by this behavioural therapy once drug treatment was stopped and to assess whether blood pressure might be further reduced by this therapy in patients who had been under regular medical supervision for as long as six years and who had already received non-pharmacological advice . The therapy was conducted by general practitioners in group sessions once a week for eight weeks . The training in relaxation was accompanied by galvanic skin resistance biofeedback . At one year follow up blood pressure in the relaxation subgroups was either maintained ( in the group who had stopped receiving drugs ) or reduced further ( in the group who had continued receiving drugs and in both placebo groups ) , while in the control group it had increased in all the subgroups , but particularly in those who had stopped receiving drugs . Differences in changes in blood pressure between the relaxation and control groups were significant . There were five new cardiovascular events , including evidence of myocardial ischaemia in blindly coded electrocardiograms in the control group , compared with one in the treatment group . General practitioners , if motivated , can successfully apply this technique of training those with mild hypertension in relaxation and management of stress",
"Twenty-one patients with essential hypertension were treated with aerobic ( lactate threshold ) exercise ( n = 21 ) and the change in blood pressure was compared with that in a non-exercising hypertensive control group ( n = 10 ) . After 10 weeks of exercise therapy blood pressure in the exercise group was significantly reduced , from 154 ± 3/100 ± 2 to 141 ± 3/93 ± 3 mmHg , and there was a significant reduction in plasma volume , cardiac index and plasma noradrenaline whereas there were no changes in the non-exercise group . Responders ( 10 mmHg or more fall in mean blood pressure ) in the exercise group had a significantly higher cardiac index , serum Na : K ratio and lower total peripheral resistance in pretraining studies than non-responders . In conclusion , exercise at lactate threshold is effective in lowering blood pressure in those mild hypertensives with higher cardiac index and serum Na : K ratio",
"1 . Three groups of young patients with borderline hypertension were studied for a 12 months period . The first was on a free sodium diet while the second was on a low-salt diet . The third group of patients underwent acute salt loading . 2 . After 12 months the group on free diet showed a significant increase of intralymphocytic sodium but no change in blood pressure was noted . Five patients who were re-checked after 24 months also had a significant increase in blood pressure . 3 . Patients treated with a low-salt diet showed a significant decrease of both intralymphocytic sodium concentration and blood pressure . 4 . After acute salt loading , borderline subjects with high intralymphocytic sodium showed a significant greater natriuresis whereas intralymphocytic sodium increased only in those subjects in whom it was initially normal",
" We examined 117 out patients ( 20- to 45-year-old men ) with mild essential hypertension before treatment , after the main treatment course ( 6 weeks ) , and at 12-month follow-up . The patients were r and omized into two major groups : ( a ) a treatment group that received autogenic training ( 23 patients ) , biofeedback ( 24 patients ) , or breathing-relaxation training ( 23 patients ) and ( b ) a control group that consisted of 24 patients who did not receive any intervention and 23 patients who were treated with a \" psychological placebo . \" Clinical , psychological , and psychophysiological data from all patients who were offered relaxation therapy were analyzed . By the end of follow-up , and compared to the control group , the treatment group demonstrated a significant reduction in systolic and diastolic blood pressures , peripheral vascular resistance , and hypertensive response to emotional stress , and an improvement in psychological adaptation , quality of life , and capacity for work . Comparative analysis of the efficacy of different relaxation methods revealed that biofeedback and breathing-relaxation training result ed in the greatest reduction in blood pressure . The antihypertensive effect of relaxation therapy correlated positively with pretreatment blood pressure levels and negatively with the duration of illness and certain psychological features",
"We used 24-h monitoring of blood pressure ( BP ) to evaluate the effect of calcium supplementation on mild to moderate essential hypertension in elderly hospitalized patients for the first time in a controlled crossover study . The mean systolic and diastolic BP over a period of 24 h declined by 13.6 mm Hg ( P less than .005 ) and 5.0 mm Hg ( P less than .05 ) respectively in patients whose diet was supplemented with 1 g of elemental calcium in the form of oystershell electrolysate ( AA calcium ) . Serum ionized calcium and urinary calcium and sodium excretion increased ( serum Ca2 + 0.16 + /- 0.03 mEq/L , P less than .05 ; FECa 0.5 + /- 0.2 % , P less than .05 ; FENa 0.4 + /- 0.1 % , P less than .05 ) and plasma parathyroid hormone was suppressed ( 12.2 + /- 2.3 pg/mL , P less than .005 ) . These data suggest that supplementation of dietary calcium may contribute to a reduction of BP in elderly patients with essential hypertension",
"The purpose of this study was to investigate the effect of 1-year diet intervention , exercise intervention and both combined on blood pressure ( BP ) in normotensives and mild hypertensives . Two hundred and nineteen sedentary middle aged men and women with slightly deranged coronary heart disease ( CHD ) risk factors were r and omised to a control , a diet , an exercise and a diet + exercise group . Based on baseline diastolic BP , participants were divided into tertiles , giving baseline average BP of 141.4/96.7 in tertile 1 , 130.7/87.6 in tertile 2 and 121.9/79.0 in tertile 3 . The 1-year net-difference in BP between the intervention groups and the control group decreased across the tertiles ; in tertile 1 being -11.2/-6.7 ( p systolic BP only ) and -7.0/-5.1 ( NS ) in the combined , diet and exercise group respectively . Triglycerides , HDL cholesterol , and insulin variables were significantly and favourably changed , the changes being most marked in the combined group . The results show that diet and diet + exercise are about equally effective in reducing BP , and the effects may be dependent on the baseline level . Within the upper tertile of baseline BP , the decline in BP in the combined intervention and the diet group are almost comparable to those obtained with drug treatment . In addition , other important CHD risk factors were all changed in a beneficial direction",
"BACKGROUND Lifestyle modifications , such as physical activity , are recommended as first-line or adjunctive therapy for hypertension . However , controversy exists regarding the type , amount , and intensity of physical activity for optimal blood pressure lowering . DESIGN AND METHODS This study evaluated the blood pressure changes in 18 post-menopausal , sedentary , untreated hypertensive women r and omized to an individualized 8-week programme of intermittent moderate-intensity physical activity versus no change in physical activity . The physical activity group was asked to select activities ( such as walking ) to engage in physical activity for 10 min , three times a day , 5 days per week at an intensity of 50 - 60 % heart rate reserve . RESULTS Independent T-tests were used to compare the difference in resting blood pressure between groups . After 8 weeks , resting blood pressure was 8/5 mmHg lower in the physical activity group ( systolic blood pressure , P= 0.006 and diastolic blood pressure , P = 0.059 ) . The between group differences remained significant after adjustment for age , baseline blood pressure and previous use of antihypertensive drug therapy . CONCLUSION These data show that hypertensive , post-menopausal women who engage in intermittent , moderate-intensity physical activity experience a reduction in blood pressure",
"Unmedicated mildly hypertensive Type A men were r and omly allocated to one of three conditions : stress management intervention training ( N = 15 ) , Type A management ( N = 15 ) , and delayed Type A management intervention . Significantly greater reductions in blood pressure at rest and during the Type A structured interview were found following the active interventions than during the minimal treatment control period of the delayed intervention . Type A management was more successful in changing a number of Type A behaviours , including anger , hostility and global Type A behaviour . Changes on measures of anger-in , -out , hostility , and SI ratings of Type A behaviour were associated with changes in systolic and diastolic blood pressure reactivity during interview",
"1 . The effect of oral magnesium supplementation was assessed in a group of untreated , mild hypertensive subjects who were following a moderately low sodium diet ( baseline urinary sodium 86 ± 6 mmol/day )",
"This was a r and omized and double-blind study to examine : ( 1 ) the effect of a 1500 mg/day calcium supplement vs a placebo for 8 wk in 42 adults with high normal or mildly elevated blood pressure ( BP ) and , ( 2 ) the relationship between baseline serum total calcium levels and BP response to calcium supplementation . Following the experimental protocol , mean pressures were lower in the treatment vs placebo group ( 95.7 mmHg and 102.1 mmHg , p = 0.002 ) , but response was not related to initial serum total calcium levels . After 8 wk of calcium supplementation , serum total calcium was greater in the treatment group compared to the placebo group ( p = 0.02 ) . Within the treatment group only , the change in total serum calcium was related to the change in parathyroid hormone ( r = -0.92 , p = 0.0002 ) ; and the change in ionized calcium was related to the change in parathyroid hormone ( r = -0.68 , p = 0.03 ) in the subgroup with low baseline serum total calcium . This study provides further support for the hypotensive effect of supplemental calcium in some people . However , it fails to clarify or exp and upon previous reports that a low serum total calcium level might be predictive of the blood pressure response to increased calcium",
"It has been cl aim ed that calcium lowers BP . The present r and omised , double-blind , placebo-controlled crossover study is the first to investigate the effect on BP of a high oral dose of calcium given for a long period to patients with previously untreated hypertension . Elemental calcium ( 2 g ) was administered for 12 weeks interchanging with a period of 12 weeks of placebo . Twenty patients completed the protocol . There was no significant difference in change of BP during the period of additional calcium intake when compared with placebo ( P = 0.33 ) . The risk of not detecting a real BP-lowering effect of calcium of at least 3 mmHg was calcium supplementation given for 12 weeks does not decrease BP in previously untreated patients with mild to moderate hypertension",
"Thirty subjects with essential hypertension were assigned r and omly to either a no treatment control , education , or education with relaxation training group . Independent blood pressure recordings were collected by medical staff at pretest , posttest , and 8-week follow-up . Results suggest a significant interaction between treatment and time for the dependent physiological measure , systolic blood pressure . During the pretest to follow-up period , the control group averaged a 5.9 mm . Hg . increase , the education with relaxation group an 8.8 mm . Hg . decrease , and the education group a 14.9 mm . Hg . decrease in systolic blood pressure . There was no significant difference in group means for diastolic blood pressure within groups over time . As measured at follow-up , education appeared more effective in reducing systolic blood pressure than education with relaxation training . More than one-third of subjects associated unpleasant side effects with their antihypertensive medication . Almost all treatment subjects rated the education and relaxation as helpful for underst and ing and managing their hypertension",
"OBJECTIVE --To determine the long term effects of relaxation therapy on 24 hour ambulatory intra-arterial blood pressure in patients with mild untreated and uncomplicated hypertension . DESIGN --Four week screening period followed by r and omisation to receive either relaxation therapy or non-specific counselling for one year . Ambulatory intra-arterial blood pressure was measured before and after treatment . SETTING --Outpatient clinic in Amsterdam 's university hospital . SUBJECTS--35 Subjects aged 20 - 60 who were being treated by general practitioners for hypertension but were referred to take part in the study . At three consecutive screening visits all subjects had a diastolic blood pressure without treatment of 95 - 110 mm Hg . Subjects were excluded if they had damaged target organs , secondary hypertension , diabetes mellitus , a cholesterol concentration greater than 8 mmol/l , or a history of malignant hypertension . INTERVENTIONS --The group allocated to relaxation therapy was trained for eight weeks ( one hour a week ) in muscle relaxation , yoga exercises , and stress management and continued exercising twice daily for one year with monthly visits to the clinic . The control group had the same attendance schedule but had no training and were requested just to sit and relax twice a day . All subjects were asked not to change their diet or physical activity . MAIN OUTCOME MEASURE -- Changes in ambulatory intra-arterial blood pressure after one year of relaxation therapy or non-specific counselling . RESULTS --Mean urinary sodium excretion , serum concentration of cholesterol , and body weight did not change in either group . Diastolic pressures measured by sphygmomanometry were 2 and 3 mm Hg lower in subjects in the relaxation group and control group respectively at the one year follow up compared with initial readings . The mean diastolic ambulatory intra-arterial pressure during the daytime had not changed after one year in either group , but small treatment effects could not be excluded : the mean change for the relaxation group was -1 mm Hg ( 95 % confidence interval -6 to 3.9 mm Hg ) and for the control group -0.4 mm Hg ( -5.3 to 4.6 mm Hg ) . Mean ambulatory pressure in the evening also had not changed over the year , and in both groups nighttime pressure was 5 mm Hg higher . The variability in blood pressure was the same at both measurements . CONCLUSIONS --Relaxation therapy was an ineffective method of lowering 24 hour blood pressure , being no more beneficial than non-specific advice , support , and reassurance -- themselves ineffective as a treatment for hypertension",
"In this study eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) were given in a cumulative manner , every 6 weeks , starting with 10 mg , then 100 mg , 1000 mg and 10,000 mg EPA daily to mild to moderate essential hypertensive black patients . The corresponding DHA doses were 3 , 33 , 333 and 3333 mg . A control group was given olive oil as placebo for the entire 24 weeks . The placebo group had lower diastolic and systolic blood pressures after 24 weeks than the EPA and DHA group . No effect was seen on plasma triglycerides , cholesterol , HDL-cholesterol and gamma-glutamyltranspeptidase at any stage of the trial . In the EPA group plasma free-EPA increased significantly from 1000 mg onwards and plasma free-arachidonic acid ( AA ) decreased after 1000 mg EPA . No other plasma free essential fatty acid changed during the trial , although the HDL : cholesterol increased slightly but non-significantly with an increase in EPA and DHA . No significant changes in diet pattern or body mass was observed . It is therefore concluded that EPA and DHA supplementation had no beneficial effects in mild to moderate essential hypertensive black patients except for a lowering of plasma AA",
"In the first of two studies , 42 unmedicated mild hypertensives completed either 16 sessions of thermal biofeedback ( TBF ) training for h and ( 7 sessions ) and foot ( 9 sessions ) warming or 8 weeks of monitoring BPs at home . There was a trend ( p DBPs lower than 90 mm Hg than for those only monitoring BPs at home ( 33 % ) . Analyses of clinic BP values from r and om zero sphygmomanometer measurements , from 24-hour ambulatory BP monitoring , and from home BP measurements made by the patient showed no advantage for treatment versus BP monitoring . Sixteen of the 21 patients in BP monitoring were later treated . Analyses of treatment effects across all treated subjects by gender revealed a significant ( p=.02 ) decrease in DBP for treated female subjects ( n=13 ) but not for males ( n=24 ) . In the second study the 22 initial treatment successes , that is , those whose DBP was below 90 mm Hg at posttreatment ( 59.4 % of those who completed treatment ) , were r and omized to an intensive follow-up ( monthly visits for 6 months , then visits every two months ) emphasizing regular home practice with an electronic TBF device or regular follow-up ( visits every 3 months ) . Twelve of the 22 were still normotensive at 12 months . There were no differences at any point during the follow-up between the two conditions in success rate or BPs despite a numerical advantage in reported frequency of home practice by those in the intensive follow-up condition",
"Both n-3 and n-6 polyunsaturated fats have been suggested to lower blood pressure , an effect ascribed to altered bio synthesis of eicosanoids . To test these hypotheses , we studied blood pressure and eicosanoid production during supplementation of dietary fat for four weeks in 32 men with mild essential hypertension . Supplementation was preceded and followed by four-week run-in and recovery periods . Groups of eight subjects received either 10 ml or 50 ml of fish oil ( 3 or 15 g of n-3 fatty acids ) daily , 50 ml of safflower oil ( 39 g of n-6 fatty acids ) , or 50 ml of a mixture of oils that approximated the types of fat present in the American diet . The bio synthesis of eicosanoids was assessed by the measurement of urinary metabolites . Blood pressure decreased in the men who received the high dose of fish oil ( systolic pressure by a mean of 6.5 mm Hg [ P less than 0.03 ] and diastolic pressure by 4.4 mm Hg [ P less than 0.015 ] ) , but not in the other groups . Although the formation of vasodilatory prostacyclins ( prostagl and ins I2 and I3 ) increased initially , this increase was not maintained as blood pressure fell . The level of thromboxane A2 metabolites fell ; metabolites of thromboxane A3 were detected in the groups receiving fish oil . The formation of prostagl and in E2 increased during supplementation with safflower oil and tended to decrease with fish oil ; no prostagl and in E3 metabolite was detected . Our data indicate that high doses of fish oil can reduce blood pressure in men with essential hypertension . However , the clinical usefulness and safety of fish oil in the treatment of hypertension will require further study",
"Studies of whether polyunsaturated fatty acids in fish oil -- in particular , eicosapentaenoic and docosahexaenoic acids -- lower blood pressure have varied in design and results . We conducted a population -based , r and omized , 10-week dietary-supplementation trial in which the effects of 6 g per day of 85 percent eicosapentaenoic and docosahexaenoic acids were compared with those of 6 g per day of corn oil in 156 men and women with previously untreated stable , mild essential hypertension . The mean systolic blood pressure fell by 4.6 mm Hg ( P = 0.002 ) , and diastolic pressure by 3.0 mm Hg ( P = 0.0002 ) in the group receiving fish oil ; there was no significant change in the group receiving corn oil . The differences between the groups remained significant for both systolic ( 6.4 mm Hg ; P = 0.0025 ) and diastolic ( 2.8 mm Hg ; P = 0.029 ) pressure after control for anthropometric , lifestyle , and dietary variables . The decreases in blood pressure were larger as concentrations of plasma phospholipid n-3 fatty acids increased ( P = 0.027 ) . Dietary supplementation with fish oil did not change mean blood pressure in the subjects who ate fish three or more times a week as part of their usual diet , or in those who had a base-line concentration of plasma phospholipid n-3 fatty acids above 175.1 mg per liter . We conclude that eicosapentaenoic and docosahexaenoic acids reduce blood pressure in essential hypertension , depending on increases in plasma phospholipid n-3 fatty acids",
"Employees of a large industry were screened for the presence of coronary risk factors . A total of 204 employees , aged 35 - 64 years , with two or more such factors ( serum cholesterol concentration greater than or equal to 6.3 mmol/l ( 243.6 mg/100 ml ) , blood pressure greater than or equal to 140/90 mm Hg , and current cigarette consumption greater than or equal to 10 cigarettes a day ) were r and omly allocated to a biofeedback group receiving training in relaxation and management of stress or a control group . Both groups received simple health education literature . After eight weeks of training , and again eight months later , the biofeedback group showed a significantly greater fall in systolic and diastolic blood pressures than the control group ( p less than 0.001 ) . Plasma renin activity and plasma aldosterone concentration were measured in a sub sample at entry to the study and again at eight weeks and eight months ; both showed a greater reduction in the biofeedback compared with the control group at eight weeks ' follow-up . The greater reduction in blood pressure in the subjects in the biofeedback group compared with the control group ( 11.0 mm Hg systolic and 8.8 mm Hg diastolic ) , persisting eight months after the training , suggests that relaxation-based behavioural methods might be offered as a first-time treatment to patients with mild hypertension",
"& NA ; This study tested the efficacy of relaxation therapy as sole treatment for mild hypertension in 110 men and women recruited from a five‐stage worksite blood pressure screening program . Participants were r and omized to 12‐weeks of relaxation therapy or support therapy . Outcome blood pressure assessment s made by assessors who were unaware of group allocation revealed similar decreases in both treatment groups at post‐treatment and 6‐month follow‐up . While body weight did not change , alcohol consumption decreased similarly in both groups , and alcohol consumption was positively correlated with both absolute diastolic blood pressure and change in diastolic blood pressure at outcome . In conclusion , a superior blood pressure effect was not associated with relaxation therapy ; however , alcohol consumption decreased in both treatment groups , suggesting that both interventions facilitated changes in health risk behaviors and indirectly on blood pressure level",
"OBJECTIVE To determine whether provision of individualised physical activity advice by an exercise specialist in general practice is effective in modifying physical activity and cardiovascular risk factors in older adults . DESIGN R and omised controlled trial of individualised physical activity advice , reinforced at three and six months ( intervention ) versus no advice ( control ) . SETTING Two general practice s in Adelaide , South Australia , 1996 . PARTICIPANTS 299 adults aged 60 years or more who were healthy , sedentary and living in the community . MAIN OUTCOME MEASURES Changes to physical activity ( frequency and duration of walking and vigorous exercise ) , selected cardiovascular risk factors ( blood pressure , body weight , serum lipid levels ) and quality of life over 12 months . RESULTS Self-reported physical activity increased over the 12 months in both groups ( P time spent walking ( P intention to exercise ( P Serum levels of total and low-density lipoprotein cholesterol and triglycerides fell significantly over the 12 months to a similar extent in the two groups . No other significant changes in cardiovascular risk factors were seen . Quality -of-life scores decreased over the 12 months . The decrease was significantly greater among intervention than control women , but not men , for emotional well-being ( P = 0.02 ) , physical well-being ( P = 0.04 ) and social functioning ( P = 0.04 ) . DISCUSSION Provision of general practice -based physical activity advice reinforced three-monthly produced a sustained increase in self-reported physical activity . However , there were no associated changes in clinical measures of cardiovascular risk factors and minimal changes in quality -of-life measures"
] | 41167806-06ff-11f0-808a-c43d1ab1c353 |
A systematic review of literature was conducted to examine the association between changes in health-related fitness ( e.g. aerobic capacity and muscular strength /endurance ) and chronic disease risk factors in overweight and /or obese youth . Studies published from 2000 - 2010 were included if the physical activity intervention was a r and omized controlled trial and reported changes in fitness and health outcomes by direction and significance ( p Aerobic capacity improved in 91 % and muscular fitness improved in 82 % of measures reported . Nearly all studies ( 32 of 33 ) reported improvement in at least one fitness test . Changes in outcomes related to adiposity , cardiovascular , musculoskeletal , metabolic , and mental/emotional health improved in 60 % , 32 % , 53 % , 41 % , and 33 % of comparisons studied , respectively . In conclusion , overweight and obese youth can improve physical fitness across a variety of test measures . When fitness improves , beneficial health effects are observed in some , but not all chronic disease risk factors | [
"Background : The program The combined DAK therapy for obesity in children and adolescents ’ funded and conducted by the Deutsche Angestellten-Krankenkasse ( DAK ) , a German health insurance company , commenced in 2003 . The treatment program lasts for 1 year and comprises of 2 phases : an initial inpatient therapy for 6 weeks followed by a home-based outpatient treatment of the overweight children , adolescents , and their families for 10.5 months . The therapy complies with the guidelines of the German Working Group of Obesity in Childhood and Adolescence ( AGA ) . Participants and Methods : In this study , 162 obese children and adolescents were compared with a control group of 75 obese subjects recruited from the waiting list for the program . The aim was to analyze whether the changes in weight , eating behavior , and physical fitness during the therapy period are a result of the therapy itself or whether they are attributable to external effects . Body weight , height , and physical fitness were assessed through direct measurements while behavior and quality of life were assessed using self-report question naires . The development of body weight was evaluated using the BMI -SDS which is a measure of how many st and ard deviations an individual BMI is above or below the age- and gender-specific mean . Results : Within the observation period the BMI SDS decreased significantly by 0.36 ± 0.34 in the intervention group , whereas no changes of BMI -SDS were observed in the control group ( 0.04 ± 0.17 ) . The study revealed significant , positive treatment effects in exploratory analyses with regard to weight loss , behavior changes , physical fitness , and development of quality of life as a result of the therapy . These effects were not seen in the control group . Conclusion : We conclude that these positive developments are a result of the treatment program",
"BACKGROUND Little is known about how the intensity of exercise influences cardiovascular fitness and body composition , especially in obese adolescents . OBJECTIVE Our goal was to determine the effects of physical training intensity on the cardiovascular fitness , percentage of body fat ( % BF ) , and visceral adipose tissue ( VAT ) of obese adolescents . DESIGN Obese 13 - 16-y-olds ( n = 80 ) were assigned to 1 ) biweekly lifestyle education ( LSE ) , 2 ) LSE + moderate-intensity physical training , or 3 ) LSE + high-intensity physical training . The intervention lasted 8 mo . Physical training was offered 5 d/wk , and the target energy expenditure for all subjects in physical training groups was 1047 kJ ( 250 kcal)/session . Cardiovascular fitness was measured with a multistage treadmill test , % BF with dual-energy X-ray absorptiometry , and VAT with magnetic resonance imaging . RESULTS The increase in cardiovascular fitness in the high-intensity physical training group , but not in the moderate-intensity group , was significantly greater than that in the LSE alone group ( P = 0.009 ) ; no other comparisons of the 3 groups were significant . Compared with the LSE alone group , a group composed of subjects in both physical training groups combined who attended training sessions > or=2 d/wk showed favorable changes in cardiovascular fitness ( P % BF ( P = 0.001 ) , and VAT ( P = 0.029 ) . We found no evidence that the high-intensity physical training was more effective than the moderate-intensity physical training in enhancing body composition . CONCLUSIONS The cardiovascular fitness of obese adolescents was significantly improved by physical training , especially high-intensity physical training . The physical training also reduced both visceral and total-body adiposity , but there was no clear effect of the intensity of physical training",
"INTRODUCTION The purpose of this study was to test the hypothesis that physical training ( PT ) , especially high-intensity PT , would have a favorable effect on components of the insulin resistance syndrome ( IRS ) in obese adolescents . METHODS Obese 13- to 16-yr-olds ( N = 80 ) were r and omly assigned to one of the following 8-month interventions ; 1 ) lifestyle education (LSE)-alone every 2 wk , 2 ) LSE+moderate-intensity PT , and 3 ) LSE+high-intensity PT . PT was offered 5 d x wk(-1 ) . Plasma triacylglycerol ( TAG ) , total cholesterol ( TC ) , high-density lipoprotein cholesterol ( HDLC ) , very low-density lipoprotein cholesterol ( VLDLC ) , low-density lipoprotein cholesterol ( LDLC ) , low-density lipoprotein ( low density lipoprotein ( LDL ) ) particle size , apolipoproteins AI and B , glucose , insulin , and blood pressure were measured with st and ardized methods . RESULTS The intent-to-treat analyses for all subjects who completed pre- and post-tests regardless of their adherence to the interventions showed that the LSE+high-intensity PT group had more favorable changes than the LSE-alone group in TAG level ( P = 0.012 ) , TC/HDLC ( P = 0.013 ) , and diastolic blood pressure ( P = 0.031 ) . For efficacy analyses , all PT subjects who attended at least 2 d x wk(-1 ) ( 40 % ) were combined into one group ( LSE+PT ) and compared with the LSE-alone group . These two-group analyses showed significant interactions ( P deltaTAG , deltaVLDLC , and deltaTC/HDLC , such that subjects who had the least favorable baseline values showed the most beneficial impact of the PT . Of particular interest was a favorable effect of the PT on LDL particle size . CONCLUSION PT , especially high-intensity PT , had a favorable effect on several IRS markers in obese adolescents",
"OBJECTIVES We sought to characterize the impact of obesity on vascular function in adolescents and to determine whether an exercise program reverses abnormalities in endothelial function . BACKGROUND Obesity , a major modifiable risk factor for cardiovascular disease , is epidemic in Western societies , with rapid rates of increase in the young . Atherosclerosis begins in childhood , and endothelial dysfunction is its earliest detectable manifestation . METHODS The influence of eight weeks of circuit training ( CT ) was examined in 19 obese subjects ( 14.3 + /- 1.5 years ) , using a r and omized , crossover protocol . Functional capacity and muscular strength were assessed by st and ard techniques . Body composition was examined using anthropometric measures and dual-energy X-ray absorptiometry . Conduit vessel endothelial function was assessed using high-resolution ultrasound and flow-mediated dilation ( FMD ) of the brachial artery . RESULTS Circuit training decreased abdominal and trunk fat and significantly improved fitness and muscular strength ( p obese group , FMD was significantly impaired relative to control subjects ( n = 20 ) at entry ( 5.3 + /- 0.9 % vs. 8.9 + /- 1.5 % , p Circuit training improved functional capacity , muscular strength , and body composition in obese adolescents . Furthermore , conduit vessel function was normalized after exercise training . If vascular dysfunction is an integral component of the pathogenesis of vascular disease , this study supports the value of an exercise program in the management of obese adolescents",
"OBJECTIVES The aim of this study was to determine the effects of physical activity on systemic blood pressure ( BP ) and early markers of atherosclerosis in pre-pubertal obese children . BACKGROUND Hypertension and endothelial dysfunction are premature complications of obesity . METHODS We performed a 3-month r and omized controlled trial with a modified crossover design : 44 pre-pubertal obese children ( age 8.9 + or - 1.5 years ) were r and omly assigned ( 1:1 ) to an exercise ( n = 22 ) or a control group ( n = 22 ) . We recruited 22 lean children ( age 8.5 + or - 1.5 years ) for baseline comparison . The exercise group trained 60 min 3 times/week during 3 months , whereas control subjects remained relatively inactive . Then , both groups trained twice/week during 3 months . We assessed changes at 3 and 6 months in office and 24-h BP , arterial intima-media thickness ( IMT ) and stiffness , endothelial function ( flow-mediated dilation ) , body mass index ( BMI ) , body fat , cardiorespiratory fitness ( maximal oxygen consumption [ VO(2)max ] ) , physical activity , and biological markers . RESULTS Obese children had higher BP , arterial stiffness , body weight , BMI , abdominal fat , insulin resistance indexes , and C-reactive protein levels , and lower flow-mediated dilation , VO(2)max , physical activity , and high-density lipoprotein cholesterol levels than lean subjects . At 3 months , we observed significant changes in 24-h systolic BP ( exercise -6.9 + or - 13.5 mm Hg vs. control 3.8 + or - 7.9 mm Hg , -0.8 + or - 1.5 st and ard deviation score [ SDS ] vs. 0.4 + or - 0.8 SDS ) , diastolic BP ( -0.5 + or - 1.0 SDS vs. 0 + or - 1.4 SDS ) , hypertension rate ( -12 % vs. -1 % ) , office BP , BMI z-score , abdominal fat , and VO(2)max . At 6 months , change differences in arterial stiffness and IMT were significant . CONCLUSIONS A regular physical activity program reduces BP , arterial stiffness , and abdominal fat ; increases cardiorespiratory fitness ; and delays arterial wall remodeling in pre-pubertal obese children . ( Effects of Aerobic Exercise Training on Arterial Function and Insulin Resistance Syndrome in Obese Children : A R and omized Controlled Trial ; NCT00801645 )",
"Background —The effects of diet and diet plus exercise training on muscle vasodilatation during physiological maneuvers in obese children are unknown . We tested the hypothesis that ( 1 ) blood pressure ( BP ) and forearm vascular conductance ( FVC ) responses during h and grip exercise and mental stress would be altered in obese children and ( 2 ) diet plus exercise training would restore BP and FVC responses during exercise and mental stress in obese children . Methods and Results —Thirty-nine obese children ( aged 10±0.2 years ) were r and omly divided into 2 groups : diet plus exercise training ( n=21 ; body mass index [ BMI ] = 28±0.5 kg/m2 ) and diet ( n=18 ; BMI = 30±0.4 kg/m2 ) . Ten age-matched lean control children ( BMI = 17±0.5 kg/m2 ) were also studied . Forearm blood flow was measured by venous occlusion plethysmography . BP was monitored noninvasively . H and grip exercise was performed at 30 % maximal voluntary contraction for 3 minutes . Stroop color word test was performed for 4 minutes . Baseline BP was significantly higher and FVC was significantly lower in obese children . During exercise and mental stress , BP responses were significantly higher and FVC responses were significantly lower in obese children . Diet and diet plus exercise training significantly reduced body weight . Diet and diet plus exercise training significantly decreased BP levels during exercise and mental stress . Diet plus exercise training , in contrast to diet alone , significantly increased FVC responses during exercise ( 3.7±0.3 versus 5.6±0.4 U ; P=0.01 ) and mental stress ( 3.5±0.5 versus 4.5±0.4 U ; P=0.02 ) . After diet plus exercise training , BP and FVC responses during exercise and mental stress were similar between obese children and the control group . Conclusions —Obesity exacerbates BP responses and impairs FVC responses during exercise and mental stress in children . Diet and exercise training restore BP and FVC responses in obese children",
"The aim of the present study was to examine the effect of exercise training on adipokines , inflammatory markers , and oxidative stress in overweight children . Nineteen overweight children were r and omly assigned to an aerobic exercise training or sedentary control group for 8 weeks . Measurements included peak oxygen uptake ( V o(2)max ) , body weight and composition , adipokines ( C-reactive protein , interleukin 6 , tumor necrosis factor alpha , adiponectin , leptin , and resistin ) , and oxidative stress ( 8-isoprostane ) . There were no differences between groups for change in body weight or composition over the 8 weeks . Exercise training improved V o(2)max ( exercise group , 1.64 + /- 0.13 to 1.85 + /- 0.17L/min vs control group , 1.83 + /- 0.12 to 1.60 + /- 0.13 L/min , P measured adipokines or the marker of systemic oxidative stress , 8-isoprostane . These data suggest that in the absence of weight loss , exercise training alone does not improve the adipokine profile or levels of oxidative stress in overweight children",
"Background . Obesity has become the most common pediatric chronic disease in the modern era . Early prevention and treatment of childhood and adolescent obesity is m and ated . Surprisingly , however , only a minor fraction of obese children participate in weight reduction interventions , and the longer-term effects of these weight-reduction interventions among children have not been eluci date d. Objective . To examine prospect ively the short- and long-term effects of a 3-month , combined dietary-behavioral-physical activity intervention on anthropometric measures , body composition , dietary and leisure-time habits , fitness , and lipid profiles among obese children . Methods . In this r and omized prospect i ve study , 24 obese subjects completed the 3-month intervention and were compared with 22 obese , age- and gender-matched , control subjects . Results . At 3 months , there were significant differences in changes in body weight ( −2.8 ± 2.3 kg vs 1.2 ± 2.2 kg ) , BMI ( −1.7 ± 1.1 kg/m2 vs −0.2 ± 1.0 kg/m2 ) , body fat percentage ( from skinfold tests ; −3.3 ± 2.6 % vs 1.4 ± 4.7 % ) , serum total cholesterol level ( −24.6 ± 15.1 mg/dL vs 0.8 ± 18.7 mg/dL ) , low-density lipoprotein cholesterol level ( −23.3 ± 15.2 mg/dL vs −3.7 ± 17.3 mg/dL ) , and fitness ( 215 ± 107 seconds vs 50 ± 116 seconds ) in the intervention group versus the control group . After a 1-year follow-up period , there were significant differences between the intervention group ( n = 20 ) and the control group ( n = 20 ) in body weight ( 0.6 ± 6.0 kg vs 5.3 ± 2.7 kg ) , BMI ( −1.7 ± 2.3 kg/m2 vs 0.6 ± 0.9 kg/m2 ) , and body fat percentage . There was a significant increase in leisure-time physical activity among the intervention participants , compared with a decrease among the control subjects . Conclusions . Our data demonstrate the short- and longer-term beneficial effects of a combined dietary-behavioral-physical activity intervention among obese children . These results highlight the importance of multidisciplinary programs for the treatment of childhood obesity and emphasize their encouraging long-term effects",
"Abstract . We assessed the effect of a weight management programme on body weight , body mass index ( BMI ) , and fitness in obese children and adolescents . The study was design ed as a longitudinal , non-r and omised , clinical experience of a 3 and 6 month combined dietary-behavioural-exercise intervention . A total of 177 obese children ( age 6–16 years ) participated in the 3 month programme , of whom 65 completed the 6 month intervention . A group of 25 age- and maturity-matched obese children who did not participate in the structured programme served as controls . Body weight , BMI , and fitness were evaluated at baseline , and after the 3 and 6 months intervention . Body weight and BMI were significantly reduced ( P and endurance time significantly increased ( P Obese children who continued the programme for 6 months maintained the decrease in BMI and further improved endurance time . In contrast , obese children who did not participate in the structured programme gained weight , increased their BMI , and improved fitness less significantly . Gender , pubertal status , and the degree of obesity had no influence on BMI changes . Children without parental overweight had significantly greater decreases in BMI compared to children of obese parents . Conclusion : a combined , structured multidisciplinary intervention for childhood obesity results in decreased body weight , decreased body mass index and improved fitness",
"INTRODUCTION Developing effective exercise programmes for the paediatric population is a strategy for decreasing obesity and is expected to help in eventually limiting obesity-associated long-term health and societal impact . In this study , the effects of a 12-week twice weekly additional exercise training , which comprised a combination of circuit-based resistance training and aerobic exercises , in additional to typical physical education sessions , on aerobic fitness , body composition and serum C-reactive protein ( CRP ) and lipids were analysed in 13- to 14-year-old obese boys contrasted with a control group . MATERIAL S AND METHODS Both the exercise group ( EG , n = 12 ) and control group ( CG , n = 12 ) participated in the typical 2 sessions of 40-minute physical education ( PE ) per week in schools , but only EG participated in additional 2 sessions per week of 45 to 60 minutes per session of exercise training , which comprised a combination of circuit-based resistance training and aerobic exercises maintained at 65 % to 85 % maximum heart rate ( HRmax = 220 - age ) . Body composition was measured using dual energy X-ray absorptiometry ( DEXA ) . Fasting serum CRP and blood lipids were analysed pre- and postexercise programme . Aerobic fitness was measured by an objective laboratory submaximal exercise test , PWC170 ( Predicted Work Capacity at HR 170 bpm ) . RESULTS Exercise training significantly improved lean muscle mass , body mass index , fitness , resting HR , systolic blood pressure and triglycerides in EG . Serum CRP concentrations were elevated at baseline in both groups , but training did not result in a change in CRP levels . In the CG , body weight increased significantly at the end of the 12-week period . CONCLUSION This study supports the value of an additional exercise training programme , beyond the typical twice weekly physical education classes , to produce physiological benefits in the management of obesity in adolescents , including prevention of weight gain",
"PURPOSE To date , no study has examined the synergistic effects of a nutrition and combination of aerobic and strength training ( CAST ) on both adiposity and metabolic parameters in overweight Latina adolescent females . The goal was to assess if a 16-wk nutrition plus CAST pilot study had stronger effects on reducing adiposity and on improving glucose/insulin indices compared with control ( C ) , nutrition only ( N ) , and a nutrition plus strength training ( N + ST ) groups . METHODS In a 16-wk r and omized trial , 41 overweight Latina girls ( 15.2 + /- 1.1 yr ) were r and omly assigned to C ( n = 7 ) , N ( n = 10 ) , N + ST ( n = 9 ) , or N + CAST ( n = 15 ) . All intervention groups received modified carbohydrate nutrition classes ( once a week ) , whereas the N + ST also received strength training ( twice a week ) and the N + CAST received a combination of strength and aerobic training ( twice a week ) . The following were measured before and after intervention : strength by one repetition maximum , physical activity by the 7-d accelerometry and the 3-d physical activity recall , dietary intake by 3-d records , body composition by dual-energy x-ray absorptiometry ( DEXA ) , glucose/insulin indices by oral glucose tolerance test , and intravenous glucose tolerance test with minimal modeling . Across intervention group , effects were tested using ANCOVA with post hoc pairwise comparisons . RESULTS There were significant overall intervention effects for all adiposity measures ( weight , body mass index [ BMI ] , BMI z-scores , and DEXA total body fat ) , with a decrease of 3 % in the N + CAST group compared with a 3 % increase in the N + ST group ( P fasting glucose with the N group increasing by 3 % and the N + CAST group decreasing by 4 % ( P CAST was more effective than nutrition alone or nutrition plus strength training for reducing multiple adiposity outcomes and fasting glucose in overweight Latina girls . However , further research investigating and identifying intervention approaches that improve both adiposity and insulin indices , particularly in high-risk population s , are warranted",
"Obesity has become the most common pediatric chronic disease in the modern era . Recent data suggests that unlike obese adults , obese children and adolescents may have decreased bone strength . It was the objective to prospect ively examine the short term effects of a 3 month combined dietary-physical activity intervention on anthropometric measures , body composition , fitness and bone strength in obese children . Twelve obese subjects completed the 3 m intervention and were compared to 12 obese age and gender matched controls . Bone strength was measured using quantitative ultrasound measurements of bone speed of sound ( SOS ) . There were significant differences in changes of body weight ( 0.01 + /- 0.7 vs. 2.3 + /- 0.6 kg , p = 0.033 ) , BMI percentiles ( - 2.8 + /- 1.1 vs. - 0.2 + /- 0.2 % , p = 0.037 ) , body fat percent ( by skinfolds , - 1.5 + /- 0.8 vs. 0.7 + /- 0.5 % , p = 0.035 ) , and endurance time ( 170 + /- 42 vs. 50 + /- 27 s , p = 0.045 ) in the intervention vs. control subjects , respectively . In addition , we found a significant difference in the change of bone SOS between the intervention and control group subjects ( 21.5 + /- 21.6 vs. - 87.0 + /- 37 m/s , p = 0.023 ) . During the critical period of bone development of childhood and adolescence , a combined dietary-physical activity intervention leads to increased bone strength in obese children . These results highlight the importance of multi-disciplinary programs for the treatment of childhood obesity and its complications",
"BACKGROUND Parental obesity reduces the likelihood of a multidisciplinary childhood obesity program to succeed , suggesting that special family-based interventions should be constructed for obese children from obese families . AIM To examine the effects of an intense combined 3-month familial dietary-behavioral-physical activity intervention for a subgroup of obese children ( BMI > 95th percentile ) from obese families ( parental BMI > 27 kg/m2 ) compared to a control group of obese children and obese parents who did not participate in the combined intervention . CHILDREN Twenty-two obese children were r and omly assigned to the intervention ( n = 11 ) or control ( n = 11 ) group . Anthropometric measurements , body composition , dietary and activity habits and fitness levels were measured before and at the end of a 3-month intervention . RESULTS The intervention led to a significant difference in change in body weight ( -0.2 + /- 0.3 vs 1.7 + /- 0.6 kg ; p BMI percentiles ( -1.4 + /- 0.5 vs -0.1 + /- 0.2 % ; p screen ( television and computer ) time ( -2.2 + /- 0.6 vs 0.1 + /- 0.3 h/day ; p fitness level determined by endurance time ( 181 + /- 30 vs 26 + /- 63 seconds in the intervention vs control group , respectively ; p Obese children from obese families pose a therapeutic challenge to health care providers . Intense family-oriented multidisciplinary weight management intervention should be design ed for treatment in this unique population",
"The purpose of this study was to test the hypothesis that in obese children : 1 ) Ventilatory efficiency ( VentE ) is decreased during grade d exercise ; and 2 ) Weight loss through diet alone ( D ) improves VentE , and 3 ) diet associated with exercise training ( DET ) leads to greater improvement in VentE than by D. Thirty-eight obese children ( 10+/-0.2 years ; BMI > 95th percentile ) were r and omly divided into two study groups : D ( n=17 ; BMI = 30+/-1 kg/m ( 2 ) ) and DET ( n=21 ; 28+/-1 kg/m ( 2 ) ) . Ten lean children were included in a control group ( 10+/-0.3 years ; 17+/-0.5 kg/m ( 2 ) ) . All children performed maximal treadmill testing with respiratory gas analysis ( breath-by-breath ) to determine the ventilatory anaerobic threshold ( VAT ) and peak oxygen consumption ( VO ( 2 ) peak ) . VentE was determined by the VE/VCO ( 2 ) method at VAT . Obese children showed lower VO ( 2 ) peak and lower VentE than controls ( p body weight ( p D group did not improve in terms of VO ( 2 ) peak or VentE ( p>0.05 ) . In contrast , the DET group showed increased VO ( 2 ) peak ( p=0.01 ) and improved VentE ( DeltaVE/VCO (2)=-6.1+/-0.9 ; p=0.01 ) . VentE is decreased in obese children , where weight loss by means of DET , but not D alone , improves VentE and cardiorespiratory fitness during grade d exercise",
"OBJECTIVE : To determine the effect of exercise training ( ET ) on components of the insulin resistance syndrome ( IRS ) in obese children . DESIGN : R and omized , modified cross-over study , with subjects assigned to one of two conditions : ( 1 ) 4 months of ET followed by 4 months of no-ET ; or ( 2 ) 4 months of no-ET followed by 4 months of ET . Measurements were made at three time points : 0 , 4 and 8 months . SUBJECTS : 79 obese , but otherwise healthy children ( age : 7–11 y , percent fat ( % fat ) 27–61 % ) . MEASUREMENTS : Plasma lipid and lipoprotein concentrations , plasma insulin and glucose concentrations ; % fat ; submaximal heart rate ( HR ) as an index of fitness . EXERCISE TRAINING : ET was offered 5 d/week 40 min/d . For the 73 children who completed 4 months of ET , the mean attendance was 80 % ( that is , 4 d/week ) and the average HR during ET was 157 bpm . RESULTS : Significant ( P for plasma triglyceride ( TG ) and insulin concentrations and % fat . The average change for both groups , from just before ET to just after the 4 month ET was −0.24 mmolċl−1 for TG , −25.4 pmolċl−1 for insulin and −1.6 units for % fat . When Group 1 ceased ET , over the following 4 month period the average change for insulin was + 26.6 pmolċl−1 and for % fat + 1.3 units . CONCLUSION : Some components ( plasma TG , insulin , % fat ) of the IRS are improved as a result of 4 months of ET in obese children . However , the benefits of ET are lost when obese children become less active",
"The prevalence of overweight or fat children and adolescents has markedly increased in Hungary during the past three decades . Among the possible factors insufficient physical activity and a relative or absolute excess of calorie intake associated to it can be regarded as the most important ones . The aim of the study was to analyse the effects of a 20-week aerobic exercise on body composition and on the exercise tested cardio-respiratory functions in 10-year-old obese boys . Obesity was defined by a BMI greater than the cut-off value reported by Cole and co-workers ( 5 ) and a relative body fat content above 30 % ( 13 ) . Of the study group 21 volunteer children completed the program ; the contrast group contained 28 obese boys . Mean calendar age was 10.03 + /- 0.26 in the study group ( S ) and 9.88 + /- 0.29 in the control group ( C ) . The members of group S had two curricular physical education ( PE ) classes a week and three extracurricular aerobic physical activity sessions of 60 min net time in the afternoon , on Mondays ( swimming and water games ) , Wednesdays ( folk dance ) and Fridays ( soccer ) . Group C had only 2 PE classes a week . Anthropometric and spiroergometric data were collected in the middle of January and June of 2004 . Relative body fat content and BMI did not increase during the observation period in contrast to the significant increase of both in the control group . Peak minute ventilation , aerobic power , oxygen pulse , and running distance ( performed on a treadmill ) increased in group S , and did not change in group C. The program was considered successful despite that the changes in the observed physiological and physical indicators appeared to be slight . However , the 5-month elevated level of physical activity brought about such development in the physical status of the obese subjects that might be an appropriate basis for regular training . Fortunately , the cardio-respiratory functions of the investigated boys were not affected yet by obesity , consequently the really dramatic change in their further lifestyle exclusively depends on their decision",
"PURPOSE Children with high levels of total body fat mass ( TFM ) and visceral adipose tissue ( VAT ) have elevated levels of certain risk factors for coronary artery disease and non-insulin-dependent diabetes mellitus . We tested the hypothesis that controlled physical training , without dietary intervention , would have a favorable impact on VAT and percent body fat ( % BF ) in obese children . METHODS A volunteer sample of 74 obese children , 7 - 11 yr of age , accepted r and om assignment to physical training or control groups . Before and after 4 months of intervention , measurements were obtained for VAT , TFM , % BF , daily physical activity , and cardiovascular fitness . The intervention involved 4 months of controlled physical training 5 d x wk(-1 ) , 40 min per session , at a mean heart rate ( HR ) of 157 beats x min(-1 ) . The estimated energy expenditure ( EE ) per training session was 925+/-201 kJ. RESULTS Compared with the control group , the physical training group declined significantly in % BF ( delta = -2.2 % ) ( P TFM ( delta = -3.1 % ) ( P subcutaneous abdominal adipose tissue ( delta = - 16.1 % ) ( P fat-free mass ( delta = + 6.1 % ) ( P moderate-to-very hard physical activity ( delta = + 14.1 % ) ( P VAT was significantly less in the physical training group ( delta = + 0.5 % ) as compared with that in the control group ( delta = + 8.1 % ) ( P physical training obese children : 1 ) were capable of participating in a substantial amount of high intensity physical training over a 4-month period : 2 ) accumulated significantly less VAT as compared with nonexercising controls ; and 3 ) experienced other beneficial changes in total and regional body composition",
"OBJECTIVE Heart rate variability provides non-invasive information about cardiac parasympathetic activity ( PSA ) . We determined in obese children : ( 1 ) relations of baseline PSA to body composition and hemodynamics ; ( 2 ) effects of physical training ( PT ) and cessation of PT ; and ( 3 ) which factors explained individual differences in responsivity of PSA to the PT . RESEARCH METHODS AND PROCEDURES The root mean square of successive differences ( RMSSD ) was the index of PSA . Obese children ( n = 79 ) were r and omly assigned to groups that participated in PT during the first or second 4-month periods of the study . RESULTS Baseline RMSSD was significantly ( p : fat mass , fat-free mass , subcutaneous abdominal adipose tissue , resting heart rate ( HR ) , resting systolic blood pressure , and exercise HR . Stepwise multiple regression produced a final model ( R2 = 0.36 ) that included only resting HR . The analysis of changes over the three time points of the study found a significant ( p = 0.026 ) time by group interaction , such that RMSSD increased during periods of PT and decreased following cessation of PT . Greater individual increases in response to the PT ( p pre-PT RMSSD levels , showed the greatest decreases in resting HR , and increased most in vigorous physical activity . The final regression model retained only the change in resting HR as a significant predictor of the changes in the RMSSD ( R2 = 0.23 ) . DISCUSSION Regular exercise that improved fitness and body composition had a favorable effect on PSA in obese children",
"AIM The aim of this study was to examine the effects of a 6-week diet and exercise program , with emphasis on strength training , on the physical self-concept , body composition , and physical fitness of young overweight and obese children . METHODS Eighty-two overweight and obese children aged 8 - 11 years were r and omized into a diet-only or a diet- and -strength training group . Self-concept , body composition and physical fitness were measured before and after the 6-week study period using the Physical Self Description Question naires ( PSDQ ) , dual-energy X-ray absorptiometry ( DXA ) , and st and ard fitness tests . Dietary intake was assessed with a food frequency question naire . Total daily energy intake was significantly reduced in both groups with a trend of more reduction in the diet-only group . RESULTS Both groups developed greater confidence in strength . Those in the diet- and -strength training group also improved their endurance self-concept . Body Mass Index ( BMI ) decreased significantly in both groups . Lean mass increased significantly in both groups but significantly more in the diet- and -strength training group ( + 0.8 kg vs + 0.3 kg , P H and grip , shuttle run , sit-up , and push-up were significantly improved in both groups , to a significantly greater extent in the diet- and -strength training group . CONCLUSION These findings confirm the 6-week program of either diet-only or diet- and -strength training improved overweight/obese children 's self-perception of muscular strength and body composition . With the diet- and -strength training program , self-concept in endurance also improved and the gain in lean body mass was more than double that of the diet only group",
"The aim of this study was to evaluate the effectiveness of the Mind , Exercise , Nutrition , Do it ( MEND ) Program , a multicomponent community-based childhood obesity intervention ( www.mend central .org ) . One hundred and sixteen obese children ( BMI > or= 98 th percentile , UK 1990 reference data ) were r and omly assigned to intervention or waiting list control ( 6-month delayed intervention ) . Parents and children attended eighteen 2-h group educational and physical activity sessions held twice weekly in sports centers and schools , followed by a 12-week free family swimming pass . Waist circumference , BMI , body composition , physical activity level , sedentary activities , cardiovascular fitness , and self-esteem were assessed at baseline and at 6 months . Children were followed up 12 months from baseline ( 0 and 6 months postintervention for the control and intervention group , respectively ) . Participants in the intervention group had a reduced waist circumference z-score ( -0.37 ; P BMI z-score ( -0.24 ; P cardiovascular fitness , physical activity , sedentary behaviors , and self-esteem . Mean attendance for the MEND Program was 86 % . At 12 months , children in the intervention group had reduced their waist and BMI z-scores by 0.47 ( P cardiovascular fitness , physical activity levels , and self-esteem were sustained . High-attendance rates suggest that families found this intensive community-based intervention acceptable . Further larger controlled trials are currently underway to confirm the promising findings of this initial trial",
"The purpose of this study was to apply the lactate threshold concept to develop a more evidence -informed exercise program for obese children . 60 obese children ( 26 girls and 34 boys , age : 9 - 10 years , BMI : 25.4 + /- 2.2kg/m(2 ) ) were recruited and half of them were r and omly selected to be trained for eight weeks with a controlled exercise intensity at lactate threshold . The trained children achieved significant improvements on their body composition and functional capacity compared with the control group . The findings suggested that the training program with intensity at lactate threshold is effective and safe for 9 - 10 year old children with obesity",
"The aim of the present study was to compare the effects of a multidisciplinary approach ( MTG ) and aerobic interval training ( AIT ) on cardiovascular risk factors in overweight adolescents . A total of 62 overweight and obese adolescents from Trøndelag County in Norway , referred to medical treatment at St Olav 's Hospital , Trondheim , Norway , were invited to participate . Of these , 54 adolescents ( age , 14.0 + /- 0.3 years ) were r and omized to either AIT ( 4 x 4 min intervals at 90 % of maximal heart rate , each interval separated by 3 min at 70 % , twice a week for 3 months ) or to MTG ( exercise , dietary and psychological advice , twice a month for 12 months ) . Follow-up testing occurred at 3 and 12 months . VO(2max ) ( maximal oxygen uptake ) increased more after AIT compared with MTG , both at 3 months ( 11 compared with 0 % ; P AIT enhanced endothelial function compared with MTG at both 3 months ( absolute change , 5.1 compared with 3.9 % ; P AIT was favourable compared with MTG in reducing BMI ( body mass index ) , percentage of fat , MAP ( mean arterial blood pressure ) and increasing peak oxygen pulse . In addition , AIT induced a more favourable regulation of blood glucose and insulin compared with MTG . In conclusion , the novel findings of the present proof-of-concept study was that 3 months of twice weekly high-intensity exercise sessions reduced several known cardiovascular risk factors in obese adolescents more than that observed after a multitreatment strategy , which was initiated as hospital treatment . Follow-up at 12 months confirmed that AIT improved or maintained these risk factors to a better degree than MTG",
"OBJECTIVES Atherosclerosis is a disease that begins in childhood ; endothelial dysfunction is its earliest detectable manifestation , and primary prevention strategies are likely to be most effective if instituted early . The aim of this study was to characterize the impact of obesity on vascular function in young children and to determine whether an exercise program improves abnormalities in vascular function . STUDY DESIGN The influence of 8 weeks of exercise training was examined in 14 obese subjects , 8.9 + /- 0.4 years of age , with the use of a r and omized crossover protocol . Conduit vessel endothelial function was assessed by means of high-resolution ultrasound and flow-mediated dilation of the brachial artery ( FMD ) . RESULTS Exercise training did not change subcutaneous fat mass , body weight , or body mass index . FMD in the obese group was significantly impaired relative to matched control subjects at entry ( 6.00 % + /- 0.69 % to 12.32 % + /- 3.14 % , P FMD significantly improved with exercise training ( 7.35 % + /- 0.99 % , P Conduit vessel FMD , a vali date d surrogate measure of early atherosclerosis , was impaired in obese children but improved as a result of exercise training . This study supports the value of an exercise program in the treatment of obese children in a primary prevention setting",
"PURPOSE Insulin resistance is thought to be a core defect in the pathophysiology of obesity-related comorbidities in children , such as type 2 diabetes . Exercise training is known to improve insulin resistance and reduce the risk of type 2 diabetes in adults . However , very little is known regarding the effects of exercise on insulin resistance in youth . Therefore , we examined the effects of a 16-wk resistance training exercise intervention on insulin sensitivity in youth at high risk for developing type 2 diabetes . METHODS Twenty-two overweight Latino adolescent males were r and omly assigned to either a twice-per-week resistance training group ( RT=11 ) or a nonexercising control group ( C=11 ) for 16 wk . Strength was assessed by one-repetition maximum , body composition was quantified by dual-energy x-ray absorptiometry , and insulin sensitivity was determined by the frequently sample d intravenous glucose tolerance test with minimal modeling . RESULTS Significant increases in upper- and lower-body strength were observed in the RT compared with the C group . The RT group significantly increased insulin sensitivity compared with the C group ( P baseline values , insulin sensitivity increased 45.1+/-7.3 % in the RT group versus -0.9+/-12.9 % in controls ( P resistance training program can significantly increase insulin sensitivity in overweight Latino adolescent males independent of changes in body composition",
"PURPOSE The primary purpose of this study was to determine the effects of resistance exercise training on early diastolic myocardial velocities ( E ' ) in an obese pediatric population . METHODS Twenty-three obese adolescents were selected to participate in either a resistance-based training program ( RT ; n = 13 , 12.2 + /- 0.4 yr , body mass index [ BMI ] = 32.5 + /- 1.9 kg m(-2 ) ) or a nonexercise control intervention ( n = 10 , 13.6 + /- 0.7 yr , BMI = 30.2 + /- 2.6 kg m(-2 ) ) for 8 wk . All subjects had repeated echocardiographic assessment s to determine left ventricular ( LV ) geometry , early transmitral flow velocity ( E ) , and E ' . RESULTS LV mass and wall thicknesses did not significantly change with training or in controls . RT improved E ' ( 11.9 + /- 0.5 to 13.3 + /- 0.5 cm s(-1 ) , P E/E ' ( 8.17 + /- 0.39 to 7.06 + /- 0.30 cm s(-1 ) , P RT exercise program improved early diastolic tissue velocity in obese children , independent of changes in LV morphology",
"OBJECTIVE To determine whether an exercise intervention using an active video game ( Dance Dance Revolution [ DDR ] ) is effective in improving endothelial dysfunction ( EDF ) and other risk factors in overweight children . DESIGN Thirty-five children ( Body mass index > or = 85(th ) percentile , mean age 10.21+/-1.67 years , 17 females ) with EDF were assessed for flow-mediated dilation ( FMD ) , lipids , insulin , glucose , NO(2)+NO(3 ) , asymmetric dimethylarginine , symmetric dimethylarginine , l-arginine , height , weight , aerobic fitness , and blood pressure . In a sub sample , tumor necrosis factor alpha , interleukin-6 , C-reactive protein , and adiponectin were also assessed . Subjects were r and omly assigned to 12-weeks of aerobic exercise ( EX ) using DDR or to a non-exercising delayed-treatment control group ( DTC ) . RESULTS EX had significant improvements in FMD ( 5.56+/-5.04 % compared with 0.263+/-4.54 % , p=0.008 ) , exercise time on the grade d exercise test ( 53.59+/-91.54 compared with -12.83+/-68.10 seconds , p=0.025 ) , mean arterial pressure ( MAP ) ( -5.62+/-7.03 compared with -1.44+/-2.16 mmHg , p=0.05 ) , weight ( 0.91+/-1.53 compared with 2.43+/-1.80 kg , p=0.017 ) and peak VO(2 ) ( 2.38+/-3.91 compared with -1.23+/-3.18 mg/kg/min , p=0.005 ) compared with the DTC . Thirteen EX subjects achieved normal EDF while ten did not . These groups differed at baseline with regard to total cholesterol ( TC ) and low-density lipoprotein ( LDL ) . CONCLUSION Twelve weeks of DDR-use improved FMD , aerobic fitness , and MAP in overweight children . Improvements occurred without changes in inflammatory markers or nitric oxide production . The results document the need to explore relationships between obesity , endothelial function , inflammation , lipids , exercise intensity , and gender in a larger sample of overweight children",
"BACKGROUND Childhood obesity has become a growing public health issue in Taiwan . Obese children have risk factors for type 2 diabetes and cardiovascular disease . In this prospect i ve study , we investigated the effect of a twelve-week heart health education and physical activity program on body weight and risk factors for type 2 diabetes and cardiovascular disease . METHODS Subjects were 120 obese fifth grade rs ( 65 boys and 55 girls , aged 10 - 13 years ( mean 10.6 yrs ) , body mass index ( BMI ) at the 95th percentile or more ) and were r and omly assigned to an intervention group ( n=60 ) or control group ( n=60 ) . The intervention group received a twelve-week heart health education and physical activity program , while the control group did not . In both groups , a series of examinations were done at baseline and post-test , including height , weight , BMI , body fat , blood pressure ( BP ) , physical fitness ( 800-meter running test ) , heart health knowledge , and serum biochemistry . Differences for baseline and post-test data were compared between both groups . RESULTS Mean changes in the intervention group versus control group were significant for weight ( P = 0.024 ) , BMI ( P = 0.047 ) , percentage body fat ( P = 0.008 ) , physical fitness ( 800-meter running test ) ( P = 0.025 ) , heart health knowledge ( P = 0.006 ) , total cholesterol ( P = 0.027 ) , triglycerides ( P = 0.018 ) , high-density lipoprotein cholesterol ( HDL-C ) ( P = 0.009 ) , low-density lipoprotein cholesterol ( LDL-C ) ( P = 0.041 ) , sugar ( P = 0.035 ) , insulin ( P = 0.007 ) , and insulin resistance ( HOMA-IR ) ( P = 0.028 ) . At post-test , weight , BMI , body fat , total cholesterol , triglycerides , LDL-C , sugar , insulin and HOMA-IR had decreased , but HDL-C had increased in the intervention group . CONCLUSIONS A classroom-based weight-control intervention provides educational programs to promote cardiovascular health in children . This intervention is simple , practical , and beneficial for elementary school children",
"OBJECTIVES To determine the relation of hemostatic markers to cardiovascular fitness and adiposity and the effect of physical training ( PT ) on these markers . STUDY DESIGN Seventy-four obese teenagers were r and omly assigned to 8 months of lifestyle education ( LSE ) , LSE plus moderate-intensity PT , or LSE plus high-intensity PT . Measures included fibrinogen , plasminogen activator inhibitor-1 ( PAI-1 ) , D-dimer , C-reactive protein ( CRP ) , fitness , percent body fat ( % BF ) , and visceral adiposity ( VAT ) . RESULTS At baseline , fibrinogen and CRP were significantly correlated with % BF and VAT ( 0.27 fitness ( r = -0.39 , r = -0.43 , respectively ) ; PAI-1 with % BF ( r = 0.30 ) and VAT ( r = 0.48 ) ; D-dimer with fitness ( r = -0.24 ) . Although PT produced significant changes in fitness and adiposity , there were no significant group differences in the hemostatic markers . Change in PAI-1 was significantly correlated with its baseline value ( r = -0.47 ) and change in % BF ( r = 0.38 ) . Changes in D-dimer and CRP were significantly correlated with their respective baseline values ( r = -0.68,r = -0.48 , respectively ) . CONCLUSIONS Unfavorable levels of fitness and adiposity were associated with higher levels of hemostatic markers , putting individuals with this profile at greater risk for future cardiovascular disease . No evidence was provided that 8 months of PT had a direct influence on these markers in obese youths",
"The objective of this study was to investigate the effect of an 8-week aerobic-exercise training program on ventilatory threshold and ventilatory efficiency in overweight children . Twenty overweight children ( BMI > 85th percentile ) performed a grade d cycle exercise test at baseline and were then r and omly assigned to 8 weeks of stationary cycling ( n = 10 ) or a nonexercising control group ( n = 10 ) . Ventilatory variables were examined at ventilatory threshold ( VT ) , which was determined via the Dmax method . After 8 weeks , significant improvements occurred in the exercise group compared with the control group for oxygen uptake at VT ( exercise = 1.03 + /- 0.13 to 1.32 + /- 0.12 L/min vs. control = 1.20 + /- 0.10 to 1.11 + /- 0.10 L/min , p ventilatory equivalent of carbon dioxide ( VE/VCO2 ) at VT ( exercise = 32.8 + /- 0.80 to 31.0 + /- 0.53 vs. control = 30.3 + /- 0.88 to 31.7 + /- 0.91 , p Aerobic-exercise training might help reverse the decrements in cardiopulmonary function observed over time in overweight children"
] | 4116784c-06ff-11f0-808a-c43d1ab1c353 |
Purpose This systematic review investigates the effectiveness of workplace interventions to rehabilitate musculoskeletal disorders ( MSDs ) among employees with physically dem and ing work . Methods A systematic search was conducted in bibliographic data bases including PubMed and Web of Science Core Collection for English articles published from 1998 to 2018 . The PICO strategy guided the assessment of study relevance and the bibliographical search for r and omized controlled trials ( RCTs ) and non- RCTs in which ( 1 ) participants were adult workers with physically dem and ing work and MSD ( including specific and non-specific MSD and musculoskeletal pain , symptoms , and discomfort ) , ( 2 ) interventions were initiated and /or carried out at the workplace , ( 3 ) a comparison group was included , and ( 4 ) a measure of MSD was reported ( including musculoskeletal pain , symptoms , prevalence or discomfort ) . The quality assessment and evidence synthesis adhered to the guidelines developed by the Institute for Work & Health ( Toronto , Canada ) focusing on developing practical recommendations for stakeholders . Relevant stakeholders were engaged in the review process . Results Level of evidence from 54 high and medium quality studies showed moderate evidence of a positive effect of physical exercise . Within this domain , there was strong evidence of a positive effect of workplace strength training . There was limited evidence for ergonomics and strong evidence for no benefit of participatory ergonomics , multifaceted interventions , and stress management . No intervention domains were associated with “ negative effects ” . Conclusions The evidence synthesis recommends that implementing strength training at the workplace can reduce MSD among workers with physically dem and ing work . In regard to workplace ergonomics , there was not enough evidence from the scientific literature to guide current practice s. Based on the scientific literature , participatory ergonomics and multifaceted workplace interventions seem to have no beneficial effect on reducing MSD among this group of workers . As these interventional domains were very heterogeneous , it should also be recognized that general conclusions about their effectiveness should be done with care . Systematic review registration PROSPERO CRD42018116752 ( https://www.crd.york.ac.uk/ prospero /display_record.php?RecordID=116752 ) | [
"OBJECTIVE Numerous studies has shown that regular physical exercise can reduce musculoskeletal pain , but the optimal setting to achieve high adherence and effectiveness remains unknown . This study investigated the effect of workplace versus home-based physical exercise on musculoskeletal pain among healthcare workers . METHODS The r and omized controlled trial ( RCT ) comprised 200 female healthcare workers from 18 departments at 3 hospitals . Participants were r and omly allocated at the cluster level to ten weeks of : ( i ) workplace physical exercise ( WORK ) performed during working hours for 5 × 10 minutes per week and up to 5 group-based coaching sessions on motivation for regular physical exercise , or ( ii ) home-based physical exercise ( HOME ) performed during leisure time for 5 × 10 minutes per week . Both groups received ergonomic counseling on patient h and ling and use of lifting aides . Average pain intensity ( 0 - 10 scale ) in the low back and neck/shoulder was the primary outcome . RESULTS Per week , 2.2 ( SD 1.1 ) and 1.0 ( SD 1.2 ) training sessions were performed in WORK and HOME groups , respectively . Pain intensity , back muscle strength and use of analgesics improved more following WORK than HOME ( P for pain intensity [ 95 % confidence interval ( 95 % CI ) -1.0- -0.3 ] , 5.5 Nm for back muscle strength ( 95 % CI 2.0 - 9.0 ) , and -0.4 days per week for use of analgesics ( 95 % CI -0.7- -0.2 ) . The effect size for between-group differences in pain intensity was small ( Cohen 's d=0.31 ) . CONCLUSIONS Workplace physical exercise is more effective than home-based exercise in reducing musculoskeletal pain , increasing muscle strength and reducing the use of analgesics among healthcare workers",
"The aim of the present study was to compare the effect of increased aerobic capacity versus muscle strength rehabilitation of female hospital staff with long-lasting musculoskeletal back pain . Seventy-nine women agreed to participate in the intervention study . After a medical examination , 65 individuals were assigned to one of three balanced groups : Endurance training ( aerobic capacity promoting training : ET : n = 22 ) , strength promotion exercise ( SP : n = 24 ) or a control group ( CON : n = 19 ) . The active groups met twice a week for 60 minutes of exercise over 15 weeks . Aerobic capacity ( VO2max ) and musculoskeletal pain were measured immediately before ( T1 ) and after the intervention period ( T2 ) . Aerobic capacity significantly increased in the ET group , whereas no change was observed in the SP group , and a significant reduction was found in the CON group from T1 to T2 . Musculoskeletal pain was significantly reduced in both intervention groups , whereas minor changes were observed in the control group . Results from a 7-month follow-up ( T3 ) survey confirmed the beneficial effects of interventions on musculoskeletal pain . In conclusion , improved aerobic capacity appeared not to be a necessary mechanism in musculoskeletal back pain reduction",
"Objective : To examine the effects of a new wearable type of lumbosacral support on low back pain . Methods : A total of 121 healthcare workers participated in this study . They were r and omly allocated into the experimental and control groups and the former wore the support with signals of compression on the back by poor posture for the first 3 months . The control group remained on a waiting list for the first 3 months . Medical history , musculoskeletal symptoms , feeling in good posture , sleep habits , psychological distress , Rol and -Morris Disability Question naire , and Somatosensory Amplification Scale ( SSAS ) were evaluated . The range of motion ( ROM ) in the shoulder and hip joints as well as spinal alignment were evaluated . Our primary concern was the difference in the change of low back pain measured by visual analog scale ( VAS ) between the two groups . Results : A total of 54 participants in the experimental and 53 participants in the control groups were analyzed . VAS and SSAS scores as well as lumbar spinal ROM in the experimental group significantly decreased . Low back pain ( OR=0.401 , 95 % CI=0.168 - 0.954 ) and neck pain in the experimental group ( OR=0.198 , 95 % CI=0.052 - 0.748 ) significantly decreased . Conclusions : The new lumbar support reduced VAS and SSAS scores , lumbar spinal ROM , low back pain , and neck pain . This new type of lumbar support reduced low back pain among healthcare workers",
"AIMS AND OBJECTIVES ( i ) To examine patient lifting techniques used by nurses , and ( ii ) to evaluate an effectiveness of the Spine Care for Nurses programme in chronic nonspecific low back pain syndrome reduction and the execution of proper patient lifting techniques . BACKGROUND Millions of nurses around the world suffer from occupational-related chronic nonspecific low back pain ( chronic nonspecific low back pain syndrome ) . Generally , low back pain in nurses is a result of increased pressure on the spine and can be associated with improperly conducted patient lifting techniques . METHODS A r and omised controlled trial was conducted among 137 nurses with chronic nonspecific low back pain syndrome . Participants were r and omised into an experimental and control group ( experimental group n = 67 , control group n = 70 ) . Nurses in the experimental group attended the Spine Care for Nurses programme for 3 months . The programme consisted of didactic education , spine-strengthening exercises and education on safe patient h and ling techniques . The control group only received a brief written lifestyle guidance . The Zebris WinSpine Triple Lumbar examination was used to analyse nurses ' patient lifting techniques ( horizontal and vertical lifting ) . The lumbar pain intensity was measured with a 0 - 100 visual analogue scale . RESULTS The pre-intervention average chronic nonspecific low back pain syndrome intensity score on visual analogue scale decreased from 49.3 to the postintervention score of 7.5 . The correct execution of vertical lifting techniques in the experimental group increased from 8.91%-97.01 % ( control group : 8.57 % pre-intervention test and postintervention test 11.42 % ) . The horizontal patient lifting technique pre-intervention increased from 10.44%-100 % correct execution in the experimental group ( control group : pre-intervention test 10.00 % and postintervention test 11.42 % ) . CONCLUSION The Spine Care for Nurses programme significantly reduced chronic nonspecific low back pain syndrome and increased the number of properly executed horizontal and vertical patient lifting techniques in nurses . RELEVANCE TO CLINICAL PRACTICE We recommend that healthcare organisations should consider the implementation of regular Spine Care for Nurses programmes as successful low back injury prevention programmes",
"OBJECTIVES To evaluate effects of a PRECEDE-PROCEED Model based , nurse-delivered Ergonomic Risk Management Program ( ERMP ) in the aim of reducing musculoskeletal symptoms of intensive care unit ( ICU ) nurses . METHODS This pre-test post-test design for non-equivalent control groups study comprised 72 ICU nurses from two hospitals . A r and omised sampling was done through the study population . The ERMP was delivered as an intervention including 26weeks of follow-up . Data was collected by \" Descriptives of Nurses and Ergonomic Risk Reporting Form \" , \" Rapid Upper Risk Assessment Form ( RULA ) \" , \" ICU Environment Assessment Form \" and \" Personal interviews form \" . RESULTS There was no difference between sociodemographic characteristics , work and general health conditions within intervention and control group . One month after the intervention , nurses had significant decrease in their total RULA scores during bending down and patient repositioning movements as 1.40 and 0.82 , respectively . Six months after the ERMP , the mean total RULA scores of nurses during the patient repositioning was 4.39±1.49 which meant \" immediate further analyses and modifications recommended \" . After all , pain intensity scores , medication use due to pain , and RULA ergonomic risk scores were significantly decreased , while exercise frequency was increased . CONCLUSIONS The ERMP was effective to increase exercise frequency and to decrease musculoskeletal pain and ergonomic risk levels of ICU nurses",
"Background Construction work frequently involves heavy physical work , and a reduction of the physical workload should have high priority . Technological development has made it possible to obtain field measurements with surface electromyography ( sEMG ) , kinematics measured with inertial measurement units ( IMUs ) , and video recordings . However , no studies have used these methods simultaneously to detect situations with excessive physical workload ( events ) during a working day . Thus , knowledge about these specific events may combat work-related risk factors . Participatory ergonomics ( PE ) has shown promising results , but whether it can be used as a tool to reduce the physical workload during construction work remains unknown . Objective This cluster r and omized controlled trial investigated whether a PE intervention with technical measurements consisting of IMUs , sEMG , heart rate monitoring , and video recordings of physical workload could reduce the number of events with excessive physical workload during a working day . Furthermore , other outcomes were obtained from question naires . Methods A total of 80 male full-time construction workers ( aged 19 to 67 years ) were r and omized at the cluster level ( gang ) to a PE intervention consisting of 3 workshops ( 7 gangs and 32 workers ) or to a control group ( 8 gangs and 48 workers ) . The physical workload was recorded by technical measurements , that is , IMUs , sEMG , heart rate monitoring , and video recordings during a full working day at baseline and 3 and 6 months ’ follow-up . On the basis of the technical measurements , a custom-made computer program detected the situations ( events ) where the construction workers were exposed to excessive physical workload and used in the intervention . Differences in the number of events from baseline to follow-up between intervention and control were evaluated using linear mixed models ( intention-to-treat ) , with individual nested in cluster as a r and om factor . Furthermore , question naires were filled out on test days . Results The results of the primary outcome showed no change in the number of events with excessive physical workload . However , compared with the control group , the other outcomes showed decreased general fatigue after a typical working day ( P=.001 ) and increased influence on own work ( P=.04 ) . Conclusions This PE intervention with technical measurements did not reduce the number of events with excessive physical workload during construction work . However , the intervention led to decreased general fatigue and increased influence on own work . Trial Registration Clinical Trials.gov NCT02498197 ; https:// clinical trials.gov/ct2/show/NCT02498197 ( Archived by WebCite at http://www.webcitation.org/74SZ3DIWS",
"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",
"OBJECTIVE Low-back pain ( LBP ) is a common and recurrent condition , but the evidence is scarce about effective strategies to prevent recurrence and disability in the longer term . This study investigated the effect of a light exercise program , initiated in the workplace and continued at home , in reducing recurrence of LBP episodes among healthcare workers . METHODS A total of 353 healthcare workers from ten hospitals were enrolled in a r and omized controlled trial ( RCT ) and were r and omized to the intervention or control groups , the latter of which received usual care . The intervention comprised three steps : ( i ) a 2-hour education session , ( ii ) five weekly 90-minutes exercise training sessions in the workplace , and ( iii ) a home-based self-managed exercise program . The main outcome was recurrence of LBP with sick-leave at 24-months follow-up . RESULTS At two-year follow-up , 35 workers ( 24 % ) in the intervention group and 31 workers ( 21 % ) in the control group had at least one LBP recurrence with sick leave . No effect was observed between groups [ odds ratio ( OR ) 1.22 , 95 % confidence interval ( 95 % CI ) 0.67 - 2.23 , P=0.516 ] . The intervention was effective in reducing fear avoidance with a mean reduction of -3.6 ( 95 % CI -4.8- -2.4 ) points on the fear-avoidance beliefs question naire score for physical activity ( FABQ-P ) in the intervention group compared with -1.3 ( 95 % CI -2.2- -0.3 ) points in the control group ( P improving muscle endurance with a mean increase of 13.9 ( 95 % CI 3.3 - 24.5 ) minutes on the Sorensen test in the intervention group compared with -8.3 ( 95 % CI-17.5 - 0.9 ) minutes in the control group ( P Healthcare utilization was reduced in the intervention group for painkillers , medical visits , imaging and outpatient physiotherapy . CONCLUSION It was not possible to conclude about the effectiveness of a light exercise program to reduce LBP recurrence episodes in the long-term in healthcare workers . However , it was effective to improve muscle endurance , and to reduce fear-avoidance beliefs and healthcare utilization . Further studies are necessary in order to identify effective interventions to reduce LBP recurrence and related sick-leaves",
"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",
"Background Health care workers comprise a high-risk workgroup with respect to deterioration and early retirement . There is high prevalence of obesity and many of the workers are overweight . Together , these factors play a significant role in the health-related problems within this sector . The present study evaluates the effects of the first 3-months of a cluster r and omized controlled lifestyle intervention among health care workers . The intervention addresses body weight , general health variables , physical capacity and musculoskeletal pain . Methods 98 female , overweight health care workers were cluster-r and omized to an intervention group or a reference group . The intervention consisted of an individually dietary plan with an energy deficit of 1200 kcal/day ( 15 min/hour ) , strengthening exercises ( 15 min/hour ) and cognitive behavioral training ( 30 min/hour ) during working hours 1 hour/week . Leisure time aerobic fitness was planned for 2 hour/week . The reference group was offered monthly oral presentations . Body weight , BMI , body fat percentage ( bioimpedance ) , waist circumference , blood pressure , musculoskeletal pain , maximal oxygen uptake ( maximal bicycle test ) , and isometric maximal muscle strength of 3 body regions were measured before and after the intervention period . Results In an intention-to-treat analysis from pre to post tests , the intervention group significantly reduced body weight with 3.6 kg ( p BMI from 30.5 to 29.2 ( p body fat percentage from 40.9 to 39.3 ( p waist circumference from 99.7 to 95.5 cm ( p blood pressure from 134/85 to 127/80 mmHg ( p musculoskeletal pain , maximal oxygen uptake and muscle strength , but on aerobic fitness . Conclusion The significantly reduced body weight , body fat , waist circumference and blood pressure as well as increased aerobic fitness in the intervention group show the great potential of workplace health promotion among this high-risk workgroup . Long-term effects of the intervention remain to be investigated . Trial registration Clinical Trials.gov :",
"AIM This paper is the report of a pilot study to assess if an Integrated Health Programme would reduce sick leave and subjective health complaints , and increase coping in a population of nursing personnel . BACKGROUND . The work group in Norway with most sick leave is healthcare workers . More than 50 % of the sick leave is because of subjective health complaints . Work place physical exercise interventions have a documented positive effect on sick leave . METHOD After baseline screening , employees who had agreed to participate ( n=40 ) were r and omized to an intervention or control group . The intervention group participated in an Integrated Health Programme twice weekly during working hours . The programme consisted of physical exercise , stress management training , health information and an examination of the participants ' workplace . The control group was offered the same intervention after the project was finished . This study was carried out from 2001 to 2002 . FINDINGS There were no statistically significant effects on sick leave or health-related quality of life . The intervention group reported fewer neck complaints compared to the control group , but otherwise there were no effects on subjective health complaints . However , the subjective effects were large and highly statistically significant , the intervention group reporting improvement in health , physical fitness , muscle pain , stress management , maintenance of health and work situation . CONCLUSION The Integrated Health Programme was not effective in reducing sick leave and subjective health complaints , but may be of use to employers wanting to increase employee job satisfaction and well-being",
"Aim : To investigate low back pain ( LBP ) , with and without other musculoskeletal pains , as a predictor of long-term work disability . Method : A four-year prospect i ve study was conducted . All inhabitants in the municipality of Ullensaker , Norway , born in 1928 - 30 , 1938 - 40 , 1948 - 50 , 1958 - 60 and 1968 - 70 , received a mailed question naire in 1990 and 1994 . The present study comprised the 1,788 responders who were working in 1990 . Of these , 1426 ( 80 % ) returned the question naire four years later . The main outcome measure was long-term work disability ( > eight weeks ) in 1994 . Results : LBP in 1990 predicted long-term work disability in 1994 ( odds ratio ( OR ) = 1.95 , 95 % confidence interval (CI)= 1.39- 2.74 ) . Localized LBP however , did not predict long-term work disability , while LBP accompanied by widespread pain did ( OR= 3.52 , 95 % CI = 1.09- 11.37 ) , also after adjustments for demographic , lifestyle , and work-related factors . Other predictors of long-term work disability were high age , sick leave last year , heavy lifting in the job , poor sleep quality and smoking . Conclusion : LBP in persons with widespread musculoskeletal pain predicted long-term work disability , while localized LBP did not",
"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",
"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",
"Topical menthol gels are classified “ topical analgesics ” and are cl aim ed to relieve minor aches and pains of the musculoskeletal system . In this study we investigate the acute effect of topical menthol on carpal tunnel syndrome ( CTS ) . We screened 645 slaughterhouse workers and recruited 10 participants with CTS and chronic pain of the arm/h and who were r and omly distributed into two groups to receive topical menthol ( Biofreeze ) or placebo ( gel with a menthol scent ) during the working day and 48 hours later the other treatment ( crossover design ) . Participants rated arm/h and pain intensity during the last hour of work ( scale 0–10 ) immediately before 1 , 2 , and 3 hours after application . Furthermore , global rating of change ( GROC ) in arm/h and pain was assessed 3 hours after application . Compared with placebo , pain intensity and GROC improved more following application of topical menthol ( P = 0.026 and P = 0.044 , resp . ) . Pain intensity of the arm/h and decreased by −1.2 ( CI 95 % : −1.7 to −0.6 ) following topical menthol compared with placebo , corresponding to a moderate effect size of 0.63 . In conclusion , topical menthol acutely reduces pain intensity during the working day in slaughterhouse workers with CTS and should be considered as an effective nonsystemic alternative to regular analgesics in the workplace management of chronic and neuropathic pain",
"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",
"Abstract This study established the effectiveness of a workplace multifaceted intervention consisting of participatory ergonomics , physical training , and cognitive – behavioural training ( CBT ) for low back pain ( LBP ) . Between November 2012 and May 2014 , we conducted a pragmatic stepped wedge cluster r and omised controlled trial with 594 workers from eldercare workplaces ( nursing homes and home care ) r and omised to 4 successive time periods , 3 months apart . The intervention lasted 12 weeks and consisted of 19 sessions in total ( physical training [ 12 sessions ] , CBT [ 2 sessions ] , and participatory ergonomics [ 5 sessions ] ) . Low back pain was the outcome and was measured as days , intensity ( worst pain on a 0 - 10 numeric rank scale ) , and bothersomeness ( days ) by monthly text messages . Linear mixed models were used to estimate the intervention effect . Analyses were performed according to intention to treat , including all eligible r and omised participants , and were adjusted for baseline values of the outcome . The linear mixed models yielded significant effects on LBP days of −0.8 ( 95 % confidence interval [ CI ] , −1.19 to −0.38 ) , LBP intensity of −0.4 ( 95 % CI , −0.60 to −0.26 ) , and bothersomeness days of −0.5 ( 95 % CI , −0.85 to −0.13 ) after the intervention compared with the control group . This study shows that a multifaceted intervention consisting of participatory ergonomics , physical training , and CBT can reduce LBP among workers in eldercare . Thus , multifaceted interventions may be relevant for improving LBP in a working population",
"Objectives Although the importance of stretching exercise for pain-relieving and patient education is well documented for chronic lumbago patients , it is uncertain how effective on-the-job training ( OJT ) is for female caregivers in nursing homes . In the present pilot trial based on multicenter r and omization , we evaluated the intervention effect of a lecture and stretching exercise on caregivers in nursing homes . Methods Eighty-eight female caregivers ( four nursing homes ) volunteered to participate in this study , and they were separated into two groups r and omly . For the intervention group , guidance by an orthopedist and an exercise instructor were provided as one OJT , and stretching exercises for only 6 min every day were recommended for low back pain prevention to the caregivers . Low back pain visual analogue scale ( VAS ) , physical fitness , and mental and physical health were compared at baseline and immediately after the intervention . Results A total of 29 ( 33 % ) participants withdrew by 12 weeks . Regarding the reasons for withdrawal , 28 participants resigned , and one took a leave of absence due to exacerbation of lumbago . Adherence to the stretching exercises was 2.3 ± 1.3 ( mean ± SD ) times per week . No significant differences were seen for any outcome measurements . The high adherence group ( ≧3 times per week ) did not show a change in the VAS , but the low adherence group ( one OJT , and exercises of only 6 min every day , the adherence of caregivers was low , and there appeared to be few effects of the OJT",
"Purpose The objective of the present study is to investigate the effects of a worksite health promotion intervention on musculoskeletal symptoms , physical functioning , work ability , work-related vitality , work performance , and sickness absence . Methods In a r and omized controlled design , 314 construction workers were r and omized into an intervention group ( n = 162 ) receiving personal coaching , tailored information , and material s , and a control group ( n = 152 ) receiving usual care . Sickness absence was recorded continuously in company records , and question naires were completed before , directly after the 6-month intervention period , and 12 months after baseline measurements . Linear and logistic regression analyses were performed to determine intervention effects . Results No significant changes at 6 or 12 months of follow-up were observed in musculoskeletal symptoms , physical functioning , work ability , work-related vitality , work performance , and sickness absence as a result of the intervention . Conclusions This study shows that the intervention was not statistically significantly effective on secondary outcomes . Although the intervention improved physical activity , dietary , and weight-related outcomes , it was not successful in decreasing musculoskeletal symptoms and improving other work-related measures . Presumably , more multifaceted interventions are required to establish significant change in these outcomes",
"OBJECTIVE This study aim ed to investigate the effectiveness of a prevention program on work ability , health , and sick leave targeted at construction worksites . METHODS A total of 15 departments ( N = 297 workers ) from 6 construction companies participated in this cluster r and omized controlled trial and were r and omly allocated to the intervention ( 8 departments ; N = 171 workers ) or control ( 7 departments ; N = 122 workers ) group . The intervention consisted of two individual training sessions with a physical therapist aim ed at lowering the physical workload , a rest-break tool to improve the balance between work and recovery , and two empowerment training sessions to increase the worker 's influence at the worksite . Data on work ability , physical and mental health status , and musculoskeletal symptoms were collected at baseline , and at 3 , 6 , and 12 months follow-up . Sick leave data were obtained from the companies . RESULTS Overall , no differences in work ability [ β 0.02 , 95 % confidence interval ( 95 % CI ) -0.34 - 0.37 ] or physical and mental health status ( β -0.04 , 95 % CI -1.43 - 1.35 , and β 0.80 95 % CI -0.51 - 2.11 , respectively ) were found between the intervention and control group . The intervention showed an overall decline in musculoskeletal symptoms ( ranging from OR 0.68 , 95 % CI 0.34 - 1.33 , to OR 0.86 , 95 % CI 0.47 - 1.57 ) and long-term sick leave ( OR 0.44 , 95 % CI 0.13 - 1.26 ) among construction workers . Both reductions were not statistically significant . CONCLUSION The prevention program seemed to result in a beneficial but not statistically significant decline in the prevalence of musculoskeletal symptoms and long-term sick leave among construction workers , but showed no effects with regard to work ability , physical health , and mental health",
"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",
"The prevalence and incidence of low back pain in general society is high . Workers whose job involves walking long distances have an even higher tendency to suffer from low back pain . A positive effect of insoles in reducing low back pain was found in professional sports players . This was not examined on people whose job involves walking long distances . In this double blind prospect i ve study we examined the effectiveness of insoles constructed in a computerized method to placebo insoles in 58 employees whose work entailed extensive walking and who suffered from low back pain . The evaluation was performed by the MILLION question naire , which is considered as a valid question naire for evaluation of low back pain . We calculated the differences of the pain intensity before and after the intervention , in the employees using the insoles manufactured by computer in comparison to the users of the placebo insoles . In each group , the analysis was performed in comparison to the baseline . A total of 81 % of the employees preferred the real insoles as effective and comfortable in comparison to 19 % of the users of the placebo insoles ( P in the low back pain after the use of the true insoles . The average pain intensity according to the MILLION question naire before the use of the insoles was 5.46 . However , after the use of the real insoles and the placebo insoles , the average pain intensity decreased to 3.96 and 5.11 , respectively . The difference of the average pain intensity at the start of the study and after the use of the real insoles was significant : −1.49 ( P=0.0001 ) , whereas this difference after the use of the placebo insoles was not significant : −0.31 ( P=0.1189 ) . The reported severity of pain also decreased significantly : a level 5 pain and above was reported by 77 % of the subjects at the start of the study . After the use of the real insoles only 37.9 % of the subjects reported a similar degree of pain severity , and 50 % of the subjects did so after the use of the placebo insoles ( P number of offspring , work seniority , smoking , previous use of insoles and previous medication . This study demonstrates that the low back pain decreased significantly after the use of real insoles compared to placebo ones",
"BACKGROUND Chronic pain and disability of the arm , shoulder , and h and severely affect labor market participation . Ergonomic training and education is the default strategy to reduce physical exposure and thereby prevent aggravation of pain . An alternative strategy could be to increase physical capacity of the worker by physical conditioning . OBJECTIVES To investigate the effect of 2 contrasting interventions , conventional ergonomic training ( usual care ) versus resistance training , on pain and disability in individuals with upper limb chronic pain exposed to highly repetitive and forceful manual work . STUDY DESIGN Examiner-blinded , parallel-group r and omized controlled trial with allocation concealment . SETTING Slaughterhouses located in Denmark , Europe . METHODS Sixty-six adults with chronic pain in the shoulder , elbow/forearm , or h and /wrist and work disability were r and omly allocated to 10 weeks of specific resistance training for the shoulder , arm , and h and muscles for 3 x 10 minutes per week , or ergonomic training and education ( usual care control group ) . Pain intensity ( average of shoulder , arm , and h and , scale 0 - 10 ) was the primary outcome , and disability ( Work module of DASH question naire ) as well as isometric shoulder and wrist muscle strength were secondary outcomes . RESULTS Pain intensity , disability , and muscle strength improved more following resistance training than usual care ( P Pain intensity decreased by 1.5 points ( 95 % confidence interval -2.0 to -0.9 ) following resistance training compared with usual care , corresponding to an effect size of 0.91 ( Cohen 's d ) . LIMITATIONS Blinding of participants is not possible in behavioral interventions . However , at baseline outcome expectations of the 2 interventions were similar . CONCLUSION Resistance training at the workplace results in clinical relevant improvements in pain , disability , and muscle strength in adults with upper limb chronic pain exposed to highly repetitive and forceful manual work . TRIAL REGISTRATION NCT01671267",
"The aim of this study was to evaluate the effect of a transfer technique education programme ( TT ) alone or in combination with physical fitness training ( TTPT ) compared with a control group , who followed their usual routine . Eleven clinical hospital wards were cluster r and omised to either intervention ( six wards ) or to control ( five wards ) . The intervention cluster was individually r and omised to TT ( 55 nurses ) and TTPT ( 50 nurses ) , control ( 76 nurses ) . The transfer technique programme was a 4-d course of train-the-trainers to teach transfer technique to their colleagues . The physical training consisted of supervised physical fitness training 1 h twice per week for 8 weeks . Implementing transfer technique alone or in combination with physical fitness training among a hospital nursing staff did not , when compared to a control group , show any statistical differences according to self-reported low back pain ( LBP ) , pain level , disability and sick leave at a 12-month follow-up . However , the individual r and omised intervention subgroup ( transfer technique/physical training ) significantly improved the LBP-disability ( p = 0.001 ) . Although weakened by a high withdrawal rate , teaching transfer technique to nurses in a hospital setting needs to be thoroughly considered . Other priorities such as physical training may be taken into consideration . The current study supports the findings of other studies that introducing transfer technique alone has no effect in targeting LBP . However , physical training seems to have an influence in minimising the LBP consequences and may be important in the discussion of how to prevent LBP or the recurrence of LBP among nursing personnel",
"OBJECTIVE The aim of this trial was to investigate the effectiveness of a worksite intervention using kettlebell training to improve musculoskeletal and cardiovascular health . METHODS This single-blind r and omized controlled trial involved 40 adults from occupations with a high prevalence of reported musculoskeletal pain symptoms ( mean age 44 years , body mass index 23 kg/m² , 85 % women , with pain intensity of the neck/shoulders 3.5 and of the low back 2.8 on a scale of 0 - 10 ) . A blinded assessor took measures at baseline and follow-up . Participants were r and omly assigned to training -- consisting of ballistic full-body kettlebell exercise 3 times per week for 8 weeks -- or a control group . The main outcome measures were pain intensity of the neck/shoulders and low back , isometric muscle strength , and aerobic fitness . RESULTS Compared with the control group , pain intensity of the neck/shoulders decreased 2.1 points [ 95 % confidence interval ( 95 % CI ) -3.7- -0.4 ] and pain intensity of the low back decreased 1.4 points ( 95 % CI -2.7- -0.02 ) in the training group . Compared with the control group , the training group increased muscle strength of the trunk extensors ( P trunk flexors and shoulders . Aerobic fitness remained unchanged . CONCLUSIONS Worksite intervention using kettlebell training reduces pain in the neck/shoulders and low back and improves muscle strength of the low back among adults from occupations with a high prevalence of reported musculoskeletal pain symptoms . This type of training does not appear to improve aerobic fitness",
"BACKGROUND Hospital workers with physically dem and ing jobs are at risk for developing recurrent LBP . There is a lack of studies evaluating multidisciplinary prevention of low back pain ( LBP ) in hospital workers . OBJECTIVE This r and omized controlled trial evaluates the effect of a multidisciplinary prevention program , focusing on a client-centred approach , on hospital workers at risk for developing LBP . METHODS Caregiving hospital workers were allocated to an experimental ( 12-week lasting multidisciplinary prevention program ) or control group ( no intervention ) . They were evaluated prior to the intervention and after a 6 months follow-up period . Primary outcome measures included incidence of LBP , work absenteeism and general health . Secondary outcomes included daily physical activity , job satisfaction and coping strategies . RESULTS A significant improvement was seen for passive coping after 6 months follow-up , but no significant differences were observed between groups in primary or other secondary outcome measures ( p > 0.05 ) . CONCLUSIONS A multidisciplinary prevention program fitting into a bio-psychosocial context may not have been intensive enough to promote a change in daily habitudes , and had no effect on work absenteeism , incidence of LBP or general health . Further research should determine whether prevention of LBP is possible in caregiving personnel",
"Objectives : To examine the efficacy of a participatory ergonomics intervention in preventing musculoskeletal disorders among kitchen workers . Participatory ergonomics is commonly recommended to reduce musculoskeletal disorders , but evidence for its effectiveness is sparse . Methods : A cluster r and omised controlled trial among the 504 workers of 119 kitchens in Finl and was conducted during 2002–2005 . Kitchens were r and omised to an intervention ( n = 59 ) and control ( n = 60 ) group . The duration of the intervention that guided the workers to identify strenuous work tasks and to seek solutions for decreasing physical and mental workload , was 11 to 14 months . In total , 402 ergonomic changes were implemented . The main outcome measures were the occurrence of and trouble caused by musculoskeletal pain in seven anatomical sites , local fatigue after work , and sick leave due to musculoskeletal disorders . Individual level data were collected by a question naire at baseline and every 3 months during the intervention and 1-year follow-up period . All response rates exceeded 92 % . Results : No systematic differences in any outcome variable were found between the intervention and control groups during the intervention or during the 1-year follow-up . Conclusions : The intervention did not reduce perceived physical work load and no evidence was found for the efficacy of the intervention in preventing musculoskeletal disorders among kitchen workers . It may be that a more comprehensive re design of work organisation and processes is needed , taking more account of workers ’ physical and mental re sources",
"AIM The aim was to evaluate efficacy of \" Tailored Physical Activity \" ( TPA ) versus a reference group ( REF ) in reducing the number of self-reported days of sickness absence for health care workers in the Sonderborg Municipality . METHODS In this r and omised controlled trial , all participants ( n = 54 ) received health guidance for 1.5 h and were r and omised to TPA or REF . The primary aim was to make a comparison of participants ' self-reported sickness absence due to musculoskeletal troubles measured three months after baseline . Secondary outcomes included anthropometric , health-related and physical capacity measures . RESULTS A TPA intervention was not significantly more effective than REF in reducing sickness absence caused by musculoskeletal troubles . However , there were significant improvements for TPA participants compared to REF in reducing pain intensity from 47.9 mm to 21.8 mm ( p work ability from 7.3 to 8.1 ( p = .04 ) and decreasing kinesiophobia from 26.7 to 22.5 ( p aerobic capacity while no effect of the intervention was found on productivity , BMI or grip strength . CONCLUSION This physical activity intervention is a promising initiative for health care workers since participants achieved a substantial effect on their experience of pain , on their work ability and on their fear of physical movement relating to pain . Moreover , a difference in aerobic capacity was apparent between the sample groups . TPA however , had no significant effect in reducing sickness absence days",
"BACKGROUND Chronic musculoskeletal pain is prevalent among laboratory technicians and work-related stress may aggravate the problem . OBJECTIVES This study investigated the effect of a multifaceted worksite intervention on pain and stress among laboratory technicians with chronic musculoskeletal pain using individually tailored physical and cognitive elements . STUDY DESIGN This trial uses a single-blind r and omized controlled design with allocation concealment in a 2-armed parallel group format among laboratory technicians . The trial \" Implementation of physical exercise at the Workplace (IRMA09)--Laboratory technicians \" was registered at Clinical Trials.gov prior to participant enrolment . SETTING The study was conducted at the head division of a large private pharmaceutical company 's research and development department in Denmark . The study duration was March 2014 ( baseline ) to July 2014 ( follow-up ) . METHODS Participants ( n = 112 ) were allocated to receive either physical , cognitive , and mindfulness group-based training ( PCMT group ) or a reference group ( REF ) for 10 weeks at the worksite . PCMT consisted of 4 major elements : 1 ) resistance training individually tailored to the pain affected area , 2 ) motor control training , 3 ) mindfulness , and 4 ) cognitive and behavioral therapy/education . Participants of the REF group were encouraged to follow ongoing company health initiatives . The predefined primary outcome measure was pain intensity ( VAS scale 0 - 10 ) in average of the regions : neck , shoulder , lower and upper back , elbow , and h and at 10 week follow-up . The secondary outcome measure was stress assessed by Cohen´s perceived stress question naire . In addition , an explorative dose-response analysis was performed on the adherence to PCMT with pain and stress , respectively , as outcome measures . RESULTS A significant ( P time interaction in pain intensity was observed with a between-group difference at follow-up of -1.0 ( 95%CI : -1.4 to -0.6 ) . No significant effect on stress was observed ( treatment by time P = 0.16 ) . Exploratory analyses for each body region separately showed significant pain reductions of the neck , shoulders , upper back and lower back , as well as a tendency for h and pain . Within the PCMT group , general linear models adjusted for age , baseline pain , and stress levels showed significant associations for the change in pain with the number of physical-cognitive training sessions per week ( -0.60 [ 95%CI -0.95 to -0.25 ] ) and the number of mindfulness sessions ( 0.15 [ 95%CI 0.02 to 0.18 ] ) . No such associations were found with the change in stress as outcome . LIMITATIONS Limitations of behavioral interventions include the inability to blind participants to which intervention they receive . Self-reported outcomes are a limitation as they may be influenced by placebo effects and outcome expectations . CONCLUSIONS We observed significant reductions in chronic musculoskeletal pain following a 10-week individually adjusted multifaceted intervention with physical training emphasizing dynamic joint mobility and mindfulness coupled with fear-avoidance and de-catastrophizing behavioral therapy compared to a reference group encouraged to follow on-going company health initiatives . A higher dose of physical-cognitive training appears to facilitate pain reduction , whereas a higher dose of mindfulness appears to increase pain . Hence , combining physical training with mindfulness may not be an optimal strategy for pain reduction . TRIAL REGISTRATION NCT02047669",
"Study Design . A cluster r and omized controlled trial and economic evaluation with a 12-month follow-up and with work department as the unit of r and omization . Objective . To evaluate the effectiveness of a prevention program for low back pain ( LBP ) in an occupational setting with an economic evaluation . Summary of Background Data . LBP accounts for high economic costs in Western societies . Little is known on the effectiveness and related costs and savings of prevention programs for LBP . Methods . The study population consisted of workers in physically dem and ing jobs from 9 large companies located throughout The Netherl and s. In each company , 2 comparable work units were r and omly allocated , result ing in 18 clusters with 258 workers assigned to the intervention group and 231 workers to the control group . Results . Results in our study did not show significant differences in effects or costs savings of the program . Indirect costs related to work absence and productivity losses accounted for the majority ( 84 % ) of total costs due to LBP . Conclusions . This study provides no evidence for the adoption of this worksite prevention program for LBP",
"Context Lumbar supports are commonly used to prevent low back pain , but evidence on their effectiveness is lacking . Contribution This trial assigned 360 home care workers with a history of low back pain to a short course on healthy work habits , with or without worker-directed use of a lumbar support . Over 12 months , participants assigned to lumbar support had a similar number of sick days but fewer days with low back pain than did those assigned to the course only . Implication Adding lumbar supports to instruction on healthy work habits may decrease low back pain recurrence , but not absenteeism , among workers with previous low back pain . The Editors Low back pain is a common problem that results in high medical expenses , work absenteeism , and disability ( 1 ) . The reported 1-year prevalence ranges from 15 % to 40 % in a general population ( 2 ) and from 44 % to 72 % among home care workers ( 3 , 4 ) . Various ergonomic aids are marketed for the prevention of low back pain . Workers frequently use lumbar supports to prevent back pain ( 5 ) , but the effectiveness of such supports remains unclear . Recent systematic review s of the sparse evidence on lumbar supports ( 6 , 7 ) concluded that no evidence exists for the effectiveness of lumbar supports in the primary prevention of low back pain in the workplace , but 2 of the 4 included r and omized , controlled trials ( 8 , 9 ) reported that lumbar supports might be effective in workers with a history of low back pain ( secondary prevention ) . However , these findings were derived from subgroup analyses , and evidence from direct research on secondary prevention was not available . In cohort studies , a history of low back pain proved to be a strong predictor for the incidence of new episodes of low back pain ( 1012 ) . Home care workers with a history of low back pain may therefore be well suited to secondary preventive measures . In a previous uncontrolled feasibility study , we found that home care workers who had frequent episodes of low back pain reported adherence rates of 61 % to 81 % with lumbar supports and a 45 % decrease in pain intensity when using lumbar supports ( 13 ) . We design ed the current trial to evaluate the effectiveness of adding worker-directed use of lumbar supports to a short course on healthy working methods to reduce low back pain and work absenteeism among home care workers with a history of low back pain . Methods Design Our r and omized , controlled trial included 2 groups . The control group received a short refresher course on healthy working methods provided by their employer at the start of their employment ( Appendix ) ; primary and secondary care for the management of low back pain was available as usual ( 14 ) . The intervention group received a lumbar support in addition to usual care . The intervention and data collection continued for 12 months after enrollment . The Medical Ethical Committee of the Erasmus University Medical Center , Rotterdam , the Netherl and s , approved the study . Participants All participants were recruited from employees of a large home care organization in Rotterdam . During staff meetings , all present team members completed a brief survey about study inclusion criteria that was distributed and collected by the team managers . We included persons who performed medical care or domestic tasks as a home care worker , were experiencing low back pain symptoms at the time of inquiry or had experienced 2 or more episodes ( on 2 consecutive days ) of low back pain symptoms in the 12 months before the inquiry , did not have specific low back pain ( for example , due to rheumatoid arthritis or vertebral fractures ) , and were not pregnant at the start of the study . Because of a possible association between lumbar supports and increased blood pressure and heart rate , we excluded workers receiving medical treatment for high blood pressure ( 15 ) . Employees who met the inclusion criteria received detailed information about the trial , and those who agreed to participate provided written consent . R and omization In the Netherl and s , home care workers provide 1 of 8 functions , each of which requires different skills and tasks . To ensure a balance in workload and working conditions between the 2 study groups , we stratified r and omization by these 8 functions . We also stratified r and omization by low back pain experience at baseline ( current pain vs. past pain ) . The r and omization process used a computer-generated r and om-number table with 16 strata ( 2 low back pain by 8 workplace functions ) , arranged in blocks of 8 within each stratum . After baseline measurements were completed , colleagues who were not otherwise involved in the study and who were blinded to participants ' baseline characteristics used the r and om-number table to allocate each participant to 1 of the study groups . Intervention All participants in the intervention group were instructed to wear the lumbar supports on working days on which they had or expected they might develop low back pain . Participants could select 1 of 4 types of lumbar supports , supplied by Bauerfeind B.V. , Haarlem , the Netherl and s. LumboTrain and LumboTrain Lady are individually adjustable , hook- and -loop fastening , fully elastic supports that are available in 5 sizes for men or women . LumboLoc and LordoLoc are more structured supports , with integrated stays in the back , that have individually adjustable hook- and -loop fastenings and are available in 6 sizes . Participants chose the lumbar support on the basis of fit and wearing comfort , and they were not given advice to direct their choice from among the 4 available supports . When measured by the research er for the lumbar support , the participants were advised to wear the support for a few days in a row , regardless of low back pain , in order to become accustomed to it . The expected duration of wearability of the lumbar supports was 1 year . The costs of the lumbar supports were 75 for LumboTrain and LumboTrain Lady , 56 for LumboLoc , and 50 for LordoLoc . Outcome Measures Our primary outcome measures were the number of days that participants reported low back pain per month and the number of calendar days of sick leave that participants took during the 12-month intervention . Secondary outcome measures were the average severity of low back pain in the previous week , rated on a scale of 0 to 10 ( 16 ) , and functional status in the previous week , measured by using a Dutch translation of the Quebec Back Pain Disability Scale ( on which 0 corresponds to no disablement and 100 corresponds to fully disabled ) ( 17 , 18 ) . Participants used a calendar to record the days per month on which they experienced low back pain . The intervention group was also asked to record on the calendar whether they had worn the lumbar support ; thus , the calendars also served as a monitor for adherence to therapy . The calendars were collected for review after 1 , 3 , 6 , 9 , and 12 months . The number of calendar days of sick leave was derived from the staff register and was provided by the home care organization at the end of the study ; this information covered 15 months , from 3 months before the start of the study until the end of the intervention . We could gather only general data on sick leave because employees are not obliged to specify their illness for the employer when they report themselves ill , and registration by a company doctor starts from 6 consecutive weeks of sick leave . We collected information on self-reported , low back painrelated sick leave ; however , this was not a predetermined outcome , and the results should be interpreted cautiously . We administered a question naire at baseline to obtain information on the secondary outcome measures and demographic characteristics ; history of low back pain ; job characteristics ( among others , the Job Content Question naire , Dutch translation [ 19 ] ) ; and other possible confounders , such as additional work ( hours per week and type ) , preference for study group assignment , confidence in pain reduction with use of the lumbar support ( scale of 0 to 10 ) , and confidence in improved functioning ( scale of 0 to 10 ) . Follow-up question naires were administered at 3 , 6 , 9 , and 12 months to measure the secondary outcomes . In the intervention group , these question naires also measured the general satisfaction with the lumbar support ( scale of 0 to 10 ) , several items on comfort of wearing ( 5-point Likert scale ) , and adherence to use of the lumbar support ( 7-point Likert scale ) . We recorded spontaneously reported side events and asked participants about side effects in the question naires . Statistical Analysis We estimated that with a power of 80 % , a significance level of 0.05 , and an SD of 20 days , we would need 140 participants in each study group to demonstrate a difference of 7 days of low back pain per year or sick leave per year between the 2 groups . To prevent inadequate power because of participant withdrawal or low adherence to therapy , we sought to enroll 400 home health care workers . We used a longitudinal marginal model with generalized estimating equation estimates to analyze the data , according to intention-to-treat principles . For the primary outcomes ( number of days of low back pain and number of days of sick leave ) , we used a negative-binomial count data model with a log-link and an exchangeable correlation structure . Covariates ( history of low back pain , body mass index , additional work , and pregnancy during follow-up ) were added to the model separately and were used in the final model if they statistically significantly contributed to the model ( P < 0.05 ) . The scale scores of the secondary outcomes were analyzed by using a normal distributed model and an exchangeable correlation structure . To investigate model misspecification and the effect of missing data , we performed sensitivity analyses in which we used various structures for the working correlation to estimate the models and used multiple imputation techniques to analyze 5 imputed data sets for missing data ( 20 ) . For all analyses , we used SAS ,",
"Background : Prevalence of musculoskeletal pain is high in jobs with high physical work dem and s. An aerobic exercise intervention targeting cardiovascular health was evaluated for its long term side effects on musculoskeletal pain . Objective : The objective was to investigate if aerobic exercise affects level of musculoskeletal pain from baseline to 4- and 12-months follow-up . Methods : One-hundred- and -sixteen cleaners aged 18–65 years were cluster-r and omized . The aerobic exercise group ( n = 57 ) received worksite aerobic exercise ( 30 min twice a week ) and the reference group ( n = 59 ) lectures in health promotion . Strata were formed according to closest manager ( total 11 strata ) ; clusters were set within strata ( total 40 clusters , 20 in each group ) . Musculoskeletal pain data from eight body regions was collected at baseline and after 4- and 12-months follow-up . The participants stated highest pain in the last month on a scale from 0 , stating no pain , up to 10 , stating worst possible pain . A repeated-measure 2 × 2 multi-adjusted mixed-models design was applied to compare the between-groups differences in an intention to treat analysis . Participants were entered as a r and om effect nested in clusters to account for the cluster-based r and omization . Results : Clinical ly significant reductions ( > 30 % , f 2 > 0.25 ) in the aerobic exercise group , compared to the reference group , in pain intensity in neck , shoulders , arms/wrists were found at 12-months follow-up , and a tendency ( p = 0.07 , f 2 = 0.18 ) to an increase for the knees . At 4-months follow-up the only significant between-group change was an increase in hip pain . Conclusions : This study indicates that aerobic exercise reduces musculoskeletal pain in the upper extremities , but as an unintended side effect may increase pain in the lower extremities . Aerobic exercise interventions among workers st and ing or walking in the majority of the working hours should tailor exercise to only maintain the positive effect on musculoskeletal pain",
"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",
"Our objective was to evaluate the effect of 12 weeks of stress management training ( SMT ) , physical exercise ( PE ) and an integrated health programme ( IHP ) in a worksite setting on subjective health complaints . To do this , we r and omly split 860 employees into the following groups : control ( n = 344 ) , PE ( n = 189 ) , IHP ( comprising physical exercise and health information ) ( n = 165 ) and SMT ( n = 162 ) . There were no significant effects on subjective health complaints , sick leave or job stress . However , strong and specific positive effects were experienced for the particular goal areas defined for each intervention . The PE group showed improved general health , physical fitness and muscle pain , while the SMT group showed improved stress management . The IHP group showed the strongest effects , affecting most goals set for treatment",
"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",
"BACKGROUND Hamstring tightness induces posterior pelvic tilt and decreased lumbar lordosis , which can result in low back pain OBJECTIVE : We investigated effects of hamstring stretch with pelvic control on pain and work ability in st and ing workers . METHODS One hundred adult volunteers from a st and ing workers were r and omly assigned to pelvic control hamstring stretching ( PCHS ) ( n = 34 ) , general hamstring stretching ( GHS ) ( n = 34 ) , control ( n = 32 ) groups . The control group was performed self-home exercise . All interventions were conducted 3 days per week for 6 weeks , and included in the hamstring stretching and lumbopelvic muscle strengthening . Outcomes were evaluated through the visual analog scale ( VAS ) , straight leg raise test ( SLR ) , sit and reach test ( SRT ) , Oswestry disability index ( ODI ) , and work ability index ( WAI ) . RESULTS Significant difference in VAS , SLR , SRT , ODI , and WAI were found in the PCHS and GHS groups . The control group was a significant difference only in ODI . The PCHS group showed a greater difference than the GHS group and control group in VAS , SLR , SRT , and ODI . CONCLUSIONS The pelvic control hamstring stretch exercise would be more helpful in back pain reduction and improvement of work ability in an industrial setting",
"Study Design . R and omized controlled trial . Objective . To evaluate the effectiveness of an ergonomic and psychosocial intervention in reducing low back pain ( LBP ) among health care workers . Summary of Background Data . LBP and injuries are reported frequently among health care workers worldwide . Improvement of person-transfer techniques is the preferred tool in the prevention of both . Although popular , to our knowledge , any effect has not been documented in controlled trials . Methods . Study participants were eldercare workers from 19 eldercare groups r and omly assigned to the transfer technique , stress management , or reference arm . A total of 163 individuals ( 79 % of the source population ) participated in both baseline and follow-up after 2 years . Outcome was intra-individual change in rating of LBP during the past 3 and 12 months . Results . We found no difference in LBP in any of the intervention arms over the study period . Conclusion . The study showed no effect of a transfer technique or stress management program targeting LBP . Thus , there is a need for discussing other priorities in the prevention of LBP among health care workers",
"Study Design . R and omized clinical trial . Objectives . To evaluate the effectiveness of a back support plus education versus education alone in promoting recovery from a work-related low back disorder ( WR-LBD ) while simultaneously considering personal , health , and occupational factors and the impact of occupational factors on recovery . Summary of Background Data . No r and omized studies of active industrial workers with low back disorders exist regarding the effectiveness of back supports plus education . Methods . A total of 433 actively employed hourly union workers who had a recent diagnosis of a WR-LBD : 1 ) those who wore a specially design ed back support plus received education on back health ; and 2 ) those who received education on back health only . Demographic , health , medical , and occupational factors were obtained through interview or abstract ion of computer files ; individual ergonomic exposures were measured with a lumbar motion monitor . Outcomes evaluated over a 12-month period included : self-reported measures of back pain , back pain disability level , physical health , mental health , and administrative measures of recurrence , lost work time , and medical care utilization . Results . There was no difference between the study groups with respect to mental or physical health , low back pain , back pain disability , neurogenic symptoms , lost work time , likelihood of recurrence of an episode of a back disorder , or other administrative measures of healthcare utilization or lost work time . However , significant decreases in low back pain , low back pain disability , neurogenic symptoms , and an increase in physical health were observed over the 12 months of observation in both study groups . The only occupational variable found to influence was plant group whereby service parts operations workers in the back support plus education group experienced a lower likelihood of WR-LBD recurrence . Conclusion . Although there was no overall effect on self-reported recovery or administrative measures or lost work time between the study groups , a back support plus health education may have some value in preventing recurrent WR-LBD in industrial workers who work in psychosocial environments and perform manual material h and ling tasks similar to those found in parts distribution centers ",
"H and cultivation and harvest of agricultural products constitute strenuous physical tasks . Working with labor-management ergonomics committees in agricultural setting s , the UC Agricultural Ergonomics Research Center ( AERC ) tested an experimental rest and recovery protocol for its impact on symptoms and productivity during two types of work tasks . The experimental condition consisted of adding a 5 min rest break to every working hour in which there was no other scheduled break ( e.g. , lunchtime ) . This result ed in an additional 20 min of rest per workday . We tested the intervention in two trials : Trial one compared workers ( n=66 ) r and omly assigned to an experimental or a control group during the harvest of commercial strawberries . Trial two utilized a cross-over design ( n=16 pairs of workers ) to compare experimental and control conditions while workers inserted bud grafts into young 18 ' ' high citrus trees . For both trials , workers under the experimental condition reported significantly less severe symptoms than workers under control conditions . The order in which the intervention was given , however , appeared to result in variations in productivity . We conclude that the introduction of frequent , brief rest breaks may improve symptoms for workers engaged in strenuous work tasks ",
"ABSTRACT Objectives : In viticulture , the prevalence of low back pain is particularly high among vineyard workers exposed to sustained and awkward postures . One promising setting for low back pain prevention resides in the implementation of workplace physical activity . Methods : This nonr and omized pilot study aims at evaluating the effects of a worksite supervised adapted physical activity program among 17 vineyard workers volunteered to enter either an intervention group ( n = 10 ) or a control group ( n = 7).The intervention group followed a physical activity program for 8 weeks involving ( 1 ) 15 minutes of warm-up every working day and ( 2 ) two weekly 1-hour adapted physical activity sessions targeting trunk muscle endurance and flexibility . The control group was advised to continue normal physical activity . Evaluations were carried out at weeks 0 , 4 , 8 , and 12 . Physical capacity was assessed using flexibility tests for the trunk , along with trunk muscle flexor and extensor endurance tests . Finally , pain sensitivity was evaluated by assessing pressure pain thresholds over 14 anatomical locations in the low back region . Results : For the intervention group , the endurance of the trunk extensor and flexor significantly increased from baseline to week 8 as well as the pressure pain thresholds . No change was observed for the control group over the same period . Conclusions : These encouraging results in combination with the high adherence rate set interesting foundations for the promotion of worksite supervised adapted physical activity and , most likely , offer a new promising approach to prevent low back pain among vineyard workers",
"This study evaluated the efficacy of an integrated Total Worker Health ® program , “ All the Right Moves ” , design ed to target the conditions of work and workers ’ health behaviors through an ergonomics program combined with a worksite-based health promotion Health Week intervention . A matched-pair cluster r and omized controlled trial was conducted on ten worksites ( five intervention ( n = 324 ) ; five control sites ( n = 283 ) ) . Worker surveys were collected at all sites pre- and post- exposure at one- and six-months . Linear and logistic regression models evaluated the effect of the intervention on pain and injury , dietary and physical activity behaviors , smoking , ergonomic practice s , and work limitations . Worker focus groups and manager interviews supplemented the evaluation . After controlling for matched intervention and control pairs as well as covariates , at one-month following the ergonomics program we observed a significant improvement in ergonomic practice s ( B = 0.20 , p = 0.002 ) , and a reduction in incidences of pain and injury ( OR = 0.58 , p = 0.012 ) in the intervention group . At six months , we observed differences in favor of the intervention group for a reduction in physically dem and ing work ( B = −0.25 , p = 0.008 ) , increased recreational physical activity ( B = 35.2 , p = 0.026 ) and higher consumption of fruits and vegetables ( B = 0.87 , p = 0.008 ) . Process evaluation revealed barriers to intervention implementation fidelity and uptake , including a fissured multiemployer worksite , the itinerant nature of workers , competing production pressures , management support , and inclement weather . The All the Right Moves program had a positive impact at the individual level on the worksites with the program . For the longer term , the multi-organizational structure in the construction work environment needs to be considered to facilitate more upstream , long-term changes",
"Objectives This r and omized controlled trial ( RCT ) evaluated the effect of a participatory organizational intervention for improved use of assistive devices ( AD ) in patient transfer . Methods We r and omly allocated 27 departments from five hospitals in Denmark to a participatory intervention ( 14 clusters , 316 healthcare workers ) or a control group ( 13 clusters , 309 healthcare workers ) . The intervention consisted of 2 × 2 hour workshops with managers , the hospital 's health and safety staff , and 2 - 5 healthcare workers from each department . Based on an assessment of barriers and solutions conducted prior to r and omization , participants developed an action plan for implementing department-specific solutions for improving the use of AD . Use of necessary AD ( using digital counters as primary outcome ) , and general use of AD ( using accelerometers as secondary outcome ) , pain intensity in the low-back , work-related back injuries during patient transfer , and communication and guidance in the use of AD were measured at baseline , 6 and 12 months . Results Use of necessary AD ( primary outcome ) , low-back pain , and back injuries did not change in the intervention compared with control group at 12-month follow-up . However , general use of AD measured with accelerometers as well as communication and guidance improved significantly in the intervention versus control group . Conclusion The intervention did not result in more frequent use of the necessary AD but led to more general use of AD , as well as increased communication and guidance",
"Aims Given the high levels of absenteeism due to musculoskeletal disorders of the upper limbs , there is a need for preventive strategies to protect workers exposed to high risk levels . The purpose of this study was to determine the effect of a workplace-based muscle resistance training exercise program in the presence of pain and musculoskeletal dysfunction of the upper extremities in manufacturing workers exposed to repetitive movements and excessive effort in the workplace . Method R and omized controlled trial in manufacturing workers . A sample of 120 healthy workers was allocated at r and om to an experimental group , which received a resistance-based exercise program , and a control group , which performed stretching exercises . Results The muscle resistance training exercise had a protective effect on the intensity of pain perceived by workers in their upper limbs ( RR : 0.62 95 % CI 0.44–0.87 ) compared with the group of workers who performed stretching exercises . Conclusion A workplace-based muscle resistance training exercise program is an effective preventive strategy in factory workers exposed to risk ; however , it is necessary for companies initially to adopt mechanisms to minimize exposure as a prevention strategy",
"Background Musculoskeletal disorders ( MSDs ) are the leading cause of work disability and sickness absence worldwide . The prevalence of MSDs increases with age , consequently challenging sustainable employability among the growing ageing workforce . Knowledge of feasible and efficient workplace-based interventions to rehabilitate MSD or prevent its consequences is therefore warranted . This systematic review will evaluate the effectiveness of workplace-based interventions on MSDs and its consequences among adult workers with physical and sedentary work tasks , respectively . Methods We will search the following bibliographic data bases : PubMed ( including the data base ‘ MEDLINE ’ ) and Web of Science Core Collection ( including the data bases ‘ Science Citation Index Exp and ed ’ , ‘ Social Sciences Citation Index ’ and ‘ Arts & Humanities Citation Index ’ ) . Manual search es will also be performed . We will include r and omised controlled trials ( RCTs ) and non- RCTs reported in English in which ( 1 ) participants are adult workers with MSD , ( 2 ) interventions are aim ing at rehabilitating pain symptoms of MSD or preventing the consequences of MSD and ( 3 ) interventions are initiated and /or carried out at the workplace . The review will adhere to the ‘ Preferred Reporting Items for Systematic review s and Meta-Analyses ’ ( PRISMA ) guidelines for reporting systematic review s and the Institute for Work and Health ( IWH ) guidelines for workplace-based interventions . For the primary evaluation of the review , the quality assessment and evidence synthesis will conform to the IWH guidelines . Secondary evaluation will include a meta- analysis ( unless the included studies do not allow this due to heterogeneity ) and employ the risk of bias domains recommended by Cochrane along with the Grading of Recommendations , Assessment , Development and Evaluations ( GRADE ) approach on the studies with pain intensity as an outcome . Discussion This systematic review will provide knowledge on effective workplace-based interventions among physical and sedentary workers with MSD . RCTs are considered the most powerful experimental design in clinical trials , but solely including these may be too restrictive to underst and effective workplace-based interventions where r and omised and carefully controlled trials ( RCTs ) are not always possible . In order to maximize practical relevance , the selection process will , therefore , include both RCTs and non- RCTs and the quality assessment and evidence synthesis will conform to IWH guidelines focusing on developing practical guidelines for stakeholders . The result of this work will form the basis for industry-specific evidence -based recommendations on effective workplace-based interventions for rehabilitation of MSDs and its consequences that will later be operationalised into concrete and user-friendly practical tools for workplaces . Systematic review registration International Prospect i ve Register of Systematic Review s ( PROSPERO ) number CRD42018116752",
"Objective To estimate the impact of pain in different body regions on future long-term sickness absence ( LTSA ) among blue- and white-collar workers . Method Prospect i ve cohort study in a representative sample of 5603 employees ( the Danish Work Environment Cohort Study ) interviewed in 2000 , and followed in 2001–2002 in a national sickness absence register . Cox regression analysis was performed to assess the risk estimates of mutually adjusted severe pain in the neck/shoulder , low back , h and /wrist and knees for onset of LTSA , defined as receiving sickness absence compensation for at least 3 consecutive weeks . Age , gender , body mass index , smoking and diagnosed disease were controlled for . Results In 2000 the prevalence among blue- and white-collar workers , respectively , of severe pain was 33 % and 29 % ( neck/shoulder ) , 33 % and 25 % ( low back ) , 16 % and 11 % ( h and /wrists ) , and 16 % and 12 % ( knees ) . During 2001–2002 , the prevalence of LTSA among blue- and white-collar workers was 18 % and 12 % , respectively . H and /wrist pain ( HR 1.49 , 95 % CI 1.23 to 1.81 ) and low back pain ( HR 1.30 , 95 % CI 1.11 to 1.53 ) were significant risk factors among the total cohort . Neck/shoulder pain was a significant risk factor among white-collar workers only ( HR 1.35 , 95 % CI 1.21 to 1.85 ) . Knee pain was not a significant risk factor . Conclusion While h and /wrist pain and low back pain are general risk factors for LTSA , neck/shoulder pain is a specific risk factor among white-collar workers . This study suggests the potential for preventing future LTSA through interventions to manage or reduce musculoskeletal pain"
] | 41167892-06ff-11f0-808a-c43d1ab1c353 |
Background The health benefits of regular physical activity and exercise have been widely acknowledged . Unfortunately , a decline in physical activity is observed in older adults . Knowledge of the determinants of physical activity ( unstructured activity incorporated in daily life ) and exercise ( structured , planned and repetitive activities ) is needed to effectively promote an active lifestyle . Our aim was to systematic ally review determinants of physical activity and exercise participation among healthy older adults , considering the method ological quality of the included studies . Methods Literature search es were conducted in PubMed / Medline and PsycINFO /OVID for peer review ed manuscripts published in English from 1990 onwards . We included manuscripts that met the following criteria : 1 ) population : community dwelling healthy older adults , aged 55 and over ; 2 ) reporting determinants of physical activity or exercise . The outcome measure was qualified as physical activity , exercise , or combination of the two , measured objective ly or using self-report . The method ological quality of the selected studies was examined and a best evidence synthesis was applied to assess the association of the determinants with physical activity or exercise . Results Thirty-four manuscripts reporting on 30 studies met the inclusion criteria , of which two were of high method ological quality . Physical activity was reported in four manuscripts , exercise was reported in sixteen and a combination of the two was reported in fourteen manuscripts . Three manuscripts used objective measures , twenty-two manuscripts used self-report measures and nine manuscripts combined a self-report measure with an objective measure . Due to lack of high quality studies and often only one manuscript reporting on a particular determinant , we concluded " insufficient evidence " for most associations between determinants and physical activity or exercise . Conclusions Because physical activity was reported in four manuscripts only , the determinants of physical activity particularly need further study . Recommendations for future research include the use of objective measures of physical activity or exercise as well as valid and reliable measures of determinants | [
"Examines types of social support that best predicts adherence at different time points during a 1-year endurance exercise program in 269 women and men ages 50 to 65 years . Results indicate that social support had similar effects on exercise participation for women and men , and support specific to exercise was a better predictor of exercise adherence than general social support . A preference for receiving a lesser amount of initial support from exercise staff was the strongest social support-related predictor of exercise adherence during the initial 6 months of the program . Support currently received from family and friends and exercise staff at Month 6 was found to be the strongest predictor of adherence during Months 7 to 12 . Format of exercise was also a strong predictor of exercise adherence with home-based programs related to greater adherence . Additionally , divorced nonsmokers appear to be at increased risk for poor early exercise adherence and should be targeted in interventions to promote exercise participation",
"BACKGROUND Project ACTIVE was a r and omized clinical trial comparing two physical activity interventions , lifestyle and traditional structured exercise . The two interventions were evaluated and compared in terms of cost effectiveness and ability to enhance physical activity among sedentary adults . DESIGN This was a r and omized clinical trial . SETTING / PARTICIPANTS The study included 235 sedentary but healthy community-dwelling adults . INTERVENTION A center-based lifestyle intervention that consisted of behavioral skills training was compared to a structured exercise intervention that included supervised , center-based exercise . MAIN OUTCOME MEASURES The main outcome measures of interest included cost , cardiorespiratory fitness , and physical activity . RESULTS Both interventions were effective in increasing physical activity and fitness . At 6 months , the costs of the lifestyle and structured interventions were , respectively , $ 46.53 and $ 190.24 per participant per month . At 24 months these costs were $ 17.15 and $ 49.31 per participant per month . At both 6 months and 24 months , the lifestyle intervention was more cost-effective than the structured intervention for most outcomes measures . CONCLUSIONS A behaviorally-based lifestyle intervention approach in which participants are taught behavioral skills to increase their physical activity by integrating moderate-intensity physical activity into their daily lives is more cost-effective than a structured exercise program in improving physical activity and cardiorespiratory health . This study represents one of the first attempts to compare the efficiency of intervention alternatives for improving physical activity among healthy , sedentary adults",
"Follow-up evaluation was conducted of 101 older men and women ( mean age = 67 + /- 5 years ) who had participated in a r and omized study of physiological and psychological effects of aerobic exercise . Eighty-five subjects completed the follow-up evaluation , and almost all of them ( 94 % ) reported continuing with physical activity , as assessed by a self-report measure . Total energy expenditure was calculated as an indicator of exercise maintenance , and energy expenditure at follow-up was predicted from measures of physiological functioning , psychological well-being , and cognitive functioning obtained at the conclusion of the structured exercise program . Greater cardiorespiratory endurance , faster psychomotor speed , and lower anxiety predicted exercise behavior at follow-up , accounting for 13 % of the variance in exercise behavior . Gender was not a significant predictor of exercise behavior",
"Little is known about the predictors of maintenance in organized exercise programmes . The aim of this study was to investigate the behavioral predictors of maintenance of exercise participation in older adults , using an integrated social psychological model . To this end , we carried out a prospect i ve cohort study ( n = 1,725 ; age 50 years or older ) involving 10 different types of exercise programmes , with measurements at baseline and after 6 months . Predictors of intention to continue participating and the actual maintenance of exercise participation in the exercise programme were assessed using a step-wise logistic regression model . Significant odds ratios ( ORs ) predicting the intention to continue with the exercise programme were found for female sex , younger age , being married , being a non-smoker , being in paid employment , having a positive attitude towards exercise and having a high self-efficacy at baseline . Significant ORs predicting actual maintenance of exercise participation were short lapses , absence of lapses , high intention at baseline , high perceived quality of the programme , positive attitude at baseline and few risk situations at baseline . In order to promote maintenance of exercise participation for older adults , effort should be taken to prevent lapses , to help people cope with risk situations for lapses , to improve the attitude towards exercise participation and to improve the quality of the programme",
"Signal detection methodology was used to identify the best combination of predictors of long-term exercise adherence in 269 healthy , initially sedentary adults ages 50 - 65 years . Less educated individuals who were assigned to supervised home-based exercise of either higher or lower intensity and who were less stressed and less fit at baseline than other individuals had the greatest probability of successful adherence by the 2nd year . Overweight individuals assigned to a group-based exercise program were the least likely to be successful 2 years later . Predictors of short-term ( 1-year ) adherence were generally similar to predictors of 2-year adherence . Signal detection analysis may be useful for identifying subgroups of people at risk for underadherence who subsequently might be targeted for intervention",
"Background . Counseling sedentary primary care patients can increase physical activity , but whether this approach will increase exercise and fitness in elderly adults with chronic diseases remains to be determined . Methods . After receiving individualized nurse counseling to begin a program of walking for health , 60- to 80-year-old primary care patients were r and omized to one of three levels of telephone contacts over 10 months : ( i ) 20 nurse-initiated calls , ( ii ) 10 nurse-initiated calls plus 10 motivational calls programmed through an automated phone calling system , or ( iii ) no program-initiated phone contacts . Self-reported ( diary ) walking adherence was the primary outcome ; other activity , social support , health quality of life , and measured walking performance , mobility , and body mass index and girths were also assessed during the initiation ( months 1 - 6 ) and maintenance ( months 7 - 10 ) phases of the trial . Results . Average adherence for the 181 participants to the goal of walking at least 20 minutes on 3 or more days per week was 44 % for initiation and 42 % for maintenance . Participants receiving the combination of nurse-initiated personal and automated phone calls walked significantly more frequently than those with no phone contacts . Fitness improved in all three groups ; changes were generally correlated with self-reported walking . Having a companion was associated with more frequent walking . Perceived quality of physical and mental health did not change . Conclusions . Simple and relatively inexpensive nurse contacts can motivate elderly primary care patients to walk for exercise , and this activity is associated with measurable health benefits",
"The present study evaluated whether , and to what extent , the constructs implicated in the theory of planned behavior could predict behavioral intention to exercise and exercise-class attendance of older adults ( age 65 - 90 years ) already enrolled in a physical activity program . The study also evaluated whether including self-efficacy judgments might improve the predictive capacity of the model . Participants ( N = 1,095 ) were r and omly sample d Italian volunteers from exercise classes for older adults . First , they completed question naires assessing the above-mentioned constructs . Then , class attendance was recorded during the following 3 months . Results indicated a substantial correspondence between the model and the data . Perceived behavioral control and self-efficacy were the strongest predictors of behavioral intention , whereas attitudes and subjective norms only partially contributed to its prediction . The inclusion of self-efficacy improved the predictive capacity of the overall model . Finally , results showed a weak relation between behavioral intention and attendance rate in physical activity sessions",
"This study examines dropout incidence , moment of dropout , and switching behavior in organized exercise programs for seniors in the Netherl and s , as determined in a prospect i ve cohort study ( with baseline measurements at the start of the exercise program and follow-up after 6 months ; N = 1,725 , response rate 73 % ) . Participants were community-living individuals 50 + who participated in different forms of organized exercise programs . The average dropout incidence was 0.15 per 6 months , which is lower than that for the general population . The dropout incidence and the timing of dropout differed substantially between the exercise programs . In total , 31 % of people who dropped out of one type of exercise program switched to another type of exercise . The type of program and exercise had a strong effect on differences in this switching behavior . It is recommended that switching behavior be monitored in future studies",
"OBJECTIVE To evaluate the effects of a lifestyle intervention and a structured exercise intervention on physical activity in older adults . METHOD Participants were r and omly assigned to a lifestyle intervention ( n=60 ) , including an individualized home-based program supported by phone calls , or to a structured intervention ( n=60 ) consisting of three weekly supervised sessions . Results were compared with a control group ( n=66 ) . Physical activity was measured with self-report question naires , pedometers , and accelerometers before the start ( pretest ) , at the end ( 11 months , posttest ) , and after 23 months ( follow-up ) . The study took place in Belgium from March 2004 until April 2006 . RESULTS At posttest , both intervention groups had significantly increased their total physical activity compared with the control group . At follow-up , the lifestyle group showed significantly larger increases in active transportation and total steps than the control and structured group respectively . There were no longer significant differences between the structured intervention and the control group . CONCLUSIONS The structured and lifestyle interventions were equally effective at the end of the intervention . One year after the intervention the lifestyle group maintained a significant increase in physical activity , which highlights the potential of lifestyle programs in the battle against inactivity in older adults ",
"This study prospect ively investigated the effects of major life events on subsequent exercise adherence rates of individuals ( N = 173 ) participating in a 2-year , r and omized , controlled clinical trial of 3 different exercise conditions ( higher-intensity home-based ; lower-intensity home-based ; and higher-intensity class-based ) . For 3 of 4 6-month exercise-adherence periods , an analysis of variance indicated a significant main effect ( p life event , exercise adherence in the maintenance phase was significantly lower for those reporting 3 or 4 major life events regardless of the exercise condition . No significant life-event-exercise-adherence relationship was found in the adoption phase of exercise participation ( i.e. , Months 1 to 6 ) . The deleterious effect of life events emphasizes the importance of instruction regarding how to prepare for high-risk situations that can lead to missed exercise sessions or to program attrition",
"Objectives . To investigate the relationships among self-efficacy , changes in self-efficacy , past exercise participation , future exercise adherence , and exercise program format . Methods . Two-year r and omized trial involving subjects ( n = 63 ) participating in an aerobic exercise program . Subjects were r and omly assigned to one of three exercise conditions : higher-intensity home-based exercise , higher-intensity class-based exercise , or lower-intensity home-based exercise . Results . Results indicated that baseline self-efficacy and exercise format had significant ( p behavior . In contrast , in predicting long-term exercise program maintenance , a significant ( p self-efficacy predicted adherence only in the supervised home-based exercise conditions . Results also suggest that baseline self-efficacy , independent of the effect of past adherence , significantly ( p adherence during the adoption phase , but not early maintenance phase , of exercise behavior . Finally , adherence change during the adoption phase of exercise behavior significantly ( p self-efficacy even after adjusting far the effect of baseline self-efficacy . Conclusions . These results suggest that exercise program format as well as an individual 's initial cognitive and behavioral experiences in an exercise program play significant roles in determining exercise adherence",
"This study examined whether psychological , physiological , and health and lifestyle measures were associated with adherence to a structured exercise program for older women . Women aged \" 60 to 85 years ( N = 102 ) , \" r and omly recruited from the community , were assessed on these measures before and after a 12-month exercise trial . Sixty-nine women completed the trial , and 54 continued participation after the trial for at least 6 months . Adherence was examined at various stages during the trial . Multiple regression analysis revealed that reduced muscle strength , slow reaction time , and psychoactive drug use explained most of the variance in adherence during the trial . In contrast , muscle strength , reasoning ability , depression , and self-reported improvement in strength best predicted continued participation after the trial . The findings have implication s for community-based exercise programs and research trials",
"CONTEXT Participation in regular physical activity is recognized as one of the most important health behaviors associated with the prevention of chronic disease and the promotion of health and well-being among the elderly . Although a number of cross-sectional studies have reported predictors of physical activity participation , few studies have assessed changes in intervention-related mediators associated with physical activity adherence in the elderly . OBJECTIVE The purpose of this study was to compare the relative abilities of cognitive mediating variables ( i.e. , self-efficacy beliefs and outcome expectancies/realizations ) versus a social mediating variable ( i.e. , exercise-related social support ) to examine mediators of a telephone-based , exercise-counseling intervention on exercise adherence during months 7 to 12 of an exercise intervention . METHOD Participants were 103 community-dwelling , healthy , sedentary , older adults ( 67 women and 36 men ) . Self-efficacy for exercise , outcome expectancies/realizations , and social support for exercise were assessed at baseline , 6 months , and 12 months . Participants received telephone-based exercise counseling to promote exercise adherence during the course of two 12-month exercise programs ( i.e. , aerobic/strength or flexibility exercises ) . RESULTS Changes in cognitive mediators ( i.e. , self-efficacy and fitness outcome realizations ) were associated with 7- to 12-month exercise adherence while exercise-related social support was not . CONCLUSION Attention should be given to increasing confidence in the elderly to overcome barriers to exercise and achieve relevant fitness outcomes in exercise programs",
"PURPOSE To compare ( i ) the convergent validity of the self-report Zutphen Physical Activity Question naire with the 7-d objective physical activity ( PA ) measurement by accelerometers and pedometers and ( ii ) the construct validity of these measures by examining their associations with physical health and psychological and anthropometric variables . METHODS Five hundred and sixty community-dwelling people aged > or = 65 yr were invited from a UK primary care practice and 238 ( 43 % ) participated ( mean age = 74 , 53 % male ) . PA was assessed subjectively by the Zutphen question naire ( modified to include housework questions ) and objective ly by the 7-d accelerometer monitoring : a r and om half also had a pedometer . A question naire assessed health , disability , and psychological factors , and anthropometric assessment was performed . RESULTS Mean daily PA levels were as follows : Zutphen = 9.1 kcal x kg(-1 ) x d(-1 ) ( SD = 6.6 kcal x kg(-1 ) x d(-1 ) ) ; accelerometer activity count = 226,648 ( SD = 121,966 ) ; accelerometer step count = 6495 ( SD = 3212 ) ; and pedometer step count = 6712 ( SD = 3526 ) . Zutphen score was moderately correlated with accelerometer activity count ( R = 0.34 , P pedometer step count ( R = 0.36 , P Pedometer step count was highly correlated with accelerometer activity count ( R = 0.82 , P accelerometer step count ( R = 0.86 , P health and anthropometric and psychological variables . Zutphen score was not significantly related to most health or anthropometric measures but was associated with psychological variables and provided information about activity type . CONCLUSIONS Convergent validity was strong between accelerometers and pedometers but weaker between these and self-report Zutphen . Pedometers may be preferred to accelerometers for simple studies due to their lower cost . Objective measures had better construct validity , being more strongly associated with established PA determinants , and thus offered better value to research ers than the question naire , but the latter provided useful detail on activity type , so a combined approach to PA assessment may be preferable",
"Objectives The purpose of this study was to report habitual physical activity levels in women and document the change in level of activity and factors affecting this change over a 5-year period . Methods A 5-year prospect i ve cohort design was used . Women aged 40–80 years , living independently in the community , were recruited via the electoral role . The effects were investigated , first , of age , activity level , history of falls , number of co-morbidities and medications , body mass index and stability at baseline on change in activity level and , second , change in these demographics on activity level over the study period . Results Data from 459 women who completed our study are reported . Only activity level and body mass index at baseline significantly affected change in activity level ( p in activity level was not influenced by change in demographics over the study period . The forties and fifties cohorts accounted for the baseline body mass index effect on activity change ( p number of medical conditions ( p = 0.011 ) affected activity level change . Conclusions Activity level at baseline and body mass index in younger women were most likely to affect change over time . Being unsteady or having already fallen did not stimulate change",
"OBJECTIVE To examine the contribution of social-cognitive factors ( self-efficacy and affect ) in predicting long-term physical activity in a sample of older adults ( N=174 ) . DESIGN A prospect i ve design assessed physical activity and psychosocial variables at 2 and 5 years following a 6-month r and omized , controlled exercise trial . MAIN OUTCOME MEASURES The primary outcome variable was self-reported physical activity , with previous behavior , self-efficacy , and affect assessed as determinants of physical activity . RESULTS Covariance modeling analyses indicated that physical activity at Year 2 was the strongest predictor of physical activity at 5-year follow-up . Both self-efficacy and affect at Year 2 were also associated with physical activity at Year 5 , as was original treatment condition . Variables accounted for 35 % of the variance in Year 5 activity . CONCLUSION Older adults with higher levels of physical activity , more positive affect , and higher self-efficacy at Year 2 were more likely to continue to be active at Year 5 . This study is one of the longest follow-ups of exercise behavior in older adults and has implication s for structuring environments to maximize the maintenance of physical activity",
"OBJECTIVE Less than half of all U.S. adults meet public health recommendations for physical activity , and even fewer older adults ( aged 50 years and over ) are sufficiently active . Because inactivity increases the risk of costly medical complications , successful efforts to increase physical activity among older adults may potentially be cost-effective . We sought to test if financial incentives for walking could increase physical activity among sedentary older adults . METHODS We conducted a 4-week r and omized controlled study using pedometers . A total of 51 adults age 50 + from the Raleigh-Durham area of North Carolina participated in the study in April-May 2007 . Individuals were r and omized into one of two arms . The control group received a fixed payment of $ 75 ; the intervention group received a fixed payment of $ 50 plus up to $ 25 more per week depending on the number of weekly aerobic minutes , defined as 10 + minutes of continuous walking or jogging . RESULTS The control group logged 2.3 h per week , on average . The intervention group logged 4.1 h per week and received an additional weekly payment of $ 17.50 , on average . CONCLUSION Modest financial incentives tied to aerobic minutes are an effective , and potentially cost-effective , approach for increasing physical activity among sedentary older adults ",
"ABSTRACT Purpose : To compare the efficacy of five versus one session of Behavioral Counseling in a 12-week intervention to increase self-efficacy and family and friend support for activity , and examine self-efficacy and support as mediators of activity among 46 urban women . Methods : A r and omized , controlled trial conducted during 2004 in Omaha , Nebraska . Outcomes were analyzed with Repeated Measures -ANOVA and path analysis . Findings : No significant change was observed in self-efficacy in the five-session group , but a significant decrease was observed in the one-session group ( p = .005 ) . Family and friend support increased significantly in the five-session group ( p activity was mediated through change in self-efficacy and family support . Conclusions : Five behavioral counseling sessions maintained self-efficacy and increased family and friend support although the intervention did not directly affect activity . Implication s : The intervention can be replicated within various community setting"
] | 411678ce-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Growth hormone is widely abused by athletes , frequently with and rogenic steroids . Its effects on performance are unclear . OBJECTIVE To determine the effect of growth hormone alone or with testosterone on body composition and measures of performance . DESIGN R and omized , placebo-controlled , blinded study of 8 weeks of treatment followed by a 6-week washout period . R and omization was computer-generated with concealed allocation . ( Australian-New Zeal and Clinical Trials Registry registration number : ACTRN012605000508673 ) SETTING Clinical research facility in Sydney , Australia . PARTICIPANTS 96 recreationally trained athletes ( 63 men and 33 women ) with a mean age of 27.9 years ( SD , 5.7 ) . INTERVENTION Men were r and omly assigned to receive placebo , growth hormone ( 2 mg/d subcutaneously ) , testosterone ( 250 mg/wk intramuscularly ) , or combined treatments . Women were r and omly assigned to receive either placebo or growth hormone ( 2 mg/d ) . MEASUREMENTS Body composition variables ( fat mass , lean body mass , extracellular water mass , and body cell mass ) and physical performance variables ( endurance [ maximum oxygen consumption ] , strength [ dead lift ] , power [ jump height ] , and sprint capacity [ Wingate value ] ) . RESULTS Body cell mass was correlated with all measures of performance at baseline . Growth hormone significantly reduced fat mass , increased lean body mass through an increase in extracellular water , and increased body cell mass in men when coadministered with testosterone . Growth hormone significantly increased sprint capacity , by 0.71 kJ ( 95 % CI , 0.1 to 1.3 kJ ; relative increase , 3.9 % [ CI , 0.0 % to 7.7 % ] ) in men and women combined and by 1.7 kJ ( CI , 0.5 to 3.0 kJ ; relative increase , 8.3 % [ CI , 3.0 % to 13.6 % ] ) when coadministered with testosterone to men ; other performance measures did not significantly change . The increase in sprint capacity was not maintained 6 weeks after discontinuation of the drug . LIMITATIONS Growth hormone dosage may have been lower than that used covertly by competitive athletes . The athletic significance of the observed improvements in sprint capacity is unclear , and the study was too small to draw conclusions about safety . CONCLUSION Growth hormone supplementation influenced body composition and increased sprint capacity when administered alone and in combination with testosterone . PRIMARY FUNDING SOURCE The World Anti-Doping Agency | [
"Twelve children with documented Prader-Labhart-Willi syndrome were treated with human growth hormone ( 24 U/m2/week ) during 1 year . The children were divided into three groups : group 1 : overweight and prepubertal ( n = 6 , age 3.8–7.0 years ) ; group 2 : underweight and prepubertal ( n = 3 , age 0.6–4.1 years ) ; group 3 : pubertal ( n = 3 , age 9.2–14.6 years ) . In group 1 , height increased from -1.7 SD to -0.6 SD , while weight decreased from 1.1 SD to 0.4 SD , with a dramatic drop in weight for height from 3.8 SD to 1.2 SD . H and length increased from -1.5 SD to -0.4 SD and foot length from -2.5 SD to -1.4 SD . Body fat , measured by dual X-ray energy absorptiometry , dropped by a third , whereas muscle mass increased by a fourth . Physical capability ( Wingate test ) improved considerably . The children were reported to be much more active and capable . In group 2 , similar changes were seen , but weight for height increased , probably because muscle mass increase exceeded fat mass decrease . Changes in group 3 were similar as in group 1 , even though far less distinct . Conclusion Growth hormone treatment in Prader-Labhart-Willi syndrome led to dramatic changes : distinct increase in growth velocity , height and muscle mass , as well as an improvement in physical performance . Fat mass and weight for height decreased in the initially overweight children , and weight for height increased in underweight children",
"CONTEXT Symptoms of fluid retention in GH-deficient patients during GH replacement are greater in men than in women , suggesting that testosterone may augment or estradiol may attenuate the antinatriuretic actions of GH . The mechanisms underlying the sodium-retaining effects of GH are poorly understood . AIM The aim of this study was to investigate the effects of GH and testosterone , alone and in combination , on extracellular water ( ECW ) and the hormonal mechanisms involved . DESIGN Two separate , open-label , r and omized , two-period , crossover studies were performed ; the first compared the effects of GH alone with those of GH and testosterone , and the second compared the effects of testosterone alone with those of GH and testosterone . PARTICIPANTS Twelve hypopituitary men with GH deficiency and hypogonadism were studied . INTERVENTION During the weeks of intervention , GH ( 0.5 mg/d ) and testosterone enanthate ( 250 mg ) were administered by i m injection . OUTCOME MEASURES The outcome measures were ECW , IGF-I , plasma renin activity ( PRA ) , aldosterone ( Aldo ) , and atrial natriuretic peptide ( ANP ) . RESULTS GH treatment significantly increased ( P IGF-I and ECW , and these changes were enhanced by cotreatment with testosterone ( P = 0.07 for both ) . PRA , Aldo , and ANP levels did not change . Testosterone treatment alone did not change the IGF-I concentration , whereas cotreatment with GH induced a marked increase . Testosterone alone increased ( P ECW , and the effect was augmented ( P PRA and ANP did not change , plasma Aldo decreased after single and combined treatments . CONCLUSION GH and testosterone exerted independent and additive effects on ECW . The mechanisms of fluid retention for both hormones are likely to be exerted on the renal tubules . This is the first direct evidence that testosterone increases ECW",
"The purpose of this study was to determine whether growth hormone ( GH ) administration enhances the muscle anabolism associated with heavy-resistance exercise . Sixteen men ( 21 - 34 yr ) were assigned r and omly to a resistance training plus GH group ( n = 7 ) or to a resistance training plus placebo group ( n = 9 ) . For 12 wk , both groups trained all major muscle groups in an identical fashion while receiving 40 micrograms recombinant human GH.kg-1.day-1 or placebo . Fat-free mass ( FFM ) and total body water increased ( P less than 0.05 ) in both groups but more ( P less than 0.01 ) in the GH recipients . Whole body protein synthesis rate increased more ( P less than 0.03 ) , and whole body protein balance was greater ( P = 0.01 ) in the GH-treated group , but quadriceps muscle protein synthesis rate , torso and limb circumferences , and muscle strength did not increase more in the GH-treated group . In the young men studied , resistance exercise with or without GH result ed in similar increments in muscle size , strength , and muscle protein synthesis , indicating that 1 ) the larger increase in FFM with GH treatment was probably due to an increase in lean tissue other than skeletal muscle and 2 ) resistance training supplemented with GH did not further enhance muscle anabolism and function",
"We studied the acute effects of a single , sc GH dose on exercise performance and metabolism during bicycling . Seven highly trained men [ age , 26 + /- 1 yr ( mean + /- SEM ) ; weight , 77 + /- 3 kg ; maximal oxygen uptake , 65 + /- 1 ml O(2).min(-1).kg(-1 ) ] performed 90 min of bicycling 4 h after receiving 7.5 IU ( 2.5 mg ) GH or placebo in a r and omized , double-blinded , cross-over design trial . A st and ardized pre-exercise meal was given 2 h before exercise . Blood was sample d at rest and during exercise and analyzed for GH , IGF-I , glucose , lactate , insulin , glycerol , and nonesterified fatty acids ( NEFA ) . In the placebo trial , all subjects completed the exercise protocol without any difficulties . In contrast , two subjects were not able to complete the exercise protocol in the GH trial , and one subject barely managed to complete the protocol . In addition , GH administration result ed in exaggerated increases in plasma lactate concentrations during exercise ( P lipolytic effect of GH and exercise , evidence d by increased plasma glycerol and serum NEFA concentrations , was 3-fold greater than the effect of exercise alone ( P whole body fat oxidation ( indirect calorimetry ) . Plasma glucose was , on average , 9 % higher during exercise after GH administration compared with placebo ( P plasma lactate and glycerol as well as serum NEFA during 90 min of subsequent bicycling at moderate to high intensity . The exaggerated increase in plasma lactate may be associated with substantially decreased exercise performance",
"Background / Aims : Recombinant human growth hormone ( rhGH ) as opposed to cadaver pituitary GH is misused for physical improvement . Six days ’ rhGH administration , in abstinent anabolic- and rogenic steroid dependents , was compared with controls . Method : Male subjects ( n = 48 ) were r and omly divided into two groups : ( 1 ) : control group ( C ) , n = 24 , mean ± SD , age 32 ± 11 years , height 1.8 ± 0.06 m ; ( 2 ) : rhGH-using group ( 0.058 IU·kg–1·day–1 ) ( GH ) , n = 24 , mean ± SD , age 32 ± 9 years , height 1.8 ± 0.07 m. Physiological measurements included anthropometry , strength , power and peak oxygen uptake ( VO2 peak ) . Biochemical measurements included haemoglobin , packed cell volume , glucose , sodium , potassium , urea , creatinine , total protein , albumin , thyroid function , testosterone , prolactin , cortisol , GH and insulin-like growth factor-I ( IGF-I ) . Results : Strength , peak power output and IGF-I significantly increased and total protein , albumin and free tetra-iodothyronine significantly decreased compared to controls ( p ( p peak significantly increased , while body fat and thyroid-stimulating hormone significantly decreased within the GH group ( p rhGH increased strength and power . Of therapeutic value is the possibility that muscle bulk and strength could be increased in patients with muscle-wasting conditions",
"The effect of recombinant GH on strength , body composition and endocrine parameters in power athletes was investigated in a controlled study . Twenty-two healthy , non-obese males ( age 23.4 + /- 0.5 years ; ideal body weight 122 + /- 3.1 % , body fat 10.1 + /- 1.0 % ; mean + /- SEM ) were included . Prob and s were assigned in a double-blind manner to either GH treatment ( 0.09U ( kg BW)-1 day-1 sc ) or placebo for a period of six weeks . To exclude concurrent treatment with and rogenic-anabolic steroids urine specimens were tested at regular intervals for these substances . Serum was assayed for GH , IGF-I , IGF-binding proteins , insulin and thyroxine before the onset of the study and at two-weekly intervals thereafter . Maximal voluntary strength of the biceps and quadriceps muscles was measured on a strength training apparatus . Fat mass and lean body mass were derived from measurements of skinfolds at ten sites with a caliper . For final evaluation only data of those 8 and 10 subjects in the two groups who completed the study were analyzed . GH , IGF-I and IGF-binding protein were in the normal range before therapy and increased significantly in the GH-treated group . Fasting insulin concentrations increased insignificantly and thyroxine levels decreased significantly in the GH-treated prob and s. There was no effect of GH treatment on maximal strength during concentric contraction of the biceps and quadriceps muscles . Body weight and body fat were not changed significantly during treatment . We conclude that the anabolic , lipolytic effect of GH therapy in adults depends on the degree of fat mass and GH deficiency . ( ABSTRACT TRUNCATED AT 250 WORDS",
"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",
"Initiation of GH treatment in adults is frequently complicated by the development of symptomatic fluid retention . To investigate the mechanism and extent of fluid retention that occurs with dosages of GH used in the treatment of GH-deficient adults , we conducted a double blind study in which seven GH-deficient patients ( aged 24 - 74 yr ) each received in r and om order daily sc injections of placebo , a physiological dose of GH ( 0.04 U/kg , low dose ) , and a supraphysiological dose of GH ( 0.08 U/kg , high dose ) for 7 days , separated by 21-day washout periods . On the seventh day , measurements were made of serum insulin-like growth factor I , body weight , exchangeable sodium , plasma volume , angiotensinogen , PRA , aldosterone , atrial natriuretic peptide ( ANP ) , and mean 24-h ambulatory heart rate and blood pressure . GH significantly increased mean insulin-like growth factor I levels from 105 + /- 11 to 304 + /- 45 micrograms/L during low dose treatment ( P = 0.006 ) and 400 + /- 76 micrograms/L during high dose treatment ( P = 0.004 ) . High dose GH caused a 1.2 + /- 0.3 kg increase in body weight ( P = 0.01 ) and a 193 + /- 65 mmol increase in exchangeable sodium ( P = 0.008 ) . Low dose GH had a lesser effect , with no significant increase in body weight , but an increase in exchangeable sodium of 113 + /- 37 mmol ( P = 0.02 ) . Plasma volume was not significantly affected by GH treatment . Mean supine angiotensinogen levels were significantly higher during both GH treatments compared to placebo ( low dose , P = 0.017 ; high dose , P = 0.028 ) as were mean supine PRA levels ( low dose , P = 0.0002 ; high dose , P = 0.0025 ) . Supine angiotensin II , aldosterone , and ANP levels were not significantly affected by GH treatment . There was no significant change from placebo in any of the sodium-regulating hormones in the erect posture . The mean 24-h heart rate was significantly higher during low dose ( 82 + /- 2 beats/min ; P = 0.0001 ) and high dose ( 88 + /- 3 beats/min ; P = 0.0001 ) GH treatment than during placebo ( 67 + /- 3 beats/min ) . However , no significant change in mean 24-h systolic or diastolic blood pressure was observed . In summary , acute GH administration using doses currently employed in treating adults causes a dose-related increase in body weight and body sodium , but no associated increase in blood pressure . We conclude that 1 ) sodium retention is a physiological effect of GH , but does not cause an acute rise in blood pressure ; and 2 ) the mechanism of sodium and fluid retention is not primarily due to enhanced aldosterone secretion or inhibition of ANP release , but more likely to a direct renal tubular effect",
"Measurements of serum insulin-like growth factor I ( IGF-I ) and related markers are routinely used in the diagnosis and treatment of GH deficiency and excess . The validity of these markers for assessment of exogenous GH exposure in healthy adults is , however , unknown . We therefore conducted a double blind , placebo-controlled GH treatment trial in 99 healthy subjects [ 49 women and 50 men ; mean + /- SE age , 25.6+/-0.6 (women)/25.7+/-0.6 yr ( men ) ] . Blood was collected weekly during a 4-week treatment period ( days 1 - 28 ) , and the subjects were subsequently followed for additional 8 weeks ( days 29 - 84 ) . The treatment arms included : I ) 0.1 IU/kg x day GH ( n = 30 ; GH 0.1 ) , II ) 0.2 IU/kg x day GH ( n = 29 ; GH 0.2 ) , and III ) placebo ( n = 40 ) . At baseline no gender-specific differences existed , except that the acid-labile subunit ( ALS ) levels were higher in females . Serum insulin-like growth factor I ( IGF-I ) levels in males receiving GH increased significantly through day 42 with no significant difference between the 2 doses . The absolute IGF-I response was significantly lower in females , and there was a clear dose-response relationship . ALS levels in males increased through day 30 ( P ALS levels were only modestly increased on day 28 compared with those in the placebo group ( P IGF-binding protein-3 ( IGFBP-3 ) levels in males increased significantly in the GH 0.1 and the GH 0.2 groups on day 30 ( P IGFBP-2 levels decreased insignificantly during GH exposure in both genders . A gender-specific upper normal range for each analyte was arbitrarily defined as 4 SD above the mean level at baseline . On the basis of IGF-I levels alone , GH exposure in the GH 0.2 group was detected in 86 % of the males and in 50 % of the females on day 21 . On day 42 GH exposure was only weakly detectable in males and was not detectable in females . We conclude that 1 ) males are significantly more responsive than females to exogenous GH ; 2 ) the increase in IGF-I is more robust compared with those in IGFBP-3 and ALS ; 3 ) IGFBP-2 changes very little during GH treatment ; and 4 ) among IGF-related substances , IGF-I is the most specific marker of supraphysiological GH exposure"
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Oats are a rich source of β-glucan , a viscous , soluble fibre recognised for its cholesterol-lowering properties , and are associated with reduced risk of CVD . Our objective was to conduct a systematic review and meta- analysis of r and omised-controlled trials ( RCT ) investigating the cholesterol-lowering potential of oat β-glucan on LDL-cholesterol , non-HDL-cholesterol and apoB for the risk reduction of CVD . MEDLINE , Embase , CINAHL and Cochrane CENTRAL were search ed . We included RCT of ≥3 weeks of follow-up , assessing the effect of diets enriched with oat β-glucan compared with controlled diets on LDL-cholesterol , non-HDL-cholesterol or apoB. Two independent review ers extracted data and assessed study quality and risk of bias . Data were pooled using the generic inverse-variance method with r and om effects models and expressed as mean differences with 95 % CI . Heterogeneity was assessed by the Cochran 's Q statistic and quantified by the I 2-statistic . In total , fifty-eight trials ( n 3974 ) were included . A median dose of 3·5 g/d of oat β-glucan significantly lowered LDL-cholesterol ( -0·19 ; 95 % CI -0·23 , -0·14 mmol/l , P ( -0·20 ; 95 % CI -0·26 , -0·15 mmol/l , P and apoB ( -0·03 ; 95 % CI -0·05 , -0·02 g/l , P analysis of LDL-cholesterol ( I 2=79 % ) and non-HDL-cholesterol ( I 2=99 % ) . Pooled analyses showed that oat β-glucan has a lowering effect on LDL-cholesterol , non-HDL-cholesterol and apoB. Inclusion of oat-containing foods may be a strategy for achieving targets in CVD reduction | [
"BACKGROUND In 1997 , the US Food and Drug Administration passed a unique ruling that allowed oat bran to be registered as the first cholesterol-reducing food at a dosage of 3 g beta-glucan/d . OBJECTIVE The effects of a low dose of oat bran in the background diet only were investigated in volunteers with mild-to-moderate hyperlipidemia . DESIGN The study was a double-blind , placebo-controlled , r and omized , parallel study . Sixty-two healthy men ( n = 31 ) and women ( n = 31 ) were r and omly allocated to consume either 20 g oat bran concentrate ( OBC ; containing 3 g beta-glucan ) or 20 g wheat bran ( control ) daily for 8 wk . Fasting blood sample s were collected at weeks -1 , 0 , 4 , 8 , and 12 . A subgroup ( n = 17 ) was studied postpr and ially after consumption of 2 meals ( containing no OBC or wheat bran ) at baseline and after supplementation . Fasting plasma sample s were analyzed for total cholesterol , HDL cholesterol , triacylglycerol , glucose , and insulin . LDL cholesterol was measured by using the Friedewald formula . The postpr and ial sample s were anlayzed for triacylglycerol , glucose , and insulin . RESULTS No significant difference was observed in fasting plasma cholesterol , LDL cholesterol , glucose , or insulin between the OBC and wheat-bran groups . HDL-cholesterol concentrations fell significantly from weeks 0 to 8 in the OBC group ( P = 0.05 ) . There was a significant increase in fasting glucose concentrations after both OBC ( P = 0.03 ) and wheat-bran ( P = 0.02 ) consumption . No significant difference was found between the OBC and wheat-bran groups in any of the postpr and ial variables measured . CONCLUSIONS A low dosage of beta-glucan ( 3 g/d ) did not significantly reduce total cholesterol or LDL cholesterol in volunteers with plasma cholesterol concentrations representative of a middle-aged UK population",
"This study was design ed as a test of the serum lipid response and dietary adaptation to recommended daily inclusion of instant oats in an otherwise regular diet . Hypercholesterolemic adults were r and omly assigned to a control or intervention group . Participants in the intervention group were given packages of instant oats and requested to eat two servings per day ( approximately two ounces dry weight ) , substituting the oats for other carbohydrate foods in order to maintain baseline calorie intake and keep weight stable . Serum lipids were measured in blood collected by venipuncture at baseline , four weeks , and eight weeks . Baseline mean total cholesterol ( TC ) levels were 6.56 mmol/L and 6.39 mmol/L for intervention and control groups , respectively . After eight weeks , mean serum total cholesterol of the intervention group was lower by -0.40 mmol/L , and mean net difference in TC between the two groups was 0.32 mmol/L ( 95 % CI : 0.09 , 0.54 ) . Low-density lipoprotein-cholesterol was similarly reduced with mean net difference of 0.25 mmol/L ( 95 % CI : 0.02 , 0.48 ) between the two groups . Mean soluble fiber intake increased along with slight self-imposed reductions in mean total fat , saturated fat , and dietary cholesterol intake in the intervention group . Neither group changed mean body weight . Daily inclusion of two ounces of oats appeared to facilitate reduction of serum total cholesterol and LDL-C in these hyperlipidemic individuals ",
"BACKGROUND No studies have examined whether increased consumption of oat cereal , rich in soluble fiber , favorably alters lipoprotein particle size and number . OBJECTIVE We examined the effects of large servings of either oat or wheat cereal on plasma lipids , lipoprotein subclasses , lipoprotein particle diameters , and LDL particle number . DESIGN Thirty-six overweight men aged 50 - 75 y were r and omly assigned to consume daily for 12 wk either oat or wheat cereal providing 14 g dietary fiber/d . Before and after the intervention , plasma lipid and lipoprotein subclasses were measured with proton nuclear magnetic resonance spectroscopy , and whole-body insulin sensitivity was estimated with the frequently sample d intravenous-glucose-tolerance test . RESULTS Time-by-treatment interactions ( P LDL cholesterol ( oat : -2.5 % ; wheat : 8.0 % ) , small LDL cholesterol ( oat : -17.3 % ; wheat : 60.4 % ) , LDL particle number ( oat : -5.0 % ; wheat : 14.2 % ) , and LDL : HDL cholesterol ( oat : -6.3 % ; wheat : 14.2 % ) were observed . Time-by-treatment interactions were nearly significant for total cholesterol ( oat : -2.5 % ; wheat : 6.3 % ; P = 0.08 ) , triacylglycerol ( oat : -6.6 % ; wheat : 22.0 % ; P = 0.07 ) , and VLDL triacylglycerol ( oat : -7.6 % ; wheat : 2.7 % ; P = 0.08 ) . No significant time-by-treatment interactions were observed for HDL cholesterol , HDL-cholesterol subclasses , or LDL , HDL , and VLDL particle diameters . Insulin sensitivity did not change significantly with either intervention . CONCLUSIONS The oat compared with the wheat cereal produced lower concentrations of small , dense LDL cholesterol and LDL particle number without producing adverse changes in blood triacylglycerol or HDL-cholesterol concentrations . These beneficial alterations may contribute to the cardioprotective effect of oat fiber",
"Water-soluble fiber has been reported to reduce serum cholesterol and consequently , oat bran , which has a high soluble-fiber content , has been recommended as part of a lipid-lowering diet . However , a recent small study of 20 volunteers with low mean serum cholesterol concentrations ( 4.8 mmol/L ) demonstrated no lipid-lowering effect of oat bran . The present study investigated 64 volunteers with cholesterol concentrations much more typical of the UK population ( 6 mmol/L ) . Subjects were r and omly allocated to receive either a normal-sized helping of an oat-based cereal or a cereal containing no oats for 4 wk and then crossed over to the alternative regimen for a further 4 wk . Small ( 2.23 % and 4.55 % ) but significant ( P total and low-density-lipoprotein cholesterol , respectively , were observed in association with the consumption of oat-based cereal . These data support the view that consumption of oat-based cereals may well contribute usefully to a lipid-lowering diet",
"BACKGROUND Findings about the effects of beta-glucan on serum lipoproteins are conflicting . OBJECTIVE The study investigated the effects of beta-glucan from oat bran in bread and cookies ( study 1 ) and in orange juice ( study 2 ) on serum lipoproteins in mildly hypercholesterolemic subjects . DESIGN In study 1 , 48 subjects ( 21 men , 27 women ) received for 3 wk control bread and cookies rich in wheat fiber . For the next 4 wk , by r and om assignment , 23 subjects continued to consume the control products , and 25 received bread and cookies rich in beta-glucan . Mean daily intake of beta-glucan was 5.9 g. Total dietary fiber intake did not differ significantly between the groups . In study 2 , the same sources of control fiber and beta-glucan ( 5 g/d ) as in study 1 were provided . For 2 wk , 25 of the original 48 subjects ( 10 men , 15 women ) were r and omly assigned to consume orange juice containing either wheat fiber ( n = 13 ) or beta-glucan from oat bran ( n = 12 ) . After a washout period of 1 wk , dietary regimens were crossed over . RESULTS In study 1 , the change in LDL cholesterol did not differ significantly ( -0.12 mmol/L ; P = 0.173 ) between the 2 groups . In study 2 , the drink rich in beta-glucan decreased LDL cholesterol by 0.26 + /- 0.07 mmol/L ( 6.7 + /- 1.8 % ; P = 0.001 ) and the ratio of total to HDL cholesterol by 0.26 + /- 0.11 ( 5.4 + /- 2.1 % ; P = 0.029 ) compared with the other drink . HDL-cholesterol and triacylglycerol concentrations did not change significantly . CONCLUSIONS The food matrix or the food processing , or both , could have adverse effects on the hypocholesterolemic properties of oat beta-glucan",
"Scientific studies support recommendations to increase dietary soluble fiber as part of hyperlipidemia treatment . Rice bran contains minimal soluble fiber , but rice bran oil has a hypolipidemic effect . Full-fat rice bran was compared with oat bran and a rice starch placebo in hyperlipidemic humans to see if it might have a role in the treatment of hyperlipidemia . Moderately hypercholesterolemic ( 5.95 - 8.02 mmol/L ) , nonsmoking , nonobese adults were studied in a 6-wk , r and omized , double-blind , noncross-over trial . Three groups added 84 g/d of a heat-stabilized , full-fat , medium-grain rice bran product ( n = 14 ) , oat bran product ( n = 13 ) or rice starch placebo ( n = 17 ) to their usual low-fat diet . Serum cholesterol , triglycerides , HDL-cholesterol ( HDL-C ) , LDL-cholesterol ( LDL-C ) , apoA1 and apoB were measured before and at the end of the supplementation period . Serum cholesterol decreased significantly ( P LDL-C , which decreased by 13.7 + /- 2.8 % in the rice bran group and 17.1 + /- 2.4 % in the oat bran group ( P Serum apoB decreased proportionately . There was no consistent effect on triglycerides within each group and HDL-C and apoA concentrations did not change . The LDL-C : HDL-C ratio decreased significantly in the rice bran and oat bran groups . Stabilized , full-fat rice bran or oat bran , added to the prudent diet of hyperlipidemic adults , similarly reduced cholesterol and LDL-C and improved lipid ratios in 78 % of these individuals . Rice bran , as well as oat bran , should be included in the prudent diet of individuals with hyperlipidemia",
"The hypocholesterolemic effects of oat bran ( OB ) have been recently challenged . To carefully document the hypocholesterolemic effects of OB , 20 hypercholesterolemic men admitted to a metabolic ward were r and omly allocated to either OB or wheat bran ( WB ) for 21 d after a 7-d control-diet period . Control and treatment diets were design ed to be identical in energy content and nutrients , differing only in the amount of soluble fiber . After 21 d , OB significantly decreased total cholesterol by 12.8 % ( P less than 0.001 ) , low-density-lipoprotein cholesterol by 12.1 % ( P less than 0.004 ) , and apolipoprotein B-100 by 13.7 % ( P less than 0.001 ) whereas WB had no significant effect . High-density-lipoprotein cholesterol and apolipoprotein A-I did not change significantly in either group . Serum triglycerides decreased by 10 % in both groups but the decrease was only significant ( P less than 0.04 ) in WB subjects . OB but not WB significantly reduced total cholesterol and other atherogenic lipoprotein fractions independent of other dietary changes",
"Hypertension , dyslipidemia and overweight contribute substantially to cardiovascular disease risk . One of the most effective methods for improving high blood pressure and lipid profiles is loss of excess weight . Other recommendations for reducing cardiovascular risk include changes in dietary micronutrient , macronutrient and fiber intakes . To better define a diet for reduction in cardiovascular risk , 43 adults ( body mass index 26.4 + /- 3.3 , range 20.5 - 33.9 kg/m(2 ) ) participated in an 8-wk study to determine the effects of two diets on weight , blood pressure , lipids and insulin sensitivity . For 2 wk , weight was maintained and all subjects consumed a control diet . For the next 6 wk , subjects consumed one of two hypocaloric diets ( maintenance energy minus 4.2 MJ/d ) : the control diet ( n = 21 ) or a diet containing oats [ 45 g/(4.2 MJ dietary energy . d ) , n = 22 ] . There was no significant difference between groups in changes in weight loss ( control -4.0 + /- 1.1 kg , oats -3.9 + /- 1.6 kg , P = 0.8 ) . The oats diet result ed in greater decreases in mean systolic blood pressure ( oats -6 + /- 7 mm Hg , control -1 + /- 10 mm Hg , P = 0.026 ) , whereas diastolic blood pressure change did not differ between the two groups ( oats -4 + /- 6 mm Hg , control -3 + /- 5 mm Hg , P = 0.8 ) . The oat diet result ed in significantly greater decreases in total cholesterol ( oats -0.87 + /- 0.47 mmol/L , control -0.34 + /- 0.5 mmol/L , P = 0.003 ) and LDL cholesterol ( oats -0.6 + /- 0.41 mmol/L , control -0.2 + /- 0.41mmol/L , P = 0.008 ) . In summary , a hypocaloric diet containing oats consumed over 6 wk result ed in greater improvements in systolic blood pressure and lipid profile than did a hypocaloric diet without oats",
"Background Soluble fibers lower serum lipids , but are difficult to incorporate into products acceptable to consumers . We investigated the physiological effects of a concentrated oat β-glucan on cardiovascular disease ( CVD ) endpoints in human subjects . We also compared the fermentability of concentrated oat β-glucan with inulin and guar gum in a model intestinal fermentation system . Methods Seventy-five hypercholesterolemic men and women were r and omly assigned to one of two treatments : 6 grams/day concentrated oat β-glucan or 6 grams/day dextrose ( control ) . Fasting blood sample s were collected at baseline , week 3 , and week 6 and analyzed for total cholesterol , HDL cholesterol , LDL cholesterol , triglycerides , glucose , insulin , homocysteine and C-reactive protein ( CRP ) . To estimate colonic fermentability , 0.5 g concentrated oat β-glucan was incubated in a batch model intestinal fermentation system , using human fecal inoculum to provide representative microflora . Fecal donors were not involved with the β-glucan feeding trial . Inulin and guar gum were also incubated in separate serum bottles for comparison . Results Oat β-glucan produced significant reduction from baseline in total cholesterol ( -0.3 ± 0.1 mmol/L ) and LDL cholesterol ( -0.3 ± 0.1 mmol/L ) , and the reduction in LDL cholesterol were significantly greater than in the control group ( p = 0.03 ) . Concentrated oat β-glucan was a fermentable fiber and produced total SCFA and acetate concentrations similar to inulin and guar gum . Concentrated oat β-glucan produced the highest concentrations of butyrate at 4 , 8 , and 12 hours . ConclusionS ix grams concentrated oat β-glucan per day for six weeks significantly reduced total and LDL cholesterol in subjects with elevated cholesterol , and the LDL cholesterol reduction was greater than the change in the control group . Based on a model intestinal fermentation , this oat β-glucan was fermentable , producing higher amounts of butyrate than other fibers . Thus , a practical dose of β-glucan can significantly lower serum lipids in a high-risk population and may improve colon health",
"AIM Previous studies have shown that the water-soluble dietary fibre betaglucan , a natural component of oats , reduces cholesterol and postpr and ial hyperglycaemia . The aim of the present study was to investigate the effect of betaglucan-enriched bread consumption on the lipid profile and glucose homoeostasis of patients with type 2 diabetes ( T2D ) . METHODS We conducted a r and omized , double-blind study in which 46 patients with T2D and LDL-C greater than 3.37 mmol/l ( 130 mg/dl ) were r and omized to incorporate into their diet , for 3 weeks , either bread enriched with betaglucan ( providing 3g/day of betaglucan ) or white bread without betaglucan . RESULTS The consumption of bread containing betaglucan led to significant reductions ( vs the control group ) in LDL-C of 0.66 mmol/l ( 15.79 % ) versus 0.11 mmol/l ( 2.71 % ) ( P=0.009 ) , in total cholesterol of 0.80 mmol/l ( 12.80 % ) versus 0.12 mmol/l ( 1.88 % ) ( P=0.006 ) , in Fasting plasma insulin ( FPI ) of 3.23 microU/ml versus an increase of 3.77 microU/ml ( P=0.03 ) and in Homa-IR ( Homoeostasis model assessment -insulin resistance ) by 2.08 versus an increase of 1.33 ( P=0.04 ) . CONCLUSIONS Betaglucan enriched bread may contribute to the improvement of the lipid profile and insulin resistance in patients with T2D",
"A low-fat , low-cholesterol diet and oat bran supplementation for treatment of hypercholesterolemia were studied for their effectiveness in lowering blood lipids and their impact on dietary intake . Seventy-one free-living men and women with hypercholesterolemia ( serum cholesterol greater than 75th percentile ) were r and omly assigned to one of the following four groups : low-fat , low-cholesterol diet ( LFLC ) ; low-fat , low-cholesterol diet plus 50 gm/day oat bran ( LFLC + OB ) ; 50 gm/day oat bran supplemented diet ( OB ) ; or 42.5 gm/day processed oat bran ( ready-to-eat cereal containing beta-glucan concentrated from oat bran ) ( POB ) . Subjects assigned to regimens OB and POB were requested to add the oat supplement without making additional changes in their diet . Serum cholesterol and high-density lipoprotein cholesterol analyses were performed at 4-week intervals , and diet records were assigned and analyzed . All groups experienced significant decreases in cholesterol from original levels ( p less than .05 ) . The average decrease in total serum cholesterol varied from 10 % to 17 % , with no significant differences among the four groups . High-density lipoprotein cholesterol concentrations decreased in all groups except group 4 , in which there was a slight increase ; however , no differences were found between groups . Energy , fat , and cholesterol intakes decreased in all groups , suggesting that displacement of higher fat foods from the diet may be one of the many mechanisms whereby oat supplements lower serum cholesterol . In addition , all groups reduced their intakes of calcium , copper , folic acid , and potassium from marginal levels at the beginning of the study . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND Increased lipid profile after each meal can disturb the endothelial function . The present study assessed the effects of bread supplemented with oat bran on serum lipids and endothelial dysfunction in patients with hypercholesterolemia . METHODS This clinical trial was conducted on 60 isolated hypercholesterolemic patients . The subjects were r and omly allocated to either intervention ( consuming at least five daily servings of oat bread with 6 g beta-glucan ) or control ( receiving at least five servings of wheat bread ) . Anthropometric indicators , fasting blood sugar and lipid profiles ere measured at baseline and after 6 weeks ( in the end of the intervention ) . Endothelial function was assessed using flow-mediated dilation ( FMD ) . Within the group and between group differences were investigated using paired t-test and Student ’s t-test , respectively . RESULTS Oat bread consumption could significantly reduce total cholesterol ( P = 0.029 ) . A significant increase in baseline and after ischemia brachial artery diameters at the end of the study was seen . However , it did not have a significant effect on FMD ( P = 0.825 ) . In the control group , none of the measured indices had changed significantly at the end of the study . Finally , only the mean change of brachial artery diameter after ischemia and baseline brachial artery diameter were significantly higher in the intervention group than in the control group ( P = 0.036 and P = 0.012 respectively ) . CONCLUSION Oat bread with beta-glucan could successfully reduce cholesterol levels . Furthermore , in this study oat bread did not reduce FMD more than wheat bread . Since hypercholesterolemia is a proven risk factor for endothelial dysfunction , hypercholesterolemic patients can hence be advised to eat oat bread",
"Epidemiological evidence shows an inverse relationship between dietary fibre intake and body weight gain . Oat beta-glucan , a soluble fibre alters appetite hormones and subjective satiety in acute meal test studies , but its effects have not been demonstrated with chronic consumption . The present study aim ed to test the effects in women of two different doses of oat beta-glucan on weight loss and hormones associated with appetite regulation . In a 3-month parallel trial , sixty-six overweight females were r and omised into one of three 2 MJ energy-deficit diets : a control and two interventions including 5 - 6 g or 8 - 9 g beta-glucan . Anthropometric and metabolic variables ( blood glucose level , insulin , total cholesterol ( TC ) , LDL , HDL , TAG and leptin ) , together with markers of appetite regulation ( cholecystokinin ( CCK ) , glucagon-like peptide-1 ( GLP-1 ) , ghrelin , peptide YY ( PYY ) and PYY3 - 36 ) were measured at baseline and at 3 months . After 3 months , all groups lost weight ( P waist circumference ( P TC , LDL , HDL , leptin , PYY , GLP-1 values ( all P CCK levels ( P PYY levels ( P = 0.018 ) . In broad terms , the addition of oat beta-glucan did not enhance the effect of energy restriction on weight loss in mildly overweight women , although wide variations in observed results suggests that individual responsiveness may be an issue",
"Aims In the UK , lifestyle intervention is first-line management in Type 2 diabetes . It is unclear what type of diet is most efficacious for improving glycaemic control . This study investigated the effects of an oat-enriched diet on glycaemic control , postpr and ial glycaemia , inflammation and oxidative stress compared with st and ard dietary advice . Methods In a r and omized crossover design , 27 volunteers with Type 2 diabetes , managed on diet and lifestyle only , were observed for two consecutive 8-week periods following either the oat-enriched diet or re-enforced st and ard dietary advice . Volunteers attended at baseline ( habitual intake ) and 8 and 16 weeks . Measurements included basic clinical measurements and fasted and postpr and ial ( 3-h ) glucose and insulin in response to a healthy test meal . Markers of inflammation and oxidative stress , including high-sensitivity C-reactive protein , interleukin 6 , interleukin 18 , tumour necrosis factor-alpha , adiponectin , thiobarbituric acid reactive substances , oxygen radical antioxidant capacity , oxidized LDL and urinary isoprostanes , were also measured at fasting and in the postpr and ial period . Results There were no diet-related effects on glycaemic control or glycaemic or insulinaemic responses to the test meal . Total cholesterol ( 5.1 ± 1.0 vs. 4.9 ± 0.8 mmol/l , P = 0.019 ) concentrations declined following the oat-enriched diet compared with st and ard dietary advice . There was a postpr and ial decline in adiponectin concentration ( P = 0.009 ) , but no effect of dietary intervention . None of the measures of oxidative stress or inflammation were altered by the oat-enriched diet compared with st and ard dietary advice . Conclusion The oat-enriched diet had a modest impact on lipid lowering , but did not impact on oxidative stress or inflammation in these volunteers with Type 2 diabetes",
"BACKGROUND Consumption of 3 g oat β-glucan/d is considered sufficient to lower serum LDL cholesterol , but some studies have shown no effect . LDL cholesterol lowering by oat β-glucan may depend on viscosity , which is controlled by the molecular weight ( MW ) and amount of oat β-glucan solubilized in the intestine ( C ) . OBJECTIVES Our 2 primary objectives were to determine whether consumption of 3 g high-MW oat β-glucan/d would reduce LDL cholesterol and whether LDL cholesterol lowering was related to the log(MW × C ) of oat β-glucan . DESIGN In a double-blind , parallel- design , multicenter clinical trial , subjects with LDL cholesterol ≥3.0 and ≤5.0 mmol/L ( n = 786 screened , n = 400 ineligible , n = 19 refused , n = 367 enrolled , and n = 345 completed ) were r and omly assigned to receive cereal containing wheat fiber ( n = 87 ) or 3 g high-MW ( 2,210,000 g/mol , n = 86 ) , 4 g medium-MW ( 850,000 g/mol , n = 67 ) , 3 g medium-MW ( 530,000 g/mol , n = 64 ) , or 4 g low-MW ( 210,000 g/mol , n = 63 ) oat β-glucan/d ( divided doses , twice daily ) for 4 wk . RESULTS LDL cholesterol was significantly less with 3 g high-MW , 4 g medium-MW , and 3 g medium-MW oat β-glucan cereals than with the wheat-fiber cereal by 0.21 ( 5.5 % ; 95 % CI : -0.11 , -0.30 ; P = 0.002 ) , 0.26 ( 6.5 % ; 95 % CI : -0.14 , -0.37 ; P = 0.0007 ) , and 0.19 ( 4.7 % ; 95 % CI : -0.08 , -0.30 ; P = 0.01 ) mmol/L , respectively . However , the effect of 4 g low-MW oat β-glucan/d ( 0.10 mmol/L ) was not significant ( 2.3 % ; 95 % CI : 0.02 , -0.20 ) . By analysis of covariance , log(MW × C ) was a significant determinant of LDL cholesterol ( P = 0.003 ) . Treatment effects were not significantly influenced by age , sex , study center , or baseline LDL cholesterol . CONCLUSIONS The physicochemical properties of oat β-glucan should be considered when assessing the cholesterol-lowering ability of oat-containing products ; an extruded breakfast cereal containing 3 g oat β-glucan/d with a high-MW ( 2,210,000 g/mol ) or a medium-MW ( 530,000 g/mol ) lowered LDL cholesterol similarly by ≈0.2 mmol/L ( 5 % ) , but efficacy was reduced by 50 % when MW was reduced to 210,000 g/mol . This trial was registered at www . clinical trials.gov as NCT00981981",
"Background Cardiovascular disease ( CVD ) is the leading cause of death in China and worldwide . Whole grain oats can reduce risk of CVD by reducing total and LDL-cholesterol , major risk factors for CVD . While this association has been established in many population s , data from Asian population s is limited . Thus , this study investigated the impact of oat consumption on cholesterol levels in Chinese adults . Male and female data from this work were previously published separately in m and arin in two Chinese journals . The combined male and female data were reanalyzed and are presented here . Methods A r and omized , controlled , parallel-arm study was conducted at Beijing Hospital , Beijing china . Subjects were adults ( men and women ) with mild to moderate hypercholesterolemia . The oat group ( n=85 ) consumed 100grams of instant oat cereal versus the control group ( n=81 ) who consumed 100grams of wheat flour-based noodles daily for 6weeks . Laboratory and anthropometric measurements were conducted at baseline and at the end of the 6-week intervention . Results Dietary fiber intake increased significantly in the oat group compared to the control group at the end of the 6-week intervention . Total- , LDL-cholesterol and waist circumference decreased significantly in the oat group compared to the control . HDL-cholesterol decreased significantly in the control group versus the oat group . There were no significant changes in blood pressure , other anthropometric or laboratory measures between the two groups at the end of the intervention . Conclusions Instant oatmeal consumed daily for 6 weeks significantly increased fiber intake and decreased major risk factors for CVD in Chinese adults with hypercholesterolemia . Increased consumption of whole grains , including oats , should continue to be encouraged",
"Type 2 diabetes is associated with a higher cardiovascular risk and there has been a growing interest in using dietary intervention to improve lipid profile and glucose control . The present work aims at analysing the effects of the enrichment of a normal diet with beta-glucan ( 3.5 g/d ) in free-living type 2 diabetic subjects for 2 months , using a palatable soup . This trial was a parallel , placebo-controlled , double-blinded r and omised study performed in fifty-three type 2 diabetic subjects . During a 3-week run-in period , subjects daily consumed a ready meal control soup ( without beta-glucan ) . For the following 8 weeks , subjects were r and omly assigned to consume daily either a control soup or a beta-glucan soup . Changes in lipid profile ( total cholesterol ( TC ) , HDL- and LDL-cholesterol ( HDLc and LDLc ) , apo B and TAG ) and in glucose control ( HbA1c and fasting glucose ) were measured . There was no significant alteration in lipid profile in the two groups ( TC , HDLc , LDLc and apo B ) . TAG decreased significantly in the beta-glucan group compared with the control group ( - 0.12 ( SD 0.38 ) v. 0.12 ( SD 0.44 ) mmol/l , P = 0.03 ) . HbA1c and fasting glucose were not reduced in any group . A single daily ingestion of 3.5 g beta-glucan , as required by official dietary recommendations , for 8 weeks did not change the lipid profile and HbA1c in type 2 diabetic subjects . To improve the metabolic profile of type 2 diabetic subjects in the long term , the quantity , the food vectors and the tolerability of beta-glucan products may be re-evaluated",
"Several regulatory bodies have approved a health cl aim on the cholesterol-lowering effects of oat β-glucan at levels of 3·0 g/d . The present study aim ed to test whether 1·5 g/d β-glucan provided as ready-to-eat oat flakes was as effective in lowering cholesterol as 3·0 g/d from oats porridge . A 6-week r and omised controlled trial was conducted in eighty-seven mildly hypercholesterolaemic ( ≥ 5 mmol/l and ( 25 % energy ( E% ) protein ; 45 E% carbohydrate ; 30 E% fat , at energy requirements for weight maintenance ) : ( 1 ) minimal β-glucan ( control ) ; ( 2 ) low-dose oat β-glucan ( 1·5 g β-glucan ; oats low - OL ) or ( 3 ) higher dose oat β-glucan ( 3·0 g β-glucan ; oats high - OH ) . Changes in total cholesterol and LDL-cholesterol ( LDL-C ) from baseline were assessed using a linear mixed model and repeated- measures ANOVA , adjusted for weight change . Total cholesterol reduced significantly in all groups ( - 7·8 ( sd 13·8 ) % , - 7·2 ( sd 12·4 ) % and - 5·5 ( sd 9·3 ) % in the OH , OL and control groups ) , as did LDL-C ( - 8·4 ( sd 18·5 ) % , - 8·5 ( sd 18·5 ) % and - 5·5 ( sd 12·4 ) % in the OH , OL and control groups ) , but between-group differences were not significant . In responders only ( n 60 ) , β-glucan groups had higher reductions in LDL-C ( - 18·3 ( sd 11·1 ) % and - 18·1 ( sd 9·2 ) % in the OH and OL groups ) compared with controls ( - 11·7 ( sd 7·9 ) % ; P = 0·044 ) . Intakes of oat β-glucan were as effective at doses of 1·5 g/d compared with 3 g/d when provided in different food formats that delivered similar amounts of soluble β-glucan",
"Aim : To study whether an oat bran enriched diet has a specific effect in lowering total and low-density lipoprotein cholesterols , in addition to caloric and fat restriction . Methods : We performed a r and omized , controlled , parallel-group , single-centre study in which 1,994 patients from the Wehrawald Hospital ( Todtmoos , Germany ) were screened and 235 met the criteria male gender , hypercholesterolemia , and overweight . All patients in the Wehrawald Hospital took part in a 4-week st and ardized inpatient lifestyle health program consisting of dietary intervention , increased physical activity , and health education . Caloric restriction , fat modification , and oat bran supplementation were part of the nutritional regimen within the lifestyle health program . Ninety-nine patients were r and omized to a fat-modified diet with caloric restriction and a daily intake of 35–50 g oat bran and 136 patients to a fat-modified , oat bran-free diet with caloric restriction . Fifty-three male overweight but normocholesterolemic subjects were selected as controls . Results : The most significant decreases in total cholesterol ( –67.7 ± 37.2 mg/dl ; p ) , low-density lipoprotein cholesterol ( –56.3 ± 35.1 mg/dl ; p ) , and apolipoprotein B ( –42.4 ± 34.1 mg/dl ; p of the fat-modified and oat bran enriched food . Conclusions : Added to a fat-modified diet , oat bran within a practical range of intake significantly reduces total cholesterol , low-density lipoprotein cholesterol , and apolipoprotein B. These beneficial effects occurred independent of covariables such as physical activity or caloric and fat restriction in the diet",
"Objective : Clinical trials have indicated that water-soluble fiber from oats reduces serum cholesterol among hypercholesterolemic patients on a low-fat diet . We examined the effect of dietary fiber intake on serum lipids among persons without hypercholesterolemia . Design : R and omized controlled trial . Setting and subjects : We recruited 110 participants who were aged 30–65 years and had a serum cholesterol level Intervention : Study participants were r and omly assigned to receive 8 g per day of water-soluble fiber from oat bran or a control intervention . Results : At baseline , the mean levels of serum cholesterol and other measured variables were comparable between the high-fiber and control groups . Over the 3-month intervention , mean changes ( 95 % confidence interval ( CI ) ) in total , HDL- , and LDL-cholesterol were −2.42 mg/dl ( −8.90 to 4.05 mg/dl ; P=0.46 ) , −0.24 mg/dl ( −2.19 to 1.71 mg/dl ; P=0.81 ) , and −1.96 mg/dl ( −7.32 to 3.40 mg/dl ; P=0.47 ) in the fiber group and −0.02 mg/dl ( −5.29 to 5.26 mg/dl ; P=0.99 ) , 1.42 mg/dl ( −0.74 to 3.59 mg/dl ; P=0.19 ) , and −0.64 mg/dl ( −5.30 to 4.03 mg/dl ; P=0.79 ) in the control group , respectively . The net changes ( 95 % confidence interval ) in total , HDL- , and LDL-cholesterol were −2.40 mg/dl ( −10.6 to 5.81 mg/dl ; P=0.56 ) , −1.66 mg/dl ( −4.55 to 1.22 mg/dl ; P=0.26 ) and −1.33 mg/dl ( −8.33 to 5.68 mg/dl ; P=0.71 ) , respectively . Conclusions : Our study does not support the hypothesis that water-soluble fiber intake from oat bran reduces total and LDL-cholesterol in study participants with a normal serum cholesterol level",
"OBJECTIVE Several studies have indicated that consumption of oat bran lowers blood cholesterol and this effect has been attributed specifically to oat bran 's soluble fiber ( beta-glucan ) . This study was design ed to test this hypothesis . DESIGN The purified fibre ( oat gum , 80 % beta-glucan ) was isolated , and agglomerated in the presence of maltodextrin to facilitate dispersion in a drink . Subjects consumed the oat gum ( 2.9 g beta-glucan ) , or maltodextrin placebo , twice daily for 4 weeks , in a r and omized , cross-over design with a 3 week wash-out between phases . Consumption was equivalent to a daily dose of about 70 g of oat bran . SETTING The study was with free-living individuals . SUBJECTS Twenty hypercholesterolemic male and female adults entered , and 19 completed , the study . INTERVENTIONS Blood lipids from fasting individuals were measured weekly throughout the study . Diet was monitored using 3 day food diaries . RESULTS There were no significant changes ( P > 0.05 ) in blood lipids during the placebo phase . Mean initial total cholesterol ( 6.76 + /- 0.13 mmol/l ) and low density lipoprotein ( LDL ) cholesterol ( 4.59 + /- 0.14 mmol/l ) levels fell throughout the oat gum phase , and at week 4 each was reduced 9 % relative to initial values ( P = 0.0004 and 0.005 respectively ) . When oat gum was discontinued , total and LDL cholesterol returned to initial levels . There were no significant changes in high density lipoprotein ( HDL ) cholesterol . Triglyceride levels also remained unchanged except for a singular decrease at week 4 of the oat gum phase relative to the initial value , but not compared to the placebo value . The lowered mean total and LDL cholesterol levels occurred in the absence of any dietary changes . CONCLUSIONS The main component of the soluble fibre of oats , beta-glucan , significantly reduced the total and LDL cholesterol levels of hypercholesterolemic adults without changing HDL cholesterol",
"OBJECTIVES Our study compared 2 whole grain oat-based cereals with 2 refined grain wheat-based cereals to determine their effects on the need for antihypertensive medications in people with high blood pressure ( BP ) . STUDY DESIGN This 12-week , r and omized controlled parallel-group trial with = 6 weeks of voluntary follow-up was design ed to investigate the antihypertensive effects of oats . After 4 weeks of baseline feeding , medication dose was maintained or reduced by half or completely throughout the middle 4 weeks of the study . In the final 4 weeks , participants continued cereal consumption ; medication was adjusted according to the protocol . POPULATION Men and women ( n = 88 ) being treated for hypertension with a mean baseline BP below 160/100 . OUTCOMES MEASURED Primary study outcomes included change in SBP and DBP as well as antihypertensive medication reduction . Secondary measures included blood lipid , fasting glucose , and insulin levels and side effects related to elevated BP and increased dietary fiber intake . RESULTS Seventy-three percent of participants in the oats group versus 42 % in the control group were able to stop or reduce their medication by half . Treatment group participants whose medication was not reduced had substantial decreases in BP . The oats group experienced a 24.2-mg/dL reduction in total cholesterol levels , a 16.2-mg/dL decrease in low-density lipoprotein cholesterol levels , and a 15.03-mg/dL drop in plasma glucose levels vs controls . CONCLUSIONS Results suggest that a diet containing soluble fiber-rich whole oats can significantly reduce the need for antihypertensive medication and improve BP control . Considering the lipid and glucose improvements as well , increased consumption of whole oats may significantly reduce cardiovascular disease risk",
"Objective : To investigate the effect of bread formulated with 6 g of β-glucan ( oat soluble fiber ) on serum lipids in overweight normotensive subjects with mild to moderate hypercholesterolemia . Design : Thirty-eight male subjects [ mean age 59.8 ± 0.6 yr , mean body mass index ( BMI ) 28.3 ± 0.6 kg/m2 ] who were eligible for the study ate an isocaloric diet for a 1-week period . They were then divided into 2 groups : group A ( n = 19 ) , who were maintained on American Heart Association ( AHA ) Step II diet , including whole wheat bread , and group B ( n = 19 ) , who were maintained on AHA Step II diet containing high levels of monounsaturated fatty acids plus bread containing 6 g of β-glucan ( Nutrim-OB ) for 8 weeks . Plasma lipids and glucose were measured at baseline and after weeks 8 in all subjects . All subjects were advised to walk for 60 minutes every day . Results : There was a significant increase ( ↑27.8 % ) in plasma high density lipoprotein ( HDL ) cholesterol in the β-glucan group ( group A ) from 39.4 ± 2.0 to 49.5 ± 2.1 mg/dL ( P reduction in total cholesterol in the 2 groups to approximately the same extent : group A , from 232.8 ± 2.7 mg/dL to 202.7 ± 6.7 mg/dL ; P ; P also decreased significantly in the two groups : group A , from 160.3 ± 2.8 mg/dL to 133.2 ± 5.4 mg/dL ; P 0.04 ) . There was a small and insignificant reduction in plasma very LDL ( VLDL ) cholesterol and triglycerides in the two groups . Similarly , non-HDL cholesterol levels were also decreased , with β-glucan diet producing significantly higher effect ( ↓24.5 % vs. ↓16.1 % ; P The β-glucan diet also produced higher reduction in total cholesterol/HDL cholesterol ratio ( ↓33.3 % vs. ↓8.4 % ; P 0.003 ) and LDL cholesterol/HDL cholesterol ratio ( ↓42.1 % vs. ↓13.3 % ; P without β-glucan . The β-glucan diet also decreased fasting plasma glucose ( P reduced body weight and BMI significantly , with β-glucan diet having a greater effect . Conclusions : Six grams of β-glucan from oats added to the AHA Step II diet and moderate physical activity improved lipid profile and caused a decrease in weight and , thus , reduced the risk of cardiovascular events in overweight male individuals with mild to moderate hypercholesterolemia . The diet with added β-glucan was well accepted and tolerated",
"Low-glycemic index diets are associated with a wide range of benefits when followed on a chronic basis . The chronic effects , however , of the substitution of 1 meal per day are not well known in diabetic subjects . Therefore , we aim ed to evaluate whether the chronic use of a low-glycemic index breakfast ( low-GIB ) rich in low-GI carbohydrates and a modest amount of soluble fibers could have an effect on lipemia at a subsequent lunch , and improve glucose and lipid metabolism in men with type 2 diabetes . A total of 13 men with type 2 diabetes were r and omly allocated in a double-blind cross-over design to a 4-week daily intake of a low-GI versus a high-GI breakfast separated by a 15-day washout interval . The low-GI breakfast was composed of whole grain bread and muesli containing 3 g beta-glucan from oats . Low-GIB induced lower postpr and ial plasma glucose peaks than the high-GIB at the beginning ( baseline , P incremental area under the plasma glucose curve was also lower ( P fasting plasma glucose , insulin , fructosamine , or glycosylated hemoglobin ( HbA(1c ) ) . Fasting plasma cholesterol , as well as the incremental area under the cholesterol curve , were lower ( P Apolipoprotein B ( apo B ) was also decreased by the 4-week low-GIB . There was no effect of the low-GI breakfast on triacylglycerol excursions or glucose and insulin responses at the second meal . The high-GIB , however , tended to decrease the amount of mRNA of leptin in abdominal adipose tissue , but had no effect on peroxisome proliferator-activated receptor gamma ( PPARgamma ) and cholesterylester transfer protein ( CETP ) mRNA amounts . In conclusion , the intake of a low-GI breakfast containing a modest amount ( 3 g ) of beta-glucan for 4 weeks allowed good glycemic control and induced low plasma cholesterol levels in men with type 2 diabetes . The decrease in plasma cholesterol associated with low-GI breakfast intake may reduce the risk of developing cardiovascular complications in subjects with type 2 diabetes",
"The aim of this study was to investigate whether consumption of a newly developed oat milk deprived of insoluble fiber would result in lower serum cholesterol and low-density lipoprotein ( LDL ) cholesterol levels in men with moderate hypercholesterolemia . The study had a r and omized , controlled double-blind design , and oat milk was compared with an identically flavored control drink . Sixty-six men were recruited from a screening program and were r and omly assigned to two groups . Each group took either oat milk or a control drink ( rice milk ) for 5 weeks ( 0.75 liters/day ) and then switched to the other drink regimen for another 5-week period with a 5-week washout period between the test periods . The oat milk contained more dietary fiber , especially β-glucan ( 0.5 g/100 g ) , than the control drink ( sensory evaluation , indicating that the double-blind design had been attained . In the final analysis 52 subjects remained . Compared with the control drink , intake of oat milk result ed in significantly lower serum total cholesterol ( 6 % , p = 0.005 ) and LDL cholesterol ( 6 % , p = 0.036 ) levels . The decrease in LDL cholesterol was more pronounced if the starting value was higher ( r = –0.55 , p The concentration of high-density lipoprotein cholesterol was not significantly different after consumption of the two drinks . Serum triglycerides did not change significantly after intake of oat milk , but a significant increase was observed after intake of the control drink ( p = 0.003 ) . It is concluded that also oat milk deprived of insoluble fiber has cholesterol-reducing properties ",
"The purpose of this study was to confirm and extend previous findings that serum cholesterol response to a fat-modified diet is enhanced by oat fiber . Participants ( n = 236 ) were recruited from the Continental Illinois National Bank in Chicago . Data including weight , serum lipid level , lipoproteins , and 3-day food records were collected at baseline and every 4 weeks for 12 weeks . All participants were instructed to follow the fat-modified ( Phase II ) diet recommended by the American Heart Association ( AHA ) . After 4 weeks , participants were r and omly assigned to one of two groups . While both groups continued to follow the AHA diet , Group 1 was instructed to include 2 oz ( 56 g , dry wt ) of oatmeal , isocalorically substituted for other carbohydrate foods . Group 2 served as the control and consumed no oat products throughout the study . Serum cholesterol values at baseline and after 4 weeks of the AHA diet were similar for both groups ( 203.9 and 193.0 mg/dl for Group 1 and 205.3 and 194.5 mg/dl for Group 2 ) . After 4 weeks of oatmeal intervention , mean group differences were -6.8 and -2.1 mg/dl ( P = 0.008 one-tailed t test ) for Groups 1 and 2 , respectively . Following an additional 4 weeks of oatmeal intervention , the Group 1 mean cholesterol increased slightly ( 0.9 mg/dl ) , while the Group 2 level decreased slightly ( -0.7 mg/dl ) . Overall serum cholesterol responses for the two groups from Visit 2 to Visit 4 were -6.0 and -2.8 mg/dl for Groups 1 and 2 , respectively ( P = 0.074 , one tail ) . Changes in weight were small and nonsignificant . Subgroup analyses revealed greater reductions in serum cholesterol among participants with the highest baseline serum cholesterol ( -8.0 mg/dl vs -1.7 mg/dl for Subgroups 1 and 2 , respectively ) . These data support previous findings that inclusion of oatmeal in a fat-modified diet is helpful in lowering serum cholesterol , particularly for individuals with elevated serum cholesterol levels",
"Background / Aims : To investigate whether a daily intake of a nutrient-balanced ready meal containing 4 g of oat β-glucans lowers total cholesterol ( T-C ) and low-density-lipoprotein cholesterol ( LDL-C ) in hyperlipidemic subjects and to evaluate its effect on postpr and ial glucose and insulin concentrations . Methods : A parallel , placebo-controlled trial was carried out in 43 healthy men and women with elevated serum cholesterol levels . During the 3-week run-in period , all subjects consumed daily a ready-meal soup , low in energy and fat and high in fiber but without oat β-glucans . Subjects were then r and omly assigned for the following 5-week intervention period to either continue consumption of the control soup or an equal soup supplemented with β-glucan . Results : Consumption of the β-glucan-enriched ready meal decreased T-C ( 0.22 ± 0.41 mmol/l ) and LDL-C ( 0.16 ± 0.36 mmol/l ) , but the reductions were not significantly lower compared with control . After a meal with β-glucan soup , neither postpr and ial glucose nor insulin concentrations were significantly different from those after a control soup . Conclusion : A daily dose of 4 g of oat β-glucans incorporated into a healthy ready meal did not significantly lower T-C and LDL-C compared with an equal ready meal without β-glucans . Thus , if a food product fulfils general healthy dietary recommendations it may not necessarily be a c and i date for supplementation with β-glucans ",
"BACKGROUND Psyllium and oat bran have been shown to lower plasma LDL cholesterol levels in different population s. Hypercholesterolemia is prevalent in the Northern part of Mexico and might be associated to dietary habits and sedentary lifestyle . METHODS Sedentary normal ( cholesterol220 mg/dL ) ( n=30 ) men from the Northern part of Mexico aged 20 to 45 years of age participated in an 8-week study to determine the effects of dietary soluble fiber , either psyllium or oat bran , in lowering plasma LDL cholesterol in this population . Fiber was administered by feeding the subjects an amount of cookies ( 100 g ) equivalent to 1.3 or 2.6 g/day of soluble fiber from psyllium or oat bran , respectively . Subjects were r and omly allocated to three groups : a control group consuming cookies with wheat bran , a known source of fiber with no cholesterol lowering effects , psyllium , or oat bran . RESULTS Food frequency question naires indicated that subjects from the three groups had similar intakes of foods classified as hypercholesterolemic ( p>0.05 ) . Plasma LDL cholesterol concentrations were reduced by an average of 22.6 and 26 % in the psyllium and oat bran groups ( p plasma HDL or triglycerides levels were observed among the three dietary treatments except for hypercholesterolemic individuals supplemented with oat bran where a 28 % reduction in plasma triglycerides was observed after 8 weeks ( p psyllium and oat bran are efficacious in lowering plasma LDL cholesterol in both normal and hypercholesterolemic individuals from this population",
"A higher excretion of dry matter , fat , nitrogen , energy , and total bile acids in ileal effluents ; a lower plasma low-density-lipoprotein ( LDL ) and total cholesterols ( 12.1 % and 9.0 % lower respectively ) ; but no change in plasma high-density-lipoprotein ( HDL ) cholesterol or apolipoproteins A-I and B were observed in nine subjects with ileostomies when they consumed an oat-bran , bread-based , high-fiber diet ( HFD ) as compared with a wheat-flour , bread-based , low-fiber diet ( LFD ) for 3 wk with a crossover design . Of the nine subjects only the subjects with a low daily excretion of bile acids had an elevated excretion of total bile acids during the HFD compared with the LFD . Total cholesterol , LDL cholesterol , and apolipoprotein B in plasma also decreased by 11.3 % , 15.3 % , and 10.7 % , respectively , after consumption of the HFD for 3 wk",
"This r and omized , controlled trial of cholesterol lowering by an oat bran cereal containing beta glucan vs a corn cereal without soluble fiber in Hispanic Americans was conducted for 11 weeks . One-hundred fifty-two men and women , ages 30 to 70 years , with baseline low-density lipoprotein cholesterol ( LDL-C ) levels between 120 and 190 mg/dL and triglycerides After eating a National Cholesterol Education Program Step 1 diet for 5 weeks , subjects were r and omly assigned to the corn or the oat cereal for the next 6 weeks . The daily dose of beta glucan was 3 g. Consumption of oat cereal was associated with a reduction in plasma levels of both total cholesterol ( -10.9+/-21.6 mg/dL ; -4.5 % ) and LDL-C ( -9.4+/-20.3 mg/dL ; -5.3 % ) . Consumption of corn cereal did not affect either total cholesterol ( + 1.2+/-18.3 mg/dL ; 1.1 % ) or LDL-C ( + 1.2+/-17.5 mg/dL ; 2.2 % ) . Differences between the effects of the two cereals on total cholesterol and LDL-C were significant , P = .0003 and P = .0007 , respectively",
"Previous studies have shown that supplementation of the diet with oat bran may lower serum cholesterol levels . However , it is not known whether oat-bran diets lower serum cholesterol levels by replacing fatty foods in the diet or by a direct effect of the dietary fiber contained in oat bran . To determine which is the case , we compared the effect of isocaloric supplements of high-fiber oat bran ( 87 g per day ) and a low-fiber refined-wheat product on the serum lipoprotein cholesterol levels of 20 healthy subjects , 23 to 49 years old . After a one-week base-line period during which they consumed their usual diets , the subjects were given each type of supplement for six-week periods in a double-blind , crossover trial . Mean serum cholesterol levels ( + /- SD ) were not significantly different during the high-fiber and low-fiber periods : total cholesterol , 4.44 + /- 0.73 and 4.46 + /- 0.64 mmol per liter ( 172 + /- 28 and 172 + /- 25 mg per deciliter ) ; low-density lipoprotein , 2.69 + /- 0.63 and 2.77 + /- 0.59 mmol per liter ( 104 + /- 24 and 107 + /- 23 mg per deciliter ) ; and high-density lipoprotein , 1.40 + /- 0.39 and 1.32 + /- 0.39 mmol per liter ( 54.2 + /- 15.0 and 50.9 + /- 15.2 mg per deciliter ) , respectively . However , both types of supplements lowered the mean base-line serum cholesterol level , 4.80 + /- 0.80 mmol per liter ( 186 + /- 31 mg per deciliter ) , by 7 to 8 percent ( 95 percent confidence interval for high fiber , 11 to 4 percent , and for low fiber , 11 to 3 percent ) . The subjects ate less saturated fat and cholesterol and more polyunsaturated fat during both periods of supplementation than at base line . Those changes in dietary fats were sufficient to explain all of the reduction in serum cholesterol levels caused by the high-fiber and low-fiber diets . The average blood pressure was 112/68 mm Hg at base line and did not change during either dietary period . We conclude that oat bran has little cholesterol-lowering effect and that high-fiber and low-fiber dietary grain supplements reduce serum cholesterol levels about equally , probably because they replace dietary fats",
"AIMS to assess the hypocholesterolaemic effect of adding 50 g of oatbran to the diet of hypercholesterolaemic subjects already prescribed a diet with less than 30 % of energy from fat . METHODS twenty-nine volunteers aged 21 - 67 years with total serum cholesterol levels 5.59 - 8.5 mmol/L prescribed a diet containing less than 30 % of energy intake as fat , and with a body mass index between 19.8 and 29.3 , were enrolled in a crossover study to assess the effect of the addition to the diet of 50 g daily of oatbran . After six weeks of an oat-free control diet , subjects were r and omised to eat 50 g daily of oatbran or to continue on the oat-free diet . Six weeks later the subjects crossed to the alternative diet for a further six week period . Lipid levels were assessed in weeks five and six of each study period . RESULTS twenty-four subjects completed the study consuming 51.7 ( SD 15.5 ) g of oatbran daily during the treatment phase . No significant difference was seen between the oatbran and control diet periods in body mass index , energy or fat intake , or in total cholesterol , LDL and HDL fractions , apolipoprotein A1 and B levels , or triglyceride levels . Considerable variation was observed between the paired lipid results . CONCLUSIONS ingestion of 50 g of oatbran daily by hypercholesterolaemic subjects on a low fat diet showed no influence on serum lipid levels . The importance of using at least duplicate sample s in assessing changes in lipid values is emphasised",
"The effects of oat bran and wheat bran on plasma lipid concentrations were compared in a crossover study . Each bran ( 123 g oat bran or 54 g wheat bran ) added nearly 18 g of nonstarch polysaccharide to a background diet containing about 10 g nonstarch polysaccharide . Twenty-three men ( average plasma cholesterol level = 5.84 mmol/L , and low-density-lipoprotein ( LDL ) cholesterol level = 4.11 mmol/L ) were r and omly assigned to either the oat or wheat bran diet for 4 weeks and then changed to the alternate bran diet for a similar period . The oat bran diet produced significantly lower levels of plasma total cholesterol and LDL cholesterol : 5.65 + /- 0.16 and 3.88 + /- 0.15 mmol/L ( mean + /- st and ard error ) for oat bran vs 5.89 + /- 0.16 and 4.11 + /- 0.16 mmol/L for wheat bran . Food intake diaries showed that average consumption of total fat and saturated fat was identical during the two test periods , which excluded displacement of fat as an explanation for lowering of plasma cholesterol by oat bran . Our results indicate that in mildly hypercholesterolemic men , a diet high in soluble oat fiber can significantly lower plasma total cholesterol and LDL cholesterol and thus potentially lower the risk of coronary heart disease",
"Oat cereals rich in the water-soluble fiber beta-glucan have been studied as a dietary therapy for hypercholesterolemia . To determine the hypocholesterolemic response of beta-glucan in the diet , 156 adults with low-density lipoprotein cholesterol ( LDL-C ) levels above 4.14 mmol/L ( 160 mg/dL ) or between 3.37 and 4.14 mmol/L ( 130 and 160 mg/dL ) with multiple risk factors were r and omized to one of seven groups . Six groups received either oatmeal or oat bran at doses ( dry weight ) of 28 g ( 1 oz ) , 56 g ( 2 oz ) , and 84 g ( 3 oz ) . A seventh group received 28 g of farina ( beta-glucan control ) . At week 6 of treatment , significant differences were found for both total cholesterol and LDL-C levels among the farina control and the treatment groups who were receiving 84 g of oatmeal , 56 g of oat bran , and 84 g of oat bran , with decreases in LDL-C levels of 10.1 % , 15.9 % , and 11.5 % , respectively . Fifty-six grams of oat bran result ed in significantly greater reductions in LDL-C levels than 56 g of oatmeal . Nutrient analysis shows no difference in dietary fat content between these treatment groups ; therefore , the higher beta-glucan content of oat bran most likely explains the significantly greater LDL-C reductions . A dose-dependent reduction in LDL-C levels with oat cereals supports the independent hypocholesterolemic effects of beta-glucan",
"OBJECTIVE To determine whether adding 60 g oatbran per day to a low saturated fat , low cholesterol diet has any additional effect of lowering serum lipids . DESIGN A double blind , prospect i ve , r and omised , placebo controlled crossover study . SETTING Lipid clinic in a teaching hospital . SUBJECTS Thirty-seven subjects ( 16 men , 21 women ) with serum cholesterol of 5.5 - 8.0 mmol/L were recruited from staff and medical clinics . All subjects were aware of their hyperlipidaemia and no subject was previously treated with lipid lowering agents . INTERVENTIONS After an eight-week diet period subjects were r and omised to receive two muffins per day containing either 60 g of oatbran or the equivalent amount of fibre from wheatbran in a double blind crossover study . MAIN OUTCOME MEASURES Measurement of lipids , lipoproteins and biochemical parameters at the end of each eight-week period . RESULTS Mean serum lipid levels at the end of the oatbran and wheatbran periods were significantly different from each other only for low density lipoprotein ( LDL ) cholesterol ( oatbran , 4.67 mmol/L ; SD , 0.85 ; and wheatbran , 4.95 mmol/L ; SD , 0.81 ; P LDL/HDL ( high density lipoprotein ) ratio ( oatbran , 3.68 ; SD , 1.25 ; and wheatbran , 4.01 ; SD , 1.25 ; P apoprotein B ( oatbran , 1.03 g/L ; SD , 0.21 ; and wheatbran , 1.08 g/L ; SD , 0.19 ; P Oatbran fibre is more effective than wheatbran fibre in lowering cholesterol in subjects with mild hyperlipidaemia who are already on a low saturated fat , low cholesterol diet",
"OBJECTIVES To study possible synergistic effects of oats and soy on reducing total and low-density lipoprotein cholesterol ( LDL-C ) concentrations in human beings and the efficacy and feasibility of including these adjustments to a National Cholesterol Education Program Step I diet . SUBJECT/ SETTING : One hundred twenty-seven postmenopausal women with moderate hypercholesterolemia were recruited from a large Midwestern workforce and senior centers in the surrounding community . Intervention and clinical visits were conducted in these same facilities . DESIGN After a 3-week lead-in period on the Step I diet , participants were r and omly assigned to 1 of 4 dietary treatments for an additional 6 weeks : an oats/milk group , a wheat/soy group , an oats/soy group , and a wheat/milk group . Clinical measurements included blood draws , body weight and height , blood pressure , and medical history data . Three-day food records were collected at baseline and Weeks 3 and 9 of the intervention . R and omization was stratified based on the status of hormone replacement therapy and was blocked with sizes 4 or 8 for group assignment . RESULTS After 3 weeks on the Step I diet , total cholesterol , LDL-C , and triglyceride levels ; total fat and saturated fat intake , dietary cholesterol intake , Keys score , and body mass index were all reduced . Following an additional 6 weeks on the Step I diet plus intervention , total cholesterol and LDL-C were further reduced for both the oats/soy group and oats/milk group . There were no significant further changes in total cholesterol , LDL-C , or high-density lipoprotein cholesterol levels in the wheat/soy and wheat/milk groups . Body mass index remained stable in all groups from Week 3 to Week 9 . APPLICATIONS Nonpharmacologic dietary interventions like the Step I diet are feasible in a community setting and can produce rapid and significant lipid-lowering benefits . Daily consumption of 2 servings of oats can contribute to further lipid alterations in this population although soy intake at this dose may not . Palatability and convenience are important considerations in achieving dietary adherence",
"OBJECTIVE To evaluate the long-term effects oat bran concentrate bread products in the diet of free-living subjects with non-insulin-dependent diabetes ( NIDDM ) via dietary , clinical , and biochemical methods . DESIGN A 24-week crossover study consisting of two 12-week periods . SUBJECTS/ SETTING Eight men with NIDDM ( mean age = 45 years ) who lived in the community . Glucose and insulin profiles were conducted in a clinical investigation unit . INTERVENTION Palatable , high-fiber , oat bran concentrate ( soluble fiber [ beta-glucan ] content = 22.8 % ) bread products were developed . Four r and omly chosen subjects ate oat bran concentrate breads first ; the other subjects ate control white bread first . MAIN OUTCOME MEASURES Dietary intake ( four 48-hour dietary recalls per period ) was assessed . Blood glucose and insulin ( 8-hour profiles ) and lipid parameters after fasting were measured ( at 0 , 12 , and 24 weeks ) . STATISTICAL ANALYSES PERFORMED Analysis of variance and repeated- measures analysis of variance . RESULTS Total energy and macronutrient intakes were similar in both periods . Mean total dietary fiber intake was 19 g/day in the white bread period and 34 g/day ( 9 g soluble fiber per day from oat bran concentrate ) in the oat bran concentrate period . Body weight remained stable . Mean glycemic and insulin response areas ( area under the curve ) were lower ( P oat bran concentrate period than the white bread period . After breakfast , area under the curve for the oat bran concentrate period was lower for glucose ( P insulin ( P insulin peak was reached earlier ( P Dietary fiber intake was correlated negatively with insulin area under the curve ( P Mean total plasma cholesterol and low-density lipoprotein cholesterol levels were lower ( P oat bran concentrate period than in the white bread period . In the oat bran concentrate period , the mean ratio of low-density lipoprotein cholesterol to high-density lipoprotein cholesterol was reduced by 24 % ( P oat bran concentrate bread products improved glycemic , insulinemic , and lipidemic responses",
"The effects of beta-glucan-rich oat bran on serum lipids and lipoproteins were examined in a r and omized 8-week study . After a 4-week run-in phase , subjects with mild to moderate hypercholesterolemia [ serum total cholesterol ( TC ) 5.5 - 8.5 mmol/l ] on cholesterol-lowering diets were r and omly allocated to an oat bran ( 10.3 g beta-glucan/day ) or wheat bran group . Thirty-six subjects ( 20 in the oat bran group , 16 in the wheat bran group ) completed the study . The diet was identical in both groups during the trial and no significant changes in body weight were found . Serum TC and low-density lipoprotein cholesterol ( LDL-C ) significantly declined in the oat bran group during the first 4 weeks from 7.03 + /- 0.81 to 6.72 + /- 0.97 ( p = 0.028 ) and from 4.90 + /- 0.69 to 4.61 + /- 0.89 mmol/l ( p = 0.038 ) , respectively , but at 8 weeks the values were not significantly different from baseline . Changes in serum TC were mainly confined to those who ate at least two-thirds of the planned daily dose of oat bran . In wheat bran group no changes were observed in serum TC or LDL-C levels . Apolipoprotein A1 and B did not change significantly in either group . Only subjects with apolipoprotein E 3/3 phenotype ( n = 12 ) had hypocholesterolemic response to oat bran at 4 weeks , but no change was found in those with apolipoprotein E 4/4 or 4/3 ( n = 7 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND Hypercholesterolemia is a strong risk factor in cardiovascular disease . Oat ( Avena sativa L. ) beta-glucan , the soluble fiber in oat , has been known to reduce blood cholesterol levels considerably . However , the effect of oat soluble fiber in the Thai population is unknown . OBJECTIVE To determine the effect of oat consumption on serum lipid profiles in Thai hypercholesterolemic adults . MATERIAL AND METHOD The present study was a r and omized , crossover design . Twenty-four hypercholesterolemic adults , male and female aged 30 - 60 years , were r and omly assigned into two groups of twelve each . Group 1 consumed 70 g ( 3 g beta-glucan ) of oatmeal daily through the first 4-week intervention , and then switched to 70 g rice porridge ( control product ) daily for the next 4-week intervention . Group 2 consumed rice porridge first and then oatmeal . Before and after each intervention period , lipid profiles including total cholesterol ( TC ) , triglycerides ( TG ) , high density lipoprotein cholesterol ( HDL-C ) , and low density lipoprotein cholesterol ( LDL-C ) of all subjects were measured . RESULTS Following daily oat consumption , total cholesterol and LDL-cholesterol levels were significantly lower than baseline levels and lower than the levels observed with rice consumption . Oat consumption reduced total cholesterol by 5 % and LDL-cholesterol by 10 % from baseline levels . In addition , mean and percent changes were significantly different from the levels after consuming rice porridge ( p Oatmeal reduced serum total cholesterol and LDL-cholesterol levels in hypercholesterolemic Thai adults . Hence , oat consumption is a reasonable recommendation for Thai individuals with hyperlipidemia",
"Abstract Most placebo‐controlled studies testing the hypo‐cholesterolaemic action of oat bran have compared high fibre against low fibre diets . To determine whether oat bran had greater cholesterol‐lowering action than another source of fibre ( wheat bran ) we compared the effect of breads of similar total fibre content containing either oat bran or additional wheat bran . Twelve hyperlipidaemic subjects ( 38–66 years ) were stabilised on lipid‐lowering diets for at least three months prior to the study . Subjects were given each type of bread for four‐week periods in a single‐blind , cross‐over design",
"OBJECTIVE Weight loss and consumption of viscous fibers both lower low-density lipoprotein ( LDL ) cholesterol levels . We evaluated whether or not a whole-grain , ready-to-eat ( RTE ) oat cereal containing viscous fiber , as part of a dietary program for weight loss , lowers LDL cholesterol levels and improves other cardiovascular disease risk markers more than a dietary program alone . DESIGN R and omized , parallel-arm , controlled trial . SUBJECTS/ SETTING Free-living , overweight and obese adults ( N=204 , body mass index 25 to 45 ) with baseline LDL cholesterol levels 130 to 200 mg/dL ( 3.4 to 5.2 mmol/L ) were r and omized ; 144 were included in the main analysis of participants who completed the trial without significant protocol violations . INTERVENTION Two portions per day of whole-grain RTE oat cereal ( 3 g/day oat b-glucan ) or energy-matched low-fiber foods ( control ) , as part of a reduced energy ( approximately 500 kcal/day deficit ) dietary program that encouraged limiting consumption of foods high in energy and fat , portion control , and regular physical activity . MAIN OUTCOME MEASURES Fasting lipoprotein levels , waist circumference , triceps skinfold thickness , and body weight were measured at baseline and weeks 4 , 8 , 10 , and 12 . RESULTS LDL cholesterol level was reduced significantly more with whole-grain RTE oat cereal vs control ( -8.7+/-1.0 vs -4.3+/-1.1 % , P=0.005 ) . Total cholesterol ( -5.4+/-0.8 vs -2.9+/-0.9 % , P=0.038 ) and non-high-density lipoprotein-cholesterol ( -6.3+/-1.0 vs -3.3+/-1.1 % , P=0.046 ) were also lowered significantly more with whole-grain RTE oat cereal , whereas high-density lipoprotein and triglyceride responses did not differ between groups . Weight loss was not different between groups ( -2.2+/-0.3 vs -1.7+/-0.3 kg , P=0.325 ) , but waist circumference decreased more ( -3.3+/-0.4 vs -1.9+/-0.4 cm , P=0.012 ) with whole-grain RTE oat cereal . Larger reductions in LDL , total , and non-high-density lipoprotein cholesterol levels and waist circumference were evident as early as week 4 in the whole-grain RTE oat cereal group . CONCLUSIONS Consumption of a whole-grain RTE oat cereal as part of a dietary program for weight loss had favorable effects on fasting lipid levels and waist circumference"
] | 4116795a-06ff-11f0-808a-c43d1ab1c353 |
Chronic anterior glenohumeral joint instability is a common situation and can lead to progressive cartilage deterioration and ultimately instability arthopathy . Progressive cartilage deterioration can occur despite conservative or surgical treatment and the sequelae of these conditions are often addressed with total shoulder arthroplasty . Aims of the present study were to analyze the available literature to describe the technical aspects of this particular operation and to report outcomes and complication rates . The hypothesis was that shoulder arthropalsty in the sequelae of instability had lower outcomes and higher complication rates than arthroplasties for primary arthritis . A systematic review of the literature was performed , in accordance with the PRISMA guidelines . PubMed , Ovid , Cochrane Review s , and Google Scholar were comprehensively search ed using a combination of the following keywords : shoulder arthroplasty , reverse shoulder arthroplasty , dislocation arthropathy , capsulorrhaphy arthropathy and stabilization procedures . Thirteen studies with 365 patients met inclusion criteria . Since 13 patients were lost to follow-up , 352 were review ed at an average follow-up of 53.4 months . The average Constant – Murley ( CM ) and American Shoulder and Elbow Society ( ASES ) scores improved from 35.6 and 35.7 to 72.7 and 77 , respectively . The overall complication rate was 25.7 % and the reoperation rate was 18.5 % . Radiographs at follow-up revealed radiolucent lines on the humerus in 12.4 % of cases and radiolucent lines or notching on the glenoid side in 22.7 % of cases . The average Method ological Index for Non-r and omized Studies Score ( MINORS ) was 12.9 for non-comparative studies and 21.3 for comparative studies . Shoulder arthroplasty to address the sequelae of instability arthropathy and stabilization procedures can be a challenging procedure as a consequence of the distorted anatomy and severe glenohumeral joint pathology . Complication and reoperation rates are higher compared to shoulder arthroplasty for primary glenohumeral joint arthritis ; however , the difference is not statistically significant . When reverse shoulder arthroplasties ( RSA ) were considered as a subgroup and compared to anatomic shoulder replacements ( total shoulders and hemiarthroplasties ) , they showed a lower revision rate | [
"Background : The indications for resurfacing of the glenoid in patients who have osteoarthritis of the shoulder are not clearly defined ; some investigators routinely perform hemiarthroplasty whereas others perform total shoulder arthroplasty . Methods : Forty-seven patients ( fifty-one shoulders ) who were scheduled to have a shoulder arthroplasty for the treatment of degenerative osteoarthritis were r and omly assigned , according to a r and om-numbers table , to one of two groups : replacement of the humeral head with resurfacing of the glenoid with a polyethylene component with cement ( total shoulder arthroplasty [ twenty-seven shoulders ] ) or replacement of the humeral head without resurfacing of the glenoid ( hemiarthroplasty [ twenty-four shoulders ] ) . All patients received the same type of humeral component , and all operations were performed by or under the direct supervision of the same surgeon . The patients were followed for a mean of thirty-five months ( range , twenty-four to seventy-two months ) postoperatively . Evaluation was performed with use of the scoring systems of the University of California at Los Angeles and the American Shoulder and Elbow Surgeons . Results : No difference was observed between the preoperative scores for the two groups of patients . Postoperatively , the mean scores with use of the University of California at Los Angeles system and the American Shoulder and Elbow Surgeons system were 23.2 points ( range , 10 to 31 points ) and 65.2 points ( range , 15 to 94 points ) , respectively , after hemiarthroplasty and 27.4 points ( range , 9 to 34 points ) and 77.3 points ( range , 3 to 100 points ) , respectively , after total shoulder arthroplasty . With the numbers available for study , no significant difference was found between the two operative groups with respect to the postoperative score . ( Thirty-five subjects per group would be needed , assuming an effect size of 0.60 and a power of 0.80 . ) Total shoulder arthroplasty provided significantly greater pain relief ( p = 0.002 ) and internal rotation ( p = 0.003 ) than hemiarthroplasty did . Total shoulder arthroplasty also provided superior results in the specific areas of patient satisfaction , function , and strength , although none of these differences were found to be significant , with the numbers available . Total shoulder arthroplasty was associated with increased cost ( $ 1177 ) , operative time ( thirty-five minutes ) , and blood loss ( 150 milliliters ) per patient compared with hemiarthroplasty . To date , none of the total shoulder arthroplasties in the study group have been revised . Hemiarthroplasty yielded equivalent results for elevation and external rotation . Three of the twenty-five patients who had had a hemiarthroplasty needed a subsequent operation for resurfacing of the glenoid . The mean cost for the revision operations was $ 15,998 . Conclusions : Total shoulder arthroplasty provided superior pain relief compared with hemiarthroplasty in patients who had glenohumeral osteoarthritis , but it was associated with an increased cost of $ 1177 per patient",
"BACKGROUND We compared hemiarthroplasty ( HA ) and total shoulder replacement ( TSR ) for the treatment of osteoarthritis at minimum of 10 years from primary arthroplasty . METHODS Thirty-three patients ( 13 HA and 20 TSR ) were intraoperatively r and omized to HA or TSR after glenoid exposure and were assessed to a minimum of 10 years postoperatively . Apart from those who died , no patients were lost to follow-up . RESULTS At 6 months and 1 year , the TSR patients had less pain than the HA patients ( P pain , function , and daily activities . No patients in the HA group rated their shoulders as pain-free at 10 years ; however , 42 % of the surviving TSR patients rated their shoulders as pain-free at 10 years . Four HA patients were revised to TSR due to severe pain secondary to glenoid erosion . Two shoulders in the TSR group have been revised . Nine of the 13 HA patients ( 69 % ) and 18 of the 20 TSR patients ( 90 % ) remained in situ at death or at the 10-year review . CONCLUSION TSR has advantages over HA with respect to pain and function at 2 years , and there has not been a reversal of the outcomes on longer follow-up . This longer-term review does not support the contention that HA will avoid later TSR complications , and in particular , an unacceptable rate of glenoid component failure",
"Background : Because of specific method ological difficulties in conducting r and omized trials , surgical research remains dependent predominantly on observational or non‐r and omized studies . Few vali date d instruments are available to determine the method ological quality of such studies either from the reader 's perspective or for the purpose of meta‐ analysis . The aim of the present study was to develop and vali date such an instrument",
"Background Glenohumeral osteoarthritis has been a well-described complication of open procedures to correct shoulder instability . What remains unknown is whether chondral injuries sustained during instability episodes contribute to osteoarthritis or whether the cause is primarily the stabilization procedure itself . Purpose To determine the prevalence of osteoarthrosis in a large data base of patients with acute and chronic shoulder instability before primary stabilization surgery . Study Design Retrospective review of prospect ively collected data . Methods Surgical and demographic data were collected on 422 patients with a diagnosis of shoulder instability who underwent arthroscopic examination and shoulder stabilization . Results There was a significant association between the grade of osteoarthrosis and the presence of osteoarthritis ( grade III or IV chondral damage ) with time from injury to surgery . Patients with osteoarthritis were significantly older than those without ( 34.9 versus 29.6 years ) . Multivariate analysis identified older age and time from injury to surgery as independent predictors of osteoarthritis . We found no association between direction of instability and the presence of osteoarthritis . Conclusion The overall prevalence of glenohumeral osteoarthrosis was low . Predictors of osteoarthritis included time from injury to surgery and age"
] | 411679a0-06ff-11f0-808a-c43d1ab1c353 |
The role of metronidazole alone , percutaneous aspiration ( PA ) , and percutaneous catheter drainage ( PCD ) in the treatment of uncomplicated amebic liver abscess ( ALA ) is still unclear . This systematic review and meta- analysis evaluated the available evidence s with regard to treatment modalities in such patients . The data base was search ed for relevant r and omized controlled trials ( RCTs ) published until May 2019 . All studies were assessed for risk of bias . The relevant data were pooled in a r and om or fixed-effect model to calculate the mean difference ( MD ) or relative risks . After the detailed screening , 570 patients from 10 RCTs comparing metronidazole alone with metronidazole + PA were included . Most studies had uncertain risk of biases . Days to resolution of abdominal pain ( MD − 1.59 , 95 % confidence interval [ CI ] − 2.77 , − 0.42 , I2 = 89 % ) and tenderness ( MD − 1.76 , 95 % CI − 2.93 , − 0.58 , I2 = 72 % ) were significantly shorter in the metronidazole + PA group . There was no significant difference in relation to the resolution of fever , abscess size , and hospital stay . The beneficial effects of PA were seen with medium-to-large ( > 5 cm ) ALA and not with small ( PCD to metronidazole therapy was better than metronidazole alone in one low- quality RCT . Two RCTs found PCD to be better than PA for large ALA . Percutaneous aspiration as compared with metronidazole alone results in the early resolution of pain and tenderness in patients with medium-to-large ALA . Percutaneous catheter drainage is better for larger ALA . However , discrepancies in RCTs create therapeutic dilemmas necessitating further efforts to generate more reliable data | [
"Recent sonographic monitoring of patients treated for amoebic liver abscess has shown the healing or resolution time varying between 10 and 300 days . The effect of percutaneous needle aspiration under or resolution time was studied in 36 patients . Nineteen patients had drugs and needle aspiration under ultrasound guide whilst the 17 patients had drugs -- metronidazole , diloxanide , and chloroquine -- alone . Both groups were monitored clinical ly and sonographically . Results showed that the abscess cavities of 18 out of 19 patients ( 94.7 % ) of the aspirated group and 10 of 17 patients ( 58.8 % ) of the non-aspirated group had resolved at the end of three weeks . The difference in response to treatment was significant ( P less than 0.02 ) more so for lesion size more than 6 cm ( P less than 0.01 ) . There was also a more rapid clinical response in the aspirated group than in the non-aspirated group , particularly for patients whose lesion size was more than 6 cm ( P less than 0.01 ) . In conclusion , percutaneous needle aspiration is safe , enhances clinical recovery , and accelerates resolution particularly in patients with large abscess cavities",
"This prospect i ve study was carried out on 200 patients with clinical ly , ultrasonographically and serologically confirmed amoebic liver abscess . The role of ultrasound-guided needle aspiration in addition to medications was evaluated compared to drug treatment alone . Both the groups were monitored clinical ly and sonographically for up to 6 months after diagnosis . The initial response ( after 15 days ) was better in the aspirated group ( P rapid clinical response in the aspirated group , particularly in those with larger ( > 6 cm ) abscesses and there were no complications . Percutaneous ultrasound-guided needle aspiration is a safe diagnostic and therapeutic approach which enhances clinical recovery , accelerates resolution , especially in large abscesses , and prevents complications",
"This prospect i ve study was carried out on 33 patients with clinical ly , serologically and ultrasonographically confirmed amoebic liver abscess . All patients were r and omly treated with metronidazole and chlorochin or a combination of medicamentous therapy and percutaneous drainage . Ultrasonographic characteristics of amoebic liver abscesses were rotound or oval shape , usually hypoechogenic content with specific dorsal sonic enhancement , and in the majority of cases , location near liver capsule . Shorter duration of amoebic liver abscess resolution time in the group of patients treated with the combined therapy was observed particularly in the first four weeks of the treatment . The authors concluded that percutaneous drainage in combination with medicamentous therapy represents a successful therapeutic approach in the treatment of amoebic liver abscesses",
"OBJECTIVE --To determine the value of needle aspiration in uncomplicated amoebic liver abscess . DESIGN --R and omised case-control study with a minimum follow up of one year , comparing patients treated with drugs alone with those treated with additional needle aspiration . SETTING --Referral based gastroenterology clinic . PATIENTS --39 Consecutive patients with amoebic liver abscess in the right lobe , of whom 37 completed the study . INTERVENTION -- Metronidazole 2.4 g/day was given to all patients for 10 days . Needle aspiration of the abscess was performed in 19 patients on the day of admission to hospital . MAIN OUTCOME MEASURES --Abdominal pain , fever , anorexia , and hepatomegaly were measured . Erythrocyte sedimentation rate , serum aspartate , and alanine aminotransferase activities , and alkaline phosphatase activity were also measured . RESULTS -- Clinical improvement was similar in both groups of patients . Improvement in haematological and biochemical variables and rates of healing of cavities were also similar . CONCLUSIONS --Chemotherapy with potent tissue amoebicidal drugs such as metronidazole is optimally effective in treating amoebic liver abscess , and in uncomplicated cases routine aspiration is not required",
"OBJECTIVE The purpose of this study was to determine the effectiveness of percutaneous catheter drainage ( PCD ) and to compare PCD with percutaneous needle aspiration in the management of liver abscess . SUBJECTS AND METHODS Sixty patients with pyogenic liver abscess were r and omly assigned to two groups in a prospect i ve study . Antibiotics were administered for 10 days , starting the day of the beginning of percutaneous treatment . One group was treated with sonographically guided PCD and the other group with repeated percutaneous needle aspiration . Percutaneous needle aspiration was attempted a maximum of three times . Lack of response to the third aspiration was considered failure of treatment ; these patients were treated with PCD but were not included in the PCD group for analysis . Patient demographics , duration of hospital stay , treatment outcome , and complications were analyzed . RESULTS Percutaneous needle aspiration was successful in 20 ( 67 % ) of the 30 patients after one ( n = 12 ) , two ( n = 7 ) , or three ( n = 1 ) aspirations . PCD was curative in all 30 patients after one ( n = 24 ) or two ( n = 6 ) procedures . All abscesses 50 mm or less in longest diameter were successfully managed , 10 by percutaneous needle aspiration and 12 by PCD . None of patients in the percutaneous needle aspiration group with multiloculated abscesses ( n = 5 ) was successfully treated . Hospital stay did not differ significantly between the groups . There were no complications related to the procedure . CONCLUSION PCD is more effective than percutaneous needle aspiration in the management of liver abscess . Percutaneous needle aspiration can be used as a valid alternative for simple abscesses 50 mm in diameter or smaller",
"Objective To compare the effectiveness of percutaneous catheter drainage ( PCD ) and percutaneous needle aspiration ( PNA ) in the management of large ( > 10 cm diameter ) liver abscesses . Methods Seventy-two patients with liver abscess ( amebic 48 , pyogenic 24 ) were r and omly allocated to PCD or PNA ( 36 each ) , which were done within 24 hours of admission . Both groups received parenteral antibiotics for at least 10 days . PNA was repeated every third day if the cavity size had not declined to 50 % of the original for up to three times . Persistence of cavity or of clinical symptoms was considered failure of treatment . Duration to attain clinical relief , duration of hospital stay , complications , treatment failure , and deaths were recorded . Results PNA was successful in 31 of 36 ( 86 % ) patients ( one aspiration in 10 , two in 18 , and three in 3 patients ) , whereas PCD was successful in 35 ( 97 % ) patients ( p = ns ) . Duration to attain clinical relief ( 10.2 [ 2.0 ] vs. 8.1 [ 2.7 ] days ; p=0.02 ) and parenteral antibiotics needed ( 15.5 [ 1.1 ] vs. 10.9 [ 2.7 ] days ; p=0.04 ) were significantly lower in PCD group . Duration of hospital stay was similar in the two groups . One patient with PNA had a subcapsular hematoma and one with PCD had continuous bile leakage which stopped spontaneously . One patient in PCD group died . Conclusion PCD is a better treatment option than PNA for the management of large liver abscesses of size > 10 cm , in terms of duration to attain clinical relief and duration for which parenteral antibiotics are needed",
"The performance of therapeutic aspiration in the treatment of amebic liver abscess , advocated and practice d in many centers , is controversial . Previously , this practice has been evaluated in retrospective analyses . To test the potential benefit of therapeutic aspiration , the authors undertook a prospect i ve r and omized trial in 57 patients admitted for suspected amebic liver abscess during a 15-month period . Sixteen patients were excluded from the trial . The remaining 41 patients were r and omly included in one of two study groups to receive amebicidal therapy alone or amebicidal therapy coupled with image-guided percutaneous therapeutic aspiration . All patients in the trial recovered . No statistically significant benefit was demonstrated in the aspiration group for the two objective parameters evaluated : length of hospitalization and duration of time to becoming afebrile . Subjective improvement in symptoms after aspiration was greater in the aspiration group at a marginally statistically significant level . These data do not support the adjunctive performance of percutaneous therapeutic aspiration in the treatment of uncomplicated amebic liver abscess . Amebicidals alone were equally efficacious in treating the group studied",
"Background The aim of the study was to evaluate the clinical presentation , and to investigate the effectiveness of continuous catheter drainage in comparison to needle aspiration in the treatment of liver abscesses . Methods This is a prospect i ve r and omized comparative study of 60 patients , presented in outpatient and emergency department at the hospital , r and omized equally into two groups , percutaneous needle aspiration and pigtail catheter drainage . The effectiveness of either treatment was measured in terms of duration of hospital stay , days to achieve clinical improvement , 50 % reduction in abscess cavity size and total/near total resolution of abscess cavity . Independent t-test was used to analyze these parameters . Results The success rate was significantly better in catheter drainage group ( P=0.006 ) . The patients in pigtail catheter drainage group showed earlier clinical improvement ( P=0.039 ) and 50 % decrease in abscess cavity volume ( P=0.000 ) as compared to those who underwent percutaneous needle aspiration . Conclusion Percutaneous catheter drainage is a better modality as compared to percutaneous needle aspiration especially in larger abscesses which are partially liquefied or with thick pus",
"Thirty-nine patients with amoebic liver abscess ( ALA ) , admitted to the Central Hospital of Hué ( Vietnam ) , were evaluated in a comparative , prospect i ve and r and omized study for the treatment of ALA . Adult patients with an abscess located in the right liver lobe and an abscess diameter of 6 to 10 cm were included . Bacterial abscesses were excluded by microbiological examination of abscess fluid in all patients . Nineteen patients were treated with metronidazole for 10 days alone and 20 patients were punctured under ultrasound guidance with aspiration of abscess fluid in addition to drug administration . The clinical symptoms fever , pain in right upper abdomen and liver tenderness , and the laboratory parameters erythrocyte sedimentation rate , white blood cells , haemoglobin and C-reactive protein and the abscess size were determined on the day of admission and followed during an observation period of 38 days . Improvement of liver tenderness was significantly faster in the aspiration group during the first 3 days ( P aspiration and advocates drug treatment alone for uncomplicated amoebic liver abscesses with a diameter up to 10 cm located in the right liver lobe",
"Summary Amoebic liver abscess develops in less than 1 % of patients with amoebaisis and metronidazole is the drug of choice for the treatment of amebic liver abscess . Abscesses of less than 5 cm can be treated with metronidazole alone . However , abscesses of more than 10 cm must undergo ultrasound guided percutaneous needle aspiration along with metronidazole . The role of percutaneous needle aspiration in abscesses of 5 to 10 cm is not clear . Fifty-seven patients with a solitary , right lobe , uncomplicated amoebic liverabscess of 5–10 cm were r and omized to receive either metronidazole alone ( control group ; n = 29 ) or ultrasound guided percutaneous needle aspiration along with metronidazole ( intervention group ; n = 28 ) . Although the resolution of pain and fever occurred earlier in the intervention group ( 27 h and 17 h , respectively ) than the control group ( 48 h and 30 h , respectively ) , the difference was not statistically significant ( P = 0.16 and 0.48 , respectively ) . There were no deaths during the study period and treatment failure , complications ( rupture of abscess ) , days to normalization of leukocytosis and duration of hospitalization were similar in both groups . Ultrasound guided percutaneous needle aspiration along with metronidazole was no better than metronidazole alone in the management of uncomplicated , solitary , right lobe amoebic liver abscess of 5 to 10 cm",
"BACKGROUND Amebic liver abscess ( ALA ) is a common and serious problem in our country . There are only a few controlled trials on the efficacy and advantages of combination therapy with percutaneous needle aspiration and pharmacotherapy , over pharmacotherapy alone for amebic liver abscess . MATERIAL AND METHODS This study was conducted to compare the efficacy of two different treatment modalities i.e. drug treatment alone vs. drug treatment and aspiration of abscess cavity in patients with small ( up to 5 cm ) and large ( 5 cm to 10 cm ) size ALA . This is one of the largest single center , prospect i ve , r and omized studies comparing the efficacy of aspiration in ALA . RESULTS ( i ) Mean body temperature , liver tenderness , total leukocyte count ( TLC ) , serum alanine aminotransferase ( ALT ) and liver span were significantly decreased in the aspiration group on days 8 and 15 as compared to non-aspiration group especially in large abscess ( 5 cm to 10 cm ) . ( ii ) Abscess cavity maximum diameter decreased significantly in aspiration group on days 8 and 15 , and 1 month & 3 months in large abscess ( 5 cm to 10 cm ) . CONCLUSIONS ( i ) Needle aspiration along with metronidazole hastens clinical improvement especially in large ( 5 cm up to 10 cm ) cavities in patients with ALA . ( ii ) Aspiration is safe and no major complications occurred . ( iii ) Hence , combination therapy should be the first choice especially in large ALA ( 5 cm to 10 cm )",
"Evidence shows that the quality of r and omized clinical trials ( RCTs ) affects estimates of intervention efficacy , which is significantly exaggerated in low- quality trials . The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998 . Quality was assessed by means of a vali date d 5-point scale and separate quality components associated with empirical evidence of bias . Only 26 % of all RCTs reported sample size calculations , 52 % adequate generation of the allocation sequence , 34 % adequate allocation concealment and 34 % double-blinding . The median quality score of all trials was 3 points ( range , 1 - 5 points ) . Multiple logistic regression analysis explored the association between quality and therapeutic areas , number of centers , external funding , year of publication , and country of origin . High- quality trials were most likely to investigate portal hypertension ( odds ratio [ OR ] : 2.4 ; 95 % CI : 1.1 - 5.5 ; P = .03 ) , be multicentered ( OR : 3.4 ; 95 % CI : 1.3 - 8.9 ; P = .01 ) , sponsored by public organizations ( OR : 4.2 ; 95 % CI : 2.1 - 8.6 ; P = .0001 ) , or the drug and device industry ( OR : 4.7 ; 95 % CI : 2.2 - 10.2 ; P = .0001 ) compared with other therapeutic areas , single-center trials , and trials with no external funding . Quality did not improve with time and was not associated with country of origin . The main conclusions are that the quality of RCTs in HEPATOLOGY needs improvement and that the probability of high quality increased with the number of centers involved and external funding",
"This study aims to compare the therapeutic effectiveness of continuous catheter drainage versus intermittent needle aspiration in the percutaneous treatment of pyogenic liver abscesses . Over a 5-year period , 64 consecutive patients with pyogenic liver abscess were treated with intravenous antibiotics ( ampicillin , cefuroxime , and metronidazole ) and r and omized into two percutaneous treatment groups : continuous catheter drainage ( with an 8F multi-sidehole pigtail catheter ) ; and intermittent needle aspiration ( 18 G disposable trocar needle ) . There was no statistically significant difference between the two groups regarding patient demographics , underlying coexisting disease , abscess size , abscess number , number of loculation of abscess , the presenting clinical symptoms such as fever , abdominal pain , and pretreatment liver function test . Although not statistically significant , the duration of intravenous antibiotics treatment before percutaneous treatment was longer with the catheter group , and the change of antibiotics after the sensitivity test was more frequent with the needle group . The needle group was associated with a higher treatment success rate , a shorter duration of hospital stay , and a lower mortality rate , although this did not reach statistical significance . In conclusion , this study suggests that intermittent needle aspiration is probably as effective as continuous catheter drainage for the treatment of pyogenic liver abscess , although further proof with a large-scale study is necessary . Due to the additional advantages of procedure simplicity , patient comfort , and reduced price , needle aspiration deserves to be considered as a first-line drainage approach",
"Amoebiasis in endemic in the tropical countries with amoebic liver abscesses being a common complication . Different modalities of treatment of amoebic liver abscess are conservative ( medical management ) , percutaneous needle aspiration , percutaneous catheter drainage , surgical drainage and endoscopic drainage . This study was carried out to compare the efficacy , safety and outcome of needle aspiration comparing with percutaneous catheter drainage of large ( > or = 5 cm diameter ) amoebic liver abscesses . This was a prospect i ve study carried over a period of two years ( 2006 - 2008 ) at the general surgery department of Calcutta National Medical College and Hospital , Kolkata . A total of 45 patients were included in this study . All of them had amoebic liver abscess with diameter of abscess cavity > or = 5 cm . They were divided into two groups . Group A included 22 patients and they were treated with needle aspiration . Group B included 23 patients and they were treated by catheter drainage . Improvement in clinical features , liver function tests , ultrasonic evidence of decrease in the size of abscess cavity was considered as criteria for successful treatment . The sex ratio and the age incidence in the two groups were similar . In about 80 % patients the right lobe was affected , in about 18 % the left lobe was affected and in rest the abscess involved both lobes . Needle aspiration was successful in 15 ( 68.2 % ) and catheter drainage was successful in 23 patients ( 100 % ) . The mean hospital stay of patients treated with needle aspiration was more than those treated with catheter drainage . The mean time in days taken for 50 % decrease in the size of abscess cavity was significantly greater in group treated with needle aspiration than in those treated with catheter drainage ( 9 days versus 4 days ) . It is concluded that percutaneous catheter drainage is more effective in management of large amoebic liver abscess than needle aspiration",
"The role of percutaneous needle aspiration for therapy of uncomplicated , large amoebic liver abscess ( ALA ) is not defined . Twenty nine patients of ALA with a cavity larger than 5 cm were r and omised to two groups : ( i ) metronidazole 800 mg tid for 10 days combined with needle aspiration ( group A , n = 15 ) and ( ii ) metronidazole therapy alone ( group B , n = 14 ) . Clinical parameters , viz , fever , pain and abdominal tenderness were recorded daily and grade d 0 to 3 ( in order of increasing severity ) . A statistically significant benefit was demonstrated in group A for clinical parameters evaluated . Group A patients took less time to become afebrile from the grade 2 level as compared to group B ( 3.8 + /- 1.7 days and 5.6 + /- 2.2 days respectively ; p pain intensity and abdominal tenderness from grade 2 to 1 also occurred earlier in group A ( 0.7 + /- 0.7 days vs 2.9 + /- 0.9 days for pain , P tenderness , p mean duration of hospitalization was significantly shorter in group A as compared to group B ( 5.8 + /- 0.8 days vs 7.4 + /- 1.5 days , p haematological and biochemical variables was similar in both groups . We conclude that percutaneous therapeutic needle aspiration of uncomplicated , large ALA hastens clinical recovery",
"A prospect i ve study was undertaken to evaluate the clinical and sonographic patterns of resolution in amebic liver abscess ( ALA ) . There were 146 patients of ALA attending the gastroenterology clinic of a tertiary care centre of whom 25 died . Of the remaining 121 patients , 107 were followed up for 20.9 + /- 11.4 months . 14 ( 11.3 % ) patients were lost to follow up before complete disappearance of the cavity . Complete disappearance of the cavity was seen in 84 ( 78.5 % ) and a reduction in volume to 50 % at entry in 23 ( 21.5 % ) . Abdominal pain , fever and hepatomegaly were the predominant forms of clinical presentation . On ultrasound , there were 121 cavities in 107 patients . The most frequent type of lesion was solitary , ( 96 % ) round cavity ( 80.4 % ) in the right lobe of liver ( 85 % ) . Clinical and hematological parameters of resolution occurred rapidly ( 3.2 + /- 2.9 months ) . Sonographic resolution took much longer ( 9.6 + /- 6.8 % months ) in the 84 patients . The remaining 23 patients are on follow up . Three pattern of resolution were observed : Type I -- where complete disappearance of the cavity occurred within 3 months ( 29.8 % ) , Type II -- where a gradual reduction and disappearance of the cavity occurred ( 64.3 % ) and Type III -- where a rapid reduction till 25 % of original cavity size remained and then a delayed resolution occurred ( 5.9 % ) . There were no relapses in the patients on follow up . Factors that influenced healing time included the size of the abscess cavity at admission , hypoalbuminemia and anemia . The type of clinical presentation , nature of therapy , number or location of abscesses and time for clinical resolution did not influence the resolution time . None of the variables studied influenced the pattern of resolution . We conclude that rapid clinical resolution is common in patients with ALA . Sonographic resolution may be delayed and does not warrant additional or prolonged therapy",
"A two-part study was undertaken to determine whether aspiration of amoebic liver abscess ( ALA ) prevents complications . Eighty patients studied prospect ively were r and omised into aspiration or non-aspiration groups and were treated with metronidazole . Common factors in patients with complicated diseases were determined to formulate and test indications for aspiration . Records of all patients with ALA admitted to King Edward VIII Hospital , Durban , between October 1983 and December 1984 were analysed to test the validity of the criteria derived from the first part of the study . The findings suggest that aspiration influences the course and outcome of ALA and that the criteria are valid although not necessarily complete",
"OBJECTIVE This study was design ed to determine and compare the efficacy of sonographically guided percutaneous needle aspiration and percutaneous catheter drainage in the treatment of liver abscesses . SUBJECTS AND METHODS In a r and omized study , 50 patients ( 38 males and 12 females ; age range , 2 - 72 years ; average age , 35 years ) with liver abscesses ( amebic , 20 ; pyogenic , 11 ; indeterminate , 19 ) underwent either percutaneous needle aspiration ( n = 25 ) or catheter drainage ( n = 25 ) along with appropriate antimicrobial therapy . In patients assigned to the needle aspiration group , an 18-gauge needle was used to aspirate the abscess cavity . Repeated aspiration was attempted only once in each patient not responding to the first aspiration ; nonresponse to the second aspiration was considered failure of treatment , and these patients were given catheter drainage ( however , these patients were not included in the catheter drainage group ) . For catheter drainage , 8- to 12-French catheters were introduced into the abscess cavity using the Seldinger technique . In patients with multiple abscesses ( seven in aspiration group and five in catheter group ) , all the abscesses except those smaller than 3 cm were subjected to percutaneous treatment . Patients were followed up to assess the outcome of the percutaneous treatment , length of hospital stay , and development of any complications . Sonography was performed every third day during hospitalization . After discharge of the patient , periodic clinical and sonographic examinations were done until total resolution of abscesses was achieved . RESULTS Although percutaneous needle aspiration was successful in only 15 ( 60 % ) of the 25 patients after one ( n = 11 ) or two ( n = 4 ) aspirations , catheter drainage was curative in all 25 patients ( 100 % ) ( p average time for clinical improvement and the mean hospital stay were similar in the two treatment groups . Although the average time needed for a 50 % reduction in the size of the abscess cavity was significantly ( p aspiration group than in the catheter group ( 11 days versus 5 days ) , the average time taken for total resolution of abscess was the same ( 15 weeks ) in both groups . No major complications were encountered . No relapse was documented on clinical and sonographic examination during follow-up , which ranged from 8 to 37 weeks . CONCLUSION Our results show that percutaneous catheter drainage is more effective than needle aspiration in the treatment of liver abscesses . Needle aspiration , if limited to two attempts , has a high failure rate",
"Twenty proven cases of amoebic liver abscess were treated at r and om with either tinidazole or metronidazole . The dose of both was 2 g once daily for 2 days . Clinical , radiological , and biochemical follow-up was done for 30 days . Of the 19 patients who completed the trial , complete recovery was observed in all 10 patients given tinidazole and in 5 of 9 patients given metronidazole ( p=0.05 ) . Moreover , patients on tinidazole required repeat aspirations less frequently than those on metronidazole . Mild gastrointestinal side-effects occurred in 1 patient on metronidazole . The results suggest that tinidazole is a more efficacious drug than metronidazole , with rapid therapeutic effect",
" Summary 20 patients with amoebic liver abscess , confirmed by aspiration of typical amoebic ‘ pus ’ , were treated in r and om order with either tinidazole or metronidazole in a dose of 2 g once daily for 2 days . Clinical , radiological , and biochemical follow-up was done for 1 month . One patient , given metronidazole , absconded and 19 completed the trial . Complete recovery occurred in all 10 patients given tinidazole but in only 5 of the 9 given metronidazole ( p = 0.05 ) . Patients on tinidazole required repeat aspirations less frequently than those on metronidazole . Mild gastrointestinal side-effects occurred in 1 patient on metronidazole but in none on tinidazole . From the present study , tinidazole appears to be a more effective , better tolerated drug with a more rapid therapeutic effect than metronidazole",
"Background Metronidazole is a drug of choice for amebic liver abscess ( ALA ) , but has long course and significant side effects . Thus , drugs like tinidazole with a better tolerability record need evaluation . Methods We conducted a r and omized controlled trial at the Department of Gastroenterology , SMS Hospital , Jaipur , India . One hundred and fifty admitted patients were r and omized into two treatment groups , metronidazole ( group M , n = 75 ) and tinidazole ( group T , n = 75 ) . Patients were observed for clinical response , laboratory parameters , imaging , and side effects . Early clinical response ( ECR ) was defined as the absence of fever and abdominal pain within 72 h of treatment . Symptomatic clinical response ( SCR ) was defined as the absence of fever and abdominal pain irrespective of duration of treatment required . Follow up was done at 1 , 3 , and 6 months . Results ECR was 62.3 % in group T vs. 37.7 % in group M ( p = 0.02 ) . SCR was shorter in group T than group M ( 3.29 ± 1.61 days vs. 5.67 ± 2.93 , p ≤ 0.001 ) . Mean residual volume at the end of 1 month was lower in group T ( 130.7 ± 108.1 vs. 184.7 ± 143.3 mL , p = 0.01 ) and no significant difference was seen at 3 and 6 months . Tinidazole was better tolerated with fewer side effects . Low socioeconomic status , baseline abscess volume > 500 mL , hypoalbuminemia , pleural effusion , and history of ethanol use were associated with a late clinical response on univariate analysis of which low socioeconomic status was the only associated factor . Conclusion Tinidazole , as compared to metronidazole , has early clinical response , shorter treatment course , favorable rate of recovery , and high tolerability ; thus , tinidazole can be preferred over metronidazole in ALA"
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Objective : To determine whether progressive resistance strength training reduces impairments , activity limitations and participation restrictions after stroke . Methods : Electronic data bases were search ed to find trials conducted from 1966 to 2002 . Articles were assessed independently by two review ers according to the following inclusion criteria : ( 1 ) population : adults with stroke , ( 2 ) intervention : progressive resistive strength training in isolation , and ( 3 ) outcomes : changes in body function , physical activity or societal participation . Results : From the 350 articles initially identified , eight met the criteria for detailed review . Three were r and omized controlled trials , with the remainder being single-case time-series analyses or pre – post trials . The five trials that measured impairments of muscle strength showed positive outcomes for progressive resistance strength training , with large effect sizes ( d = 1.2–4.5 ) . Few negative effects of strength training were reported , and these were minor . Only three of the eight trials that measured activity limitations reported improvements in activities such as walking and stair climbing . The effects of strength training on societal participation could not be determined due to insufficient data . Conclusions : There is preliminary evidence that progressive resistance strength training programmes reduce musculoskeletal impairment after stroke . Whether strengthening enhances the performance of functional activities or participation in societal roles remains unknown | [
"PURPOSE To determine whether isokinetic training can improve the strength of the hemiparetic knee musculature , functional mobility , and physical activity and to evaluate its effect on spasticity in long-term stroke survivors . DESIGN Nonr and omized self-controlled trial . SUBJECTS A volunteer sample of 15 community-dwelling stroke survivors of at least 6 months . INTERVENTION A 6-week ( 3 days/week , 40 minutes/day ) program consisting of warm-up , stretches , reciprocal knee extension and flexion isokinetic strengthening , and cool-down for the paretic limb . MAIN OUTCOME MEASURES Peak isokinetic hamstring and quadriceps torque , quadriceps spasticity , gait velocity , timed Up and Go , timed stair climb , and the Human Activity Profile ( HAP ) scores were recorded at baseline , after training , and 4 weeks after training cessation ( follow-up ) . RESULTS Paretic muscle strength improved after training ( p tone remained consistent ( p > .87 ) . Gait velocity increased after training ( p in stair climbing and timed Up and Go were not significant ( p > .37 ; p > .91 ) , although subjects perceived gains in their physical abilities at follow-up ( p strength and gait velocity without concomitant increases in muscle tone are possible after a short-term strengthening program for stroke survivors . The psychological benefit associated with physical activity is significant",
"OBJECTIVE To test the effects of a high intensity home-based progressive strength training program on the clinical signs and symptoms of osteoarthritis ( OA ) of the knee . METHODS Forty-six community dwelling patients , aged 55 years or older with knee pain and radiographic evidence of knee OA , were r and omized to a 4 month home based progressive strength training program or a nutrition education program ( attention control ) . Thirty-eight patients completed the trial with an adherence of 84 % to the intervention and 65 % to the attention control . The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis ( WOMAC ) index pain and physical function subscales . Secondary outcomes included clinical knee examination , muscle strength , physical performance measures , and question naires to measure quality of life variables . RESULTS Patients in the strength training group who completed the trial had a 71 % improvement in knee extension strength in the leg reported as most painful versus a 3 % improvement in the control group ( p self-reported pain improved by 36 % and physical function by 38 % in the strength training group versus 11 and 21 % , respectively , in the control group ( p = 0.01 for between group comparison ) . In addition , those patients in the strength training group who completed the trial had a 43 % mean reduction in pain ( p = 0.01 vs controls ) , a 44 % mean improvement in self-reported physical function ( p physical performance , quality of life , and self-efficacy when compared to the control group . CONCLUSION High intensity , home based strength training can produce substantial improvements in strength , pain , physical function and quality of life in patients with knee OA",
"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",
"Bourbonnais D , Bilodeau S , Lepage Y , Beaudoin N , Gravel D , Forget R : Effect of force-feedback treatments in patients with chronic motor deficits after a stroke . Am J Phys Med Rehabil 2002;81:890–897 . Objective To assess the effects a motor reeducation approach based on static dynamometers used to provide feedback on the force produced . Design The study design was a single-blind , r and omized , controlled trial . Chronic stroke subjects participated in a 6-wk , thrice-weekly , force-feedback program of either the upper paretic limb ( n = 13 ) or the lower paretic limb ( n = 12 ) . Baseline and postintervention assessment s of the performance of both the upper and the lower limb were measured for each subject , the untreated paretic limb of each group serving as a control for the other group . Results With the exception of the h and grip force , strength measurements of the treated limb increased after completion of the treatment . The outcome measurements of the upper limb of the subjects included in the upper paretic limb were not significantly different after treatment from those measured in the lower paretic limb . In contrast , gait velocity and the distance walked in 2 min increased after treatment in the lower paretic limb as compared with the upper paretic limb , whereas the scores in the Fugl-Meyer test for the lower limb and the timed up- and -go test did not increase for either group after treatment . Conclusion The results indicate that treatment of the lower limb based on force feedback produces an improvement of gait velocity",
"The purpose of this study was to determine the effects of isokinetic training on the rate of movement during ambulation in hemiparetic patients . Ten male and 10 female subjects , aged 40 to 75 years , participated in the study . The 20 hemiparetic subjects were assigned r and omly to either a control group or an experimental group . All of the subjects participated in a conventional therapeutic exercise program and gait training . The experimental group also received isokinetic training on the Kinetron exercise machine as part of their program . Functional ambulation profile tests were administered to each subject before and after the five-week experimental period . All of the subjects showed improvement in the rate of ambulation and in overall ambulation performance . The differences in ambulation times and functional ambulation profile scores between the two groups were shown to be insignificant",
"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",
"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",
"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",
"OBJECTIVE To evaluate the effects of a progressive resistance strength training program on changes in muscle strength , gait , and balance in older individuals 1 yr after stroke , seven individuals were recruited who were greater than 60-yr-old , 1 yr after stroke , living at home , and able to follow verbal comm and s. DESIGN Subjects participated in a 12-wk 2x per wk resistance training program at 70 % of 1 repetition maximum . RESULTS Lower limb strength improved 68 % on the affected side and 48 % on the intact side during training , with the largest increases observed for hip extension ( affected side : 88 % , P Repeated chair st and time decreased 21 % ( P 0.02 ) . Motor performance assessed by the Motor Assessment Scale improved 9 % ( P static and dynamic balance ( Berg balance scale ) improved 12 % ( P Progressive resistance training in individuals 1 yr after stroke improves affected and intact side lower limb strength and was associated with gains in chair st and time , balance , and motor performance . CONCLUSIONS These results support the concept that strength training is an appropriate intervention to improve the quality of physical function in older community dwelling stroke survivors",
"The effects of training with isokinetic maximal voluntary knee extensions were studied in stroke patients . Two groups of 10 patients each trained twice a week for 6 weeks . One group trained exclusively eccentric movements and the other exclusively concentric movements . The effects were evaluated from the following tests before and after the training period . The maximal voluntary strength in concentric and eccentric actions of the knee extensor and flexor muscles was recorded together with surface electromyography at constant velocities of 60 , 120 , and 180 deg.s-1 on three different days . The body weight distribution on the legs while rising and sitting down was measured with two force plates . The self-selected and maximal walking speeds and the swing to stride ratio of the paretic leg were measured . After the training period , the knee extensor strength had increased in eccentric and concentric actions in both groups ( p eccentric and the concentric strength in the paretic leg relative to that of the nonparetic leg increased in the eccentrically trained group ( p restraint of the antagonistic muscles in concentric movements increased after concentric ( p . A nearly symmetrical body weight distribution on the legs in rising from a sitting position was noted after eccentric ( p . Changes in walking variables were not significantly different between the groups . Eccentric knee extensor training was thus found to have some advantages as compared to concentric training in stroke patients",
"Previous studies concerning psychological benefits of exercise among the elderly has focused predominantly on the effects of aerobic exercise . In the present study , psychological and behavioral adaptations in response to 12-weeks of strength training were examined in medically healthy but sedentary 42 older adults ( mean age = 68 years ) . The purpose of this study was to evaluate the effects of high and low intensity resistance training intensity on a ) muscular fitness , b ) psychological affect , and c ) neurocognitive functioning . Subjects were r and omly assigned to high intensity/low volume ( EXH : 2 sets of 8 to 10 repetitions for 75 to 85 % of 1 RM ) , low intensity/high volume ( EXL : 2 sets of 14 to 16 repetitions for 55 to 65 % of 1 RM ) , or no exercise control programs . Prior to and following the 12-week program , subjects underwent comprehensive physiological and psychological evaluations . Physiological assessment included measurements of blood pressure , heart rate , arm and leg muscle strength , body composition , and oxygen consumption ( VO2max ) . Psychological measures included evaluations of mood , anxiety , and physical self-efficacy as well as cognitive functioning . The results of this study indicated that both high and low intensity strength programs were associated with marked improvements in physiological fitness and psychological functioning . Specifically , subjects in the strength training programs increased overall muscle strength by 38.6 % and reduced percent body fat by 3.0 % . Favorable psychological changes in the strength-trained subjects included improvements in positive and negative mood , trait anxiety , and perceived confidence for physical capability . The treatment effects of neurocognitive functioning were not significant . In summary , this study demonstrated that participation in 12-weeks of high or low intensity strength training can improve overall physical fitness , mood , and physical self-efficacy in older adults while cognitive functioning remains constant",
"Objective : To investigate the influence of depression on functional recovery after stroke . Design : Multicentre cohort study of 85 patients admitted for clinical rehabilitation . A two-stage case-finding procedure was used to identify patients with depression . For the control group , consecutive nondepressed stroke patients were enrolled . Patients were interviewed at 3–6 weeks and six months after stroke onset . Setting : Three rehabilitation centres in the vicinity of Amsterdam . Main outcome measures : Functional outcome was determined by the Functional Independence Measure ( FIM ) and the Rehabilitation Activities Profile ( RAP ) . Results : The prevalence of depression ( 35 % ) was comparable with the findings of earlier studies in other setting s. Patients classified as depressed according to DSM III R criteria ( American Psychiatric Association Diagnostic and statistical manual of mental disorders ) had a significantly lower functional score , both at onset and after follow-up ( FIM and RAP ) . There was , however , no significant difference in functional improvement between the depressed and the nondepressed group . Mean functional improvement in the six patients treated with antidepressants was 30 % better than in the untreated ( depressed ) patients ; numbers were too small for the results to attain statistical significance . Subset analysis showed a significantly higher outcome for nondepressed patients for the FIM subitems personal care and transfers . However , functional improvement was not significantly different for any of the subitems in depressed versus nondepressed patients . Conclusion : Stroke patients with depression have significantly lower functional scores both at onset and after six months . Our results suggest under-recognition of post-stroke depression and a possible beneficial effect of antidepressant medication in depressed stroke patients . Further studies are required to determine the effect of antidepressants"
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The aim of this systematic review is to assess whether metformin could change the concentration of serum homocysteine ( Hcy ) with and without simultaneous supplementation of B-group vitamins or folic acid . A literature search was conducted in PubMed , EmBase , and Cochrane Central Register of Controlled Trials ( CENTRAL ) to identify r and omized controlled trials ( RCTs ) reporting the concentration of serum Hcy in metformin-treated adults . Meta- analysis was applied to assess the association between metformin and the changes of Hcy concentration . Twelve publications were included in this study . In the overall analysis , metformin administration was not statistically associated with the change of Hcy when compared with the control treatment ( mean difference ( MD ) , 0.40 μmol/L ; 95 % confidence interval ( CI ) , −0.07~0.87 μmol/L , p = 0.10 ) . In the subgroup analysis , metformin was significantly associated with an increased concentration of Hcy in the absence of exogenous supplementation of folic acid or B-group vitamins ( MD , 2.02 μmol/L ; 95 % CI , 1.37~2.67 μmol/L , p decreased concentration of serum Hcy in the presence of these exogenous supplementations ( MD , −0.74 μmol/L ; 95 % CI , −1.19~−0.30 μmol/L , p = 0.001 ) . Therefore , although the overall effect of metformin on the concentration of serum Hcy was neutral , our results suggested that metformin could increase the concentration of Hcy when exogenous B-group vitamins or folic acid supplementation was not given | [
"Objectives To study the effects of metformin on the incidence of vitamin B-12 deficiency ( , low concentrations of vitamin B-12 ( 150 - 220 pmol/l ) , and folate and homocysteine concentrations in patients with type 2 diabetes receiving treatment with insulin . Design Multicentre r and omised placebo controlled trial . Setting Outpatient clinics of three non-academic hospitals in the Netherl and s. Participants 390 patients with type 2 diabetes receiving treatment with insulin . Intervention 850 mg metformin or placebo three times a day for 4.3 years . Main outcome measures Percentage change in vitamin B-12 , folate , and homocysteine concentrations from baseline at4 , 17 , 30 , 43 , and 52 months . Results Compared with placebo , metformin treatment was associated with a mean decrease in vitamin B-12 concentration of −19 % ( 95 % confidence interval −24 % to −14 % ; P ) and in folate concentration of −5 % ( 95 % CI −10 % to −0.4 % ; P=0.033 ) , and an increase in homocysteine concentration of 5 % ( 95 % CI −1 % to 11 % ; P=0.091 ) . After adjustment for body mass index and smoking , no significant effect of metformin on folate concentrations was found . The absolute risk of vitamin B-12 deficiency ( the metformin group than in the placebo group ( 95 % CI 2.3 to 12.1 ; P=0.004 ) , with a number needed to harm of 13.8 per 4.3 years ( 95 % CI 43.5 to 8.3 ) . The absolute risk of low vitamin B-12 concentration ( 150 - 220 pmol/l ) at study end was 11.2 percentage points higher in the metformin group ( 95 % CI 4.6 to 17.9 ; P=0.001 ) , with a number needed to harm of 8.9 per 4.3 years ( 95 % CI 21.7 to 5.6 ) . Patients with vitamin B-12 deficiency at study end had a mean homocysteine level of 23.7 µmol/l ( 95 % CI 18.8 to 30.0 µmol/l ) , compared with a mean homocysteine level of 18.1 µmol/l ( 95 % CI 16.7 to 19.6 µmol/l ; P=0.003 ) for patients with a low vitamin B-12 concentration and 14.9 µmol/l ( 95 % CI 14.3 to 15.5 µmol/l ; P 220 pmol/l ) . Conclusions Long term treatment with metformin increases the risk of vitamin B-12 deficiency , which results in raised homocysteine concentrations . Vitamin B-12 deficiency is preventable ; therefore , our findings suggest that regular measurement of vitamin B-12 concentrations during long term metformin treatment should be strongly considered . Trial registration Clinical trials.gov NCT00375388",
"Background . Women with polycystic ovary syndrome have elevated homocysteine levels . Elevated homocysteine levels associate with pregnancy complications . Women with polycystic ovary syndrome are often treated with metformin , a drug that may increase homocysteine levels . Hence , we investigated the effect of metformin treatment on homocysteine levels in nonpregnant and pregnant women with polycystic ovary syndrome . Methods . Two prospect i ve r and omized placebo‐controlled studies included women with polycystic ovary syndrome in a university hospital setting . Sixty‐three infertile women were treated with metformin 1,000 mg bid or placebo for 16 weeks and 38 pregnant women with metformin 850 mg bid or placebo from the first trimester and throughout pregnancy . All the women had polycystic ovary syndrome and all participants received diet and lifestyle advice , and oral folate and vitamin B12 substitution , and a daily oral multivitamin tablet . The main outcome measures were serum levels of homocysteine , folate , and vitamin B12 . Results . Serum homocysteine levels were unaffected by metformin treatment both in nonpregnant and pregnant women with polycystic ovary syndrome . However , in nonpregnant women both serum folate and vitamin B12 levels decreased with treatment . At inclusion in nonpregnant women , serum homocysteine levels associated negatively with serum levels of folate and methyl malonic acid and positively with free testosterone index . No such associations were seen in pregnant women . Conclusions . Metformin treatment in women with polycystic ovary does not increase serum homocysteine levels in the nonpregnant or the pregnant state",
"Background Women with polycystic ovary syndrome ( PCOS ) are at increased risk for cardiovascular ( CV ) and metabolic disorders . There is a close relationship between elevated and rogen plasma levels and the ultrasound findings of stromal hypertrophy . In r and omized trials , the administration of metformin has been shown to be followed by an improvement in insulin sensitivity and decrease in and rogen levels in most women . In the present study , we investigate the association between reduced ovarian volume in PCOS patients after administration of metformin with improvement in CV risk factors . Material s and Methods This was a r and omized clinical trial study . A total of 28 women diagnosed with PCOS who referred to the infertility clinic were selected . Anthropometric characteristics of the patients , mean ovarian volume and plasma levels of fasting blood sugar ( FBS ) , lipid profile , luteinizing hormone ( LH ) , follicle stimulating hormone ( FSH ) , estradiol , testosterone , 17-α-OH progesterone ( 17OHP ) , dehydroepi and rosterone sulfate ( DHEAS ) , C-reactive protein ( CRP ) and homocysteine ( Hcy ) were evaluated before and after treatment with 500 mg metformin , three times daily for three months . Statistics were calculated with the aid of SPSS 16.0 with student ’s paired t- and Pearson ’s correlation coefficient tests . Significance was set at p in mean ovarian volume and body mass index ( BMI ) , in addition to CRP , Hcy , testosterone , FBS , HDL and LDL levels . There was a positive correlation between mean ovarian volume and waist-to-hip ratio (WHR).After treatment , there correlation noted with reduction in mean ovarian volume and decreased BMI , in addition to reductions in CRP , LDL , Hcy and testosterone levels . Conclusion A positive correlation may exist between reduced mean ovarian volume and improvement in CV risk factors after administration of metformin ( Registeration Number : I RCT 138903244176N1 )",
"OBJECTIVE The severity of peripheral neuropathy in diabetic patients varies for unclear reasons . Long-term use of metformin is associated with malabsorption of vitamin B12 ( cobalamin [ Cbl ] ) and elevated homocysteine ( Hcy ) and methylmalonic acid ( MMA ) levels , which may have deleterious effects on peripheral nerves . The intent of this study was to clarify the relationship among metformin exposure , levels of Cbl , Hcy , and MMA , and severity of peripheral neuropathy in diabetic patients . We hypothesized that metformin exposure would be associated with lower Cbl levels , elevated Hcy and MMA levels , and more severe peripheral neuropathy . RESEARCH DESIGN AND METHODS This was a prospect i ve case-control study of patients with type 2 diabetes and concurrent symptomatic peripheral neuropathy , comparing those who had received > 6 months of metformin therapy ( n = 59 ) with those without metformin exposure ( n = 63 ) . Comparisons were made using clinical ( Toronto Clinical Scoring System and Neuropathy Impairment Score ) , laboratory ( serum Cbl , fasting Hcy , and fasting MMA ) , and electrophysiological measures ( nerve conduction studies ) . RESULTS Metformin-treated patients had depressed Cbl levels and elevated fasting MMA and Hcy levels . Clinical and electrophysiological measures identified more severe peripheral neuropathy in these patients ; the cumulative metformin dose correlated strongly with these clinical and para clinical group differences . CONCLUSIONS Metformin exposure may be an iatrogenic cause for exacerbation of peripheral neuropathy in patients with type 2 diabetes . Interval screening for Cbl deficiency and systemic Cbl therapy should be considered upon initiation of , as well as during , metformin therapy to detect potential secondary causes of worsening peripheral neuropathy",
"OBJECTIVE The objective of this study was to evaluate and compare the effects of gliclazide-modified release ( gliclazide-MR ) , metformine ( MET ) and pioglitazone ( PIO ) monotherapies on glycemic control and conventional/non-conventional cardiovascular risk factors in patients with newly diagnosed type 2 diabetes mellitus ( T2DM ) . MATERIAL AND METHODS A single center , r and omized , 52-wk comparator-controlled clinical study was carried out in patients with newly diagnosed uncontrolled T2DM . A total of 57 patients were r and omized into gliclazide-MR , metformin and pioglitazone groups . Drugs were administered for 12 months . Anthropometric measurements , fasting plasma glucose ( FPG ) , postpr and ial plasma glucose ( PPG ) , HbA1c , insulin , HOMA-IR , lipid parameters , the markers of coagulation/fibrinolysis , inflammation and endothelial dysfunction were measured at baseline and at months 3 , 6 , and 12 . RESULTS In the gliclazide-MR group , HC , FPG , HbA1c , insulin , HOMA-IR , TC , trigylcerides , Lp ( a ) , E-selectin and Hcy were significantly decreased after treatment compared to baseline . In the MET group , BMI , WC , FPG , PPG , HbA1c , ICAM-1 and Hcy significantly decreased after treatment compared to baseline . In PIO group , WC , HC , FPG , PPG , HbA1c , C-peptid , HOMA-IR , trigylcerides , vWF , IL-6 , ICAM-1 , E-selectin and Hcy significantly decreased after treatment compared to baseline , whereas , HDL-C increased . At the end of the month 12 , the decreases in insulin and HOMA-IR score were more pronounced with PIO compared to gliclazide . CONCLUSIONS Gliclazide-MR , MET and PIO monotherapies , were equally effective in proving glycemic control in patients with newly diagnosed , oral antidiabetic (OAD)-naive T2DM . But , improvements in conventional/non-conventional cardiovascular risk factors were more pronounced in patients on PIO therapy compared to gliclazide and MET therapies . Also , all of the 3 drugs represent effective and safe first-line pharmacological treatment options in these patients",
"OBJECTIVE Metformin is a key treatment option in type 2 diabetes . However , metformin may decrease vitamin B12 levels and increase levels of homocysteine , a cardiovascular risk factor . We investigated whether 16 weeks of treatment with metformin affects serum concentrations of homocysteine , folate and vitamin B12 in subjects with type 2 diabetes treated with insulin . DESIGN Placebo-controlled , r and omized trial . MEASUREMENTS at baseline and 16 weeks later . SETTING This trial was conducted in the outpatient clinics of three general hospitals in The Netherl and s. SUBJECTS A total of 745 patients with type 2 diabetes , treated with insulin and not known with a contraindication for the use of metformin , were approached ; 390 gave informed consent and entered the study . Thirty-seven subjects dropped out ( 12 placebo and 25 metformin users ) . INTERVENTION Addition of metformin or placebo to insulin therapy . PRIMARY OUTCOME PARAMETERS : Serum homocysteine , folate , vitamin B12 , indices of glycaemic control and body weight . RESULTS Amongst those who completed 16 weeks of treatment , metformin use , as compared with placebo , was associated with an increase in homocysteine of 4 % ( 0.2 to 8 ; P=0.039 ) and with decreases in folate [ -7 % ( -1.4 to -13 ) ; P=0.024 ] and vitamin B12 [ -14 % ( -4.2 to -24 ) ; P in homocysteine could be explained by the decreases in folate and vitamin B12 . CONCLUSION In patients with type 2 diabetes , 16 weeks of treatment with metformin reduces levels of folate and vitamin B12 , which results in a modest increase in homocysteine . The clinical significance of these findings remains to be investigated",
"Background Plasma homocysteine ( tHCY ) has been associated with coronary artery disease ( CAD ) . We tested whether tHCY also increases secondary risk , after initial CAD diagnosis , and whether it is independent of traditional risk factors , C-reactive protein ( CRP ) , and methylenetetrahydrofolate reductase ( MTHFR ) genotype . Methods and Results Blood sample s were collected from 1412 patients with severe angiographically defined CAD ( stenosis ≥70 % ) . Plasma tHCY was measured by fluorescence polarization immunoassay . The study cohort was evaluated for survival after a mean of 3.0±1.0 years of follow-up ( minimum 1.5 years , maximum 5.0 years ) . The average age of the patients was 65±11 years , 77 % were males , and 166 died during follow-up . Mortality was greater in patients with tHCY in tertile 3 than in tertiles 1 and 2 ( mortality 15.7 % versus 9.6 % , P = 0.001 [ log-rank test ] , hazard ratio [ HR ] 1.63 ) . The relative hazard increased 16 % for each 5-&mgr;mol/L increase in tHCY ( P of mortality ( HR 1.64 , P = 0.009 ) , together with age ( HR 1.72 per 10-year increment , P of tHCY levels but not mortality . Conclusions In patients with angiographically defined CAD , tHCY is a significant predictor of mortality , independent of traditional risk factors , CRP , and MTHFR genotype . These findings increase interest in tHCY as a secondary risk marker and in secondary prevention trials ( ie , with folate/B vitamins ) to determine whether reduction in tHCY will reduce risk",
"Background Cardiovascular disease is the leading cause of mortality in Type 1 diabetes ( T1D ) . Vascular dysfunction is an early and critical event in the development of cardiovascular disease . Children with T1D have vascular dysfunction therefore early interventions to improve vascular health are essential to reduce cardiovascular mortality in T1D . Metformin is an insulin sensitising agent which is known to improve vascular health outcomes in type 2 diabetes ( T2D ) and other individuals with insulin resistance . It has been used safely in children and adolescents with T2D for over 10 years . This study aims to assess the effect of metformin on vascular health in children with T1D . Methods / Design This study is a 12 month , double blind , r and omised , placebo controlled trial to determine the effect of metformin on vascular health in children ( age 8–18 ) with T1D . The sample size is 76 with 38 children in the metformin group and 38 children in the placebo group . Vascular health and biochemical markers will be measured at baseline , 3 , 6 and 12 months . Vascular function will be measured using flow mediated dilatation and glyceryl trinitrate mediated dilatation of the brachial artery and vascular structure will be measured with carotid and aortic intima media thickness , using st and ardised protocol s. Discussion This study will be the first to investigate the effect of metformin on vascular health in children with T1D . It will provide important information on a potential intervention to improve cardiovascular morbidity and mortality in this population at high risk from cardiovascular disease . Trial registration Australia New Zeal and Clinical Trials Registry",
"BACKGROUND Oxidative stress and hyperhomocysteinaemia are risk factors for cardiovascular diseases . The aim of this study was to assess the effects of rosiglitazone and metformin on cardiovascular disease risk factors such as insulin resistance , oxidative stress and homocysteine levels in lean patients with polycystic ovary syndrome ( PCOS ) . METHODS Fifty lean patients ( BMI this study . Serum homocysteine , sex steroids , fasting insulin , fasting glucose and lipid levels were measured . Total antioxidant status ( TAS ; combines concentrations of individual antioxidants ) and malonyldialdehyde concentration ( MDA ) were determined . Insulin resistance was evaluated by using the homeostasis model insulin resistance index ( HOMA-IR ) , quantitative insulin sensitivity check index ( QUICKI ) , Area under the curve insulin ( AUCI ) and the insulin sensitivity index ( ISI ) . Patients were divided into two groups . One group was treated with metformin ( n = 25 ) and the other received rosiglitazone ( n = 25 ) for 12 weeks . All measurements were repeated at the end of 12 weeks . RESULTS Compared with healthy women , those with PCOS had significantly elevated serum MDA , homocysteine , HOMA-IR , AUCI and lipoprotein a levels , and significantly decreased serum TAS , QUICKI and ISI . Serum free testosterone levels showed a significant positive correlation with MDA , AUCI and HOMA-IR , and a negative correlation with TAS , ISI and QUICKI in PCOS patients . HOMA-IR and AUCI significantly decreased , while QUICKI and ISI significantly increased after treatment in both groups . Serum TAS level increased and serum MDA level decreased after the rosiglitazone treatment , but these parameters did not change after the metformin treatment . Serum homocysteine and lipid levels did not change in either group , while serum and rogen levels and LH/FSH ratio significantly decreased after the treatment period in only the rosiglitazone-treated group . CONCLUSION Elevated insulin resistance , oxidative stress and plasma homocysteine levels and changes in serum lipid profile ( risk factors for cardiovascular disease ) were observed in lean PCOS patients . Rosiglitazone seemed to decrease elevated oxidative stress when compared with metformin treatment in lean PCOS patients",
"AIM The aim of the study is to compare the effects of metformin and insulin treatment for gestational diabetes mellitus ( GDM ) on vitamin B12 and homocysteine ( Hcy ) status . METHODS Women with GDM , who met criteria for insulin treatment , were r and omly assigned to metformin ( n = 89 ) or insulin ( n = 91 ) in the Adelaide cohort of the metformin in gestational diabetes ( MiG ) trial . Fasting serum total vitamin B12 ( TB12 ) , holotranscobalamin ( HoloTC ) , a marker of functional B12 status and plasma Hcy concentrations were measured at 20 - 34 weeks ( at r and omization ) and 36 weeks gestation , then at 6 - 8 weeks postpartum . RESULTS Circulating TB12 , HoloTC and Hcy were similar in both treatment groups at each time point . Women who were taking dietary folate supplements at r and omization had higher serum TB12 and HoloTC at r and omization than those not taking folate . Overall , serum TB12 fell more between r and omization and 36 weeks gestation in the metformin group than in the insulin group ( metformin : -19.7 ± 4.7 pmol/l , insulin : -6.4 ± 3.6 pmol/l , p = 0.004 ) . The decrease in serum TB12 during treatment was greater with increasing treatment duration in metformin-treated ( p insulin-treated women . CONCLUSIONS Total , but not bioavailable , vitamin B12 stores were depleted during pregnancy to a greater extent in metformin-treated than in insulin-treated women with GDM , but neither analyte differed between groups at any stage . This adds further evidence supporting metformin as a safe alternative treatment to insulin in GDM . Further investigation is needed to evaluate whether women treated with metformin for longer periods in pregnancy require additional B12 or other supplementation",
"AIMS We investigated in a double-blind study whether metformin reduces blood pressure ( BP ) in patients with Type 2 diabetes intensively treated with insulin . METHODS A total of 220 patients with Type 2 diabetes were asked to undergo 24-h ambulatory BP monitoring ( 24-h ABPM ) . One hundred and eighty-two gave informed consent . Eighty-nine were r and omized to metformin and 93 to placebo . Thirty-five subjects dropped out ( 13 placebo , 22 metformin users ) ; 147 patients underwent a second 24-h ABPM , 16 weeks after r and omization . RESULTS Systolic BP ( SBP ) , diastolic BP ( DBP ) , pulse BP ( PP ) , mean BP ( MP ) and heart rate ( HR ) were measured as office BP measurements and as 24-h ABPM for 24-h , day and night . Office BP measurements did not differ significantly between the placebo- and metformin-treated groups for any BP measure , but showed a non-significant trend for SBP reduction with metformin use ( mean baseline-adjusted difference , metformin minus placebo : -4.2 mmHg , 95 % CI , -9.9 to + 1.5 ; P = 0.15 ) . The baseline-adjusted differences of the ambulatory measurements were -0.2 mmHg ( 95 % CI , -2.9 to + 2.6 ) for the 24-h SBP , and + 1.1 mmHg ( 95 % CI , -0.7 to + 2.8 ) for the 24-h DBP . On the whole , BP differences between metformin- and placebo-treated groups were not statistically significant . The only significant difference was for night-time PP ( baseline-adjusted difference : -2.2 mmHg ; 95 % CI , -4.2 to -0.2 ) . These results were not different after adjustment for age and diabetes duration , or for ( changes in ) body mass index , glycated haemoglobin , insulin dose or plasma homocysteine . CONCLUSION Metformin does not significantly affect BP in patients with Type 2 diabetes intensively treated with insulin",
"BACKGROUND Serum uric acid levels have emerged as a cardiovascular risk factor , and interventions aim ed to decrease its level have been related with an improvement in clinical and non- clinical cardiovascular outcomes . METHODS Serum uric acid levels were measured in 40 polycystic ovary syndrome ( PCOS ) patients and 40 non-hyper and rogenic women matched for BMI and grade of obesity , and were followed-up in 34 PCOS patients who were r and omized to an oral contraceptive containing 35 mg ethinyl-estradiol plus 2 mg cyproterone acetate ( Diane(35 ) Diario ) or metformin ( 850 mg twice daily ) for 24 weeks . RESULTS There were no statistically significant differences in uric acid levels between PCOS and non-hyper and rogenic control women . Considering all PCOS and non-hyper and rogenic control women as a whole , obese women showed higher uric acid concentrations than lean and overweight women , and the main determinant of serum uric acid level was the BMI . In PCOS women , Diane(35 ) Diario treatment was related with a decrease in uric acid levels ( P = 0.018 ) , whereas no changes were observed with metformin . CONCLUSIONS Obesity is the main determinant of serum uric acid concentrations in PCOS patients , yet amelioration of and rogen excess with an anti and rogenic contraceptive pill results in a significant decrease in these levels , an effect that is not observed with metformin . Clinical Trials.gov NLM Identifier : NCT00428311",
"High blood glucose level , lipid profile disturbances and plasma homocysteine ( Hcy ) are important risk factors for cardiovascular diseases in patients with type 2 diabetes . This study was conducted to evaluate and compare effects of glimepiride/metformin combination versus gliclazide/metformin combination on cardiovascular risk factors in type-2 diabetes mellitus ( T2DM ) patients . One hundred and eighty T2DM patients were r and omly allocated for treatment with placebo ( control ) , metformin ( 500 mg twice daily ) , glimepiride ( 3 mg once daily ) , gliclazide ( 80 mg once daily ) , metformin plus glimepiride or metformin plus gliclazide for 3 months . We evaluated plasma levels of glucose ( PG ) , glycated hemoglobin ( HbA1C ) , Hcy , vitamin B12 , folic acid and lipid profile before treatment and 3 months post treatment . Compared to metformin treated patients , glimepiride plus metformin induced significant reductions in : fasting plasma glucose , postpr and ial PG level , HbA1C % and Hcy level . Conversely , plasma folic acid and vitamin B12 were significantly increased . The levels of total cholesterol and triglyceride were significantly decreased ; low-density lipoprotein was markedly decreased , whereas high-density lipoprotein was significantly increased and hence risk ratio was significantly decreased . Similar results but with lower values were obtained using combination of metformin plus gliclazide on glycemic control only . Combination of glimepiride with metformin was superior to gliclazide plus metformin in alleviating the cardiovascular risk factors in type 2 diabetes mellitus patients",
"BACKGROUND Elevated levels of plasma homocysteine ( Hcy ) have been implicated as a significant risk factor for cardiovascular disease . Although long-term treatment with metformin can increase Hcy levels in patients with type II diabetes mellitus or coronary heart disease , it is becoming an increasingly accepted and widespread medication in polycystic ovary syndrome ( PCOS ) . In the literature , only one study has demonstrated that metformin increases Hcy levels in PCOS patients , but the effect of other insulin sensitizers on Hcy levels have not been reported previously in women with PCOS . We aim ed to assess the effects of metformin and rosiglitazone on plasma Hcy levels in patients with PCOS . METHODS Thirty women were r and omized to two groups : 15 women in group 1 received 850 mg of metformin twice daily for 3 months . In group 2 , 15 women received 4 mg of rosiglitazone for 3 months . In both groups , body mass index , menstrual pattern , and plasma total Hcy , insulin , glucose and lipid metabolism parameters were recorded at baseline and at 3 months . RESULTS Hcy levels increased from 8.93+/-0.49 to 11.26+/-0.86 micromol/l ( P = 0.002 ) and from 10.70+/-0.86 to 12.36+/-0.81 micromol/l ( P = 0.01 ) in the metformin and rosiglitazone groups , respectively . Apolipoprotein ( Apo ) A1 levels increased from 127.10+/-6.85 to 145.7+/-7.18 mg/dl ( P = 0.018 ) in the metformin group . Total cholesterol ( total-C ) , high-density lipoprotein cholesterol ( HDL-C ) , low-density lipoprotein cholesterol ( LDL-C ) , lipoprotein ( a ) and Apo B levels decreased in the metformin group , but the change was not significant . Total-C levels decreased from 161.15+/-8.94 to 150.23+/-8.73 mg/dl ( P = 0.026 ) , HDL-C decreased from 43.13+/-2.65 to 39.15+/-2.52 mg/dl ( P = 0.005 ) and LDL-C levels decreased from 93.83+/-6.06 to 80.7+/-2.30 mg/dl ( P = 0.021 ) in the rosiglitazone group . CONCLUSION Treatment with insulin sensitizers in women with PCOS may lead to increases in Hcy levels",
"It is known that the metabolism of homocysteine ( Hcy ) depends on the vitamins B6 , B12 and folate , and furthermore that metformin reduces serum vitamin B12 levels . In order to investigate whether metformin treatment affects serum total Hcy ( tHcy ) levels we performed an open , prospect i ve , r and omised study in 60 non-diabetic male patients with cardiovascular disease . After a 4-week run-in period with lovastatin 40 mg day-1 , and diet and lifestyle advice , patients were r and omised into two groups , both continuing the run-in treatment . One group received metformin up to 2000 mg day-1 , whereas the control group got no additional treatment . After 12 and 40 weeks of metformin treatment , tHcy levels increased moderately but significantly by 7.2 % ( p serum vitamin B12 levels decreased by 13.4 % ( p Serum folate levels did not change after 12 weeks , but decreased by 8.0 % after 40 weeks ( p = 0.061 ) relative to the control group . Serum levels of total cysteine and methylmalonic acid ( MMA ) did not change . In conclusion , metformin treatment increased tHcy levels and decreased levels of vitamin B12 and folate . Since MMA levels were unchanged , it remains an open question whether the increase in tHcy levels is secondary to reduced vitamin B12 levels , folate levels or a combination of both",
"Background Polycystic ovary syndrome ( PCOS ) afflicts at least 5 % of women . Both metformin and statin have been used as methods to ameliorate symptoms and improve prognosis . Aim To test the efficacy of concomitant usage of metformin and statins in PCOS patients . Material s and methods This is a prospect i ve , r and omized , double-blinded , placebo controlled study . 37 patients received rosuvastatin ( 10 mg/day ) for a period of 3 months , then the patients were r and omly allocated to one of two groups : the first group ( or intervention group ) received rosuvastatin ( 10 mg/day ) plus metformin ( 850 mg twice daily after meals ) , and the second group ( referred to as control group hereafter ) received rosuvastatin ( 10 mg/day ) plus placebo for a period of 3 months . Biochemical and clinical data were collected at each time point . Results There were no significant differences between the intervention and control groups for baseline lipid profile ( LDL , HDL , triglycerides , total cholesterol ) , CRP , homocysteine , DHEAS , testosterone and insulin ( p > 0.05 for all variables ) . There were no significant differences in lipid profile , CRP , homocysteine , DHEAS , testosterone and insulin between the intervention and placebo groups at 3 and 6 months after treatment ( p > 0.05 for all ) . Significant differences in the outcome variables of LDL , total cholesterol and FBS emerged within the intervention group , with significantly higher levels at 6 months compared to 3 months . We also did not find any significant group differences in unit change of the outcome variables between baseline and 3 months . Conclusions We found that the combination of statin and metformin has no advantage in PCOS management . In fact , the increase of LDL , total cholesterol and FBS within the intervention group warrants re assessment of current regimens to avoid any patient harm",
"OBJECTIVE To study the blood clotting tests and endothelial function of polycystic ovary syndrome ( PCOS ) patients and non-hyper and rogenic women , and their changes during PCOS treatment , as a function of the presence of obesity and smoking . DESIGN Case-control study followed by a r and omized clinical trial . METHODS Blood clotting and endothelial function were analyzed in 40 PCOS patients and 20 non-hyper and rogenic women . Thirty-four PCOS women were r and omized to an oral contraceptive containing 35 microg ethinyl-estradiol plus 2 mg cyproterone acetate ( Diane(35)Diario ) or metformin ( 850 mg twice daily ) , monitoring the changes on these parameters during 24 weeks of treatment . The influence of obesity and smoking was also analyzed . RESULTS Blood clotting and endothelial function tests were similar among PCOS patients and controls with the exception of a higher platelet count in the former . Obesity increased circulating fibrinogen levels , prothrombin activity and platelet counts , and reduced prothrombin and activated partial thromboplastin times . Smoking increased fibrinogen levels , platelet counts , and prothrombin activity , and reduced prothrombin time , in relation to the larger waist circumference of smokers . Irrespective of the treatment received , PCOS patients showed a decrease in prothrombin time and an increase in prothrombin activity , with a parallel increase in homocysteine levels in metformin users . The activated partial thromboplastin time decreased markedly in the patients treated with Diane(35)Diario . Finally , flow-mediated dilation improved in non-smokers irrespective of the drug received , but worsened in smokers . CONCLUSIONS Oral contraceptives and metformin may exert deleterious effects on blood clotting tests of PCOS women , yet the effects of metformin appear to be milder . Because smoking potentiates some of these effects and deteriorates endothelial function , smoking cessation should be promoted in PCOS patients ",
"OBJECTIVE To compare glycaemic control and cardiovascular risk profile in patients with type 2 diabetes following 12 months ' treatment with either repaglinide or metformin . STUDY DESIGN AND METHODS This was an open uncontrolled r and omised study in n=112 patients with inadequately controlled type 2 diabetes not previously treated with oral hypoglycaemic agents . Patients beginning treatment with either repaglinide or metformin entered an 8-week titration period ( to optimise dosage : repaglinide , 2 - 4 mg/day ; metformin , 1500 - 2500 mg/day ) followed by a 12-month treatment period . Glycaemic control and cardiovascular risk factors were determined at baseline and at the end of the treatment period . RESULTS Mean ( S.D. ) final drug doses were 3 ( + /-1 ) mg/day in the repaglinide group and 2000 ( + /-500 ) mg/day in the metformin group . Significant improvements in glycaemic control [ glycated haemoglobin , fasting and 2-h postpr and ial plasma glucose ( PPG ) ] were demonstrated in both treatment groups . The decrease in PPG was significantly greater in the repaglinide group ( P fasting plasma insulin ( FPI ) decreased significantly in both groups , more so with metformin ( P postpr and ial plasma insulin ( PPI ) levels decreased only in the metformin group ( P cardiovascular risk factors : total cholesterol , low-density lipoprotein cholesterol ( LDL-C ) , triglycerides , plasminogen activator inhibitor , lipoprotein(a ) and homocysteine . No changes were observed in high-density lipoprotein cholesterol ( HDL-C ) , apolipoprotein A-I , apolipoprotein B , fibrinogen , body mass index ( BMI ) or blood pressure . CONCLUSIONS The use of repaglinide or metformin in drug therapy-nai;ve patients with type 2 diabetes over a 12-month period is associated with improvements in both glycaemic control and cardiovascular risk profile . The latter can not necessarily be attributed to the pharmacotherapy per se , but provides reassurance in the context of initiating oral hypoglycaemic drug therapy with these agents",
"One hundred and two women with insulin-resistant polycystic ovary syndrome were r and omized to treatment with a vitamin B preparation , metformin , or both , in conjunction with st and ard infertility treatment . Plasma homocysteine levels were significantly reduced by both B vitamins and metformin , but to a greater degree by B vitamins , and higher pregnancy rates were associated with vitamin B treatment"
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OBJECTIVE Explore the cost-effectiveness of lifestyle interventions and metformin in reducing subsequent incidence of type 2 diabetes , both alone and in combination with a screening programme to identify high-risk individuals . DESIGN Systematic review of economic evaluations . DATA SOURCES AND ELIGIBILITY CRITERIA Data base search es ( Embase , Medline , Pre Medline , NHS EED ) and citation tracking identified economic evaluations of lifestyle interventions or metformin alone or in combination with screening programmes in people at high risk of developing diabetes . The International Society for Pharmaco-economics and Outcomes Research 's Question naire to Assess Relevance and Credibility of Modelling Studies for Informing Healthcare Decision Making was used to assess study quality . RESULTS 27 studies were included ; all had evaluated lifestyle interventions and 12 also evaluated metformin . Primary studies exhibited considerable heterogeneity in definitions of pre-diabetes and intensity and duration of lifestyle programmes . Lifestyle programmes and metformin appeared to be cost effective in preventing diabetes in high-risk individuals ( median incremental cost-effectiveness ratios of £ 7490/ quality -adjusted life-year ( QALY ) and £ 8428/QALY , respectively ) but economic estimates varied widely between studies . Intervention-only programmes were in general more cost effective than programmes that also included a screening component . The longer the period evaluated , the more cost-effective interventions appeared . In the few studies that evaluated other economic considerations , budget impact of prevention programmes was moderate ( 0.13%-0.2 % of total healthcare budget ) , financial payoffs were delayed ( by 9 - 14 years ) and impact on incident cases of diabetes was limited ( 0.1%-1.6 % reduction ) . There was insufficient evidence to answer the question of ( 1 ) whether lifestyle programmes are more cost effective than metformin or ( 2 ) whether low-intensity lifestyle interventions are more cost effective than the more intensive lifestyle programmes that were tested in trials . CONCLUSIONS The economics of preventing diabetes are complex . There is some evidence that diabetes prevention programmes are cost effective , but the evidence base to date provides few clear answers regarding design of prevention programmes because of differences in denominator population s , definitions , interventions and modelling assumptions | [
"Abstract Background Diabetes prevalence is increasing . The Finnish Diabetes Prevention Study ( DPS ) showed a 58 % reduction in Type 2 Diabetes ( T2D ) incidence in adults with impaired glucose tolerance ( IGT ) . The European Diabetes Prevention Study ( EDIPS ) extends the DPS to different European population s , using the same study design . In the Newcastle arm of this study ( EDIPS-Newcastle ) , we tested the hypothesis that T2D can be prevented by lifestyle intervention and explored secondary outcomes in relation to diabetes incidence . Methods We recruited 102 participants ( 42 men and 60 women , mean age 57 years , mean BMI 34 kgm-2 ) with IGT to EDIPS-Newcastle and r and omised to Intervention and usual care Control groups . The intervention included individual motivational interviewing aim ed at : weight reduction , increase in physical activity , fibre and carbohydrate intake and reduction of fat intake ( secondary outcomes ) . The primary outcome was diagnosis of T2D . Results Mean duration of follow-up was 3.1 years . T2D was diagnosed in 16 participants ( I = 5 , C = 11 ) . Absolute incidence of T2D was 32.7 per 1000 person-years in the Intervention-group and 67.1 per 1000 person-years in the Control-group . The overall incidence of diabetes was reduced by 55 % in the Intervention-group , compared with the Control-group : RR 0.45 ( 95%CI 0.2 to 1.2).Explanatory survival analysis of secondary outcomes showed that those who sustained beneficial changes for two or more years reduced their risk of developing T2D . Conclusion Our results are consistent with other diabetes prevention trials . This study was design ed as part of a larger study and although the sample size limits statistical significance , the results contribute to the evidence that T2D can be prevented by lifestyle changes in adults with IGT . In explanatory analysis small sustained beneficial changes in weight , physical activity or dietary factors were associated with reduction in T2D incidence . Trial Registration International St and ard R and omised Controlled Trial Number registry ( IS RCT N)Registry number : IS RCT N 15670600 http://www.controlled-trials.com/is rct n/ search .html?srch=15670600%26sort=3%26dir =",
"BACKGROUND Since the Diabetes Prevention Project ( DPP ) demonstrated that lifestyle weight-loss interventions can reduce the incidence of diabetes by 58 % , several studies have translated the DPP methods to public health-friendly context s. Although these studies have demonstrated short-term effects , no study to date has examined the impact of a translated DPP intervention on blood glucose and adiposity beyond 12 months of follow-up . PURPOSE To examine the impact of a 24-month , community-based diabetes prevention program on fasting blood glucose , insulin , insulin resistance as well as body weight , waist circumference , and BMI in the second year of follow-up . DESIGN An RCT comparing a 24-month lifestyle weight-loss program ( LWL ) to an enhanced usual care condition ( UCC ) in participants with prediabetes ( fasting blood glucose=95 - 125 mg/dL ) . Data were collected in 2007 - 2011 ; analyses were conducted in 2011 - 2012 . SETTING / PARTICIPANTS 301 participants with prediabetes were r and omized ; 261 completed the study . The intervention was held in community-based sites . INTERVENTION The LWL program was led by community health workers and sought to induce 7 % weight loss at 6 months that would be maintained over time through decreased caloric intake and increased physical activity . The UCC received two visits with a registered dietitian and a monthly newsletter . MAIN OUTCOME MEASURES The main measures were fasting blood glucose , insulin , insulin resistance , body weight , waist circumference , and BMI . RESULTS Intent-to-treat analyses of between-group differences in the average of 18- and 24-month measures of outcomes ( controlling for baseline values ) revealed that the LWL participants experienced greater decreases in fasting glucose ( -4.35 mg/dL ) ; insulin ( -3.01 μU/ml ) ; insulin resistance ( -0.97 ) ; body weight ( -4.19 kg ) ; waist circumference ( -3.23 cm ) ; and BMI ( -1.40 ) , all p-values reductions in metabolic indicators and adiposity ",
"OBJECTIVE To study the overall effect of the Active Prevention in High-Risk Individuals of Diabetes Type 2 in and Around Eindhoven ( APHRODITE ) lifestyle intervention on type 2 diabetes risk reduction in Dutch primary care after 0.5 and 1.5 years and to evaluate the variability between general practice s. RESEARCH DESIGN AND METHODS Individuals at high risk for type 2 diabetes ( Finnish Diabetes Risk Score ≥13 ) were r and omly assigned into an intervention group ( n = 479 ) or a usual-care group ( n = 446 ) . Comparisons were made between study groups and between general practice s regarding changes in clinical and lifestyle measures over 1.5 years . Participant , general practitioner , and nurse practitioner characteristics were compared between individuals who lost weight or maintained a stable weight and individuals who gained weight . RESULTS Both groups showed modest changes in glucose values , weight measures , physical activity , energy intake , and fiber intake . Differences between groups were significant only for total physical activity , saturated fat intake , and fiber intake . Differences between general practice s were significant for BMI and 2-h glucose but not for energy intake and physical activity . In the intervention group , the nurse practitioners ’ mean years of work experience was significantly longer in individuals who were successful at losing weight or maintaining a stable weight compared with unsuccessful individuals . Furthermore , successful individuals more often had a partner . CONCLUSIONS Risk factors for type 2 diabetes could be significantly reduced by lifestyle counseling in Dutch primary care . The small differences in changes over time between the two study groups suggest that additional intervention effects are modest . In particular , the level of experience of the nurse practitioner and the availability of partner support seem to facilitate intervention success",
"The purpose of the present study was to evaluate the impact of a lifestyle intervention programme , combined with a daily low-glycaemic index meal replacement , on body-weight and glycaemic control in subjects with impaired glucose regulation ( IGR ) . Subjects with IGR were r and omly assigned to an intervention group ( n 46 ) and a control group ( n 42 ) . Both groups received health counselling at baseline . The intervention group also received a daily meal replacement and intensive lifestyle intervention to promote healthy eating habits during the first 3 months of the study , and follow-up visits performed monthly until the end of the 1-year study . Outcome measurements included changes in plasma glucose , glycated Hb ( HbA1c ) , plasma lipids , body weight , blood pressure and body composition ( such as body fat mass and visceral fat area ) . The results showed that body-weight loss after 1 year was significant in the intervention group compared with the control group ( -1·8 ( SEM 0·35 ) v. -0·6 ( SEM 0·40 ) 2·5 kg , P decreased 1·24 mmol/l in the intervention group and increased 0·85 mmol/l in the control group ( P 5 kg body-weight loss at 1 year was associated with a decrease of 1·49 mmol/l in 2 h plasma glucose ( P . The incidence of normal glucose regulation ( NGR ) in the two groups was significantly different ( P=0·001 ) . In conclusion , the combination of regular contact , lifestyle advice and meal replacement is beneficial in promoting IGR to NGR",
"Prevention of type 2 diabetes by intensive lifestyle intervention design ed to achieve and maintain ideal body weight was assessed in subjects with impaired glucose tolerance ( IGT ) . Male subjects with IGT recruited from health-screening examinees were r and omly assigned in a 4:1 ratio to a st and ard intervention group ( control group ) and intensive intervention group ( intervention group ) . The final numbers of subjects were 356 and 102 , respectively . The subjects in the control group and in the intervention group were advised to maintain body mass index ( BMI ) of 24.0 kg/m2 and of , respectively , by diet and exercise . In the intervention group , detailed instructions on lifestyle were repeated every 3 - 4 months during hospital visits . Diabetes was judged to have developed when two or more consecutive fasting plasma glucose ( FPG ) values exceeded 140 mg/dl . A 100 g oral glucose tolerance test was performed every 6 months to detect improvement of glucose tolerance . The subjects were seen in an ordinary outpatient clinic . The cumulative 4-year incidence of diabetes was 9.3 % in the control group , versus 3.0 % in the intervention group , and the reduction in risk of diabetes was 67.4 % ( P Body weight decreased by 0.39 kg in the control group and by 2.18 kg in the intervention group ( P decrease in body weight . The incidence of diabetes was positively correlated with the changes in body weight , and the improvement in glucose tolerance was negatively correlated . Subjects with higher FPG at baseline developed diabetes at a higher rate than those with lower FPG . Higher 2h plasma glucose values and higher BMI values at baseline were also associated with a higher incidence of diabetes , but the differences were not significant . Subjects with a low insulinogenic index ( DeltaIRI/DeltaPG 30 min after an oral glucose load ) developed diabetes at a significantly higher rate than those with a normal insulinogenic index . Comparison of the BMI data and incidence of diabetes in five diabetes prevention studies by lifestyle intervention revealed a linear correlation between the incidence of diabetes and the BMI values , with the exception of the DaQing Study . However , the slope of the reduction in incidence of diabetes in the intensive intervention groups was steeper than expected simply on the basis of the reduction of BMI , suggesting that the effect of lifestyle intervention can not be solely ascribed to the body weight reduction . We conclude that lifestyle intervention aim ed at achieving ideal body weight in men with IGT is effective and can be conducted in an outpatient clinic setting",
"BACKGROUND The Diabetes Prevention Program ( DPP ) lifestyle intervention reduced the incidence of type 2 diabetes mellitus ( DM ) among high-risk adults by 58 % , with weight loss as the dominant predictor . However , it has not been adequately translated into primary care . METHODS We evaluated 2 adapted DPP lifestyle interventions among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and /or metabolic syndrome . Participants were r and omized to ( 1 ) a coach-led group intervention ( n = 79 ) , ( 2 ) a self-directed DVD intervention ( n = 81 ) , or ( 3 ) usual care ( n = 81 ) . During a 3-month intensive intervention phase , the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD . During the maintenance phase , participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring . The primary outcome was change in body mass index ( BMI ) ( calculated as weight in kilograms divided by height in meters squared ) from baseline to 15 months . RESULTS At baseline , participants had a mean ( SD ) age of 52.9 ( 10.6 ) years and a mean BMI of 32.0 ( 5.4 ) ; 47 % were female ; 78 % , non-Hispanic white ; and 17 % , Asian/Pacific Isl and er . At month 15 , the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group ( P self-directed group vs usual care ( P = .02 ) . The percentages of participants who achieved the 7 % DPP-based weight-loss goal were 37.0 % ( P = .003 ) and 35.9 % ( P = .004 ) in the coach-led and self-directed groups , respectively , vs 14.4 % in the usual care group . Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level . CONCLUSION Proven effective in a primary care setting , the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00842426",
"Aims . To observe the rate of conversion from impaired glucose tolerance ( IGT ) to diabetes following lifestyle modification ( LSM ) or a combination of lifestyle and metformin compared to a control population with 18-month followup . Methods . Forty screening camps were organized , which 5000 people attended . Around 2300 persons filled the question naire and 1825 subjects were identified as high risk . Of 1739 subjects who took the oral glucose tolerance test , 317 subjects were identified as IGT . The 317 IGT subjects were r and omized into three groups : control group was given st and ard medical advice , LSM group was given intensive lifestyle modification advice , while LSM + drug group was given intensive lifestyle advice and metformin 500 mg twice daily . Results . At the end , 273 subjects completed the study , giving a compliance rate of 86 % . Total of 47 incident cases of diabetes were diagnosed ( overall incidence was 4 cases per 1000 person-months with the incidence of 8.6 cases in control group , 2.5 cases in the LSM , and 2.3 cases in the LSM + drug groups ) . Conclusions . Study showed that lifestyle intervention had a major impact in preventing diabetes among IGT subjects in this region . Adding drug did not show any improved results . We recommend lifestyle advice and followup should be incorporated in primary health care",
"OBJECTIVE To describe the 1 ) lifestyle intervention used in the Finnish Diabetes Prevention Study , 2 ) short- and long-term changes in diet and exercise behavior , and 3 ) effect of the intervention on glucose and lipid metabolism . RESEARCH DESIGN AND METHODS There were 522 middle-aged , overweight subjects with impaired glucose tolerance who were r and omized to either a usual care control group or an intensive lifestyle intervention group . The control group received general dietary and exercise advice at baseline and had an annual physician 's examination . The subjects in the intervention group received additional individualized dietary counseling from a nutritionist . They were also offered circuit-type resistance training sessions and advised to increase overall physical activity . The intervention was the most intensive during the first year , followed by a maintenance period . The intervention goals were to reduce body weight , reduce dietary and saturated fat , and increase physical activity and dietary fiber . RESULTS The intervention group showed significantly greater improvement in each intervention goal . After 1 and 3 years , weight reductions were 4.5 and 3.5 kg in the intervention group and 1.0 and 0.9 kg in the control group , respectively . Measures of glycemia and lipemia improved more in the intervention group . CONCLUSIONS The intensive lifestyle intervention produced long-term beneficial changes in diet , physical activity , and clinical and biochemical parameters and reduced diabetes risk . This type of intervention is a feasible option to prevent type 2 diabetes and should be implemented in the primary health care system",
"Context The Diabetes Prevention Program ( DPP ) showed that lifestyle changes or metformin effectively decreased the development of type 2 diabetes in adults with impaired glucose tolerance . The economics of these interventions is important to policymakers . Contribution This cost-effectiveness model estimates that the DPP life-style intervention would cost society about $ 8800 and metformin would cost about $ 29900 per quality -adjusted life-year saved . While lifestyle intervention had a favorable cost-effectiveness profile at any adult age , metformin was not cost-effective after age 65 years . Implication s The cost-effectiveness of lifestyle intervention to prevent type 2 diabetes in high-risk individuals is within the range that American society typically finds acceptable for health care interventions . The Editors During the past half century , the number of persons with diagnosed diabetes in the United States has increased 4- to 6-fold ( 1 ) . Recent large clinical trials from Asia , Europe , and North America have demonstrated that behavioral and medication interventions can delay or prevent the development of type 2 diabetes in persons with impaired glucose tolerance , which is defined by a plasma glucose level between 7.77 mmol/L ( 140 mg/dL ) and 11.04 mmol/L ( 199 mg/dL ) 2 hours after a 75-g oral glucose load ( 2 - 6 ) . The Diabetes Prevention Program ( DPP ) r and omly assigned 3234 nondiabetic persons 25 years of age or older with impaired glucose tolerance and fasting glucose levels between 5.27 mmol/L ( 95 mg/dL ) and 6.94 mmol/L ( 125 mg/dL ) to placebo ; a lifestyle-modification program with the goals of at least a 7 % weight loss and 150 minutes of physical activity per week ; or metformin , 850 mg twice daily ( 4 ) . The mean age of participants was 51 years , and the mean body mass index was 34.0 kg/m2 ; 68 % were women and 45 % were members of minority groups ( 4 ) . The average follow-up was 2.8 years . Compared with the placebo intervention , the lifestyle intervention reduced the incidence of type 2 diabetes by 58 % and the metformin intervention reduced the incidence of type 2 diabetes by 31 % ( 4 ) . We have previously described the costs of the DPP interventions and their cost-effectiveness within the 3-year trial period ( 7 , 8) . In this analysis , we project the costs , health outcomes , and cost-effectiveness of the DPP lifestyle and metformin interventions over a lifetime relative to the placebo intervention . Methods Clinical Trial The lifestyle intervention involved a healthy , low-calorie , low-fat diet and moderate physical activity , such as brisk walking . The lifestyle intervention was implemented with a 16-lesson core curriculum covering diet , exercise , and behavior modification that was taught by case managers on a one-on-one basis , followed by individual sessions ( usually monthly ) and group sessions with case managers ( 9 ) . At the end of the study , 38 % of participants in the lifestyle intervention group had lost at least 7 % of their initial body weight . The metformin and placebo interventions were initiated at a dosage of 850 mg once a day . At 1 month , the dosage of metformin or placebo was increased to 850 mg twice daily . Case managers reinforced adherence during individual quarterly sessions ( 10 ) . At the end of the study , 72 % of participants in the metformin intervention group and 77 % of participants in the placebo intervention group took at least 80 % of the prescribed dose . All participants received st and ard lifestyle recommendations through written information and an annual 20- to 30-minute individual session that emphasized the importance of a healthy lifestyle ( 10 ) . Simulation Model We assessed the progression from impaired glucose tolerance to onset of diabetes to clinical ly diagnosed diabetes to diabetes with complications and death by using a lifetime simulation model originally developed by the Centers for Disease Control and Prevention and Research Triangle Institute International . The model has a Markov structure and includes annual transition probabilities between disease states ( 11 ) . In addition to disease progression , the model tracks costs and quality -adjusted life-years ( QALYs ) . The model has been described elsewhere ( 11 ) . For our analyses , we modified the model to include data from the DPP on progression , costs , and quality of life associated with impaired glucose tolerance , data from the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) on diabetes progression and complications , and new data on cost and quality of life associated with diabetes . A technical report describing the model is available . Supplement . Technical Report Disease Progression , Complications , and Comorbid Conditions Impaired Glucose Tolerance to Onset of Type 2 Diabetes We analyzed data from the DPP to assess the annual hazard of diabetes onset in the lifestyle , metformin , and placebo intervention groups . For patients receiving the placebo intervention , the annual hazard of diabetes onset was 10.8 per 100 person-years . At 3 years of follow-up , the risk reductions for the lifestyle and metformin interventions were 55.8 % and 29.9 % , respectively . In the base-case analysis , we assumed that the lifestyle and metformin interventions would be applied until diabetes onset and that the health and quality -of-life benefits associated with the interventions persisted until diabetes onset . Complications and Comorbid Conditions Associated with Impaired Glucose Tolerance We analyzed data from the DPP and other published sources to assess the prevalence of complications and comorbid conditions in participants with impaired glucose tolerance . At baseline , 6.0 % of DPP participants had microalbuminuria and 0.4 % had nephropathy . The DPP did not measure peripheral neuropathy , but previous studies found that the prevalence of neuropathy in persons with impaired glucose tolerance was 74 % of that in persons with newly diagnosed type 2 diabetes ( 12 ) and 12.3 % of persons with newly diagnosed type 2 diabetes have neuropathy ( 13 ) . Therefore , we assumed that at baseline , 8.5 % of DPP participants had clinical neuropathy . At baseline , 28 % of DPP participants had hypertension , 45 % had dyslipidemia , 7 % were smokers , 1.1 % had a history of cerebrovascular disease , and 2.0 % had a history of myocardial infa rct ion . No other complications were present . We assumed that during impaired glucose tolerance , microvascular or neuropathic complications would not progress . We assumed that hypertension and dyslipidemia developed at the rates observed in the DPP . On the basis of 2 large studies ( 14 , 15 ) , we assumed that the incidences of coronary heart disease and cerebrovascular disease in patients with impaired glucose tolerance were 58 % and 56 % , respectively , of those observed in patients with type 2 diabetes . We further assumed that nondiabetes-related mortality for persons with impaired glucose tolerance was the same as for persons with diabetes ( 16 ) . Onset of Type 2 Diabetes to Clinical Diagnosis of Type 2 Diabetes In the DPP , participants were tested for diabetes every 6 months ; diabetes was diagnosed at onset . In routine clinical practice , type 2 diabetes is estimated to develop 8 to 12 years before its clinical diagnosis ( 17 , 18 ) . In our base-case analysis , we therefore assumed that a 10-year delay occurred between the onset and clinical diagnosis of diabetes . Participants in the DPP had a mean hemoglobin A1c level of 6.4 % at the onset of diabetes . Participants in the UKPDS had a mean hemoglobin A1c of 7.1 % after a dietary run-in period but before r and omization ( 13 ) . Both DPP placebo participants and UKPDS participants received st and ard lifestyle recommendations . Accordingly , we assumed that during the 10-year interval between onset and clinical diagnosis of diabetes , patients were treated for type 2 diabetes and that hemoglobin A1c level increased at 0.07 % per year from 6.4 % to 7.1 % . Complications and Comorbid Conditions Associated with Undiagnosed Diabetes We further assumed that between onset and clinical diagnosis of diabetes , microvascular and neuropathic complications progressed slowly , such that by clinical diagnosis of type 2 diabetes , their prevalence reached the level observed in the UKPDS cohort at r and omization ( 13 , 19 , 20 ) . We assumed that blood pressure and lipid levels progressed as they did in DPP participants and that cardiovascular complications occurred as they would in type 2 diabetes according to risk factors and hemglobin A1c level ( 21 , 22 ) . Clinical Diagnosis of Type 2 Diabetes to Diabetes with Complications and Death We assumed that after clinical diagnosis , all persons with type 2 diabetes received intensive glycemic management as described in the UKPDS ( 13 ) . We modeled changes in hemoglobin A1c and diabetes treatments to reflect those observed in the UKPDS intensive therapy group . We based risk for retinopathy progression on UKPDS 38 ( 23 ) , risk for nephropathy progression on UKPDS 64 ( 20 ) , and risk for neuropathy progression on UKPDS 33 ( 13 ) . We based risk for cerebrovascular disease on UKPDS 60 ( 22 ) and risk for coronary heart disease on UKPDS 56 ( 21 ) . Costs Costs of Impaired Glucose Tolerance To estimate the total direct medical costs of impaired glucose tolerance , we considered the costs of the DPP interventions ( the cost of identifying participants , implementing and maintaining the interventions , and monitoring and treating the side effects of the interventions ) and the costs of the medical care outside the DPP ( 7 ) . In analyses from the perspective of society , we included both direct medical costs and direct nonmedical costs . We did not include indirect costs because they are captured in the assessment of QALYs ( 24 ) . Table 1 shows the total direct medical costs by treatment group , sex , and year in the DPP ( 7 ) . Costs were higher in the lifestyle and metformin interventions than in the placebo intervention and higher in women than in men . Costs decreased over time in all 3 intervention groups but after year 1 tended to decrease more in the lifestyle than",
"Context A previous Markov modelbased analysis estimated that use of the Diabetes Prevention Program diet and exercise intervention to forestall diabetes in high-risk people would be cost-effective from a societal perspective . Contribution Using a vali date d model design ed to be more complete and realistic than previous models , the authors estimated that the intervention would cost society about $ 62600 per quality -adjusted life-year saved . It would be cost-saving if the annual cost of the intervention decreased from $ 672 to $ 100 . Implication s This model suggests that the Diabetes Prevention Program intervention costs more per quality -adjusted life-year saved than previously estimated , and health plans and insurers may consider it too expensive to cover . The Editors Recent r and omized , controlled studies have shown that diabetes can be prevented or delayed in high-risk individuals by intensive lifestyle modification programs ( 1 , 2 ) or glucose-lowering drugs ( 2 - 4 ) . For example , in the Diabetes Prevention Program ( DPP ) , the relative reductions in the 2.8-year incidence of diabetes were 58 % in the lifestyle modification group and 31 % in the metformin group ( 2 ) . This raises hopes of substantially reducing the morbidity , mortality , and cost of this important disease . However , the trial was too short to observe the effects on microvascular or macrovascular outcomes , and the programs cost several hundred dollars a year ( 5 ) . These findings generate obvious questions : What are the long-term effects of trying to prevent diabetes in high-risk people ? Does lifestyle modification truly prevent or just postpone diabetes ? Is such a prevention program cost-effective ? What is the best strategy ? A previous analysis has suggested that lifestyle modification would be cost-effective over 75 years from a societal perspective ( 6 ) . We used a more thorough , clinical ly realistic , and independently vali date d model to estimate the short- and intermediate-term health and economic effects of different prevention programs for high-risk individuals and health plans , as well as for society . Methods We conducted the analysis by using the Archimedes model , which has been described elsewhere ( 7 - 9 ) . Briefly , it is a simulation model written at a relatively high level of anatomic , physiologic , clinical , and administrative detail . It uses object-oriented programming to create in the model objects that correspond to objects in reality , one-to-one . Among the hundreds of objects are people , pancreases , cells , plasma glucose levels , coronary arteries , plaque , chest pain , emergency departments , electrocardiograms , aspirin , and angioplasties . Helpful analogies might be a flight simulator ( in which the objects include the plane and its wings , airports , runways , buildings , and the wind ) , or the SimCity computer game . In the Archimedes model , each individual is simulated down to the level of hepatic glucose production , insulin resistance , -cell fatigue , and similar biological variables . The core of the model is a set of differential equations that represent the anatomy and physiology pertinent to diseases and their complications . Currently , the model includes diabetes , congestive heart failure , coronary artery disease , stroke , hypertension , and asthma in a single integrated model . The structure and equations of the model pertinent to diabetes and its complications are described elsewhere ( 8 , 9 ) . The Appendix and a technical report available through our Web site ( 10 ) describe additional aspects of the model and its validations that are pertinent to this analysis . Calculations are performed by using a distributed computing network . Clinical Events The model includes the biological variables and outcomes relevant to diabetes and its complications . Examples are basal hepatic glucose production ; insulin amount ; insulin resistance ; fasting plasma glucose ; hemoglobin A1c ( HbA1c ) ; 2-hour oral glucose tolerance ; high-density lipoprotein ( HDL ) cholesterol , low-density lipoprotein ( LDL ) cholesterol , and total cholesterol ; triglycerides ; systolic and diastolic blood pressures and their determinants ( for example , cardiac output , arterial compliance , peripheral resistance ) ; weight and body mass index ( BMI ) ; stenosis of coronary arteries ; retinopathy ( assessed by the Early Treatment of Diabetic Retinopathy scale ) ; urine protein ; creatinine ; peripheral neuropathy ; foot ulcers of varying degrees of severity ; and amputations . The use of differential equations preserves the continuous nature of biological variables as well as the interactions between them . Clinical outcomes are defined in terms of the underlying variables , as occurs in reality . For example , a person is said to have diabetes if his or her fasting plasma glucose level exceeds 6.9375 mmol/L ( 125 mg/dL ) or results on a 2-hour oral glucose tolerance test exceed 11.0445 mmol/L ( 199 mg/dL ) . This enables the model to incorporate different definitions and changes in definitions . The model is continuous : Biological variables are changing and interacting continuously , the natural histories and severity of conditions progress smoothly , any clinical event can occur at any time , and the timing of events is as condensed or drawn out as occurs in reality . The model also includes a detailed representation of the processes and logistics of clinical care and their related costs . Interventions , both to prevent diabetes and to manage it when it occurs , are modeled at the level of the underlying biology . Pertinent to this analysis is that in the model , diet and exercise reduce weight ( 2 ) ; reduce blood pressure ( 11 ) ; improve LDL cholesterol , HDL cholesterol , and total cholesterol levels ( 12 ) ; and decrease fasting plasma glucose levels ( 2 ) . The effects of metformin in the model are to reduce fasting plasma glucose and 2-hour oral glucose tolerance test results ( 2 ) ( by reducing basal hepatic glucose production ) , decrease LDL cholesterol and triglyceride levels ( 13 ) , and retard weight gain . Data used to build the model were derived from basic physiologic studies , surveys , epidemiologic studies , and clinical trials using methods described in the technical report ( 10 ) . Every variable in the model is estimated from at least 1 empirical source ; no variables are simply assumed . We identified specific sources by search ing MEDLINE from 1970 to 28 February 2005 and by consulting textbooks and clinical experts . Because the model includes scores of continuously valued , interacting variables , it does not have simplified states , transitions , or events at discrete time intervals that can be tabulated , as is commonly done for a Markov-type model . The equations themselves are in the technical report ( 10 ) . For nonmathematical readers , we have calculated annualized rates of change of representative biological variables and annualized rates of occurrence of representative clinical events , and compared them with rates for comparable events observed in epidemiologic studies and clinical trials . The Appendix reports those results . Costs The DPP measured the direct medical costs of delivering the lifestyle and metformin interventions ( for example , personnel , health education material s , medications , and laboratory tests ) . Compared with the placebo group 's costs , costs in the lifestyle group were $ 1356 more per person in the first year , with approximately $ 672 in annual costs thereafter ; for the metformin group , costs were $ 977 in the first year and averaged $ 742 per year thereafter ( 5 ) . Following the completion of the DPP , metformin became generic . When this is considered , the cost of the metformin program is reduced to about $ 780 for 3 years , or about $ 260 a year . In the DPP study , costs apply to the year 2000 . To calculate the routine costs of providing health care to high-risk people before they develop diabetes , as well as to people with diabetes and its complications , the model includes a detailed mathematical representation of a health care system , including such elements as facilities , personnel , tests and treatments , protocol s , and provider behaviors . For the base-case analysis , we obtained itemized costs from Kaiser Permanente , a nonprofit , group- practice , integrated managed care organization that provides comprehensive care ( with no deductibles or copayments ) . The facilities , personnel , protocol s , and costs in the model are based on that organization 's records , at the level of detail at which actual accounts are kept ( for example , 37 different kinds of office visits ) . The model calculates costs by keeping track of the occurrence of every event that has cost implication s and adding them up . The costs assigned to any event or item were calculated by Kaiser Permanente 's cost-accounting department using micro-costing methods ( 14 ) , and they represent the real costs to the organization , not charges , reimbursements , or diagnosis-related groups . Because costs vary from setting to setting , the implication s of different cost structures are examined in the sensitivity analysis . Calculation of costs applies to the year 2000 . Indirect costs , such as lost time from work and decreased productivity , are included in the cost-effectiveness analysis through the Quality of Well-Being Index ( 14 ) . We calculated the effects of lifestyle and metformin interventions on quality of life . For people who do not yet have diabetes , we used utility weights reported for the participants of the DPP study ( 15 ) . For people who have diabetes and its complications , we used the results of a published survey by Coffey and colleagues ( 16 ) . Both surveys used the Quality of Well-Being Index . The decrements in quality of life were assumed to be additive for people who have 2 or more complications , with a limit that quality of life could not be less than 0 . Use of an additive rule biases the calculation of cost/ quality -adjusted life-year ( QALY ) in favor of a prevention program , making the program appear more cost-effective than would occur if a multiplicative model were used . We discuss the",
"Background A r and omized control trial was performed to test whether a lifestyle intervention program , carried out in a primary healthcare setting using existing re sources , can reduce the incidence of type 2 diabetes in Japanese with impaired glucose tolerance ( IGT ) . The results of 3 years ' intervention are summarized . Methods Through health checkups in communities and workplaces , 304 middle-aged IGT subjects with a mean body mass index ( BMI ) of 24.5 kg/m2 were recruited and r and omized to the intervention group or control group . The lifestyle intervention was carried out for 3 years by public health nurses using the curriculum and educational material s provided by the study group . Results After 1 year , the intervention had significantly improved body weight ( -1.5 ± 0.7 vs. -0.7 ± 2.5 kg in the control ; p = 0.023 ) and daily non-exercise leisure time energy expenditure ( 25 ± 113 vs. -3 ± 98 kcal ; p = 0.045 ) . Insulin sensitivity assessed by the Matsuda index was improved by the intervention during the 3 years . The 3-year cumulative incidence tended to be lower in the intervention group ( 14.8 % vs.8.2 % , log-rank test : p = 0.097 ) . In a sub- analysis for the subjects with a BMI > 22.5 kg/m2 , a significant reduction in the cumulative incidence was found ( p = 0.027 ) . Conclusions The present lifestyle intervention program using existing healthcare re sources is beneficial in preventing diabetes in Japanese with IGT . This has important implication s for primary healthcare-based diabetes prevention . Trial registration",
"OBJECTIVE To investigate whether a pragmatic structured education program with and without pedometer use is effective for promoting physical activity and improving glucose tolerance in those with impaired glucose tolerance ( IGT ) . RESEARCH DESIGN AND METHODS Overweight and obese individuals with IGT were recruited from ongoing screening studies at the University Hospitals of Leicester , U.K. Participants were r and omly assigned to one of three groups . Group 1 received a 3-h group-based structured education program design ed to promote walking activity using personalized steps-per-day goals and pedometers . Group 2 received a 3-h group-based structured education program design ed to promote walking activity using generic time-based goals . Group 3 received a brief information leaflet ( control condition ) . Outcomes included an oral glucose tolerance test , st and ard anthropometric measures , ambulatory activity , and psychological variables . Follow-up was conducted at 3 , 6 , and 12 months . RESULTS A total of 87 individuals ( 66 % male , mean age 65 years ) were included in this study . At 12 months , significant decreases in 2-h postchallenge glucose and fasting glucose of −1.31 mmol/l ( 95 % CI −2.20 to −0.43 ) and −0.32 mmol/l ( −0.59 to −0.03 ) , respectively , were seen in the pedometer group compared with the control group . No significant improvements in glucose control were seen in those given the st and ard education program . CONCLUSIONS This study suggests that a pragmatic structured education program that incorporates pedometer use is effective for improving glucose tolerance in those with IGT . This result is likely to have important implication s for future primary care – based diabetes prevention initiatives",
"BACKGROUND Type 2 diabetes can often be prevented by lifestyle modification ; however , successful lifestyle intervention programmes are labour intensive . Mobile phone messaging is an inexpensive alternative way to deliver educational and motivational advice about lifestyle modification . We aim ed to assess whether mobile phone messaging that encouraged lifestyle change could reduce incident type 2 diabetes in Indian Asian men with impaired glucose tolerance . METHODS We did a prospect i ve , parallel-group , r and omised controlled trial between Aug 10 , 2009 , and Nov 30 , 2012 , at ten sites in southeast India . Working Indian men ( aged 35 - 55 years ) with impaired glucose tolerance were r and omly assigned ( 1:1 ) with a computer-generated r and omisation sequence to a mobile phone messaging intervention or st and ard care ( control group ) . Participants in the intervention group received frequent mobile phone messages compared with controls who received st and ard lifestyle modification advice at baseline only . Field staff and participants were , by necessity , not masked to study group assignment , but allocation was concealed from laboratory personnel as well as principal and co-investigators . The primary outcome was incidence of type 2 diabetes , analysed by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00819455 . RESULTS We assessed 8741 participants for eligibility . 537 patients were r and omly assigned to either the mobile phone messaging intervention ( n=271 ) or st and ard care ( n=266 ) . The cumulative incidence of type 2 diabetes was lower in those who received mobile phone messages than in controls : 50 ( 18 % ) participants in the intervention group developed type 2 diabetes compared with 73 ( 27 % ) in the control group ( hazard ratio 0·64 , 95 % CI 0·45 - 0·92 ; p=0·015 ) . The number needed to treat to prevent one case of type 2 diabetes was 11 ( 95 % CI 6 - 55 ) . One patient in the control group died suddenly at the end of the first year . We recorded no other serious adverse events . INTERPRETATION Mobile phone messaging is an effective and acceptable method to deliver advice and support towards lifestyle modification to prevent type 2 diabetes in men at high risk . FUNDING The UK India Education and Research Initiative , the World Diabetes Foundation",
"OBJECTIVES The Finnish Diabetes Prevention Study ( DPS ) was a r and omized intervention program that evaluated the effect of intensive lifestyle modification on the development of diabetes mellitus type 2 in patients with impaired glucose tolerance . As such , a program is dem and ing in terms of re sources ; it is necessary to assess whether it would be money well spent . This determination was the purpose of this study . METHODS We developed a simulation model to assess the economic consequences of an intervention like the one studied in DPS in a Swedish setting . The model used data from the trial itself to assess the effect of intervention on the risk of diabetes and on risk factors for cardiovascular disease . Results from the United Kingdom Prospect i ve Diabetes Study were used to estimate the risk of cardiovascular disease and stroke . Cost data were derived from Swedish studies . The intervention was assumed to be applied to eligible patients from a population -based screening program of 60-year-olds in the County of Stockholm from which the baseline characteristics of the patients was used . RESULTS The model predicted that implementing the program would be cost-saving from the healthcare payers ' perspective . Furthermore , it was associated with an increase in estimated survival of .18 years . Taking into consideration the increased consumption by patients due to their longer survival , the predicted cost-effectiveness ratio was 2,363 euro per quality -adjusted life-year gained . CONCLUSIONS Lifestyle intervention directed toward high-risk subjects would be cost-saving for the healthcare payer and highly cost-effective for society as a whole",
"OBJECTIVES Our community-academic partnership employed community-based participatory research to develop and pilot a simple , peer-led intervention to promote weight loss , which can prevent diabetes and eliminate racial/ethnic disparities in incident diabetes among overweight adults with prediabetes . METHODS We recruited overweight adults at community sites , performed oral glucose tolerance testing to identify persons with blood glucose levels in the prediabetes range , and r and omized eligible people to a peer-led lifestyle intervention group or delayed intervention in 1 year . Outcomes , including weight , blood pressure , and health behaviors , were measured at baseline and 3 , 6 , and 12 months . RESULTS More than half of those tested ( 56 % , or 99 of 178 ) had prediabetes and enrolled in the study . Participants were predominantly Spanish-speaking , low-income , undereducated women . The intervention group lost significantly more weight than the control group and maintained weight loss at 12 months ( 7.2 versus 2.4 pounds ; P to diabetes . CONCLUSIONS In underserved minority communities , prediabetes prevalence may be higher than previously reported . Low-cost , community-based interventions can succeed in encouraging weight loss to prevent diabetes",
"Aims /hypothesisLifestyle modification helps in the primary prevention of diabetes in multiethnic American , Finnish and Chinese population s. In a prospect i ve community-based study , we tested whether the progression to diabetes could be influenced by interventions in native Asian Indians with IGT who were younger , leaner and more insulin resistant than the above population s. Methods We r and omised 531 ( 421 men 110 women ) subjects with IGT ( mean age 45.9±5.7 years , BMI 25.8±3.5 kg/m2 ) into four groups . Group 1 was the control , Group 2 was given advice on lifestyle modification ( LSM ) , Group 3 was treated with metformin ( MET ) and Group 4 was given LSM plus MET . The primary outcome measure was type 2 diabetes as diagnosed using World Health Organization criteria . Results The median follow-up period was 30 months , and the 3-year cumulative incidences of diabetes were 55.0 % , 39.3 % , 40.5 % and 39.5 % in Groups 1–4 , respectively . The relative risk reduction was 28.5 % with LSM ( 95 % CI 20.5–37.3 , p=0.018 ) , 26.4 % with MET ( 95 % CI 19.1–35.1 , p=0.029 ) and 28.2 % with LSM + MET ( 95 % CI 20.3–37.0 , p=0.022 ) , as compared with the control group . The number needed to treat to prevent one incident case of diabetes was 6.4 for LSM , 6.9 for MET and 6.5 for LSM + MET . Conclusions /interpretationProgression of IGT to diabetes is high in native Asian Indians . Both LSM and MET significantly reduced the incidence of diabetes in Asian Indians with IGT ; there was no added benefit from combining them",
"OBJECTIVES Previous research has suggested people with impaired fasting glucose ( IFG ) are less likely to develop Type 2 diabetes ( T2DM ) if they receive prolonged structured diet and exercise advice . This study examined the within-trial cost-effectiveness of such lifestyle interventions . METHODS Screen-detected participants with either newly diagnosed T2DM or IFG were r and omized 2:1 to intervention versus control ( usual care ) between February and December 2009 , in Norfolk ( UK ) . The intervention consisted of group based education , physiotherapy and peer support sessions , plus telephone contacts from T2DM volunteers . We monitored healthcare re source use , intervention costs , and quality of life ( EQ-5D ) . The incremental cost per quality -adjusted life-year ( QALY ) gain ( incremental cost effectiveness ratio [ ICER ] ) , and cost effectiveness acceptability curves ( CEAC ) were estimated . RESULTS In total , 177 participants were recruited ( 118 intervention , 59 controls ) , with a mean follow-up of 7 months . Excluding screening and recruitment costs , the mean cost was estimated to be £ 551 per participant in the intervention arm , compared with £ 325 in the control arm . The QALY gains were -0.001 and -0.004 , respectively . The intervention was estimated to have an ICER of £ 67,184 per QALY ( 16 percent probability of being cost-effective at the £ 20,000/QALY threshold ) . Cost-effectiveness estimates were more favorable for IFG participants and those with longer follow-up ( ≥ 4 months ) ( ICERs of £ 20,620 and £ 17,075 per QALY , respectively ) . CONCLUSIONS Group sessions to prevent T2DM were not estimated to be within current limits of cost-effectiveness . However , there was a large degree of uncertainty surrounding these estimates , suggesting the need for further research",
"Summary From a previously reported 5-year screening programme of 6,956 47–49-year-old Malmö males , a series of 41 subjects with early-stage Type 2 ( non-insulin-dependent ) diabetes mellitus and 181 subjects with impaired glucose tolerance were selected for prospect i ve study and to test the feasibility aspect of long-term intervention with an emphasis on life-style changes . A 5-year protocol , including an initial 6-months ( r and omised ) pilot study , consisting of dietary treatment and /or increase of physical activity or training with annual check-ups , was completed by 90 % of subjects . Body weight was reduced by 2.3–3.7 % among participants , whereas values increased by 0.5–1.7 % in non-intervened subjects with impaired glucose tolerance and in normal control subjects ( p oxygen uptake ( ml · min−1 · kg−1 ) was increased by 10–14 % vs decreased by 5–9 % , respectively ( p was normalized in > 50 % of subjects with impaired glucose tolerance , the accumulated incidence of diabetes was 10.6 % , and more than 50 % of the diabetic patients were in remission after a mean follow-up of 6 years . Blood pressure , lipids , and hyperinsulinaemia were reduced and early insulin responsiveness to glucose loading preserved . Improvement in glucose tolerance was correlated to weight reduction ( r=0.19 , p ) and increased fitness ( r=0.22 , p ) . Treatment was safe , and mortality was low ( in fact 33 % lower than in the remainder of the cohort ) . We conclude that long-term intervention in the form of diet and physical exercise is feasible even on a large scale , and that substantial metabolic improvement can be achieved which may contribute to prevent or postpone manifest diabetes",
"OBJECTIVE Individuals with impaired glucose tolerance ( IGT ) have a high risk of developing NIDDM . The purpose of this study was to determine whether diet and exercise interventions in those with IGT may delay the development of NIDDM , i.e. , reduce the incidence of NIDDM , and thereby reduce the overall incidence of diabetic complications , such as cardiovascular , renal , and retinal disease , and the excess mortality attributable to these complications . RESEARCH DESIGN AND METHODS In 1986 , 110,660 men and women from 33 health care clinics in the city of Da Qing , China , were screened for IGT and NIDDM . Of these individuals , 577 were classified ( using World Health Organization criteria ) as having IGT . Subjects were r and omized by clinic into a clinical trial , either to a control group or to one of three active treatment groups : diet only , exercise only , or diet plus exercise . Follow-up evaluation examinations were conducted at 2-year intervals over a 6-year period to identify subjects who developed NIDDM . Cox 's proportional hazard analysis was used to determine if the incidence of NIDDM varied by treatment assignment . RESULTS The cumulative incidence of diabetes at 6 years was 67.7 % ( 95 % CI , 59.8–75.2 ) in the control group compared with 43.8 % ( 95 % CI , 35.5–52.3 ) in the diet group , 41.1 % ( 95 % CI , 33.4–49.4 ) in the exercise group , and 46.0 % ( 95 % CI , 37.3–54.7 ) in the diet-plus-exercise group ( P relative decrease in rate of development of diabetes in the active treatment groups was similar when subjects were stratified as lean or overweight ( BMI baseline BMI and fasting glucose , the diet , exercise , and diet-plus-exercise interventions were associated with 31 % ( P risk of developing diabetes , respectively . CONCLUSIONS Diet and /or exercise interventions led to a significant decrease in the incidence of diabetes over a 6-year period among those with IGT",
"OBJECTIVES Prevention of type 2 diabetes ( T2DM ) is a priority in healthcare , but there is a lack of evidence investigating how to effectively translate prevention research into a UK primary care setting . We assessed whether a structured education programme targeting lifestyle and behaviour change was effective at preventing progression to T2DM in people with pre-diabetes . MATERIAL S AND METHODS Forty-four general practice s were r and omised to receive either st and ard care or a 6hour group structured education programme with an annual refresher course , and regular phone contact . Participants were followed up for 3years . The primary outcome was progression to T2DM . RESULTS Eight hundred and eighty participants were included ( 36 % female , mean age 64years , 16 % ethnic minority group ) ; 131 participants developed T2DM . There was a non-significant 26 % reduced risk of developing T2DM in the intervention arm compared to st and ard care ( HR 0.74 , 95 % CI 0.48 , 1.14 , p=0.18 ) . The reduction in T2DM risk when excluding those who did not attend the initial education session was also non-significant ( HR 0.65 , 0.41 , 1.03 , p=0.07 ) . There were statistically significant improvements in HbA1c ( -0.06 , -0.11 , -0.01 ) , LDL cholesterol ( -0.08 , -0.15 , -0.01 ) , sedentary time ( -26.29 , -45.26 , -7.32 ) and step count ( 498.15 , 162.10 , 834.20 ) when data were analysed across all time points . CONCLUSIONS This study suggests that a relatively low re source , pragmatic diabetes prevention programme result ed in modest benefits to biomedical , lifestyle and psychosocial outcomes , however the reduction to the risk of T2DM did not reach significance . The findings have important implication s for future research and primary care",
"BACKGROUND Type 2 diabetes affects approximately 8 percent of adults in the United States . Some risk factors -- elevated plasma glucose concentrations in the fasting state and after an oral glucose load , overweight , and a sedentary lifestyle -- are potentially reversible . We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes . METHODS We r and omly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo , metformin ( 850 mg twice daily ) , or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week . The mean age of the participants was 51 years , and the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 34.0 ; 68 percent were women , and 45 percent were members of minority groups . RESULTS The average follow-up was 2.8 years . The incidence of diabetes was 11.0 , 7.8 , and 4.8 cases per 100 person-years in the placebo , metformin , and lifestyle groups , respectively . The lifestyle intervention reduced the incidence by 58 percent ( 95 percent confidence interval , 48 to 66 percent ) and metformin by 31 percent ( 95 percent confidence interval , 17 to 43 percent ) , as compared with placebo ; the lifestyle intervention was significantly more effective than metformin . To prevent one case of diabetes during a period of three years , 6.9 persons would have to participate in the lifestyle-intervention program , and 13.9 would have to receive metformin . CONCLUSIONS Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk . The lifestyle intervention was more effective than metformin",
"OBJECTIVES We report the 10-year effectiveness and within-trial cost-effectiveness of the Diabetes Prevention Program ( DPP ) and its Outcomes Study ( DPPOS ) interventions among participants who were adherent to the interventions . STUDY DESIGN DPP was a 3-year r and omized clinical trial followed by 7 years of open-label modified intervention follow-up . METHODS Data on re source utilization , cost , and quality of life were collected prospect ively . Economic analyses were performed from health system and societal perspectives . Lifestyle adherence was defined as achieving and maintaining a 5 % reduction in initial body weight , and metformin adherence as taking metformin at 80 % of study visits . RESULTS The relative risk reduction was 49.4 % among adherent lifestyle participants and 20.8 % among adherent metformin participants compared with placebo . Over 10 years , the cumulative , undiscounted , per capita direct medical costs of the interventions , as implemented during the DPP , were greater for adherent lifestyle participants ( $ 4810 ) than adherent metformin participants ( $ 2934 ) or placebo ( $ 768 ) . Over 10 years , the cumulative , per capita non-interventionrelated direct medical costs were $ 4250 greater for placebo participants compared with adherent lifestyle participants and $ 3251 greater compared with adherent metformin participants . The cumulative quality -adjusted life-years ( QALYs ) accrued over 10 years were greater for lifestyle ( 6.80 ) than metformin ( 6.74 ) or placebo ( 6.67 ) . Without discounting , from a modified societal perspective ( excluding participant time ) and a full societal perspective ( including participant time ) , lifestyle cost and metformin was cost saving compared with placebo . CONCLUSIONS Over 10 years , lifestyle intervention and metformin were cost-effective or cost saving compared with placebo . These analyses confirm that lifestyle and metformin represent a good value for money",
"BACKGROUND The susceptibility to type 2 diabetes of people of south Asian descent is established , but there is little trial-based evidence for interventions to tackle this problem . We assessed a weight control and physical activity intervention in south Asian individuals in the UK . METHODS We did this non-blinded trial in two National Health Service ( NHS ) regions in Scotl and ( UK ) . Between July 1 , 2007 , and Oct 31 , 2009 , we recruited men and women of Indian and Pakistani origin , aged 35 years or older , with waist circumference 90 cm or greater in men or 80 cm or greater in women , and with impaired glucose tolerance or impaired fasting glucose determined by oral glucose tolerance test . Families were r and omised ( using a r and om number generator program , with permuted blocks of r and om size , stratified by location [ Edinburgh or Glasgow ] , ethnic group [ Indian or Pakistani ] , and number of participants in the family [ one vs more than one ] ) to intervention or control . Participants in the same family were not r and omised separately . The intervention group received 15 visits from a dietitian over 3 years and the control group received four visits in the same period . The primary outcome was weight change at 3 years . Analysis was by modified intention to treat , excluding participants who died or were lost to follow-up . We used linear regression models to provide mean differences in baseline-adjusted weight at 3 years . This trial is registered , number IS RCT N25729565 . FINDINGS Of 1319 people who were screened with an oral glucose tolerance test , 196 ( 15 % ) had impaired glucose tolerance or impaired fasting glucose and 171 entered the trial . Participants were in 156 family clusters that were r and omised ( 78 families with 85 participants were allocated to intervention ; 78 families with 86 participants were allocated to control ) . 167 ( 98 % ) participants in 152 families completed the trial . Mean weight loss in the intervention group was 1.13 kg ( SD 4.12 ) , compared with a mean weight gain of 0.51 kg ( 3.65 ) in the control group , an adjusted mean difference of -1.64 kg ( 95 % CI -2.83 to -0.44 ) . INTERPRETATION Modest , medium-term changes in weight are achievable as a component of lifestyle-change strategies , which might control or prevent adiposity-related diseases . FUNDING National Prevention Research Initiative , NHS Research and Development ; NHS National Services Scotl and ; NHS Health Scotl and",
"OBJECTIVE —In the Indian Diabetes Prevention Programme ( IDPP ) , a 3-year r and omized , controlled trial , lifestyle modification ( LSM ) and metformin helped to prevent type 2 diabetes in subjects with impaired glucose tolerance ( IGT ) . The direct medical costs and cost-effectiveness of the interventions relative to the control group are reported here . RESEARCH DESIGN AND METHODS —Relative effectiveness and costs of interventions ( LSM , metformin , and LSM and metformin ) in the IDPP were estimated from the health care system perspective . Costs of intervention considered were only the direct medical costs . Direct nonmedical , indirect , and research costs were excluded . The cost-effectiveness of interventions was measured as the amount spent to prevent one case of diabetes within the 3-year trial period . RESULTS —The direct medical cost to identify one subject with IGT was Indian rupees ( INR ) 5,278 ( $ 117 ) . Direct medical costs of interventions over the 3-year trial period were INR 2,739 ( $ 61 ) per subject in the control group , INR 10,136 ( $ 225 ) with LSM , INR 9,881 ( $ 220 ) with metformin , and INR 12,144 ( $ 270 ) with LSM and metformin . The number of individuals needed to treat to prevent a case of diabetes was 6.4 with LSM , 6.9 with metformin , and 6.5 with LSM and metformin . Cost-effectiveness to prevent one case of diabetes with LSM was INR 47,341 ( $ 1,052 ) , with metformin INR 49,280 ( $ 1,095 ) , and with LSM and metformin INR 61,133 ( $ 1,359 ) . CONCLUSIONS —Both LSM and metformin were cost-effective interventions for preventing diabetes among high risk-individuals in India and perhaps may be useful in other developing countries as well . The long-term cost-effectiveness of the interventions needs to be assessed",
"Aims /hypothesisTo assess the feasibility and effectiveness of an active real-life primary care lifestyle intervention in preventing type 2 diabetes within a high-risk Mediterranean population . Methods A prospect i ve cohort study was performed in the setting of Spanish primary care . White-European individuals without diabetes aged 45–75 years ( n = 2,054 ) were screened using the Finnish Diabetes Risk Score ( FINDRISC ) and a subsequent 2 h OGTT . Where feasible , high-risk individuals who were identified were allocated sequentially to st and ard care , a group-based or an individual level intervention ( intensive reinforced DE-PLAN [ Diabetes in Europe — Prevention using Lifestyle , Physical Activity and Nutritional ] intervention ) . The primary outcome was the development of diabetes according to WHO criteria . Analyses after 4-year follow-up were performed based on the intention-to-treat principle with comparison of st and ard care and the combined intervention groups . Results The st and ard care ( n = 219 ) and intensive intervention ( n = 333 ) groups were comparable in age ( 62.0/62.2 years ) , sex ( 64.4/68.2 % women ) , BMI ( 31.3/31.2 kg/m2 ) , FINDRISC score ( 16.2/15.8 points ) , fasting ( 5.3/5.2 mmol/l ) , 2 h plasma glucose ( 7.1/6.9 mmol/l ) and self-reported interest to make lifestyle changes at baseline . Diabetes was diagnosed in 124 individuals : 63 ( 28.8 % ) in the st and ard care group and 61 ( 18.3 % ) in the intensive intervention group . During a 4.2-year median follow-up , the incidences of diabetes were 7.2 and 4.6 cases per 100 person-years , respectively ( 36.5 % relative risk reduction , p number of participants needed to be treated by intensive intervention for 4 years to reduce one case of diabetes was 9.5 . Conclusions /interpretationIntensive lifestyle intervention is feasible in a primary care setting and substantially reduces diabetes incidence among high-risk individuals . Clinical trial registration : Clinical Trial.gov NCT01519505 Funding : Commission of the European Communities , Institute of Health Carlos III , Spanish Ministry of Health and Department of Health , Generalitat de Catalunya",
"OBJECTIVES We tested the effectiveness of a community-based , literacy-sensitive , and culturally tailored lifestyle intervention on weight loss and diabetes risk reduction among low-income , Spanish-speaking Latinos at increased diabetes risk . METHODS Three hundred twelve participants from Lawrence , Massachusetts , were r and omly assigned to lifestyle intervention care ( IC ) or usual care ( UC ) between 2004 and 2007 . The intervention was implemented by trained Spanish-speaking individuals from the community . Each participant was followed for 1 year . RESULTS The participants ' mean age was 52 years ; 59 % had less than a high school education . The 1-year retention rate was 94 % . Compared with the UC group , the IC group had a modest but significant weight reduction ( -2.5 vs 0.63 lb ; P = .04 ) and a clinical ly meaningful reduction in hemoglobin A1c ( -0.10 % vs -0.04 % ; P = .009 ) . Likewise , insulin resistance improved significantly in the IC compared with the UC group . The IC group also had greater reductions in percentage of calories from total and saturated fat . CONCLUSIONS We developed an inexpensive , culturally sensitive diabetes prevention program that result ed in weight loss , improved HbA1c , and improved insulin resistance in a high-risk Latino population",
"AIM To evaluate the effectiveness of lifestyle interventions in people with impaired glucose tolerance ( IGT ) . METHODS Participants with IGT ( n=78 ) , diagnosed on two consecutive oral glucose tolerance tests ( OGTTs ) , were r and omly assigned to a 2-year lifestyle intervention or to a control group . Main outcome measures were changes from baseline in : nutrient intake ; physical activity ; anthropometry , glucose tolerance and insulin sensitivity . Measurements were repeated at 6 , 12 and 24 months follow-up . RESULTS After 24 months follow-up , there was a significant fall in total fat consumption ( difference in change between groups ( Delta intervention-Delta control)= -17.9 , 95 % confidence interval ( CI ) -33.6 to -2.1g/day ) as a result of the intervention . Body mass was significantly lower in the intervention group compared with controls after 6 months ( -1.6 , 95 % CI -2.9 to -0.4 kg ) and 24 months ( -3.3 , 95 % CI -5.7 to -0.89 kg ) . Whole body insulin sensitivity , assessed by the short insulin tolerance test ( ITT ) , improved after 12 months in the intervention group ( 0.52 , 95 % CI 0.15 - 0.89%/min ) . CONCLUSIONS These findings complement the findings of the Finnish Diabetes Prevention Study and the American Diabetes Prevention Study , both of which tested intensive interventions , by showing that pragmatic lifestyle interventions result in improvements in obesity and whole body insulin sensitivity in individuals with IGT , without change in other cardiovascular risk factors",
"BACKGROUND Previous studies demonstrated that intensive lifestyle modification can prevent type 2 diabetes mellitus among those with impaired glucose tolerance , but similar beneficial results have not been proved among those with impaired fasting glucose levels . We investigated the efficacy of lifestyle modification on type 2 diabetes incidence among those with impaired fasting glucose levels . METHODS The present study was an unmasked , multicenter , r and omized , controlled trial . A total of 641 overweight Japanese ( aged 30 - 60 years ) with impaired fasting glucose levels were recruited nationwide in Japan and r and omly assigned to a frequent intervention group ( n = 311 ) or a control group ( n = 330 ) . For 36 months after r and omization , the frequent intervention group received individual instructions and follow-up support for lifestyle modification from the medical staff 9 times . The control group received similar individual instructions 4 times at 12-month intervals during the same period . The primary outcome was type 2 diabetes incidence in annual 75-g oral glucose tolerance tests , diagnosed according to World Health Organization criteria . RESULTS There were no significant differences between the allocation groups in baseline characteristics and dropout rates . Estimated cumulative incidences of type 2 diabetes were 12.2 % in the frequent intervention group and 16.6 % in the control group . Overall , the adjusted hazard ratio in the frequent intervention group was 0.56 ( 95 % confidence interval , 0.36 - 0.87 ) . In the post hoc subgroup analyses , the hazard ratio reduced to 0.41 ( 95 % confidence interval , 0.24 - 0.69 ) among participants with impaired glucose tolerance at baseline , and to 0.24 ( 0.12 - 0.48 ) among those with baseline hemoglobin A(1c ) levels of 5.6 % or more ( the Japan Diabetes Society method ) . Such risk reduction was not observed among those with isolated impaired fasting glucose findings or baseline hemoglobin A(1c ) levels of less than 5.6 % . CONCLUSIONS Lifestyle modifications can prevent type 2 diabetes among overweight Japanese with impaired fasting glucose levels . In addition , identifying individuals with more deteriorated glycemic status by using 75-g oral glucose tolerance test findings or , especially , measurement of hemoglobin A(1c ) levels , could enhance the efficacy of lifestyle modifications . TRIAL REGISTRATION umin.ac.jp/ctr Identifier : UMIN000001959"
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OBJECTIVES Generic health status measures such as the short form health survey ( SF-36 ) and EuroQol-5D ( EQ-5D ) are increasingly being used to inform health policy . They are cl aim ed to be applicable across disease areas and have started to be used within mental health research . This review aims to assess the construct validity and responsiveness of four generic health status measures in schizophrenia , including the preference-based SF-6D and EQ-5D . METHOD A systematic review of the literature was undertaken . Ten data bases were search ed from inception to August 2009 and reference lists scrutinized to identify relevant studies . Studies were appraised and data extracted . A narrative synthesis was performed of the evidence on construct validity including known groups validity ( detecting a difference in health-related quality of life ( HRQL ) scores between two different groups such as sample s from the general population and people with schizophrenia ) , convergent validity ( strength of association between generic HRQL and other measures ( e.g. , symptom or functional ) , and responsiveness . Responsiveness was considered by : 1 ) differences in generic HRQL measure scores in responders/non-responders and 2 ) correlation between changes on generic HRQL measures and changes in specific measures obtained from patients and clinicians . RESULTS Thirty-three studies were identified that provided data on the validity and /or responsiveness of the instruments . Most of the evidence concerns the SF-36 and EQ-5D , and for these instruments there was evidence for known group validity . The evidence for convergent validity and responsiveness was mixed , with studies presenting contradictory results . CONCLUSION Although the evidence base is limited in a number of important respects , including problems with the measures used to develop constructs in the validation studies , it is sufficient to raise doubts about the use of generic measures of health like the EQ-5D and SF-36 in patients with schizophrenia | [
"OBJECTIVES Schizophrenia causes significant impairments of quality of life . As treatment approaches have advanced , more attention has been given to re-integrating patients into their psychosocial environments , rather than simply monitoring psychotic symptoms . The development of the second-generation antipsychotics raised hope that these medications would provide better quality of life improvement than conventional antipsychotics . This improvement is particularly relevant early in the course of schizophrenia . METHODS To address these considerations , improvements in measures of general health and social function ( determined using the SF-36 ) were assessed in 195 patients with first-episode schizophrenia for up to one year following r and omization to either olanzapine or haloperidol in a double blind clinical trial . We hypothesized that olanzapine would demonstrate better improvement on these measures than haloperidol . In order to test this hypothesis , we used a repeated measure model with SF-36 scores as the outcome , and treatment group , time , time2 , time-by-treatment group interaction , and time2-by-treatment group interaction as fixed effects . RESULTS Both treatments demonstrated similar changes on the SF-36 . Independent of treatment , patients demonstrated significant improvements in most of the SF-36 subscales , which approached normative scores by the end of one year of treatment . Forty-six of 100 olanzapine-treated patients and 37 of 95 haloperidol-treated patients completed the one year of this study ( p patients with new onset schizophrenic disorders , namely that they can expect to recover significant quality of life and social function at least initially in treatment",
"Background Most tools for estimating utilities use clinical trial data from general health status models , such as the 36-Item Short-Form Health Survey ( SF-36 ) . A disease-specific model may be more appropriate . The objective of this study was to apply a disease-specific utility mapping function for schizophrenia to data from a large , 1-year , open-label study of long-acting risperidone and to compare its performance with an SF-36-based utility mapping function . Methods Patients with schizophrenia or schizoaffective disorder by DSM-IV criteria received 25 , 50 , or 75 mg long-acting risperidone every 2 weeks for 12 months . The Positive and Negative Syndrome Scale ( PANSS ) and SF-36 were used to assess efficacy and health-related quality of life . Movement disorder severity was measured using the Extrapyramidal Symptom Rating Scale ( ESRS ) ; data concerning other common adverse effects ( orthostatic hypotension , weight gain ) were collected . Transforms were applied to estimate utilities . Results A total of 474 patients completed the study . Long-acting risperidone treatment was associated with a utility gain of 0.051 using the disease-specific function . The estimated gain using an SF-36-based mapping function was smaller : 0.0285 . Estimates of gains were only weakly correlated ( r = 0.2 ) . Because of differences in scaling and variance , the requisite sample size for a r and omized trial to confirm observed effects is much smaller for the disease-specific mapping function ( 156 versus 672 total subjects ) . Conclusion Application of a disease-specific mapping function was feasible . Differences in scaling and precision suggest the clinical ly based mapping function has greater power than the SF-36-based measure to detect differences in utility",
"BACKGROUND We investigated the impact of treatment with long-acting , injectable risperidone versus placebo on health-related quality of life ( HRQoL ) in patients with schizophrenia . Results are discussed in the context of HRQoL in the general U.S. population . METHOD Patients with DSM-IV schizophrenia entered a r and omized , double-blind , placebo-controlled trial . After screening , previous antipsychotics were discontinued , and oral risperidone was titrated up to a dose of 4 mg/day over 1 week . Patients were then r and omly assigned to receive placebo [ N = 92 ] or long-acting risperidone ( 25 [ N = 93 ] , 50 [ N = 97 ] , or 75 mg [ N = 87 ] every 2 weeks ) for 12 weeks . HRQoL was measured using the Medical Outcomes Study Short-Form 36-item question naire ( SF-36 ) . RESULTS At week 12 , patients receiving long-acting risperidone had improved significantly ( p domains of the SF-36 ( bodily pain , general health , social functioning , role-emotional , and mental health ) compared with patients receiving placebo . The effect was greatest for the 25-mg group , with significant improvement versus placebo in 6 domains ( p SF-36 domain scores except bodily pain were significantly lower ( p placebo , scores in all 8 domains remained below normal values after 12 weeks , while patients receiving long-acting risperidone showed improvement in HRQoL toward normal levels , with clinical ly meaningful improvements in all mental-health domains . In the 25-mg group , scores in 7 domains were not statistically different from normal values after 12 weeks . CONCLUSIONS Long-acting , injectable risperidone improved HRQoL toward normal levels . After 12 weeks , HRQoL of patients receiving 25 mg was not significantly different from normal",
"Background : Little information is available on the impact of the atypical antipsychotic olanzapine on quality of life ( QOL ) . A 6-week , double-blind r and omized multicenter trial , with a long-term extension , was conducted to evaluate the clinical efficacy and QOL of olanzapine and haloperidol in treating schizophrenia and other psychotic disorders . Methods : A total of 828 out patients provided QOL data . Study patients were aged greater than 18 years with a DSM-III-R diagnosis of schizophrenia , schizophreniform disorder , or schizoaffective disorder and baseline BPRS ( items scored on 0–6 scale ) total scores , ≥18 were r and omized to 6 weeks of treatment with olanzapine 5 to 20 mg/day or haloperidol 5 to 20 mg/day . Patients entered a 46-week double-blind extension if they demonstrated minimal clinical response and were tolerant to study medication . The Quality of Life Scale ( QLS ) and SF-36 Health Survey were used to evaluate QOL . Results : During the 6-week acute phase , olanzapine treatment significantly improved BPRS total ( p = 0.004 ) , PANSS total scores ( p = 0.043 ) , QLS total ( p = 0.005 ) , intrapsychic foundations ( p ) and interpersonal relations scores ( p = 0.036 ) , and SF-36 mental component summary scores ( p compared with haloperidol . During the extension phase , olanzapine treatment significantly improved PANSS negative scores ( p = 0.035 ) and improved QLS total ( p = 0.001 ) , intrapsychic foundations ( p , and instrumental role category scores ( p = 0.015 ) versus haloperidol treatment . Significantly more haloperidol patients discontinued treatment due to adverse events during the acute and extension phases ( p = 0.041 and p = 0.014 , respectively ) . Changes in QLS total and MCS scores were associated with changes in clinical symptoms , depression scores and extrapyramidal symptoms . Conclusions : Olanzapine was more effective than haloperidol in reducing severity of psychopathology and in improving QOL in patients with schizophrenia and other psychotic disorders . The QOL benefits of olanzapine , although modest , may be important for long-term treatment",
"It has often been postulated that simple , short question naires are unable to reflect complex changes in well-being of individuals with chronic psychiatric disorders . To investigate these assumptions we included two recently developed instruments to measure quality of life ( the WHOQoL-Bref and the EuroQoL EQ-5D ) in a r and omised control trial ( RCT ) in which two treatment conditions were compared . Aims of the study were to assess the sensitivity and validity of these quality of life (QoL)-instruments , to establish their relationship and to examine the predictors of changes in QoL. Subjective changes in QoL were measured on three assessment s waves in a period of 18 months and compared to objective changes in psychopathology and social functioning in a sample of 76 chronic schizophrenic patients who participated in the RCT . Results indicated that both WHOQoL-Bref and EuroQoL EQ-5D are capable of detecting changes in QoL over time in physical and psychological well-being . The instruments partly measure the same aspects of QoL , indicated by 50 % common variance on total scores . Reduction of positive psychotic symptoms appeared to be the most important factor in improving QoL. The weighted TTO-score of EuroQoL-5D , which is often used as an index in economic evaluations of health care , did however not correspond with these changes , which indicates that it is less sensitive to changes in social and psychological well-being . It ’s use as the core measure in ( economic ) health evaluation in the field of psychiatry therefore seems less appropriate",
"OBJECTIVE To examine treatment-specific changes in health-related quality of life ( QOL ) among patients with schizophrenia and to assess the association between clinical and QOL improvement . METHOD This post hoc analysis used the findings of a 28-week , r and omized , multicenter trial of patients with schizophrenia ( DSM-IV ) treated with olanzapine ( 10 - 20 mg/day ) or ziprasidone ( 80 - 160 mg/day ) . Data were collected from August 2001 to December 2002 . Efficacy was measured using the Positive and Negative Syndrome Scale ( PANSS ) . Quality of life was assessed with the generic health self-administered Medical Outcomes Study Short-Form 36-Item Health Survey ( SF-36 ) and the disease-specific expert-administered Heinrichs-Carpenter Quality of Life Scale ( QLS ) . Mixed-effects-repeated- measures and last-observation-carried-forward approaches were used to assess the effects of treatment on QOL and the association of clinical outcomes to QOL outcomes . RESULTS Olanzapine- and ziprasidone-treated patients demonstrated similar improvement from baseline to endpoint on the SF-36 and QLS . All correlations between changes in PANSS scores and the SF-36 were significant ( p changes in PANSS scores and the QLS were significant ( p the 2 QOL measures were generally significant but small to moderate in magnitude . CONCLUSIONS The results of this study indicate that , in patients with schizophrenia , olanzapine and ziprasidone treatment are associated with significant QOL and clinical improvements . Further , the significant correlation between change scores on the PANSS and QOL measures suggests that treatment-related clinical improvements are associated with improved health-related and disease-specific QOL . CLINICAL TRIALS REGISTRATION Clinical Study Results .org identifier 2347",
"We developed a self-administered instrument to assess health-related quality of life ( HRQL ) among people with schizophrenia . The S-QoL , based on Calman 's approach to the subject 's point of view , is a multidimensional instrument that is sensitive to change . The scale is a 41-item question naire with eight subscales ( psychological well-being , self-esteem , family relationships , relationships with friends , resilience , physical well-being , autonomy and sentimental life ) and a total score . In-depth interviews with patients determined the pertinent issues for item development . The validation study , performed with 207 patients , showed high internal consistency reliability , reproducibility and responsiveness . Construct validity was confirmed using established clinical and HRQL measures . S-QoL covers domains that differ from areas tapped in other measures , with greater responsiveness . The S-QoL is an efficient instrument for the measurement of the impact of schizophrenia on individuals ' lives",
"OBJECTIVE The main objective of the study was to estimate a preference-based Short Form (SF)-6D index from the SF-36 for Japan and compare it with the UK results . STUDY DESIGN AND SETTING The SF-6D was translated into Japanese . Two hundred and forty-nine health states defined by this version of the SF-6D were then valued by a representative sample of 600 members of the Japanese general population using st and ard gamble ( SG ) . These health-state values were modeled using classical parametric r and om-effect methods with individual-level data and ordinary least squares ( OLS ) on mean health-state values , together with a new nonparametric approach using Bayesian methods of estimation . RESULTS All parametric models estimated on Japanese data were found to perform less well than their UK counterparts in terms of poorer goodness of fit , more inconsistencies , larger prediction errors and bias , and evidence of systematic bias in the predictions . Nonparametric models produce a substantial improvement in out-of- sample predictions . The physical , role , and social dimensions have relatively larger decrements than pain and mental health compared with those in the United Kingdom . CONCLUSION The differences between Japanese and UK valuations of the SF-6D make it important to use the Japanese valuation data set estimated using the nonparametric Bayesian technique presented in this article",
"OBJECTIVES The authors test the reliability and validity of the Medical Outcomes Study Short Form 36-Item Health Survey ( SF-36 ) as a written , self-administered survey in out patients with chronic schizophrenia . METHODS Thirty-six schizophrenic out patients completed a written and oral form of the SF-36 . A psychiatrist rated the patients using the Brief Psychiatric Rating Scale to determine severity of psychopathology . Cognitive functioning and academic achievement were also assessed . Internal consistency , test-retest reliability , concurrent and discriminative validity of the oral and written versions were determined . RESULTS The SF-36 in both forms was shown to have good internal consistency , stability , and concurrent validity . The mental health SF-36 subscales had poor discriminant validity , compared with the physical functioning scale that demonstrated good discriminant validity . CONCLUSIONS The validity of using the written form of the SF-36 on a sample of patients with chronic mental illness was demonstrated . The SF-36 appears to be an appropriate outcome measure for changes in physical and role functioning in consumers of outpatient mental health programs",
"BACKGROUND Prospect i ve outcome studies based on a community sample of mostly neuroleptic naive cases of schizophrenia are uncommon . OBJECTIVES To describe short-term symptomatic and functional outcomes of schizophrenia , and potential predictors of outcome . METHODS After a baseline assessment , 63 incident and 208 prevalent cases of schizophrenia were followed by a yearly clinical assessment for an average of 2.5 ( range 1 - 4 ) years . Scores of negative symptoms and positive symptoms were used as indicators of symptomatic outcomes . SF-36 scores of physical and social functioning , and role limitation due to mental health problems were used as indicators of functional outcomes . Several variables were evaluated as potential predictors of outcome in r and om coefficient models . RESULTS Functioning and other measures of health related quality of life were significantly diminished in cases as compared to the general population of the area at baseline and follow up . Of the socio-demographic and clinical factors evaluated , only lower negative and positive symptom scores were significantly associated with improvements in functioning . The level of functioning observed in cases from Butajira was lower than that reported for cases from developed countries . CONCLUSIONS Our findings are not in accord with other outcome studies that have reported better functional outcome for cases of schizophrenia from developing countries ",
"OBJECTIVE Time to all-cause treatment discontinuation is considered a composite proxy measure of treatment efficacy , safety , and tolerability . Longer time to discontinuation of antipsychotic medication for any cause has been shown to be associated with greater symptom improvements in the treatment of schizophrenia . This study examines whether longer time to all-cause medication discontinuation is also linked to better functional outcomes . METHOD Using pooled data from 4 r and omized , double-blind antipsychotic trials of 24- to 28-weeks ' duration , this study examined the association between time to all-cause treatment discontinuation and functional outcomes , as assessed by a disease-specific , clinician-rated measure ( Quality of Life Scale [ QLS ] ) and a generic , patient-reported measure ( Medical Outcomes Study Short Form 36 [ SF-36 ] ) . Patients in these trials had a DSM-IV diagnosis of schizophrenia , schizophreniform disorder , or schizoaffective disorder . This post hoc analysis used Pearson partial correlations to assess relationships between time to treatment discontinuation and changes in functional scores , adjusting for baseline scores . Repeated measures analyses were also conducted to compare post-baseline functional outcome change over time between completers and noncompleters . RESULTS Longer time to all-cause treatment discontinuation was found to be significantly associated with greater improvements in all assessed functional domains ( p Patients who completed their respective trials ( 46.8 % , 761/1627 ) experienced significantly greater improvement in functional outcome measures ( in 4 QLS domains and SF-36 mental health component summary score ; all , p greater symptom improvement was significantly associated with greater functional improvements in assessed domains . CONCLUSIONS Findings from this post hoc analysis illustrate the importance of longer treatment duration with antipsychotics for improving functional outcomes in the treatment of patients with schizophrenia",
"UNLABELLED Schizophrenia leads to impairments in mental , social , and physical functioning , which should be included in evaluations of treatment . OBJECTIVES This study was design ed to determine the reliability and validity of the Medical Outcomes Study Short Form Health Survey ( SF-36 ) for schizophrenic patients , to characterize perceived functioning and well being and to compare short-term change in SF-36 scores for patients treated with olanzapine or haloperidol . RESEARCH DESIGN Data were obtained from a r and omized , double-blind trial comparing these agents for safety , efficacy , and cost effectiveness . A 6-week acute treatment portion preceded a 46-week \" responder extension \" phase . SUBJECTS A sub sample ( n = 1,155 ) completing a pre-treatment SF-36 provided data for this study . MEASURES Psychometric analyses were conducted , and perceived level of functioning was compared with that for the US adult population . Change from baseline to 6 weeks was examined by treatment group . RESULTS Clear evidence was obtained for the instrument 's reliability and validity for these patients . There were marked deficits in General health , Vitality , Mental health , Social functioning , and in Role limitations result ing from both physical and emotional problems . Olanzapine-treated patients improved in 5 of 8 domains to a significantly greater degree than did haloperidol patients . CONCLUSIONS The SF-36 can be a reliable and valid measure of perceived functioning and well being for schizophrenic patients . The perceptions of functioning can be valuable indices of disease burden and can help to demonstrate the effectiveness of newer antipsychotic medications such as olanzapine"
] | 41167af4-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND The treatment and prevention of hypertrophic scars and keloids represents a special challenge particularly in plastic surgery . Given their simple , non-invasive and painless application , topical preparations are an attractive therapeutic option . On the part of the patients , the efficacy in prevention of and therapy for hypertrophic scars and keloids of these topical preparations is regularly question ed . The clarification of this issue is subject of this review . MATERIAL AND METHODS A systematic literature research on the data bases Medline , Medline Plus , Old medline and Cochrane Library was conducted . All r and omised controlled trials , meta-analyses , systematic review s , case series and case studies from the German and English literature , dealing with topical preparations approved in the German speaking area , were included . RESULTS In this research , 14 topical preparations were identified . However , there is limited data regarding their efficacy as compared to each other , to other treatment options or untreated controls . Only for 6 topical preparations studies with high evidence level exist . Contractubex showed best results in the prevention of pathological scars . CONCLUSION Even though Contractubex shows preventive effects and can be recommended based on current data , further studies are needed to strengthen the body of evidence and to prove the therapeutic efficacy of topical preparations in general | [
"BACKGROUND Ointments ( e.g. , petrolatum ) are thought to be occlusive , thereby blocking transcutaneous water loss and trapping water under the skin 's surface . If this premise is correct , then petrolatum should delay barrier recovery after barrier perturbation , as shown previously in occluded murine skin . OBJECTIVE We reexamined the assumption that Vaseline Petroleum Jelly ( VPJ ) is occlusive , ascertaining both its site and mechanism of action . METHODS Barrier recovery was measured in VPJ-treated versus untreated sites after acetone-induced barrier disruption in human volunteers . Moreover , VPJ was localized within the stratum corneum ( SC ) with tracers and ruthenium tetroxide staining , which allowed visualization of the depth of VPJ penetration and its relation to intercellular membrane structures . RESULTS VPJ accelerated , rather than impeded , barrier recovery . Moreover , VPJ was present within the interstices at all levels of the SC , where it replaced intercellular bilayers . CONCLUSION VPJ neither forms nor acts like an epicutaneous impermeable membrane ; instead , it permeates throughout the SC interstices , allowing normal barrier recovery despite its occlusive properties",
"PURPOSE To evaluate and characterize the wound healing process profile induced by allantoin incorporated in soft lotion oil/water emulsion using the planimetric and histological methods . METHODS Female Wistar rats ( n=60 ) were r and omly assigned to 3 experimental groups : ( C ) control group-without treatment ; ( E ) group treated with soft lotion O/W emulsion excipients ; ( EA ) group treated with soft lotion O/W emulsion containing allantoin 5 % . The emulsions either containing or not allantoin were topically administered for 14 days and the wound area was evaluated by planimetry and by qualitative and quantitative histological analysis of open wound model . RESULTS The data which were obtained and analyzed innovate by demonstrating , qualitatively and quantitatively , by histological analysis , the profile of healing process induced by allantoin . The results suggest that the wound healing mechanism induced by allantoin occurs via the regulation of inflammatory response and stimulus to fibroblastic proliferation and extracellular matrix synthesis . CONCLUSION This work show , for the first time , the histological wound healing profile induced by allantoin in rats and demonstrated that it is able to ameliorate and fasten the reestablishment of the normal skin",
"During a ten year observation period it was found that scar formation after thoracic surgery is influenced by various factors : metabolism , operative technique and factors of a general nature . On the basis of these findings , a study was carried out to investigate the effect of the scar-specific Contractubex gel ( Merz+Co . , D-Frankfurt/Main ) , containing 10 % onion extract , 50 U sodium heparin per g of gel and 1 % allantoin , in the treatment of children who underwent thoracic surgery and to evaluate its effect on scar development . Before and during the six-month treatment period , both macromorphology and scar colour were assessed ; furthermore , a global evaluation of the therapeutic result was made . Additionally , the scars were characterized after a six-month treatment-free follow-up period . The results of 38 Contractubex-treated and 27 untreated patients were compared . In the treated scars , the global evaluation of the therapeutic result was better than in the untreated scars . In the Contractubex group , the rating was \" good \" and \" very good \" in 84 % of cases , as compared to 59 % of the untreated cases . In the treated group , the increase in scar size was markedly lower than in the untreated patients . The treated scars showed a tendency towards quicker paling than the untreated scars . In the treated group , the conversion of primary physiological scars to unphysiological scars ( hypertrophic or keloidal scars ) was less frequent than in the untreated group . The tolerability of the product was very good in 37 of the 38 treated patients , and good in one patient . All scar-specific effects of Contractubex continued to persist after the end of treatment",
"BACKGROUND Onion extract gel ( OE ) and 0.5 % hydrocortisone , silicone and vitamin E lotion ( HSE ) are two over-the-counter preparations used to enhance the cosmesis of keloids and hypertrophic scars . OBJECTIVE To determine the tolerability and efficacy of OE versus HSE versus placebo in subjects with keloids and hypertrophic scars . METHODS Thirty subjects ( > or = 18 years ) with keloids or hypertrophic scars were r and omly assigned to one of three study preparations for 16 weeks . Scar volume was measured at baseline and weeks 4 , 8 , 12 and 16 . Subjects and blinded investigators assessed scar parameters ( in duration , erythema , pigmentation alteration , pain , itching , tenderness and cosmetic appearance ) and patient satisfaction at each visit using a visual analog scale ( VAS ) . Data analysis included : mean percentage change ( MPC ) for subjects completing the study ( n = 15 ) ; the mixed model test to determine differences between the groups over time ; and the Kruskal-Wallis test for the analysis of differences in subjects ' satisfaction within the three groups over 16 weeks for subjects who completed at least one follow-up visit ( n = 21 ) . RESULTS All three preparations were well tolerated with the exception of a mild acneiform-like eruption in one OE patient . Significant improvements were obtained with OE in volume , length , width and in duration and with HSE in volume , length , in duration , erythema and pigmentation alteration . There was a trend showing that a higher percentage of subjects were satisfied with OE than with HSE or placebo . The Mix Model Analysis ( MMA ) showed significant improvements with OE over placebo in investigator cosmetic assessment , lesion in duration , pigmentation and tenderness and with HSE over placebo in investigator cosmetic assessment , lesion in duration , pigmentation and erythema . Improvements in erythema and pigmentation were significantly greater in HSE than in OE . CONCLUSION Both OE and HSE were more effective than placebo in the management of hypertrophic scars and keloids",
"BACKGROUND Cutaneous scars result ing from surgical procedures can be erythematous , hypertrophic , pruritic , painful , or cosmetically unacceptable . An onion extract-based topical gel ( Mederma , Merz Pharmaceuticals ) has been marketed as a product to improve scar appearance and texture . However , few data are available to substantiate these cl aims . OBJECTIVE To compare the efficacy between the onion extract gel and a petrolatum-based emollient ( Aquaphor , Beiersdorf , Inc. ) in improving the appearance and symptoms of new surgical scars . METHODS Twenty-four patients with new surgical wounds at least 4 cm in length were enrolled in the study . Using a r and omized , double-blinded , split-scar study design , each scar was divided into two equal portions , and each half was assigned treatment with either onion extract gel or petrolatum ointment at the time of suture removal . Each product was applied three times daily for 8 weeks , and patients were evaluated at 2 , 8 , and 12 weeks following initiation of treatment . A follow-up phone interview was conducted at least 11 months postoperatively . RESULTS Scar halves were evaluated by blinded investigators for overall cosmetic appearance , erythema , and hypertrophy . Patients also independently rated side-specific erythema , pruritus , burning , and pain . Using the paired t-test and the Wilcoxon sign-rank test , we found no statistically significant difference ( p Petrolatum-based topical agents constitute st and ard therapy in the management of postoperative wounds . In this side-by-side , r and omized , double-blinded , split-scar study , the onion extract gel did not improve scar cosmesis or symptomatology when compared with a petrolatum-based ointment",
"Background We conducted an experimental study to compare the effect of massage using topical agents ( Kelo-cote or Contractubex ) on scar formation by massaging the healed burn wound on the dorsal area of Sprague-Dawley ( SD ) rats . Methods Four areas of second degree contact burn were made on the dorsal area of each of 15 SD rats , using a soldering iron 15 mm in diameter . After gross epithelialization in the defect , 15 SD rats were r and omly divided into four groups : the Kelo-cote group , Contractubex group , Vaseline group , and control group . Rats in three of the groups ( all but the Control group ) were massaged twice per day for 5 minutes each day , while those in the Control group were left unattended . For histologic analysis , we performed a biopsy and evaluated the thickness of scar tissue . Results In the Kelo-cote and Contractubex groups , scar tissue thicknesses showed a significant decrease , compared with the Vaseline and control groups . However , no significant differences were observed between the Kelo-cote and Contractubex groups . In the Vaseline group , scar tissue thicknesses showed a significant decrease , compared with the control groups . Conclusions The findings of this study suggest that massage using a topical agent is helpful in the prevention of scar formation and that massage only with lubricant ( no use of a topical agent ) also has a considerable effect , although not as much as the use of a topical agent . Thus , we recommend massage with a topical agent on the post-burn scar as an effective method for decreasing the scar thickness",
"OBJECTIVE : After burn injuries , scarred skin lacks elasticity , especially in hypertrophic scars . Topical treatment with tretinoin can improve the appearance and quality of the skin ( i.e. , texture , distensibility , color , and hydration ) . The objective of this prospect i ve study was to examine the effects of treatment with 0.05 % tretinoin for one year on the biomechanical behavior and histological changes undergone by facial skin with post-burn scarring . Setting : Tertiary , Institutional . METHOD : Fifteen female patients who had suffered partial thickness burns with more than two years of evolution were selected . Skin biopsies were obtained initially and after one year of treatment . The resistance and elastance of these skin biopsies were measured using a mechanical oscillation analysis system . The density of collagen fibers , elastic fibers , and versican were determined using immunohistochemical analysis . RESULTS : Tretinoin treatment significantly lowered skin resistance and elastance , which is a result that indicates higher distensibility of the skin . However , tretinoin treatment did not significantly affect the density of collagen fibers , elastic fibers , or versican . CONCLUSION : Topical tretinoin treatment alters the mechanical behavior of post-burn scarred skin by improving its distensibility and thus leads to improved quality of life for patients",
"OBJECTIVES To investigate the safety and efficacy of Contractubex administration to hypertrophic scars in routine out-patient practice and to compare it to corticosteroid treatment . PATIENTS AND METHODS This was a multicenter , retrospective cohort study , based on 38 r and omly selected practice s representatively distributed in Germany , including dermatologists and general practitioners . Data from 859 patients fulfilling the inclusion criteria were assessed and analyzed . Of these , 771 patients were eligible for the per protocol treatment with Contractubex ( n=555 ) and corticosteroid ( n=216 ) . The safety and efficacy of local administration of Contractubex to hypertrophic scars was compared to corticosteroid treatment . RESULTS At the end of defined treatment periods ( minimum 28 days for local therapy with 1 intralesional corticosteroid application ) , normalization of the pre-treatment pathological parameters ( erythema , pruritus , consistency ) of hypertrophic scars was more frequent ( 42.5 % ) after Contractubex per protocol treatment as compared to corticosteroid per protocol treatment ( 22.2 % ) . After adjusting imbalances of baseline characterisics between the treatment groups by the propensity score , the odds ratio was 2.274 , demonstrating a significant superiority ( p Contractubex treatment as compared to corticosteroid treatment . The time to normalization of erythema , pruritus and consistency was significantly ( p=0.034 ) shorter with Contractubex treatment ( median 344 days ) than with corticosteroids ( median 507 days ) . No unexpected or severe adverse events occurred in the Contractubex-treated patients . Apart from moderate pruritus ( 10 % Contractubex vs. 1 % corticosteroids ) , adverse events were significantly ( p corticosteroid-treated patients ( teleangiectasias 15 % vs. 7 % Contractubex ; cutaneous atrophy of scars 10 % vs. 2 % Contractubex ; cutaneous atrophy of scar surrounding skin tissue 11 % vs. 1 % Contractubex ) . CONCLUSION For the primary aim of this study ( assessment of normalization of erythema , pruritus , and consistency of hypertrophic scars ) and for time to normalization , local administration of Contractubex was significantly more effective than corticosteroid treatment . Concerning safety , Contractubex treatment was associated with significantly less adverse events ( e.g. teleangiectasias , cutaneous atrophy of scars and surrounding skin tissue ) than topical corticosteroid application",
"To date , few studies have compared the effectiveness of topical silicone gels versus that of silicone gel sheets in preventing scars . In this prospect i ve study , we compared the efficacy and the convenience of use of the 2 products . We enrolled 30 patients who had undergone a surgical procedure 2 weeks to 3 months before joining the study . These participants were r and omly assigned to 2 treatment arms : one for treatment with a silicone gel sheet , and the other for treatment with a topical silicone gel . Vancouver Scar Scale ( VSS ) scores were obtained for all patients ; in addition , participants completed scoring patient question naires 1 and 3 months after treatment onset . Our results reveal not only that no significant difference in efficacy exists between the 2 products but also that topical silicone gels are more convenient to use . While previous studies have advocated for silicone gel sheets as first-line therapies in postoperative scar management , we maintain that similar effects can be expected with topical silicone gel . The authors recommend that , when clinicians have a choice of silicone-based products for scar prevention , they should focus on each patient 's scar location , lifestyle , and willingness to undergo scar prevention treatment . Graphical",
"BACKGROUND Post surgical scars can be erythematous , raised , pruritic and painful . Numerous modalities are available to improve the appearance and symptomatology of these scars . A topical onion gel extract is the newest in the armamentarium of scar treatments . The active ingredient in this gel is allium cepa . Published studies evaluating the usefulness of this gel in the treatment of scars are not available . OBJECTIVE To evaluate the effectiveness of topical onion gel extract in improving the appearance and symptomatology of postsurgical scars and to compare the results of its use to those of a topical emollient ointment . METHODS Seventeen patients with surgical scars result ing from Mohs surgery were assigned to 1 of 2 groups on the day of suture removal . Each group applied a design ated topical product 3 times a day for 1 month . Photographic documentation and question naires using a visual analog scale were completed for each scar enrolled in the study . RESULTS Using the Fischer 's exact test , no statistically significant difference between pre- and posttreatment evaluations of scar erythema and pruritus in patients using topical onion extract gel was found . A statistically significant reduction in scar erythema was found in patients using a petrolatum based ointment . CONCLUSIONS Scar hydration is an important factor in wound healing and can be achieved with topical petrolatum-based ointment . Topical onion gel extract was ineffective in improving scar erythema and pruritus in our patients",
"Background Many clinical studies on scar therapy are reported in the literature , but only silicone gel sheeting and corticosteroid injections are supported by accurate prospect i ve controlled studies . This prospect i ve multicenter cross-over phase 2 study tested the effectiveness of a topical cyanoacrylate compared with silicone gel in improving postsurgical scars Methods Patients presenting with symmetric breast scars after augmentation or reduction mammaplasty were enrolled in the study . From the same day as stitch removal , the cyanoacrylate was applied on one side every 3 to 5 days and the silicone gel on the other side twice a day for 3 months . Assessment s of patients and external observers using a visual analog scale were recorded at scheduled visits during 1 year , and scars were photographed . Objective evaluations included measurements of scar width , length , and elevation . The statistical significance of objective parameter modifications was analyzed using the Wilcoxon test Results Positive effects of both tested products were observed during the scar maturation process , and final scars of good quality were achieved without any major adverse effect . The topical cyanoacrylate proved to be more efficacious in preventing scar widening , and this result was statistically significant Conclusions The tested topical cyanoacrylate had a positive effect on the scar maturation process at least comparable with that of topical silicone gel",
"Background Dermatix is a Food and Drug Administration ( FDA ) -registered substantial equivalent to silicone gel sheeting for the prevention and management of hypertrophic scars and keloids . Methods A 90-day prospect i ve study evaluated the efficacy of Dermatix , silicone gel sheeting , and a combination of these treatments in improving scars for 30 patients . Each patient had a bilateral scar that served as an untreated control . The outcome measures included profilometry analysis of scar topography before and after punch biopsies of the control and treated scars , symptoms associated with the scars , and patient evaluations of the ease of treatment . Results The results showed better resolution and improvement of scars with Dermatix treatment or the combined use of Dermatix and silicone gel sheeting than with silicone gel sheeting alone . Wound erythema was reduced , and collagen architectural reorientation was demonstrated histologically . Patients rated Dermatix as easier to use than silicone gel sheeting . Both Dermatix and silicone gel sheeting reduced symptoms of itching , irritation , and skin maceration . Conclusion The results of this study indicate that Dermatix is a useful treatment for the management of abnormal scarring",
"Use of silicone derivative and onion extract had been reported in the prevention of hypertrophic scarring . Our experience showed the preventive use of silicone derivative plus onion extract gel on hypertrophic scars after median sternotomy . In a r and omized , double blinded , placebo-controlled study , 60 patients after median sternotomy incisions were separated into two groups . All patients were treated either with silicone derivative plus onion extract gel ( Cybele ( ® ) scagel ) or placebo gel twice daily for a total treatment period of 12 weeks . During each visit , pain and itching scores were grade d by the patients and scar characteristics were observed by surgeons using the Vancouver scar scale . Pain and itch score values from patients ' who applied silicone derivative plus onion extract gel was less than another group ( P . Pigmentation was significantly different between two groups ( P reduction of scores on vascularity , pliability , height in treated group was not superior to the untreated group . No adverse events were reported by any of the patients . A silicone derivative plus onion extract gel is safe and effective for the preventing the hypertrophic scarring after median sternotomy",
"BACKGROUND With rapid advancement in cutaneous laser therapy , Q-switched lasers have become the st and ard treatment for tattoo removal . The longer wavelength Q-switched Nd : YAG laser is used when removing tattoos in darker skin patients to avoid scarring and permanent pigment changes . Nevertheless , the local experience revealed that nearly 25 % of the Chinese patients developed scarring . Meanwhile , multiple clinical studies have shown that Contractubex gel ( Merz Pharma , Frankfurt , Germany ) was effective in the treatment and prevention of hypertrophic scars and keloids . OBJECTIVE To evaluate the efficacy of Contractubex gel in the prevention of scarring after laser removal of tattoos in Chinese patients . METHODS A total of 120 Chinese patients with 144 professional blue-black tattoos were recruited into the study . They were r and omly assigned into the Contractubex group or the control group . All patients were treated with a QS 1,064-nm Nd : YAG laser using a 3-mm spot size , a 10-Hz repeat rate , a pulse duration of 6 nanoseconds , and fluences that ranged from 3.6 to 4.8 J/cm2 ( mean fluence , 4.2 J/cm2 ) . The treated areas were assessed 3 months after the last treatments for clinical clearance and complications . RESULTS Fifty-two patients with 61 tattoos in the Contractubex group were able to achieve a mean clearing rate of 82.3±11.6 % . There were 7 tattoos in 7 patients that developed scarring , 4 patients had permanent hypopigmentation , and 3 patients had transient hyperpigmentation . In contrast , 55 patients with 68 tattoos in the control group had a mean clearing rate of 80.4±11.3 % . Among them , 16 tattoos in 14 patients developed scarring , 4 patients had permanent hypopigmentation , and 5 patients had transient hyperpigmentation . Although there was no significant difference in age , sex , fluence , treatment session , and clinical clearance between the two groups , the Contractubex group had a statistically significantly lower rate of scarring than the control group ( p Chinese patients having laser removal of tattoos",
"Scar development was investigated in 45 young patients who had undergone thoracic surgery . Patients were r and omly assigned either to a group which was treated topically with Contractubex gel ( Merz + Co. , D-Frankfurt/Main ) , containing 10 % onion extract , 50/U of sodium heparin per one g of gel and 1 % allantoin , or to a group receiving no treatment . The treatment began on average 26 days after the operation and was continued for one year . The scars of all treated and untreated patients were evaluated at monthly intervals . The appearance of the scar , including scar type and scar size as well as scar colour , was assessed by the physician . A reduction of the increase of scar width was seen in the Contractubex-treated group as compared with the untreated group . Further , physiological scars and skin-coloured scars were more frequent in the treated group than in the untreated group . Hypertrophic or keloidal scars were less frequent in the treated group . No differences in scar length and scar height were seen . At the end of the observation period , the clinical course of scar development was rated as \" very good \" or \" good \" in more than 90 % of the treated patients , \" good \" in less than 40 % and \" moderate \" or \" bad \" in more than 60 % of the untreated cases . The tolerability of the drug was \" good \" or \" very good \" in all cases . In conclusion , Contractubex gel is useful in scar treatment after thoracic surgery",
"We compared the efficacy of silicone gel ( Scarfade ) , silicone gel sheet ( Epi-Derm ) , and topical onion extract including heparin and allantoin ( Contractubex ) for the treatment of hypertrophic scars . Forty-five postburn scars were included in the study . Patients with scars less than 6 months from injury were assigned at r and om to three groups each containing 15 scars , and their treatment was continued for 6 months . Scars were treated with Scarfade , Epiderm and Contractubex . Scar assessment was performed at the beginning of the treatment , and at the end of the sixth month when the treatment was completed by using the Vancouver scar scale . The difference between before and after treatment scores for each three groups was statistically significant . The difference between Scarfade group and Epi-Derm group was not significant ; however , the differences of the other groups ( Scarfade-Contractubex , Epiderm-Contractubex ) were significant . Silicone products , either in gel or sheet , are superior to Contractubex in the treatment of the hypertrophic scar . The therapist should select the most appropriate agent according to the patient 's need and guidelines of these signs",
"OBJECTIVE To evaluate the therapeutic activity of topical onion extract in gel form on hypertrophic and keloid scars , focusing on problems such as elevation , redness , hardness , itching and pain . METHOD This comparative prospect i ve study assigned 60 patients to three groups . Group I was treated with onion extract alone , group 2 with silicon gel sheet alone and 3 group with a combination of onion extract and silicon gel sheet . RESULTS In the group comparisons , a significant difference was observed at the end of six months in the colour parameter between group I and group 2 and in the height parameter between group I and group 3 ( ANOVA post-hoc Tukey 's test , p onion extract was more effective in relation to scar colour , while the silicon gel sheet was superior in decreasing the height of scar ( paired sample t-test , p silicon gel sheet treatment was combined with onion extract in group 3 . CONCLUSION Onion extract improved hypertrophic and keloids scars via multiple mechanisms . However , it was statistically ineffective in improving scar height and itching . For this reason , onion extract therapy should be used in combination with an occlusive silicon dressing to achieve a satisfying decrease in scar height",
"Background It has been reported that topical application of imiquimod 5 % cream induces interferon-α , an antifibrotic cytokine . Objective To determine the tolerability and effectiveness on the cosmetic outcome of the application of imiquimod to postsurgical excision sites . Material s and Methods A prospect i ve , double-blinded , r and omized , vehicle-controlled trial was conducted among 20 patients with two skin lesions clinical ly diagnosed as melanocytic nevi . Imiquimod 5 % cream was applied to one of the sutured surgical wounds starting the night of the excision nightly for a period of 4 weeks . The second sutured excision site was treated with vehicle cream . Scar cosmesis , erythema , pigmentary alterations , in duration , tenderness , and pain were assessed using a visual analogue scale 2 , 4 , and 8 weeks after surgery . Results Eighteen subjects completed the study , with a total of 36 excision sites ; no wound site dehisced , and no signs of infection were noted . Surgical wounds treated with imiquimod had more erythema , pigmentary alterations , and lower cosmesis rated by the investigator compared with wounds treated with placebo , both becoming nonsignificant in further evaluations . For pigmentary alterations , in duration , and cosmesis rated by the patients , no statistically significant difference between treatment groups was observed at week 8 . Conclusion Treatment of surgical excision-site wounds with imiquimod was well tolerated and without serious adverse events . Evaluations for cosmesis of placebo-treated surgical sites were better than imiquimod-treated sites at week 8 , becoming nonsignificant later",
" In 31 patients with hypertrophic scars or keloids , a side by side test was carried out to check the efficacy of an occlusive dressing technique using cream which did not contain silicone oil , versus a simple application of vaseline , used as a control . In all cases , the cream treated areas of scar and keloid demonstrated a remarkable improvement over that of the vaseline treated area . These findings strongly suggest that the mechanisms of hydration and occlusion are the main basis of the therapeutic action of this method in treating hypertrophic scars and keloids",
"BACKGROUND The treatment of earlobe keloids has historically been suboptimal ; characterized by discomfort , poor response , and high rates of recurrence . Keloids are characterized by increased fibroblast activity in the setting of an altered cytokine profile . OBJECTIVE To investigate whether topical imiquimod 5 % cream applied postoperatively after tangential excision can prevent recurrence of earlobe keloids . METHODS AND MATERIAL S Four patients with a total of eight large pedunculated earlobe keloids ( five of which were recurrent lesions ) were treated with debulking by tangential shave excision followed by daily application of imiquimod 5 % cream for 6 weeks . RESULTS At 6 and 12 months post-treatment there was an excellent cosmetic result and no evidence of recurrence in any of the lesions . Patients with keloids that were itchy and painful were completely asymptomatic at the conclusion of the study . CONCLUSION In this pilot study , imiquimod 5 % cream following tangential shave excision was efficacious for the treatment of earlobe keloids . Further study is warranted to confirm the utility of imiquimod 5 % cream in the treatment of earlobe keloids , as illustrated herein"
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OBJECTIVES To systematic ally review the measurement properties of performance-based measures to assess physical function in people with hip and /or knee osteoarthritis ( OA ) . METHODS Electronic search es were performed in MEDLINE , CINAHL , Embase , and PsycINFO up to the end of June 2012 . Two review ers independently rated measurement properties using the consensus-based st and ards for the selection of health status measurement instrument ( COSMIN ) . " Best evidence synthesis " was made using COSMIN outcomes and the quality of findings . RESULTS Twenty-four out of 1792 publications were eligible for inclusion . Twenty-one performance-based measures were evaluated including 15 single-activity measures and six multi-activity measures . Measurement properties evaluated included internal consistency ( three measures ) , reliability ( 16 measures ) , measurement error ( 14 measures ) , validity ( nine measures ) , responsiveness ( 12 measures ) and interpretability ( three measures ) . A positive rating was given to only 16 % of possible measurement ratings . Evidence for the majority of measurement properties of tests reported in the review has yet to be determined . On balance of the limited evidence , the 40 m self-paced test was the best rated walk test , the 30 s-chair st and test and timed up and go test were the best rated sit to st and tests , and the Stratford battery , Physical Activity Restrictions and Functional Assessment System were the best rated multi-activity measures . CONCLUSION Further good quality research investigating measurement properties of performance measures , including responsiveness and interpretability in people with hip and /or knee OA , is needed . Consensus on which combination of measures will best assess physical function in people with hip/ and or knee OA is urgently required | [
"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",
"OBJECTIVES The aggregated locomotor function ( ALF ) score , a simple measure of observed locomotor function , using timed walking , stairs and transfers , was developed and evaluated for intra-tester reliability , criterion-related validity and responsiveness in a sample of patients with knee osteoarthritis . METHODS Patients with knee osteoarthritis ( n = 214 ) were recruited for inclusion in a r and omized controlled trial investigating two methods of exercise provision . Before treatment , patients completed the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) and Short Form 36 health survey ( SF-36 ) question naires and were timed whilst performing an 8 m walk , ascending and descending a set of gymnasium stairs and completing a test of transferring in and out of a chair . A group of 15 patients also undertook a replicate test-retest reliability study of the above outcome measures . St and ardized response means were calculated for the ALF , WOMAC and SF-36 from data from the clinical trial . RESULTS The ALF takes 10 min to administer and demonstrated excellent intra-tester reliability , with excellent intra-class correlation coefficient ( ICC ) statistics ( ICC(2,k ) 0.99 ; 95 % CI 0.98 - 0.99 ) , and low st and ard error of measurement ( 0.86 s ) and smallest detectable difference ( 9.5 % ) values . Criterion-related validity with the physical function dimensions of the WOMAC and SF-36 was good , with correlation coefficients of 0.59 and - 0.53 respectively . St and ardized response means were higher for the ALF ( 0.49 ) than for both the WOMAC ( 0.39 ) and the SF-36 ( 0.12 ) . CONCLUSIONS This work has demonstrated that the ALF can be used as a measure of physical function status and as a means of quantifying treatment response . The measure offers a simple and convenient outcome in the assessment and treatment of locomotor dysfunction . The ALF score is a reliable , valid and responsive outcome measure over 12 months and can be recommended for use in the evaluation of patients with knee osteoarthritis",
"Objective : To compare responsiveness of the Harris Hip Score with generic measures ( that is , the Short Form-36 ( SF-36 ) , and a test of walking speed and pain during walking ) in patients with osteoarthritis ( OA ) of the hip . Method : The first 75 cases within the population of a r and omised clinical trial on manual therapy and exercise therapy were selected for secondary analysis . Experienced ( self reported ) recovery by the patients after treatment ( five weeks ) was used as an external criterion for clinical ly relevant improvement . Responsiveness was evaluated by comparing responsiveness ratios and receiver operating characteristic curves . Results : The responsiveness ratio for the Harris Hip Score was high ( 1.70 ) compared with walking speed ( 0.45 ) , pain during walking ( 0.66 ) , and the subscales of the SF-36—“bodily pain ” ( 0.42 ) and “ physical functioning ” ( 0.36 ) . The area under the curve also was highest for the Harris Hip Score ( 0.92 ) compared with walking speed ( 0.71 ) , pain during walking ( 0.73 ) , and the SF-36 subscales — bodily pain and physical functioning ( both 0.66 ) . Conclusion : The Harris Hip Score is more responsive than the test of walking speed , pain , and subscales for function of the SF-36 in patients with OA of the hip . The Harris Hip Score seems to be a suitable instrument to evaluate change in hip function in patients with OA of the hip",
"BACKGROUND The OARSI St and ing Committee for Clinical Trials Response Criteria Initiative had developed two sets of responder criteria to present the results of changes after treatment in three symptomatic domains ( pain , function , and patient 's global assessment ) as a single variable for clinical trials ( 1 ) . For each domain , a response was defined by both a relative and an absolute change , with different cut-offs with regard to the drug , the route of administration and the OA localization . OBJECTIVE To propose a simplified set of responder criteria with a similar cut-off , whatever the drug , the route or the OA localization . METHODS Data driven approach : ( 1 ) Two data bases were considered : the \" elaboration \" data base with which the formal OARSI sets of responder criteria were elaborated , and the \" revisit \" data base . ( 2 ) Six different scenarios were evaluated : The two formal OARSI sets of criteria ; Four proposed scenarios of simplified sets of criteria . Data from clinical r and omized blinded placebo controlled trials were used to evaluate the performances of the two formal scenarios with two different data bases ( \" elaboration \" versus \" revisit \" ) and those of the four proposed simplified scenarios within the \" revisit \" data base . The placebo effect , active effect , treatment effect , and the required sample arm size to obtain the placebo effect and the active treatment effect observed were the performances evaluated for each of the six scenarios . Experts ' opinion approach : Results were discussed among the participants of the OMERACT VI meeting , who voted to select the definite OMERACT-OARSI set of criteria ( one of the six evaluated scenarios ) . RESULTS Data driven approach : Fourteen trials totaling 1886 OA patients and fifteen studies involving 8164 OA patients were evaluated in the \" elaboration \" and the \" revisit \" data bases respectively . The variability of the performances observed in the \" revisit \" data base when using the different simplified scenarios was similar to that observed between the two data bases ( \" elaboration \" versus \" revisit \" ) when using the formal scenarios . The treatment effect and the required sample arm size were similar for each set of criteria . Experts ' opinion approach : According to the experts , these two previous performances were the most important of an optimal set of responder criteria . They chose the set of criteria considering both pain and function as evaluation domain and requiring an absolute change and a relative change from baseline to define a response , with similar cut-offs whatever the drug , the route of administration or the OA localization . CONCLUSION This data driven and experts ' opinion approach is the basis for proposing an optimal simplified set of responder criteria for OA clinical trials . Other studies , using other sets of OA patients , are required in order to further vali date this proposed OMERACT-OARSI set of criteria",
"BACKGROUND AND PURPOSE Measurements of walking speeds are commonly used as an objective measure of functional performance in patients with knee osteoarthritis ( OA ) and are easily performed in a clinical setting . However , the choice in which the walking speed evaluation should be performed is controversial . The aim of this study was to identify the most discriminating walking speed after surgical interventions in patients with knee osteoarthritis , and to compare the responsiveness of the different gait speeds . METHOD A prospect i ve clinical one-year follow-up study involving 54 patients with knee osteoarthritis ( 63 ( + /-5 ) years of age ) who were operated with either a unicompartmental knee arthroplasty or a high tibial osteotomy was undertaken . Thirty-nine patients had unilateral knee OA and 15 patients had bilateral knee OA or other symptoms from the lower extremities that could influence walking . The patients were examined at a gait laboratory before surgery , and one year after surgery . The patients were instructed to walk at slow , normal and fast walking speed . RESULTS All patients ( n=54 ) walked.faster one year after the surgical intervention compared to before surgery ( p = 0.001 ) at slow ( + 15 % ) , normal ( + 8 % ) and fast ( + 7 % ) walking speed . This increase was similar for the three walking speeds ( p = 0.171 ) . Patients with unilateral knee OA ( n=39 ) reached an average change of + 0.12 m/s , which was considered clinical ly important , while patients with bilateral knee OA ( n=15 ) did not increase their walking speed > 0.12 m/s . Effect size was moderate for slow walking speed and small for normal and fast walking speeds , respectively . CONCLUSIONS The different walking speeds were equally good in detecting changes one year after surgical interventions . In this study , responsiveness favoured slow walking speed , however , the advantages of normal walking speed are discussed",
"STUDY DESIGN Prospect i ve cohort study . OBJECTIVES To establish the major clinical ly important improvement ( MCII ) of the timed up- and -go test ( TUG ) , 40-meter self-paced walk test ( 40-m SPWT ) , 30-second chair st and ( 30 CST ) , and a 20-cm step test in patients with hip osteoarthritis ( OA ) undergoing physiotherapy treatment . As a secondary aim , a comparison of methods was employed to evaluate the effect of method on the reported MCII . BACKGROUND Minimal clinical ly important difference scores are commonly used by rehabilitation professionals to determine patient response following treatment . A gold st and ard for calculating MCII has yet to be determined , which has result ed in problems of interpretation due to varied results . METHODS As part of a r and omized controlled trial , 65 patients were r and omized into a physiotherapy treatment group for hip OA , in which they completed 4 physical performance measures at baseline and 9 weeks . Upon completion of physiotherapy , patients assessed their response to treatment on a 15-point global rating of change scale ( GRCS ) . MCII was estimated using 3 variations of an anchor-based method , based on the patient 's opinion . RESULTS A comparison of 3 methods result ed in the following change scores being best associated with our definition of MCII : a reduction equal to or greater than 0.8 , 1.4 , and 1.2 seconds for the TUG ; an increase equal to or greater than 0.2 , 0.3 , and 0.2 m/s for the 40-m SPWT ; an increase equal to or greater than 2.0 , 2.6 , and 2.1 repetitions for the 30 CST ; an increase equal to or greater than 5.0 , 12.8 , and 16.4 steps for the 20-cm step test . CONCLUSION The variation in methods provided very different results . This illustrates the importance of comparing method ologies and reporting a range of values associated with the MCII , as such values vary , depending upon the methodology chosen"
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Physical fitness ( PF ) is a construct of health- and skill-related attributes which have been associated with academic performance ( AP ) in youth . This study aim ed to review the scientific evidence on the association among components of PF and AP in children and adolescents . A systematic review of articles using data bases PubMed / Medline , ERIC , LILACS , SciELO , and Web of Science was undertaken . Cross-sectional and longitudinal studies examining the association between at least one component of PF and AP in children and adolescents , published between 1990 and June 2016 , were included . Independent extraction of articles was carried out by the two authors using predefined data fields . From a total of 45 studies included , 25 report a positive association between components of PF with AP and 20 describe a single association between cardiorespiratory fitness ( CRF ) and AP . According to the Strengthening the Reporting of Observational Studies in Epidemiology guidelines : 12 were classified as low , 32 as medium risk , and 1 as high risk of bias . Thirty-one studies reported a positive association between AP and CRF , six studies with muscular strength , three studies with flexibility , and seven studies reported a positive association between clustered of PF components and AP . The magnitude of the associations is weak to moderate ( β = 0.10 - 0.42 and odds = 1.01 - 4.14 ) . There is strong evidence for a positive association between CRF and cluster of PF with AP in cross-sectional studies ; and evidence from longitudinal studies for a positive association between cluster of PF and AP ; the relationship between muscular strength and flexibility with AP remains uncertain | [
"BACKGROUND Previous observational and interventional studies have suggested that regular physical exercise may be associated with reduced symptoms of depression . However , the extent to which exercise training may reduce depressive symptoms in older patients with major depressive disorder ( MDD ) has not been systematic ally evaluated . OBJECTIVE To assess the effectiveness of an aerobic exercise program compared with st and ard medication ( ie , antidepressants ) for treatment of MDD in older patients , we conducted a 16-week r and omized controlled trial . METHODS One hundred fifty-six men and women with MDD ( age , > or = 50 years ) were assigned r and omly to a program of aerobic exercise , antidepressants ( sertraline hydrochloride ) , or combined exercise and medication . Subjects underwent comprehensive evaluations of depression , including the presence and severity of MDD using Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria and Hamilton Rating Scale for Depression ( HAM-D ) and Beck Depression Inventory ( BDI ) scores before and after treatment . Secondary outcome measures included aerobic capacity , life satisfaction , self-esteem , anxiety , and dysfunctional cognitions . RESULTS After 16 weeks of treatment , the groups did not differ statistically on HAM-D or BDI scores ( P = .67 ) ; adjustment for baseline levels of depression yielded an essentially identical result . Growth curve models revealed that all groups exhibited statistically and clinical ly significant reductions on HAM-D and BDI scores . However , patients receiving medication alone exhibited the fastest initial response ; among patients receiving combination therapy , those with less severe depressive symptoms initially showed a more rapid response than those with initially more severe depressive symptoms . CONCLUSIONS An exercise training program may be considered an alternative to antidepressants for treatment of depression in older persons . Although antidepressants may facilitate a more rapid initial therapeutic response than exercise , after 16 weeks of treatment exercise was equally effective in reducing depression among patients with MDD",
"Background This prospect i ve longitudinal study investigates whether suspected motor problems and low preference for active play in childhood are associated with physical inactivity and low cardiorespiratory fitness in adolescence . Methodology /Principal Findings The study sample consisted of the Northern Finl and Birth Cohort 1986 ( NFBC 1986 ) composed of 5,767 children whose parents responded to a postal inquiry concerning their children 's motor skills at age 8 years and who themselves reported their physical activity at age 16 years . Cardiorespiratory fitness was measured with a cycle ergometer test at age 16 years . Odds ratios ( OR ) and their 95 % confidence intervals ( 95 % CI ) for the level of physical activity and fitness were obtained from multinomial logistic regression and adjusted for socio-economic position and body mass index . Low preference for active play in childhood was associated with physical inactivity ( boys : OR 3.31 , 95 % CI 2.42–4.53 ; girls : OR 1.79 , 95 % CI 1.36–2.36 ) and low cardiorespiratory fitness ( boys : OR 1.87 , 95 % CI 1.27–2.74 ; girls : OR 1.52 , 95 % CI 1.09–2.11 ) in adolescence . Suspected gross ( OR 2.16 , 95 % CI 1.33–3.49 ) and fine ( OR 1.88 , 95 % CI 1.35–2.60 ) motor problems were associated with physical inactivity among boys . Children with suspected motor problems and low preference for active play tended to have an even higher risk of physical inactivity in adolescence . Conclusions / Significance Low preference for active play in childhood was associated with physical inactivity and low cardiorespiratory fitness in adolescence . Furthermore , children with suspected motor problems and low preference for active play tended to have an even higher risk of physical inactivity in adolescence . Identification of children who do not prefer active play and who have motor problems may allow targeted interventions to support their motor learning and participation in active play and thereby promote their physical activity and fitness in later life",
"BACKGROUND This study examined associations of fitness and fatness with cognitive processes , academic achievement , and behavior , independent of demographic factors , at the baseline of an exercise trial . METHODS Overweight , sedentary but otherwise healthy 7 - 11 year olds ( N=170 ) participated in a study of health , cognition and achievement in the Augusta , GA area from 2003 - 2006 . Children underwent evaluations of fatness and fitness , psychological assessment s of cognition and academic achievement , and behavior ratings by parents and teachers . Partial correlations examined associations of fitness and fatness with cognitive and achievement scores and behavior ratings , controlling for demographic factors . RESULTS Fitness was associated with better cognition , achievement and behavior , and fatness with worse scores . Specifically , executive function , mathematics and reading achievement , and parent ratings of child behavior were related to fitness and fatness . Teacher ratings were related to fitness . CONCLUSION These results extend prior studies by providing reliable , st and ardized measures of cognitive processes , achievement , and behavior in relation to detailed measures of fitness and fatness . However , cross-sectional associations do not necessarily indicate that improving one factor , such as fatness or fitness , will result in improvements in factors that were associated with it . Thus , r and omized clinical trials are necessary to determine the effects of interventions",
"Background Obesity , sedentary lifestyle and poor cardiorespiratory fitness in childhood may increase the risk of health problems later in life . Purpose The authors studied the association of early childhood weight status with cardiorespiratory fitness and leisure-time physical activity ( LTPA ) in adolescence . The stability and associations of LTPA and fitness from childhood through adolescence were also studied . Methods Body mass index ( BMI ) was assessed annually since birth in a prospect i ve , longitudinal study . The mean BMI between ages 2 and 7 years indicated weight status at preschool age . Fitness was studied with a shuttle run test at age 9 and with a maximal cycle ergometer test at age 17 . The same question naire was used to assess LTPA at age 9 , 13 and 17 . Complete data on preschool BMI , LTPA at ages 13 and 17 and fitness at age 17 years was provided by 351 children , while fitness and LTPA data were available for 74 children at ages 9 and 17 . Results Preschool BMI was inversely associated with fitness in adolescence independently of adolescent LTPA ( p=0.0001 ) . Children who had a high preschool BMI but whose weight status was reduced in adolescence had similar fitness in adolescence as the children with a persistently low BMI . Regardless of the fitness level in childhood , the children whose LTPA increased between age 9 and 17 had a similar adolescent fitness level as persistently active subjects . Conclusions It is important to maintain a healthy body weight and a physically active lifestyle from very childhood through adolescence to improve fitness during adolescence",
"PURPOSE The aim of this study was to examine the prospect i ve associations between cardiorespiratory fitness ( CRF ) and academic achievement in the youth . METHODS The sample included 1286 fifth- , sixth- , and seventh- grade students , age 11 to 14 yr ( Mage = 11.3 ± 1.1 ) , from 14 schools followed for 3 yr . Academic achievement was assessed using the students ' marks at baseline and at follow-up 3 yr apart , in Portuguese , mathematics , foreign language ( English ) , and science . CRF was assessed by the Progressive Aerobic Cardiovascular Endurance Run test from the Fitnessgram battery . Students were classified as fit-fit , unfit-fit , fit-unfit , and unfit-unfit according to the Progressive Aerobic Cardiovascular Endurance Run test results at baseline and follow-up . Ordinal regression analyses were performed to examine associations between CRF and academic achievement . RESULTS Being persistently fit ( fit-fit ) , compared with those classified unfit-unfit , increased the odds of having high levels of academic achievement in Portuguese ( odds ratio ( OR ) = 3.49 ; 95 % CI , 1.97 - 6.20 ; P their CRF and became fit ( unfit-fit ) had also higher odds of achieving better marks than those persistently unfit-unfit in Portuguese ( OR = 2.52 ; 95 % CI , 1.42 - 4.45 ; P in cardiorespiratory fitness are prospect ively associated with better academic achievement especially in mother tongue and foreign language",
"The global epidemic of obesity and physical inactivity may have detrimental implication s for young people ’s cognitive function and academic achievement . This prospect i ve study investigated whether childhood motor function predicts later academic achievement via physical activity , fitness , and obesity . The study sample included 8,061 children from the Northern Finl and Birth Cohort 1986 , which contains data about parent-reported motor function at age 8 y and self-reported physical activity , predicted cardiorespiratory fitness ( cycle ergometer test ) , obesity ( body weight and height ) , and academic achievement ( grade s ) at age 16 y. Structural equation models with unst and ardized ( B ) and st and ardized ( β ) coefficients were used to test whether , and to what extent , physical activity , cardiorespiratory fitness , and obesity at age 16 mediated the association between childhood motor function and adolescents ’ academic achievement . Physical activity was associated with a higher grade -point average , and obesity was associated with a lower grade -point average in adolescence . Furthermore , compromised motor function in childhood had a negative indirect effect on adolescents ’ academic achievement via physical inactivity ( B = –0.023 , 95 % confidence interval = –0.031 , –0.015 ) and obesity ( B = –0.025 , 95 % confidence interval = –0.039 , –0.011 ) , but not via cardiorespiratory fitness . These results suggest that physical activity and obesity may mediate the association between childhood motor function and adolescents ’ academic achievement . Compromised motor function in childhood may represent an important factor driving the effects of obesity and physical inactivity on academic underachievement"
] | 41167bbc-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Seasonal affective disorder ( SAD ) is a seasonal pattern of recurrent depressive episodes that is often treated with second-generation antidepressants ( SGAs ) , light therapy or psychotherapy . OBJECTIVES To assess the efficacy and safety of SGAs for the treatment of SAD in adults in comparison with placebo , light therapy , other SGAs or psychotherapy . SEARCH METHODS We search ed the Cochrane Depression , Anxiety and Neuorosis Review Group 's specialised register ( CCDANCTR ) on the 26 August 2011 . The CCDANCTR contains reports of relevant r and omised controlled trials from The Cochrane Library ( all years ) , EMBASE ( 1974 to date ) , MEDLINE ( 1950 to date ) and PsycINFO ( 1967 to date ) . In addition , we search ed pharmaceutical industry trials registers via the Internet to identify unpublished trial data . Furthermore , we search ed OVID MEDLINE , MEDLINE In-process , EMBASE and PsycINFO to 27July 2011 for publications on adverse effects ( including non-r and omised studies ) . SELECTION CRITERIA For efficacy we included r and omised trials of SGAs compared with other SGAs , placebo , light therapy or psychotherapy in adult participants with SAD . For adverse effects we also included non-r and omised studies . DATA COLLECTION AND ANALYSIS Two review authors screened abstract s and full-text publications against the inclusion criteria . Data abstract ion and risk of bias assessment were conducted by one review er and checked for accuracy and completeness by a second . We pooled data for meta- analysis where the participant groups were similar and the studies assessed the same treatments with the same comparator and had similar definitions of outcome measures over a similar duration of treatment . MAIN RESULTS For efficacy we included three r and omised trials of between five and eight weeks duration with a total of 204 participants . For adverse effects we included two r and omised trials and three observational ( non-r and omised ) studies of five to eight weeks duration with a total of 225 participants . Overall , the r and omised trials had low-to-moderate risk of bias , and the observational studies had a high risk of bias ( due to small size and high attrition ) . The participants in the studies all met DSM ( Diagnostic and Statistics Manual of Mental Disorders ) criteria for SAD . The average age was approximately 40 years and 70 % of the participants were female . Results from one trial with 68 participants showed that fluoxetine was not significantly more effective than placebo in achieving clinical response ( risk ratio ( RR ) 1.62 , 95 % confidence interval ( CI ) 0.92 to 2.83 ) . The number of adverse effects were similar between the two groups . We located two trials that contained a total of 136 participants for the comparison fluoxetine versus light therapy . Our meta- analysis of the results of the two trials showed fluoxetine and light therapy to be approximately equal in treating seasonal depression : RR of response 0.98 ( 95 % CI 0.77 to 1.24 ) , RR of remission 0.81 ( 95 % CI 0.39 to 1.71 ) . The number of adverse effects was similar in both groups . Two of the three r and omised trials and three non-r and omised studies contained adverse effect data on 225 participants who received fluoxetine , escitalopram , duloxetine , reboxetine , light therapy or placebo . We were only able to obtain crude rates of adverse effects , so any interpretation of this needs to be undertaken with caution . Between 22 % and 100 % of participants who received a SGA suffered an adverse effect and between 15 % and 27 % of participants withdrew from the studies because of adverse effects . AUTHORS ' CONCLUSIONS Evidence for the effectiveness of SGAs is limited to one small trial of fluoxetine compared with placebo , which shows a non-significant effect in favour of fluoxetine , and two small trials comparing fluoxetine against light therapy , which suggest equivalence between the two interventions . The lack of available evidence precludes the ability to draw any overall conclusions on the use of SGAs for SAD . Further larger RCTs are required to exp and and strengthen the evidence base on this topic , and should also include comparisons with psychotherapy and other SGAs . Data on adverse events were sparse , and a comparative analysis was not possible . Therefore the data we obtained on adverse effects is not robust and our confidence in the data is limited . Overall , up to 27 % of participants treated with SGAs for SAD withdrew from the studies early due to adverse effects . The overall quality of evidence in this review is very low | [
"Rationale Seasonal affective disorder ( SAD ) is a relatively common cyclical depressive illness characterized by seasonal depressions during winter . The disorder is commonly responsive to light therapy , but antidepressant drug efficacy has not been definitely established . Serotonin selective re-uptake inhibitors are potentially efficacious treatments for SAD . Objectives The objective of this study was to evaluate the efficacy , tolerability and safety of sertraline treatment for SAD . Methods One hundred and eighty seven out patients with seasonal pattern recurrent winter depression ( DSM-III-R defined ) and a minimum 29-item Hamilton depression scale ( SIGH-SAD version ) score of 22 were r and omized to 8 weeks treatment with either sertraline or placebo in a double-blind , multi-country , multi-center , parallel-group , flexible dose ( 50–200 mg once daily ) study . Efficacy was investigated using physician and patient-rated scales measuring depression , anxiety and symptoms characteristic of seasonal affective disorder . Results Sertraline produced a significantly greater response than placebo at endpoint as measured by changes in the 29-item and 21-item Hamilton depression scales , the clinical global impression ( CGI ) severity scale , the Hamilton anxiety scale , and the hospital anxiety and depression scale . The proportion of sertraline-treated subjects achieving a response on the CGI improvement rating ( ratings of 1 or 2 ) at endpoint ( last observation carried forward ) was significantly greater than that of the placebo group . Overall sertraline was well tolerated with the most frequent placebo adjusted adverse events , being nausea , diarrhea , insomnia and dry mouth . Adverse events were mostly mild to moderate and transient . Conclusions Sertraline pharmacotherapy has been demonstrated to be an effective and well-tolerated therapy for out patients with SAD . As such , sertraline offers an important pharmacological option in the clinical management of this condition",
"In the context of Lewy 's phase delay hypothesis , the present study tested whether effective treatment of winter Seasonal Affective Disorder ( SAD ) is mediated by advancing of circadian phase . Following a baseline week , 78 out patients with SAD were r and omized into 8 weeks of treatment with either fluoxetine and placebo light treatment or light treatment and placebo pill . Depression levels were measured on the Ham17 + 7 and the BDI‐II , and circadian phase was estimated on the basis of daily sleep logs and self‐reported morningness‐eveningness . Among the 61 out patients with complete data , both treatments were associated with significant antidepressant effect and phase advance . However , pre‐ and post‐treatment comparisons found that the degree of symptom change did not correlate with the degree of phase change associated with treatment . The study therefore provides no evidence that circadian phase advance mediates the therapeutic mechanism in patients with SAD . Findings are discussed in terms of the limitations of the circadian measures employed",
" Of a total of 581 consecutive depressed subjects attending psychiatric services of 6 centres in Finl and , 183 patients were eligible and completed a 6-week r and omised double-blind trial with either moclobemide or fluoxetine . Of these , 32 ( 17.5 % ) patients met the DSM-III-R criteria for mood disorder with a seasonal ( winter ) pattern and 19 patients ( 10.5 % ) met the original criteria for seasonal affective disorder ( SAD ) . There were no significant difference in the antidepressive response to the treatment between the patients with SAD and other depressive disorder . The treatment of 6 weeks with either moclobemide ( 300 - 450 mg daily ) or fluoxetine ( 20 - 40 mg daily ) result ed in a full remission in 15 ( 52 % ) patients with SAD and in 44 ( 37 % ) patients with other depressive disorder . Altogether , 23 ( 79 % ) and 83 ( 70 % ) patients , respectively , got significant benefit from the treatment . The improvement in the health-related quality of life in terms of ability to work was significantly more extensive in the patients with SAD assigned to receive moclobemide compared with the other depressive patients allocated to the same medication . Subjects who in addition met the operational criteria for atypical depression were equally distributed into the SAD and other depressive patient groups",
"Background : This study sought to determine whether the prevalence of the seasonal subtype of major depression ( SAD ) in the community varied as a function of latitude . Methods : R and om telephone numbers were generated across 8 degrees of latitude ( 41.5 ° N to 49.5 ° N ) for the province of Ontario . Eight strata of 1 degree each were sample d equally throughout a 12-month period . Using a vali date d and structured diagnostic interview , we interviewed by telephone respondents over 20 years of age who had lived in the region for 3 years or more . We evaluated patterns of symptom change across seasons to establish a diagnosis of SAD according to DSM-IV criteria . Results : Of the 2078 households that were assessed for eligibility , 1605 ( 77 % ) completed the interview . The crude prevalence of lifetime SAD was 2.6 % ( 95 % CI , 1.9 to 3.5 ) . There was no impact of latitude on prevalence of either major depression or the seasonal subtype across the 8 strata , although the global measure of the severity of seasonal change in mood was significantly negatively correlated with latitude . Conclusions : SAD is a common subtype of major depression in Ontario , but there is no evidence to support an increase in prevalence with increasing latitude . Context e : Cette étude visait à déterminer si la prévalence du caractère saisonnier de la dépression majeure ( DMS ) dans la communauté variait selon la latitude . Méthodes : Des numéros de téléphone aléatoires ont été fournis sur 8 degrés de latitude ( de 41,5 ° N. à 49,5 ° N. ) dans la province de l'Ontario . Huit b and es de 1 degré chacune ont été échantillonnées également sur une période de 12 mois . À l'aide d'une entrevue diagnostique validée et structurée , nous avons interviewé par téléphone des répondants âgés de plus de 20 ans qui habitaient la région depuis 3 ans ou plus . Nous avons évalué les changements des modèles de symptômes selon les saisons pour établir un diagnostic de DMS selon les critères du DSM-IV . Résultats : Sur les 2 078 ménages admissibles , 1 605 ( 77 % ) ont terminé l'entrevue . La prévalence brute de la DMS à vie était de 2,6 % ( 95 % IC , 1,9 à 3,5 ) . La latitude n'influait pas sur la prévalence de la dépression majeure ou du caractère saisonnier dans les 8 b and es , bien que la mesure globale de la sévérité du changement saisonnier de l'humeur ait indiqué une corrélation négative significative à la latitude . Conclusions : La dépression majeure saisonnière est un sous-type rép and u de la dépression majeure en Ontario , mais aucune preuve ne soutient une augmentation de la prévalence parallèle à l'accroissement de la latitude",
"OBJECTIVE The aim of this observational study was to evaluate the effects of duloxetine in the treatment of seasonal affective disorder ( SAD ) . PATIENTS AND METHODS 26 SAD patients were treated with open-label duloxetine 60 - 120 mg per day over 8 weeks . Ratings included the Structured Interview Guide for the Hamilton Depression Rating Scale ( SAD version ; SIGH-SAD ) and the Clinical Global Impression ( CGI ) . To estimate treatment effects on social functioning in SAD we employed the Social Adaptation Self Evaluation Scale ( SASS ) , the Sheehan Disability Scale ( SDS ) , and assessment s of days lost due to illness and days with reduction in productivity . RESULTS Duloxetine led to a significant improvement ( p SIGH-SAD , CGI severity , SASS , and SDS scores . Days lost due to illness and days with reduction in productivity were significantly diminished during treatment ( p duloxetine over 8 weeks yielded a response rate ( SIGH-SAD duloxetine might be effective and able to ameliorate the negative social consequences of SAD",
"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",
"OBJECTIVE The aim of this study was to evaluate the efficacy and tolerability of escitalopram in the treatment of seasonal affective disorder ( SAD , fall-winter depression ) . METHODS Twenty SAD patients were included in an 8-week drug surveillance . Patients were treated with open-label escitalopram at a dosage of 10 to 20 mg per day . Efficacy assessment s included the Structured Interview Guide for the Hamilton Depression Rating Scale ( SAD version ; SIGH-SAD ) , the Clinical Global Impression ( CGI ) and the Social Adaptation Self Evaluation Scale ( SASS ) . Side effects were monitored with the UKU Side Effect Rating Scale . RESULTS From week 2 onwards , escitalopram significantly reduced SIGH-SAD score and CGI severity score ( p SASS score was also significantly improved ( p response rate ( SIGH-SAD remission ( SIGH-SAD Side effects were mild to moderate and did not lead to cessation of therapy . CONCLUSION These results suggest that escitalopram is an efficacious and altogether safe treatment for seasonal depression",
"BACKGROUND Disturbances of serotonergic neurotransmission appear to be particularly important for the pathophysiology of winter depression . This study investigated whether fluoxetine has antidepressant effects comparable to bright light in the treatment of seasonal affective disorder ( winter type ) . METHOD A r and omized , parallel design was used with rater and patients blind to treatment conditions . One week of placebo ( phase I ) was followed by 5 weeks of treatment ( phase II ) with fluoxetine ( 20 mg per day ) and a placebo light condition versus bright light ( 3000 lux , 2 h per day ) and a placebo drug . There were 40 patients ( 20 in each treatment condition ) suffering from seasonal affective disorder ( SAD ) according to DSM-III-R who had a total score on the Hamilton Depression Scale of at least 16 . RESULTS Forty patients entered phase II and 35 completed it ( one drop-out in the fluoxetine group and four in the bright light group ) . Fourteen ( 70 % ) of the patients treated with bright light and 13 ( 65 % ) of those treated with fluoxetine were responders ( NS ) . The remission rate in the bright light group tended to be superior ( bright light 50 % , fluoxetine 25 % ; P = 0.10 ) . Light therapy improved HDRS scores significantly faster , while fluoxetine had a faster effect on atypical symptoms . Light treatment in the morning produced a significantly faster onset of improvement , but at the end of treatment the time of light application seemed not to be crucial . CONCLUSION Both treatments produced a good antidepressant effect and were well tolerated . An apparently better response to bright light requires confirmation in a larger sample",
"BACKGROUND Although a host of studies have now examined the relationship between quality of life ( QoL ) and non-seasonal depression , few have measured QoL in seasonal affective disorder ( SAD ) . We report here on results from the Can-SAD trial , which assessed the impact of treatment with either antidepressant medication or light therapy upon QoL in patients diagnosed with SAD . METHOD This Canadian double-blind , multicentre , r and omized controlled trial included 96 patients who met strict diagnostic criteria for SAD . Eligible patients were r and omized to 8 weeks of treatment with either : ( 1 ) 10000 lux light treatment and a placebo capsule or ( 2 ) 100 lux light treatment ( placebo light ) and 20 mg fluoxetine . QoL was measured with the Quality of Life Enjoyment and Satisfaction Question naire ( Q-LES-Q ) and the Medical Outcomes Study ( MOS ) Short-Form General Health Survey ( SF-20 ) at baseline and 8 weeks . RESULTS Both intervention groups showed significant improvement in QoL over time with no significant differences being detected by treatment condition . Q-LES-Q scores increased significantly in seven of eight domains , with the average scores rising from 48 x 0 ( S.D.=10 x 7 ) at baseline to 69 x 1 ( S.D.=15 x 6 ) at week 8 . Treatment-related improvement in QoL was strongly associated with improvement in depression symptoms . DISCUSSION Patients with SAD report markedly impaired QoL during the winter months . Treatment with light therapy or antidepressant medication is associated with equivalent marked improvement in perceived QoL. Studies of treatment interventions for SAD should routinely include broader indices of patient outcome , such as the assessment of psychosocial functioning or life quality",
"OBJECTIVE The authors investigated the efficacy and safety of fluoxetine in the treatment of winter seasonal affective disorder . METHOD Sixty-eight out patients who met the DSM-III-R criteria for recurrent major depressive episodes , seasonal ( winter ) pattern , were r and omly assigned to 5 weeks of treatment with fluoxetine , 20 mg/day ( N = 36 ) , or placebo ( N = 32 ) . The outcome measures included the 29-item modified Hamilton Depression Rating Scale , administered by experienced clinicians , and the self-rated Beck Depression Inventory ; adverse events and safety data were also recorded . Clinical response was defined as a greater than 50 % reduction in depression score between baseline and study termination . RESULTS Both groups showed significant improvement . The fluoxetine group had lower depression scores at termination than the placebo group , but these differences did not achieve statistical significance . However , the rate of clinical response in the fluoxetine group ( 59 % ) was superior to that in the placebo group ( 34 % ) . Post hoc analyses showed that the greatest fluoxetine responses were in the most markedly depressed patients and that overall response was greater for patients studied later in the season . Fluoxetine was well tolerated , and few subjects dropped out because of adverse events . CONCLUSIONS On the basis of clinical response rate , fluoxetine appears to be an effective , well-tolerated treatment for seasonal affective disorder . Because the differences between fluoxetine and placebo in the continuous outcome measures did not reach statistical significance , further studies with larger study groups and longer treatment periods are required to conclusively demonstrate efficacy of fluoxetine for seasonal affective disorder",
"Objective : To examine estimates of lifetime prevalence of seasonal affective disorder ( SAD ) in Toronto , Ontario . Method R and om telephone numbers were generated for the city of Toronto , and 781 respondents completed a telephone interview . Trained nonphysician interviewers conducted all interviews , which involved structured questions for diagnosing major depression . Patterns of symptom change across seasons were evaluated to establish a diagnosis of SAD according to DSM-III-R criteria . Results Correcting for sex and age , the prevalence of SAD defined by DSM-III-R criteria was 2.9 % ( 95%CI , 1.7 % to 4.0 % ) , and the overall lifetime prevalence of major depression in the sample was 26.4 % ( 95%CI , 23.3 % to 29.4 % ) . Some subjects were contacted for a follow-up interview conducted in person ; the positive predictive value for the diagnosis of major depression for the telephone interview was 100 % , and the negative predictive value was 93 % . Conclusions The seasonal subtype of depression represents 11 % of all subjects with major depression , suggesting that SAD is a significant public health concern . The telephone interview demonstrated adequate reliability , indicating that it is appropriate for epidemiological surveys of this nature",
"Seasonal affective disorder ( SAD ) , winter type , is a condition characterized by the annual recurrence of depressive episodes during fall/winter , alternating with spring/summer euthymia or hypomania . Various neurotransmitters have been implicated in the etiology of SAD , the strongest evidence involving serotonin . Recently , increasing attention has been paid to the potential role of catecholaminergic pathways in the pathophysiology of SAD . We investigated the efficacy and tolerability of reboxetine , a selective noradrenaline inhibitor , in patients with SAD . Eleven out of sixteen patients who were included in a 6-week drug surveillance during winter season experienced full remission of depressive symptoms . Nine patients reported a rapid relief of preexistent severe atypical depressive symptoms within the first treatment week . Reboxetine might therefore be an effective and well-tolerated treatment option for SAD patients . In conclusion , our preliminary results are in line with evidence from recent studies suggesting that catecholaminergic systems might also be involved in the pathophysiology of SAD"
] | 41167c02-06ff-11f0-808a-c43d1ab1c353 |
The requirements for an ideal restorative material include adhesion to tooth structure ( enamel and dentine ) and an ability to withst and the traumas of occlusion . However , some level of an anticaries effect is also desirable . After a long history of glass-ionomer cement ( GIC ) development , an evidence base in support of the therapeutic effect of GIC , particularly with regard to its anticaries effect , is emerging . This evidence is increasingly presented through systematic review s of clinical GIC application and , to a certain extent , relates to a caries-preventive effect of the material itself . However , the strength of evidence supporting other aspects of GIC , such as a higher remineralizing effect , fluoride uptake in hard tooth tissue and fluoride release of GIC , is limited . Nevertheless , the results of these in situ and laboratory trials provide valuable insights into factors that facilitate underst and ing of the clinical efficacy of GIC | [
"The aim of the present trial was to ( 1 ) compare the caries-preventive effect of glass ionomer sealants , placed according to the atraumatic restorative treatment ( ART ) procedure , with composite resin sealants over time and ( 2 ) investigate the caries-preventive effect after complete disappearance of sealant material . Forty-six boys and 57 girls , mean age 7.8 years , were r and omly divided into two treatment groups in a parallel-group study design . A light-polymerized composite resin sealant material and a high-viscosity glass ionomer were each placed in 180 fully erupted first molars in their respective treatment groups . Evaluation took place annually for 5 years by calibrated examiners . After 5 years , 86 % composite resin and 88 % glass ionomer sealants did not survive . Three categories of re-exposure periods for caries development in pits and fissures after complete loss of sealants were distinguished : 0–1 , 1–2 and 2–3 years . In the 2- to 3-year group , 13 and 3 % of pits and fissures previously sealed with composite resin and glass ionomer , respectively , were diagnosed as having developed a dentine lesion . The relative risks ( 95 % CI ) of dentine lesion development in surfaces sealed with glass ionomer compared to those sealed with composite resin after 3 , 4 and 5 years were 0.22 ( 0.06–0.82 ) , 0.32 ( 0.14–0.73 ) and 0.28 ( 0.13–0.61 ) , respectively . The relative risks of dentine lesion development in pits and fissures previously sealed with glass ionomer compared with composite resin over re-exposure periods of 1–2 and 2–3 years were 0.26 ( 0.14–0.48 ) and 0.25 ( 0.09–0.68 ) , respectively . We conclude that the caries-preventive effect of high-viscosity glass ionomer sealants , placed using the ART procedure , was between 3.1 and 4.5 times higher than that of composite resin sealants after 3–5 years . Furthermore , high-viscosity ( ART ) glass ionomer sealants appear to have a four times higher chance of preventing caries development in re-exposed pits and fissures of occlusal surfaces in first molars than light-cured composite resin sealant material over a 1- to 3-year period . A well- design ed clinical trial using different types of oral health personnel should be implemented to confirm these initial results",
"The purpose of this study was to compare the amount of fluoride in plaque formed on glass ionomer cement or composite and to evaluate the effects of fluoride released on growth of cariogenic microflora , fluoride uptake , and secondary caries formation under in situ conditions of a high cariogenic challenge . Ten adult volunteers took part in this crossover study performed in two phases of 28 days . Eighty enamel blocks were r and omly restored with glass ionomer cement ( Chelon-Fil-Espe ) or composite ( Silux ) . During each phase of the study , an acrylic resin appliance , containing four enamel blocks restored with the same material , was constructed for each of the volunteers . During the experimental period , all subjects used fluoride-free dentifrice , refrained from brushing the restored enamel blocks , and immersed the appliances into 20 % sucrose solution eight times a day . Fluoride levels , mutans streptococci , and lactobacilli were assessed in dental plaque . Fluoride uptake and microhardness profiles were determined in enamel around the restorations . Statistical analyses indicated a significantly higher level of fluoride ( p level of mutans streptococci plaque formed on glass ionomer cement . Analysis of variance in a split-plot model indicated that in the enamel around the glass ionomer restoration the fluoride uptake was significantly greater ( p mineral loss significantly lower ( p glass ionomer cement presents a broad anticariogenic effect and may be of value in preventing secondary caries , even under conditions of a high caries risk",
"Since the last comprehensive review of anticoagulation in acute myocardial infa rct ion four additional r and omized control trials have been reported . The overwhelming majority of all trials favored anticoagulation . Rates of thromboembolism were higher in the control , and hemorrhagic complications in the anticoagulated group . Pooling of all r and omized control trials gives mean case fatality rates of 19.6 % for the control and 15.4 % for the anticoagulated group , a relative reduction of 21 % ( P less than 0.05 or less than 0.001 , depending on the analytic method ) . Five of six r and omized control trials reported \" no effect \" because the difference favoring anticoagulation was not statistically significant . However , sample sizes in these \" negative \" papers were too small to protect against missing a 21 % reduction in true case fatality rate due to anticoagulation ( beta greater than 0.10 ) . All patients who present no specific contraindication should receive anticoagulants during hospitalization for infa rct ion ",
"Previous reports have shown a release of fluoride from glass-ionomer cement ( GIC ) restorations into the oral fluids . Fluoride in the ambient fluids has a caries-preventive effect by enhancing remineralization and inhibiting demineralization of the dental hard tissues . Therefore , the current investigation was undertaken to determine whether GIC fillings could contribute to the remineralization of caries lesions in dentin . Small circular preparations were made in disks of dentin which had incipient caries-like lesions in the remaining tissue . The preparations were filled with amalgam or composite material s ( as controls ) or with GIC . The specimens thus contained a restoration close to a dentinal caries-like lesion . The specimens were placed contralaterally in the buccal surfaces of removable partial dentures and were worn intra-orally by volunteers for a 12-week experimental period , after which the specimens were sectioned and analyzed by microradiography . All specimens with GIC restorations exhibited hypermineralization in the tissue bordering the filling and in the wall of the preparation which had been in contact with the restoration . The ( caries-like ) lesions were remineralized , even under conditions of heavy plaque formation . In contrast , specimens with amalgam or composite restorations showed further extensive demineralization . This study demonstrates a significant remineralization potential exerted by the fluoride-releasing GIC restorative material . Consequently , the choice of the restorative material might be crucial for the occurrence or prevention of recurrent caries around restorations",
"BACKGROUND The authors evaluated the 24-month performance of a packable resin-based composite/dentin bonding system and a high-viscosity glass ionomer cement ( GIC ) in restorations placed in primary molars with the atraumatic restorative treatment ( ART ) approach . METHODS Three dentists placed 419 restorations in 219 children aged 6 through 10 years who had bilateral matched pairs of carious posterior Class I and II primary teeth . They used a split-mouth design to place the two material s , which were assigned r and omly to contralateral sides . The authors evaluated the restorations according to U.S. Public Health Service Ryge criteria . RESULTS After 24 months , 96.7 percent of the Class I GIC restorations and 91 percent of the resin-based composite restorations survived , while the success rates for the Class II restorations were 76.1 percent and 82 percent for the GIC and resin-based composite restorations , respectively . The survival rate of the Class II resin-based composite restorations was 5.9 percent higher than that of the GIC restorations at the 24-month evaluation , but this difference was not statistically significant . However , the study results showed a statistically significant difference in survival rates between Class I and II restorations for both material s. CONCLUSION AND CLINICAL IMPLICATION S The two-year clinical performance of both material s was satisfactory for the restoration of Class I and II primary molars using the ART approach",
"OBJECTIVE To evaluate the remineralization of carious dentine following the restoration of an extensive lesion in a permanent molar with a high strength glass-ionomer cement ( GIC ) . MATERIAL S AND METHODS Thirteen first permanent molars , which were scheduled for extraction because of the presence of extensive caries lesions , were selected for this study . They were first restored , according to the ART technique , using encapsulated Fuji IX(GP ) , which contains a strontium glass rather than the traditional calcium glass . The cavities were prepared with a clean enamel margin and minimal removal of the carious dentine around the walls . After a period of 1 - 3 months they were harvested and subsequently sectioned and examined using an electron probe micro analysis ( EPMA ) and scanning electron microscopy ( SEM ) . RESULTS EPMA demonstrated that both fluorine and strontium ions had penetrated deep into the underlying demineralized dentine . The only possible source of these ions was the GIC restoration . CONCLUSION The pattern of penetration of the fluorine and strontium ions into the dentine was consistent with a remineralization process",
"Root surface caries is of growing importance because its prevalence increases with age , and the population of the United States is growing older while edentulism and tooth loss rates have declined . Few clinical studies have evaluated material s used for the restoration of active root caries lesions . This study evaluated a Type II glass ionomer cement and a microfilled composite resin , both placed in preparations without mechanical retention or acid etching of enamel , in the restoration of root caries . Fifty adult volunteers with active root caries received one or both material s with the material chosen r and omly . Patients were recalled after 24 months to evaluate restorations for retention , additional caries , marginal integrity , and overall clinical acceptability . Seventy-seven restorations were available for reevaluation . Forty-five percent of the glass ionomer and 73 % of the composite restorations were clinical ly acceptable after 24 months . Of the glass ionomers , 39 % were fully retained compared with 73 % of composite restorations . Among those partially or fully retained , 25 % of the glass ionomer restorations had minimal loss of marginal integrity and 30 % had extensive loss while 53 % and 9 % of composite restorations had minimal and extensive loss , respectively . Most restorations were clinical ly unacceptable because of restorative material loss . Substantial numbers of glass ionomer cement and composite resin restorations were lost . This may be the result of difficulties in maintaining isolation and obtaining a proper gingival seal . Thus , routine use of mechanical retention is still highly recommended to reduce the loss of restorative material",
"The 4-year results of a fissure sealant trial are reported . Glass polyalkenoate and bis GMA sealant were applied to 590 first permanent molar teeth using a half mouth study design in a group of 228 6 - 8-year-old children . Similar cariostasis was observed for the two material s at the end of 4 years despite marked differences in retention . Polyalkenoate cements probably should be regarded as ' fluoride depot ' material s rather than fissure sealants when used in this"
] | 41167c48-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE To systematic ally review placebo-controlled r and omized trials of homeopathy for psychiatric conditions . DATA SOURCES Eligible studies were identified using the following data bases from data base inception to April 2010 : PubMed , CINAHL , PsycINFO , Hom-Inform , Cochrane CENTRAL , National Center for Complementary and Alternative Medicine grantee publications data base , and Clinical Trials.gov . Gray literature was also search ed using Google , Google Scholar , the European Committee for Homeopathy , inquiries with homeopathic experts and manufacturers , and the bibliographic lists of included published studies and review s. Search terms were as follows : ( homeopath * or homoeopath * ) and ( placebo or sham ) and ( anxiety or panic or phobia or post-traumatic stress or PTSD or obsessive-compulsive disorder or fear or depress * or dysthym * or attention deficit hyperactivity or premenstrual syndrome or premenstrual disorder or premenstrual dysphoric disorder or traumatic brain injury or fibromyalgia or chronic fatigue syndrome or myalgic encephalitis or insomnia or sleep disturbance ) . Search es included only English- language literature that reported r and omized controlled trials in humans . STUDY SELECTION Trials were included if they met 7 criteria and were assessed for possible bias using the Scottish Intercollegiate Guidelines Network ( SIGN ) 50 guidelines . Overall assessment s were made using the Grading of Recommendations Assessment , Development and Evaluation procedure . Identified studies were grouped into anxiety or stress , sleep or circadian rhythm complaints , premenstrual problems , attention-deficit/hyperactivity disorder , mild traumatic brain injury , and functional somatic syndromes . RESULTS Twenty-five eligible studies were identified from an initial pool of 1,431 . Study quality according to SIGN 50 criteria varied , with 6 assessed as good , 9 as fair , and 10 as poor . Outcome was unrelated to SIGN quality . Effect size could be calculated in 16 studies , and number needed to treat , in 10 studies . Efficacy was found for the functional somatic syndromes group ( fibromyalgia and chronic fatigue syndrome ) , but not for anxiety or stress . For other disorders , homeopathy produced mixed effects . No placebo-controlled studies of depression were identified . Meaningful safety data were lacking in the reports , but the superficial findings suggested good tolerability of homeopathy . A funnel plot in 13 studies did not support publication bias ( χ(2)(1 ) = 1.923 , P = .166 ) . CONCLUSIONS The data base on studies of homeopathy and placebo in psychiatry is very limited , but results do not preclude the possibility of some benefit | [
"OBJECTIVE To assess the efficacy of individualized classical homeopathy in the treatment of fibromyalgia . METHODS This study was a double-blind , r and omized , parallel-group , placebo-controlled trial of homeopathy . Community-recruited persons ( N = 62 ) with physician-confirmed fibromyalgia ( mean age 49 yr , s.d . 10 yr , 94 % women ) were treated in a homeopathic private practice setting . Participants were r and omized to receive oral daily liquid LM ( 1/50,000 ) potencies with an individually chosen homeopathic remedy or an indistinguishable placebo . Homeopathic visits involved joint interviews and concurrence on remedy selection by two experienced homeopaths , at baseline , 2 months and 4 months ( prior to a subsequent optional crossover phase of the study which is reported elsewhere ) . Tender point count and tender point pain on examination by a medical assessor uninvolved in providing care , self-rating scales on fibromyalgia-related quality of life , pain , mood and global health at baseline and 3 months , were the primary clinical outcome measures for this report . RESULTS Fifty-three people completed the treatment protocol . Participants on active treatment showed significantly greater improvements in tender point count and tender point pain , quality of life , global health and a trend toward less depression compared with those on placebo . CONCLUSIONS This study replicates and extends a previous 1-month placebo-controlled crossover study in fibromyalgia that pre-screened for only one homeopathic remedy . Using a broad selection of remedies and the flexible LM dose ( 1/50,000 dilution factor ) series , the present study demonstrated that individualized homeopathy is significantly better than placebo in lessening tender point pain and improving the quality of life and global health of persons with fibromyalgia",
"OBJECTIVES To assess the feasibility of a R and omised Controlled Trial ( RCT ) design of usual care compared with usual care plus adjunctive care by a homeopath for patients with Fibromyalgia syndrome ( FMS ) . METHODS In a pragmatic parallel group RCT design , adults with a diagnosis of FMS ( ACR criteria ) were r and omly allocated to usual care or usual care plus adjunctive care by a homeopath . Adjunctive care consisted of five in depth interviews and individualised homeopathic medicines . The primary outcome measure was the difference in Fibromyalgia Impact Question naire ( FIQ ) total score at 22 weeks . RESULTS 47 patients were recruited . Drop out rate in the usual care group was higher than the homeopath care group ( 8/24 vs 3/23 ) . Adjusted for baseline , there was a significantly greater mean reduction in the FIQ total score ( function ) in the homeopath care group than the usual care group ( -7.62 vs 3.63 ) . There were significantly greater reductions in the homeopath care group in the McGill pain score , FIQ fatigue and tiredness upon waking scores . We found a small effect on pain score ( 0.21 , 95 % CI -1.42 to 1.84 ) ; but a large effect on function ( 0.81 , 95 % CI -8.17 to 9.79 ) . There were no reported adverse events . CONCLUSIONS Given the acceptability of the treatment and the clinical ly relevant effect on function , there is a need for a definitive study to assess the clinical and cost effectiveness of adjunctive healthcare by a homeopath for patients with FMS",
"INTRODUCTION Chronic primary insomnia is defined as difficulty in initiating or maintaining sleep or of non-restorative sleep that lasts for at least 1 month and causes significant distress or impairment in social , occupational or other important areas of functioning . The homeopathic simillimum is that remedy which most closely corresponds to the totality of symptoms ; remedy selection is based on a full evaluation of the patient 's physical , emotional and mental characteristics . AIM / PURPOSE The purpose of this r and omised , double-blind , placebo-controlled study was to evaluate the efficacy of homeopathic simillimum in the treatment of chronic primary insomnia . METHOD 30 participants were selected in accordance with DSM-IV TR (2000)(1 ) criterion 307.42 Primary Insomnia and then r and omly divided between treatment and placebo groups . The measurement tools used were a Sleep Diary ( SD ) and the Sleep Impairment Index (SII).(2 ) After an initial consultation , 2 follow-up consultations at 2-week intervals took place . Homeopathic medication was prescribed at the first and second consultations . The SII was completed at each consultation and participants were instructed at the first consultation to start the SD . RESULTS SD data revealed that verum treatment result ed in a significant increase in duration of sleep throughout the study , compared to the placebo treatment which result ed in no significant increase in duration of sleep . A significant improvement in SII summary scores and number of improved individual questions were found in the verum group , responses to all 11 questions having improved significantly upon completion of the study . An initial improvement occurred in the placebo group , but was not sustained . Comparison of results between the groups revealed a statistically significant difference . CONCLUSION The homeopathic simillimum treatment of primary insomnia was effective , compared to placebo . Homeopathy is a viable treatment modality for this condition and further research is justified",
"OBJECTIVES ( 1 ) To replicate a study of the efficacy of Argentum nitricum 12X in the reduction of test anxiety as demonstrated previously . ( 2 ) To investigate the correlation between individuals identified to match the A. nitricum profile and the reduction of test anxiety . To compare traditionally prepared homeopathic A. nitricum 12X with radionically-prepared A. nitricum 12X and placebo . DESIGN A double blind , placebo-controlled , r and omised clinical trial with three arms . SETTING The study was conducted at Southern Cross University , Lismore , Australia . SUBJECTS Sixty-two test anxious university students . INTERVENTIONS Subjects were r and omised to one of three groups : traditionally prepared homeopathic A. nitricum 12X , radionically-prepared A. nitricum 12X , or placebo . After screening , each group received treatment twice a day for 4 days after which they were re-tested . OUTCOME MEASURES Primary : The Revised Test Anxiety Scale . Secondary : The Test Anxiety Scale ; 36-item A. nitricum question naire . RESULTS The results of this study did not replicate the Stanton study . No correlation between the reduction of test anxiety and the A. nitricum profile was demonstrated . No significant differences between treatments were demonstrated . CONCLUSION This study demonstrated that homeopathic A. nitricum 12X does not reduce test anxiety in a general population of university students",
"BACKGROUND Mild traumatic brain injury ( MTBI ) affects 750,000 persons in the United States annually . Five to fifteen percent have persistent dysfunction and disability . No effective , st and ard pharmacological treatment exists specifically for this problem . We design ed a pilot research project to study the clinical effectiveness of homeopathic medicine in the treatment of persistent MTBI . METHOD A r and omized , double-blind , placebo-controlled trial of 60 patients , with a four-month follow-up ( N = 50 ) , was conducted at Spaulding Rehabilitation Hospital ( SRH ) . Patients with persistent MTBI ( mean 2.93 years since injury , SD 3.1 ) were r and omly assigned to receive a homeopathic medicine or placebo . The primary outcome measure was the subject-rated SRH-MBTI Functional Assessment , composed of three subtests : a Difficulty with Situations Scale ( DSS ) , a Symptom Rating Scale ( SRS ) , and a Participation in Daily Activities Scale ( PDAS ) . The SRH Cognitive-Linguistic Test Battery was used as the secondary measure . RESULTS Analysis of covariance demonstrated that the homeopathic treatment was the only significant or near-significant predictor of improvement on DSS subtests ( P = .009 ; 95 % CI -.895 to -.15 ) , SRS ( P = .058 ; 95 % CI -.548 to.01 ) and the Ten Most Common Symptoms of MTBI ( P = .027 ; 95 % CI -.766 to -.048 ) . These results indicate a significant improvement from the homeopathic treatment versus the control and translate into clinical ly significant outcomes . CONCLUSIONS This study suggests that homeopathy may have a role in treating persistent MTBI . Our findings require large-scale , independent replication",
"BACKGROUND Homeopathy , a common form of alternative medicine worldwide , relies on subjective patient reports for diagnosis and treatment . Polysomnography offers a modern methodology for evaluating the objective effects of taking homeopathic remedies that clinicians cl aim exert effects on sleep quality in susceptible individuals . Animal studies have previously shown changes in non rapid eye movement sleep with certain homeopathic remedies . METHODS Young adults of both sexes ( ages 18 - 31 ) with above-average scores on st and ardized personality scales for either cynical hostility or anxiety sensitivity ( but not both ) and a history of coffee-induced insomnia participated in the month-long study . At-home polysomnographic recordings were obtained on successive pairs of nights once per week for a total of eight recordings ( nights 1 , 2 , 8 , 9 , 15 , 16 , 22 , 23 ) . Subjects ( N=54 ) received placebo pellets on night 8 ( single-blind ) and verum pellets on night 22 ( double-blind ) in 30c doses of one of two homeopathic remedies , Nux Vomica or Coffea Cruda . Subjects completed daily morning sleep diaries and weekly Pittsburgh sleep quality index scales , as well as profile of mood states scales at bedtime on polysomnography nights . RESULTS Verum remedies significantly increased PSG total sleep time and NREM , as well as awakenings and stage changes . Changes in actigraphic and self-rated scale effects were not significant . CONCLUSIONS The study demonstrated the feasibility of using in-home , all-night sleep recordings to study homeopathic remedy effects . Findings are similar though not identical to those reported in animals with the same remedies . Possible mechanisms include initial disruption of the nonlinear dynamics of sleep patterns by the verum remedies",
"OBJECTIVES To characterize initial central nervous system responses to olfactory administration of homeopathic remedies as biomarkers for subsequently exceptional , simillimum-like clinical outcomes at a systemic level ( i.e. , both locally and globally ) . DESIGN Double-blinded , r and omized , placebo-controlled clinical trial . SETTING A private homeopathic clinic in Phoenix , AZ , and a university laboratory in Tucson , AZ . PATIENTS Sixty-two ( 62 ) persons with physician-confirmed fibromyalgia ( FM ) ( mean age , 49 years ; 94 % women ) enrolled ; 53 completed the 3-month assessment visit . Exceptional responders ( n = 6 , 23 % of active treatment group ; none on placebo ) were those with improvements in the top one-third for both tender point pain and global health ratings after 3 months . INTERVENTION Patients took daily oral doses of treatment solution in LM ( 1/50,000 dilution ) potency ( active group received individualized remedy ; placebo group received plain solvent ) . Dependent measures : Baseline and 3-month difference scores for initial prefrontal electroencephalographic alpha frequency cordance ( EEG-C , a correlate of functional brain activity ) during 16 pairs of r and omized , double-blinded bottle sniffs ( treatment minus control solutions ) . RESULTS Exceptional responders versus other patients exhibited significantly more negative initial EEG-C difference scores at prefrontal sites . Right prefrontal cordance findings correlated with subsequently reduced pain ( r = 0.85 , p = 0.03 ) , better global health ( r = -0.73 , p = 0.10 ) , and trait absorption ( genetically determined ability to focus attention selectively and fully ) ( r = 0.91 , p = 0.012 ) . CONCLUSIONS These observations suggest prefrontal EEG-C as an early biomarker of individualized homeopathic medicine effects in patients with FM who later exhibit exceptional outcomes . Prefrontal cortex controls executive function , including ability to redirect attention . Interactions between executive function , absorption , and the simillimum remedy could facilitate exceptional responses",
"An increasing number of parents turn to homeopathy for treatment of their hyperactive child . Two publications , a r and omised , partially blinded trial and a clinical observation study , conclude that homeopathy has positive effects in patients with attention deficit hyperactivity disorder ( ADHD ) . The aim of this study was to obtain scientific evidence of the effectiveness of homeopathy in ADHD . A total of 83 children aged 6–16 years , with ADHD diagnosed using the Diagnostic and Statistical Manual of Mental Disorders-IV criteria , were recruited . Prior to the r and omised , double blind , placebo controlled crossover study , they were treated with individually prescribed homeopathic medications . 62 patients , who achieved an improvement of 50 % in the Conners ’ Global Index ( CGI ) , participated in the trial . Thirteen patients did not fulfill this eligibility criterion ( CGI ) . The responders were split into two groups and received either verum for 6 weeks followed by placebo for 6 weeks ( arm A ) , or vice-versa ( arm B ) . At the beginning of the trial and after each crossover period , parents reported the CGI and patients underwent neuropsychological testing . The CGI rating was evaluated again at the end of each crossover period and twice in long-term follow-up . At entry to the crossover trial , cognitive performance such as visual global perception , impulsivity and divided attention , had improved significantly under open label treatment ( P trial , CGI parent – ratings were significantly lower under verum ( average 1.67 points ) than under placebo ( P = 0.0479 ) . Long-term CGI improvement reached 12 points ( 63 % , P homeopathy in the treatment of attention deficit hyperactivity disorder , particularly in the areas of behavioural and cognitive functions",
"mens . Several treatments were required for each tumour , and injecting alcohol was often associated with considerable pain , whereas our patients did not report pain . These reports did not mention changes seen on ultrasound scans during or immediately after injection , which we found useful in laser treatment . The most important advantage of the laser is its precision . It is unlikely that it will ever be possible to predict the extent of necrosis around a site at which absolute alcohol has been injected with an accuracy comparable to that already possible with the laser technique . In conclusion , interstitial laser hyperthermia is feasible and seems to be safe . A multiple fibre system makes it feasible to treat tumours of clinical ly relevant size in the centre of solid organs . The real challenge for the future will be to develop diagnostic techniques that disclose exactly how far individual tumours extend in a wider range of organs ( unlike the well defined tumours treated in this pilot study ) and to establish the conditions of laser treatment that give complete tumour ablation with safe healing . This combination of technologies may be valuable for treating otherwise untreatable tumours in a range of solid organs and for the primary treatment of small neoplasms such as tumours of the prostate and adrenal gl and",
"OBJECTIVE There is no management regime for chronic fatigue syndrome ( CFS ) that has been found to be universally beneficial and no treatment can be considered a \" cure \" . Patients with CFS may use complementary and alternative medicine ( CAM ) . Our aim was to evaluate homeopathic treatment in reducing subjective symptoms of CFS . METHOD Using a triple-blind design ( patient and homeopath blind to group assignment and data analyst blind to group until after initial analyses to reduce the possibility of bias due to data analyst ) , we r and omly assigned patients to homeopathic medicine or identical placebo . One hundred and three patients meeting the Oxford criteria for CFS were recruited from two specialist hospital out patient departments . Patients had monthly consultations with a professional homeopath for 6 months . Main outcome measures were scores on the subscales of the Multidimensional Fatigue Inventory ( MFI ) and proportions of each group attaining clinical ly significant improvements on each subscale . Secondary outcome measures were the Fatigue Impact Scale ( FIS ) and the Functional Limitations Profile ( FLP ) . Ninety-two patients completed treatment in the trial ( 47 homeopathic treatment , 45 placebo ) . Eighty-six patients returned fully or partially completed posttreatment outcome measures ( 41 homeopathic treatment group who completed treatment , 2 homeopathic treatment group who did not complete treatment , 38 placebo group who completed treatment , and 5 placebo group who did not complete treatment ) . RESULTS Seventeen of 103 patients withdrew from treatment or were lost to follow-up . Patients in the homeopathic medicine group showed significantly more improvement on the MFI general fatigue subscale ( one of the primary outcome measures ) and the FLP physical subscale but not on other subscales . Although group differences were not statistically significant on four out of the five MFI subscales ( the primary outcome measures ) , more people in the homeopathic medicine group showed clinical ly significant improvement . More people in the homeopathic medicine group showed clinical improvement on all primary outcomes ( relative risk=2.75 , P=.09 ) . CONCLUSIONS There is weak but equivocal evidence that the effects of homeopathic medicine are superior to placebo . Results also suggest that there may be nonspecific benefits from the homeopathic consultation . Further studies are needed to determine whether these differences hold in larger sample",
"BACKGROUND Homeopathy is commonly used for the treatment of medical and psychological conditions . Such prevalent use , however , is not supported by robust , method ologically sound research . This study evaluates the effect of homeopathic treatment in generalized anxiety disorder , a prevalent mental disorder characterized by an enduring pattern of excessive apprehension and distress and by mental and bodily complaints . METHOD Forty-four patients with DSM-IV generalized anxiety disorder participated in a r and omized , double-blind , placebo-controlled 10-week trial of individually tailored homeopathic remedy . Homeopathic therapy was administered by an expert who followed the traditional routines of homeopathic diagnosis and prescription . Thirty-nine subjects completed the study ( 20 in the active treatment group and 19 in the placebo group ) . Subjects ' symptoms were rated before treatment and after 5 and 10 weeks of treatment , with the Hamilton Rating Scale for Anxiety ( HAM-A ) as main outcome measure . Additional measures of outcome included the Brief Symptom Inventory , the Psychological General Well-Being Index , the Hamilton Rating Scale for Depression , the Beck Depression Inventory , Spielberger 's State-Trait Anxiety Inventory , and a Visual Analogue Scale of subjective distress . RESULTS Significant ( p HAM-A , was observed in both the active treatment and placebo groups , yet no group effect was observed . CONCLUSION The effect of homeopathic treatment on mental symptoms of patients with generalized anxiety disorder did not differ from that of placebo . The improvement in both conditions was substantial . Improvement of such magnitude may account for the current belief in the efficacy of homeopathy and the current increase in the use of this practice",
"Night shift nurses are subject to shift lag or circadian dysrhythmia , which may result in physical and mental symptoms ranging from fatigue , irritability , depression , and apathy to gastrointestinal , cardiovascular , and sleep disorders . This study investigated the effect a homeopathic remedy No-Shift-Lag had on the night shift nurses in an intensive care unit . The study was a r and omized , double-blind , placebo-controlled , crossover trial . The measures included an objective computer-based vigilance test and a series of subjective question naires",
"More than 40 million American adults snore . Habitual snoring afflicts 44 % of adult males and 28 % of females . Uncomplicated snoring is generally due to vibration of the palatal soft tissues or the tongue base , causing intermittent airway obstruction . Loudness is correlated with the degree of vibration and /or obstruction . The tendency , frequency , duration , intensity , and sequelae of snoring are influenced by myriad structural , physiological , environmental and pharmacological factors . Uncomplicated , nonapneic snoring is treated in a wide variety of ways , ranging from self-help methods , such as positional therapy , to laser surgery . The purpose of this report is to evaluate the safety and efficacy of a natural medication for snoring in a r and omized double-blind placebo-controlled trial . The treatment is significantly more effective than placebo . Neither side effects nor intolerance to the product was reported",
"Fibromyalgia ( FM ) patients show evidence of sensitizability in pain pathways and electroencephalographic ( EEG ) alterations . One proposed mechanism for the cl aim ed effects of homeopathy , a form of complementary medicine used for FM , is time-dependent sensitization ( TDS , progressive amplification ) of host responses . This study examined possible sensitization-related changes in EEG relative alpha magnitude during a clinical trial of homeopathy in FM . A 4-month r and omized , placebo-controlled double-blind trial of daily orally administered individualized homeopathy in physician-confirmed FM , with an additional 2-month optional crossover phase , included three laboratory sessions , at baseline , 3 and 6 months ( N = 48 , age 49.2 ± 9.8 years , 94 % women ) . Nineteen leads of EEG relative alpha magnitude at rest and during olfactory administration of treatment and control solutions were evaluated in each session . After 3 months , the active treatment group significantly increased , while the placebo group decreased , in global alpha-1 and alpha-2 during bottle sniffs over sessions . At 6 months , the subset of active patients who stayed on active continued to increase , while the active-switch subgroup reversed direction in alpha magnitude . Groups did not differ in resting alpha . Consistent with the TDS hypothesis , sniff alpha-1 and alpha-2 increases at 6 months versus baseline correlated with total amount of time on active remedy over all subjects ( r = 0.45 , p = .003 ) , not with dose changes or clinical outcomes in the active group . The findings suggest initiation of TDS in relative EEG alpha magnitude by daily oral administration of active homeopathic medicines versus placebo , with laboratory elicitation by temporolimbic olfactory stimulation or sniffing",
"Alternative therapies in general , and homeopathy in particular , lack clear scientific evaluation of efficacy . Controlled clinical trials are urgently needed , especially for conditions that are not helped by conventional methods . The objective of this work was to assess the efficacy of homeopathic treatment in relieving symptoms associated with premenstrual syndrome ( PMS ) . It was a r and omised controlled double-blind clinical trial . Two months baseline assessment with post-intervention follow-up for 3 months was conducted at Hadassah Hospital outpatient gynaecology clinic in Jerusalem in Israel 1992 - 1994 . The subjects were 20 women , aged 20 - 48 , suffering from PMS . Homeopathic intervention was chosen individually for each patient , according to a model of symptom clusters . Recruited volunteers with PMS were treated r and omly with one oral dose of a homeopathic medication or placebo . The main outcome measure was scores of a daily menstrual distress question naire ( MDQ ) before and after treatment . Psychological tests for suggestibility were used to examine the possible effects of suggestion . Mean MDQ scores fell from 0.44 to 0.13 ( P Improvement > 30 % was observed in 90 % of patients receiving active treatment and 37.5 % receiving placebo ( P=0.048 ) . Homeopathic treatment was found to be effective in alleviating the symptoms of PMS in comparison to placebo . The use of symptom clusters in this trial may offer a novel approach that will facilitate clinical trials in homeopathy . Further research is in progress",
"OBJECTIVES The aim of this study was to carry out a preliminary trial evaluating the effectiveness of homeopathy in the treatment of attention-deficit/hyperactivity disorder ( ADHD ) . DESIGN This work was a r and omized , double-blind , placebo-controlled trial . SETTING S/LOCATION This study was conducted in a private homeopathic clinic in the Seattle metropolitan area . SUBJECTS Subjects included children 6 - 12 years of age meeting Diagnostic and Statistical Manual of Mental Disorders 4th edition ( DSM-IV ) criteria for ADHD . INTERVENTIONS Forty-three subjects were r and omized to receive a homeopathic consultation and either an individualized homeopathic remedy or placebo . Patients were seen by homeopathic physicians every 6 weeks for 18 weeks . OUTCOME MEASURES Outcome measures included the Conner 's Global Index-Parent , Conner 's Global Index- Teacher , Conner 's Parent Rating Scale-Brief , Continuous Performance Test , and the Clinical Global Impression Scale . RESULTS There were no statistically significant differences between homeopathic remedy and placebo groups on the primary or secondary outcome variables . However , there were statistically and clinical ly significant improvements in both groups on many of the outcome measures . CONCLUSIONS This pilot study provides no evidence to support a therapeutic effect of individually selected homeopathic remedies in children with ADHD . A therapeutic effect of the homeopathic encounter is suggested and warrants further evaluation . Future studies should be carried out over a longer period of time and should include a control group that does not receive the homeopathic consultation . Comparison to conventional stimulant medication for ADHD also should be considered"
] | 41167c8e-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Headache is a common medical problem . In view of recent discoveries about the role of serotonin in pain mechanisms , selective serotonin re-uptake inhibitors ( SSRIs ) have been evaluated for the prevention of migraine and tension-type headaches ( TTH ) . OBJECTIVES To evaluate the efficacy and tolerability of SSRIs for preventing migraine and TTH . SEARCH STRATEGY We search ed MEDLINE ( 1966 - 2004 ) , EMBASE ( 1994 - 2003 ) , the Cochrane Central Register of Controlled Trials ( Issue 4 , 2003 ) , and reference lists of retrieved articles . Headache Quarterly was h and search ed from 1990 to 2003 . SELECTION CRITERIA We included r and omised controlled trials comparing SSRIs with any type of control intervention in patients of either sex , over 18 years of age , with migraine or TTH . DATA COLLECTION AND ANALYSIS Two authors independently extracted data ( headache frequency , index , severity , and duration ; use of symptomatic/analgesic medication ; days off work ; quality of life ; mood improvement ; cost-effectiveness ; and adverse events ) and assessed the method ological quality of trials . MAIN RESULTS Thirteen studies utilizing five SSRIs met the inclusion criteria ( 636 participants ) . Most of the included studies had method ological and /or reporting shortcomings ; follow up rarely extended beyond 3 months . After 2 months SSRIs did not significantly lower headache index scores in patients with migraine when compared to placebo ( SMD -0.14 ; 95 % CI -0.57 to 0.30 ) . Patients with chronic TTH treated with an SSRI had a significantly higher analgesic intake of 5 more doses per month when compared to patients treated with a tricyclic antidepressant ( WMD 4.98 ; 95 % CI 1.12 to 8.84 ) . Tricyclics also significantly reduced headache duration by 1.26 hours per day ( WMD 1.26 ; 95 % CI 0.06 to 2.45 ) and marginally reduced headache indexes ( SMD 0.42 ; 95 % CI 0.00 to 0.85 ) when compared to SSRIs in patients with chronic TTH . When the data on adverse events were considered without regard to headache diagnostic subgroups , there were no significant differences between SSRIs and placebo for withdrawals due to adverse events ( Peto OR 1.02 ; 95 % CI 0.31 to 3.34 ) . For minor adverse events , SSRIs were generally more tolerable than tricyclics ( OR 0.34 ; 95 % CI 0.13 to 0.92 ) . However , there were no differences in the number of patients withdrawing due to any reason in the SSRI and tricyclic groups ( OR 1.01 ; 95 % CI 0.56 to 1.80 ) . AUTHORS ' CONCLUSIONS Over 2 months of treatment , SSRIs are no more efficacious than placebo in patients with migraine . In patients with chronic TTH , SSRIs are less efficacious than tricyclic antidepressants . In comparison with SSRIs , the burden of adverse events in patients receiving tricyclics was greater . These results are based on short-term trials and may not generalise to longer-term treatment | [
"Current treatment of migraine either abortive or prophylactic is often unsatisfactory . Prophylactic treatment of severe migraine may reduce attack frequency , and current therapy centers on beta-blockers , serotonin ( 5-HT ) reuptake blockers and 5-HT2 receptor antagonists . The author compared the efficacy and safety of amitriptyline and fluvoxamine among migraine patients ( 24F , 8 M vs. 23F , 9 M ) in a double blind study . The efficacy of amitriptyline has already been established by earlier clinical studies . The other investigated drug , fluvoxamine , has a more selective 5-HT reuptake blocking property than amitriptyline . In this study , amitriptyline significantly reduced the number of headache attacks , but it caused severe drowsiness in many migraineurs . The fluvoxamine also favorably influenced on the number of headache attacks and caused only slight side effects . These findings suggest , that fluvoxamine may be an alternative drug in migraine prophylaxis , however , further studies should be performed with more subjects",
"UNLABELLED Selective serotonin reuptake inhibitors have recently been used in the treatment of migraine . OBJECTIVE We studied the safety and efficacy of fluoxetine in the prevention of migraine . PATIENTS Between February 1997 and December 1997 , we examined 52 patients ( 33 women ) at the Headache Diagnosis and Therapy Service of the Second University of Naples . Ages ranged from 18 to 65 years , and all patients suffered from migraine without aura according to IHS 1988 criteria . The sample was divided into two groups : group A included 32 patients ( 19 women ; mean age , 36.8 years [ SD 12.4 ] ) who received fluoxetine at a dosage of 20 mg per day ; group B included 20 patients ( 14 women ; mean age , 38.8 years [ SD 15.6 ] ) who received placebo . METHODS Our study was a single-center , r and omized , double-blind , parallel study of fluoxetine for the prophylactic control of migraine and consisted of two phases : 30 days of pharmacological wash out and 6 months of therapy with monthly follow-up . Patients were r and omly assigned to two groups : A , fluoxetine or B , placebo . At the first visit , patients provided a detailed history and underwent neurological evaluation and a Zung test for depression . No pathological values were revealed . In order to monitor symptomatology , all patients received a form for the calculation of the total pain index at monthly follow-up . RESULTS A comparison of the total pain index between basal values ( calculated during the period of wash out ) and monthly follow-up ( calculated monthly during the period of 6 months of the therapy ) showed significant reduction ( P fluoxetine in the treatment of migraine",
"Abstract Patients with chronic tension- type headache ( CTTH ) are the most difficult to treat . Tricyclic antidepressants are the first-line therapeutic agents , but their anticholinergic side effects limit their usage . Selective serotonin reuptake inhibitors ( SSRI ) with fewer side effects than tricyclic antidepressants have also been used in treatment of CTTH , but the results are conflicting . In this study , prophylactic action of sertraline in treatment of nondepressed patients with CTTH was investigated and compared with amitriptyline in a prospect i ve , r and omized , open label , parallel-group study . A 4-week baseline period was followed by a 12-week treatment period with either 50 mg sertraline ( n=41 patients ) or 25 mg amitriptyline ( n=44 patients ) . Efficacies of treatments were determined by using a headache diary , in which patients recorded the occurrence , number , intensity and duration of headaches in days , analgesic drug consumption and any adverse events . Both drugs reduced headache symptoms and analgesic drug consumption at the first , second and third months of treatment compared to baseline values . There was significant superiority of amitriptyline in the headache symptoms and drug consumption reductions versus sertraline at the second and third months of treatment . Side effects were more favorable in the sertraline-treated patients , but dropouts were similar in both groups . These results suggest that both drugs were effective in the treatment of non-depressed patients with CTTH , but in comparison between groups , amitriptyline was more effective than sertraline",
"Amitriptyline , which is a noradrenaline reuptake and 5-HT reuptake inhibitor , has an established role in the management of chronic tension-type headaches . In a single-blind study , patients with chronic tension-type headache were r and omized to either fluoxetine 20 mg ( a selective 5-HT reuptake inhibitor ) or desipramine 75 mg ( a selective noradrenaline reuptake inhibitor ) and followed for 12 weeks to compare the effectiveness of the two drugs in improving headache , and to assess whether pain control is related to changes in depression . Patients were evaluated at weekly intervals on an analog pain-rating scale and at 4-weekly intervals on the Montgomery and Asberg Depression Rating Scale ( MADRS ) , the MOS general health status question naire ( SF36 ) , the Hospital Anxiety and Depression Scale ( HADS ) , and a side effects checklist . Eighteen patients were r and omized to take fluoxetine and 19 to take desipramine . Of the 25 patients who completed the trial , 12 were on fluoxetine and 13 were on desipramine . There was no significant difference between the two groups at baseline nor in change of pain ; reduction in use of analgesic medication ; nor change in the HADS , MADRS , or SF36 scores at 12 weeks , but 72 % of patients who completed the study improved , and this improvement almost exactly mirrored the improvement on the MADRS . The results from this trial are compatible with the notion that the beneficial effect of antidepressants in chronic tension-type headache is indirect , mediated by an effect on depression , and not more , dependent on serotonin reuptake inhibition than noradrenaline reuptake inhibition",
"SYNOPSIS",
"Neuropathic pain treatment remains unsatisfactory despite a substantial increase in the number of trials . This EFNS Task Force aim ed at evaluating the existing evidence about the pharmacological treatment of neuropathic pain . Studies were identified using first the Cochrane Data base then Medline . Trials were classified according to the aetiological condition . All class I and II controlled trials ( according to EFNS classification of evidence ) were assessed , but lower‐class studies were considered in conditions that had no top level studies . Only treatments feasible in an outpatient setting were evaluated . Effects on pain symptoms/signs , quality of life and comorbidities were particularly search ed for . Most of the r and omized controlled trials included patients with postherpetic neuralgia ( PHN ) and painful polyneuropathies ( PPN ) mainly caused by diabetes . These trials provide level A evidence for the efficacy of tricyclic antidepressants , gabapentin , pregabalin and opioids , with a large number of class I trials , followed by topical lidocaine ( in PHN ) and the newer antidepressants venlafaxine and duloxetine ( in PPN ) . A small number of controlled trials were performed in central pain , trigeminal neuralgia , other peripheral neuropathic pain states and multiple‐aetiology neuropathic pains . The main peripheral pain conditions respond similarly well to tricyclic antidepressants , gabapentin , and pregabalin , but some conditions , such as HIV‐associated polyneuropathy , are more refractory . There are too few studies on central pain , combination therapy , and head‐to‐head comparison . For future trials , we recommend to assess quality of life and pain symptoms or signs with st and ardized tools",
"OBJECTIVES : Although the tricyclic antidepressant amitriptyline is extensively used in the prophylactic treatment of chronic tension-type headache , only few studies have investigated the efficacy of this treatment and the results are contradictory . In addition , the new selective serotonin reuptake inhibiting antidepressants , which are widely used in depression and of potential value in pain management , have never been investigated in a placebo controlled study of tension-type headache . The aim was to evaluate the efficacy of amitriptyline and of the selective serotonin reuptake inhibitor citalopram in chronic tension-type headache . METHODS : Forty non-depressed patients with chronic tension type headache were included in a 32 week , double blind , placebo controlled , three-way crossover study . RESULTS : Thirty four patients completed the trial . Amitriptyline reduced area under the headache curve by 30 % compared with placebo ( P = 0.002 ) , whereas citalopram had no significant effect ( P = 0.68 ) . Explanatory analyses showed that amitriptyline significantly reduced the duration of headache ( P = 0.01 ) , headache frequency ( P = 0.01 ) , and intake of analgesics ( P = 0.02 ) but not headache intensity ( P = 0.12 ) . CONCLUSION : Although amitriptyline did not eliminate the headache , it provided a clinical ly important reduction of headache in the majority of otherwise treatment resistant patients . The differential effect of amitriptyline and citalopram indicates that mechanisms other than inhibition of serotonin reuptake are involved in the analgesic effect of the tricyclic antidepressants . Amitriptyline , but not citalopram , is valuable in the prophylactic treatment of chronic tension type headache",
"Background and Objectives .—Antidepressants are often used to treat chronic daily headache disorders such as transformed migraine , in part because of the high prevalence of associated mood disorder . We conducted this study to evaluate the efficacy and tolerability of combined treatment with amitriptyline and fluoxetine compared with amitriptyline alone for chronic daily headache due to transformed migraine",
" Forty out- patients affected by chronic tension-type headache were selected according to the diagnostic criteria of International Headache Society ( IHS ) Headache Classification Committee . In a controlled trial patients received placebo for a four-week baseline period , then they were r and omized in double-blind fashion to therapy with mianserine ( 30 - 60 mg/day ) of fluvoxamine ( 50 - 100 mg/day ) for another eight-week period . Frequency of headache , pain severity and analgesic consumption were evaluated using a self-monitoring system . Mood depression was evaluated at 0 , 4 and 8 weeks by using Zung 's Self-Rating Depression Scale and Hamilton Rating Scale for Depression . Both drugs were beneficial in the treatment of chronic tension-type headache . Non-depressed subjects with more severe headache responded best to fluvoxamine , whereas mianserine was more effective in the treatment of depressed patients with moderate headache . These results suggest that central serotoninergic neurotransmission can play a role in the pathophysiology of chronic tension-type headache also in non-depressed patients",
"SYNOPSIS",
" Many patients with severe migraine remain refractory to the current treatment regimens or can not tolerate the side effects . Since current research implicates serotonin dysregulation in migraine pathogenesis , we investigated in a double blind , placebo controlled study the prophylactic effect of the serotonergic drug fluoxetine . Sixteen subjects were r and omly assigned to 8 week fluoxetine treatment and 16 to the placebo group ; nine subjects in each group completed the study . Migraine headache scores were obtained for two weeks prior to commencement of treatment , and then for each successive two week period . Zung depression scores were obtained before and after completion of the study . Fluoxetine caused significant reduction in headache scores starting with weeks 3 - 4 of treatment ; there was no significant change with placebo . Depression scores did not differ between groups before treatment , and did not significantly change with either treatment . Fluoxetine appears to be a safe and effective drug for migraine prophylaxis , and deserves further therapeutic trials with larger groups for longer periods of time",
"SYNOPSIS We examined the socio-economic consequences of headache in a r and om sample of 514 working people living inthe Republic of San Marino . Our results show that , in the preceding year , 255 out of 514 ( 49.6 % ) suffered fromheadache ; 31.9 % ( 164/514 ) reported decreased efficiency as a consequence of headache ; 9.3 % ( 48/514 ) reportedthat head pain is always severe ; 7.4 % ( 38/514 ) were absent from work because of headache for a total of 338working days lost ; 8.4 % of all working days lost to illness were due to headache . We estimated that in the Republic of San Marino ( 21,792 inhabitants ) , headache causes a loss of at least 5,000working days every year . Since the cost of a working day in the Republic of San Marino is about 100,000 italianlire , the economic burden in this area amounts to 500 millions of lire in a year . This shows that headache is amajor socio-medical problem",
" The prophylactic effect in migraine of femoxetine , a 5‐HT‐uptake inhibitor , was compared to that of placebo in a double‐blind group‐comparative study . A total of 59 patients , referred to the department from general practitioners , was stratified according to age , sex , duration , and frequency of attacks and then allocated at r and om to treatment with either femoxetine or placebo . Each patient was treated for 12 weeks with 200 mg in the first week and 300 in the remaining weeks . Ten patients on femoxetine and four patients on placebo failed to complete the study",
"SYNOPSIS",
"The objective of this study was to assess the efficacy of sertraline in migraine prophylaxis . Other selective serotonin reuptake inhibitors have been studied for migraine prophylaxis , but this is the first report with sertraline . Twenty-seven subjects were enrolled and baseline assessment of migraine frequency and severity were measured over a 4-week period . Subjects were then r and omized to receive placebo or sertraline in a double-blind fashion with headache frequency and severity measured over an 8-week period . Subjects completed a daily diary reporting the occurrence , severity , and degree of impairment associated with migraine . The headache index , a composite measure of migraine frequency and severity , scores did not significantly improve between assessment s at baseline ( 20.8 + /- 14.88 ) , 8 weeks ( 17.6 + /- 12.27 ) , and 12 weeks ( 16.7 + /- 6.38 ) in the treatment group ( n=6 ) ( P=0.956 ) . This finding is compared to other studies with the serotonin selective reuptake inhibitors , fluoxetine , fluvoxamine , and paroxetine . The authors believe that the selective serotonin reuptake inhibitors are not as effective as conventional migraine prophylaxis medications such as beta-blockers , tricyclic antidepressants , or divalproex sodium , but that in patients with comorbid depression who have failed conventional therapy selective serotonin reuptake inhibitors may be effective",
"ABSTRACT — In a r and omized general practice study , the prophylactice effect of femoxetive ( a 5HT uptake inhibitor ) was compared with placebo in migraine patients . Treatment , with separate r and omization schedules in each practice , was allocated to 65 patients . Each patient was treated for 16 weeks with 200 mg increasing during the first nine days to 600 mg daily . No effect of femoxetine could be demonstrated in attack frequency and headache index . Separate analysis of maximum reduction in serotonin concentration during treatment revealed no difference in efficacy when compared with placebo . This supports earlier studies that femoxetine generally exerts no prophylactic effect on migraine , and the hypothesis that platelet 5HT might be of major importance in the pathogenesis of migraine is not supported",
"objectiue This article estimates lost work days and lost work day equivalents in a population sample of migraineurs , differentiating work loss due to headache episodes that met criteria for migraine from migrainous headaches not meeting full criteria and nonmigrainous headaches . Methods A r and om digit dialing survey of 5,071 adults identified 800 subjects with migraine headaches . By clinical examination , a sub sample of 225 met migraine diagnostic criteria ; 174 of these patients completed at least 11 weeks of daily diaries . This report concerns the subgroup of 122 individuals with regular paid employment . Subjects completed a daily diary over a 3-month period to assess the occurrence of headaches and International Headache Society ( IHS ) criteria for each headache occurrence . We report estimates of lost work days and lost work day equivalents by type of headache . Results Participants reported headaches on 8.1 work days , of which 2.2 headache days met criteria for migraine ( IHS 1.1 , 1.2 ) , and an additional 2.1 headache days were migrainous without meeting full migraine criteria ( IHS 1.7 ) . On average , migraineurs missed 1.1 days of work due to headache in 3 months , of which 0.7 lost work days were due to migraine and 0.3 were due to migrainous headaches . When at work with headache , work effectiveness was reduced 41 % for migraine headaches , 28 % for migrainous headaches , and 24 % for other headaches . Over 3 months , migraineurs experienced an average of 3.0 lost work day equivalents , of which 1.4 were due to migraine and an additional 0.7 were due to migrainous headaches . The most disabled 20 % of the participants accounted for 77 % of the lost work days ; 40 % of subjects accounted for 75 % of the lost work day equivalents . Conclusions Employed migraine sufferers experienced considerable work loss and reduced work performance due to headache . The most severely affected migraineurs accounted for most of the reduced work performance . Targeting the most severely affected persons may be necessary to reduce work loss among migraineurs substantially . NEUROLOGY",
"The prophylactic effect of the 5-HT uptake inhibitor femoxetine was compared with propranolol ( Frekven R ) in a double-blind crossover trial of 6 months duration . Forty-nine patients commenced the trial . Twelve patients withdrew because of drug failure or failure to attend checkups ( 6 ) , side effects ( 4 ) or other non-drug related causes ( 2 ) . In the 37 patients who completed the trial there was no significant difference between propranolol 160 mg and femoxetine 400 mg with respect to the number of headache days or the number of migraine attacks during the last 2 months of each treatment , Propranolol , however , was superior to femoxetine when the headache index was used ( P less than 0.05 ) . The study has shown that partial depletion of thrombocyte 5-HT by a 5-HT uptake inhibitor does not lead to a marked improvement in all patients contrary to what might be expected from the 5-HT hypothesis of migraine . Nevertheless , due to the infrequent subjective side effects associated with femoxetine treatment it may be a valuable prophylactic drug to a subgroup of migraine patients"
] | 41167cd4-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Task sharing for the management of hypertension could be useful for understaffed and re source -poor health systems . We assessed the effectiveness of task-sharing interventions in improving blood pressure control among adults in low-income and middle-income countries . METHODS We search ed the Cochrane Library , PubMed , Embase , and CINAHL for studies published up to December 2018 . We included intervention studies involving a task-sharing strategy for management of blood pressure and other cardiovascular risk factors . We extracted data on population , interventions , blood pressure , and task sharing groups . We did a meta- analysis of r and omised controlled trials . FINDINGS We found 3012 references , of which 54 met the inclusion criteria initially . Another nine studies were included following an up date d search . There were 43 trials and 20 before- and -after studies . We included 31 studies in our meta- analysis . Systolic blood pressure was decreased through task sharing in different groups of health-care workers : the mean difference was -5·34 mm Hg ( 95 % CI -9·00 to -1·67 , I2=84 % ) for task sharing with nurses , -8·12 mm Hg ( -10·23 to -6·01 , I2=57 % ) for pharmacists , -4·67 mm Hg ( -7·09 to -2·24 , I2=0 % ) for dietitians , -3·67 mm Hg ( -4·58 to -2·77 , I2=24 % ) for community health workers , and -4·85 mm Hg ( -6·12 to -3·57 , I2=76 % ) overall . We found a similar reduction in diastolic blood pressure ( overall mean difference -2·92 mm Hg , -3·75 to -2·09 , I2=80 % ) . The overall quality of evidence based on GRADE criteria was moderate for systolic blood pressure , but low for diastolic blood pressure . INTERPRETATION Task-sharing interventions are effective in reducing blood pressure . Long-term studies are needed to underst and their potential impact on cardiovascular outcomes and mortality . FUNDING Wellcome Trust/DBT India Alliance | [
"Background Countries in sub-Saharan Africa ( SSA ) are experiencing an epidemic of cardiovascular disease ( CVD ) propelled by rapidly increasing rates of hypertension . Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs . Although SSA bears 24 % of the global disease burden , it has only 3 % of the global health workforce . Given such limited re sources , cost-effective strategies , such as task shifting , are needed to mitigate the rising CVD epidemic in SSA . Ghana , a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization ( WHO ) task-shifting strategy . This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage , on blood pressure ( BP ) reduction . Methods Using a cluster r and omized design , 32 community health centers ( CHCs ) and district hospitals in Ghana will be r and omized to either the intervention group ( 16 CHCs ) or the control group ( 16 CHCs ) . A total of 640 patients with uncomplicated hypertension ( BP 140–179/90–99 mm Hg and absence of target organ damage ) will be enrolled in this study ( 20 patients per CHC ) . The intervention consists of WHO Package of CV risk assessment , patient education , initiation and titration of antihypertensive medications , behavioral counseling on lifestyle behaviors , and medication adherence every three months for 12 months . The primary outcome is the mean change in systolic BP from baseline to 12 months . The secondary outcomes are rates of BP control at 12 months ; levels of physical activity , percent change in weight , and dietary intake of fruits and vegetables at 12 months ; and sustainability of intervention effects at 24 months . All outcomes will be assessed at baseline , six months and 12 months . Trained community health nurses will deliver the intervention as part of Ghana ’s community-based health planning and services ( CHPS ) program . Discussion Findings from this study will provide policy makers and other stakeholders needed information to recommend scalable and cost-effective policy with respect to comprehensive CV risk reduction and hypertension control in re source -poor setting s . Trial registration NCT01802372",
"Background The high burden of undetected and undertreated hypertension and diabetes mellitus is a major health challenge worldwide . The mPower Heart Project aim ed to develop and test a feasible and scalable intervention for hypertension and diabetes mellitus by task‐sharing with the use of a mobile phone – based clinical decision support system at Community Health Centers in Himachal Pradesh , India . Methods and Results The development of the intervention and mobile phone – based clinical decision support system was carried out using mixed methods in five Community Health Centers . The intervention was subsequently evaluated using pre – post evaluation design . During intervention , a nurse care coordinator screened , examined , and entered patient parameters into mobile phone – based clinical decision support system to generate a prescription , which was vetted by a physician . The change in systolic blood pressure , diastolic blood pressure , and fasting plasma glucose ( FPG ) over 18 months of intervention was quantified using generalized estimating equations models . During intervention , 6797 participants were enrolled . Six thous and sixteen participants had hypertension ( mean systolic blood pressure : 146.1 mm Hg , 95 % CI : 145.7 , 146.5 ; diastolic blood pressure : 89.52 mm Hg , 95 % CI : 89.33 , 89.72 ) , of which 3152 ( 52 % ) subjects were newly detected . Similarly , 1516 participants had diabetes mellitus ( mean FPG : 177.9 mg/dL , 95 % CI : 175.8 , 180.0 ) , of which 450 ( 30 % ) subjects were newly detected . The changes in systolic blood pressure , diastolic blood pressure , and FPG observed at 18 months of follow‐up were −14.6 mm Hg ( 95 % CI : −15.3 , −13.8 ) , −7.6 mm Hg ( CI : −8.0 , −7.2 ) , and −50.0 mg/dL ( 95 % CI : −54.6 , −45.5 ) , respectively , and were statistically significant even after adjusting for age , sex , and Community Health Center . Conclusions A nurse‐facilitated , mobile phone – based clinical decision support system‐enabled intervention in primary care was associated with improvements in blood pressure and blood glucose control and has the potential to scale‐up in re source poor setting s. Clinical Trial Registration URL : https://www . clinical trials.gov . Unique identifiers : NCT01794052 . Clinical Trial Registry — India : CTRI/2013/02/003412",
"OBJECTIVE To evaluate a simple cardiovascular risk management package for assessing and managing cardiovascular risk using hypertension as an entry point in primary care facilities in low-re source setting s. METHODS Two geographically distant regions in two countries ( China and Nigeria ) were selected and 10 pairs of primary care facilities in each region were r and omly selected and matched . Regions were then r and omly assigned to a control group , which received usual care , or to an intervention group , which applied the cardiovascular risk management package . Each facility enrolled 60 consecutive patients with hypertension . Intervention sites educated patients about risk factors at baseline and initiated treatment with hydrochlorothiazide at 4 months in patients at medium risk of a cardiovascular event , according to a st and ardized treatment algorithm . Systolic blood pressure change from baseline to 12 months was the primary outcome measure . FINDINGS The study included 2397 patients with baseline hypertension : 1191 in 20 intervention facilities and 1206 in 20 control facilities . Systolic and diastolic blood pressure decreased more in intervention patients than in controls . However , at 12 months more than half of patients still had uncontrolled hypertension ( systolic blood pressure > 140 mmHg and /or diastolic blood pressure > 90 mmHg ) . Behavioural risk factors had improved among intervention patients in Nigeria but not in China . Only about 2 % of hypertensive patients required referral to the next level of care . CONCLUSION Even in low-re source setting s , hypertensive patients can be effectively assessed and managed in primary care facilities",
"BACKGROUND Coronary artery disease is a major cause of morbidity and mortality among adults worldwide , including China . After a hospital stay , transitional care could help to ensure improved patient care and outcomes , and reduce Medicare costs . Nevertheless , the results of the existing transitional care are not always satisfactory and our knowledge of how to perform effective transitional care for patients with coronary artery disease is limited in mainl and China . OBJECTIVES To examine the effectiveness of a nurse-led transitional care program on clinical outcomes , health-related knowledge , and physical and mental health status among Chinese patients with coronary artery disease . DESIGN R and omized controlled trial . METHODS The Omaha system and Pender 's health promoting model were employed in planning and implementing this nurse-led transitional care program . The sample was comprised of 199 Chinese patients with coronary artery disease . The experimental group ( n=100 ) received nurse-led transitional care intervention in addition to routine care . The nurse-led transitional care intervention included a structured assessment and health education , followed by 7 months of individual teaching and coaching ( home visits , telephone follow-up and group activity ) . The control group ( n=99 ) received a comparable length routine care and follow-up contacts . Evaluations were conducted at baseline and completion of the interventions using the perceived knowledge scale for coronary heart disease , the medical outcomes study 36-item short-form health survey and clinical measures ( blood pressure , blood glucose , lipids , body mass index ) . Data were collected between March and October 2014 . RESULTS Compared with the control group , participants in the experimental group showed significant better clinical outcomes ( systolic blood pressure , t=5.762 , P=0.000 ; diastolic blood pressure , t=4.250 , P=0.000 ; fasting blood glucose , t=2.249 , P=0.027 ; total cholesterol , t=4.362 , P=0.000 ; triglyceride , t=3.147 , P=0.002 ; low density lipoprotein cholesterol , t=2.399 , P=0.018 ; and body mass index , t=3.166 , P=0.002 ) , higher knowledge scores for coronary artery disease ( total knowledge score , t=-7.099 , P=0.000 ) , better physical health status ( t=-2.503 , P=0.014 ) and mental health status ( t=-2.950 , P=0.004 ) . CONCLUSIONS This study provides evidence for the value of a nurse-led transitional care program using both the Omaha system and Pender 's health promoting model as its theoretical framework . The structured interventions in this nurse-led transitional care program facilitate the use of this program in other setting",
"Background : Lifestyle factors such as weight , salt intake , and physical activity have shown to be important in treating hypertension . The object of this study was to describe feasibility and to assess the effectiveness of a multicomponent lifestyle intervention on high blood pressure ( BP ) of Iranian women . Material s and Methods : This r and omized controlled trial was conducted in four health centers by recruiting 161 women aged 35 - 65 years with high BP and r and omizing them to a 4-week lifestyle modification ( n = 80 ) or control group ( n = 81 ) . BP level and other health behavioral factors were assessed before and after the 4-week intervention and also after 6 months . Results : The mean systolic BP changed from 158.8 ( ±8.1 ) mmHg to 153.2 ( ±6.4 ) mmHg during 4-week and to 145.5 ( ±4.6 ) ) mmHg after 6 months in the intervention group ( P between systolic BP ( SBP ) and diastolic BP ( DBP ) with weight , body mass index , waist circumference , salt intake , and physical activity level ( P the weight , dietary salt intake , and physical activity level were significant predictors of SBP and DBP . Conclusion : The results of this study suggest that lifestyle modification program is associated with improvements in BP level in Iranian women",
"BACKGROUND Adherence to drugs and healthy lifestyles is low after acute coronary syndrome . We assessed whether trained community health workers could improve adherence to drugs , lifestyle changes , and clinical risk markers in patients with acute coronary syndrome in India . METHODS In this study done at 14 hospitals in India we r and omly assigned ( 1:1 ) patients with acute coronary syndrome 1 or 2 days before discharge from hospital to a community health worker-based intervention group or a st and ard care group . Patients were r and omly assigned with a telephone r and omisation service . In the intervention group , during four in-hospital and two home visits , community health workers used unstructured discussion s , visual methods , and patient diaries to educate patients on healthy lifestyle and drugs , and measures to enhance adherence . The primary outcome was adherence to proven secondary prevention drugs ( antiplatelet drugs , β blockers , angiotensin-converting enzyme inhibitors or angiotensin receptor blockers , and statins ) estimated using a Composite Medication Adherence Scale at 1 year . The secondary outcomes were difference in lifestyle factors ( diet , exercise , and tobacco and alcohol use ) , and clinical risk markers ( blood pressure , bodyweight , BMI , heart rate , and lipids ) . All analyses were by intention to treat . This trial is registered with the Clinical Trial Registry of India , number REF/2013/03/004737 , and Clinical Trials.gov , number NCT01207700 . RESULTS Between Aug 23 , 2011 , and June 25 , 2012 , 806 participants were r and omly assigned ( 405 to a community health worker-based intervention group and 401 to a st and ard care group ) . At 1 year , 40 patients had died and 15 had discontinued or been lost to follow-up , so 750 ( 93 % ) were included in the analyses ( 375 in each group ) . Secondary prevention drugs prescribed at discharge were 98 % ( 786/803 ) for any antiplatelet drug , 79 % ( 638/803 ) for dual antiplatelet drugs , 69 % ( 555/803 ) for β blockers , 69 % ( 552/803 ) for angiotensin-converting enzyme inhibitors and angiotensin receptor blockers , and 95 % ( 762/803 ) for statins . At one year , overall adherence ( ≥80 % ) to prescribed evidence -based drugs was higher in the intervention group than in the control group ( 97 % vs 92 % , odds ratio [ OR ] 2·62 , 95 % CI 1·32 - 5·19 ; p=0·006 ) . For individual drugs , we recorded significant differences for angiotensin-converting enzyme inhibitors and angiotensin receptor blockers ( 97 % [ 233/240 ] in the intervention group vs 93 % [ 223/240 ] in the control group ; p=0·036 ) and statins ( 97 % [ 346/356 ] vs 93 % [ 321/345 ] ; p=0·011 ) . The intervention group had significantly greater adherence to smoking cessation ( 85 % [ 110/129 ] vs 52 % [ 71/138 ] , OR 5·46 , 95 % CI 3·03 - 9·86 ; p ( 89 % [ 333/375 ] vs 60 % [ 226/375 ] , OR 5·23 , 95 % CI 3·57 - 7·66 ; p healthy diet ( score 5·0 vs 3·0 , OR 2·47 , 95 % CI 1·88 - 3·25 ; p ) . More patients in the intervention group had stopped alcohol use at 1 year ( 87 % [ 64/74 ] vs 46 % [ 46/67 ] , OR 2·92 , 95 % CI 1·26 - 6·79 ; p = 0·010 ) . At 1 year , the mean systolic blood pressure ( 124·4 mm Hg [ SD 13·5 ] vs 128·0 mm Hg [ 15·9 ] ; p=0·002 ) , weight ( 65·0 kg [ 11·0 ] vs 66·5 kg [ 11·5 ] ; p , cholesterol ( 157·0 [ 40·2 ] vs 166·9 [ 48·4 ] ; p=0·184 ) , LDL ( 81·0 [ 20·6 ] vs 87·3 [ 29·9 ] ; p=0·191 ) , HDL ( 42·0 [ 11·4 ] vs 38·2 [ 6·5 ] ; p=0·042 ) , and BMI ( 24·4 kg/m(2 ) [ SD 3·7 ] vs 25·0 kg/m(2 ) [ 3·8 ] ; p the intervention group than in the control group . However , we noted no significant difference in diastolic blood pressure and heart rate . INTERPRETATION A community health worker-based personalised intervention strategy in patients with acute coronary syndrome improved adherence to evidence -based drugs and healthy lifestyles , and result ed in an improvement in clinical risk markers . Integration of trained community health workers can improve secondary prevention in coronary artery disease . FUNDING US National Heart , Lung , and Blood Institute ( NHLBI ) , National Institutes of Health , Department of Health and Human Services , and the UnitedHealth group , USA",
"BACKGROUND Given the paucity of neurologists in Sub-Saharan Africa ( SSA ) , task-shifting post-stroke care to nurses could be a viable avenue for enhancing post-stroke outcomes . This pilot study assessed the feasibility and short-term impact of a nurse-led intervention to manage blood pressure ( BP ) control in recent stroke survivors in Nigeria . METHODS A r and omized pilot trial allocated patients within one month of an index stroke from two participating hospitals in Nigeria to either nurse-led group clinic or st and ard care for 14days . Key study endpoints were successful execution of the protocol , subject retention , and short-term BP effects . RESULTS There were no significant differences between the intervention ( n=17 ) and control ( n=18 ) groups at baseline . At the post-intervention clinic , patient retention rate was 100 % . In the intervention group , both the systolic and diastolic BPs measured at home were lower than the clinic BPs post-intervention ( 127±12.88/78.13±19.26mmHg versus 137.50±23.05/84.06±9.67mmHg ; p=0.05 ) . However , there was no significant change in clinic blood pressure ( BP ) recordings in both the intervention and control groups . CONCLUSION It is possible to initiate a nurse-led group clinic intervention to address BP management among stroke survivors in SSA with good early retention of participants . A larger and longer-term trial is being planned",
"Importance Despite extensive knowledge of hypertension treatment , the prevalence of uncontrolled hypertension is high and increasing in low- and middle-income countries . Objective To test whether a community health worker – led multicomponent intervention would improve blood pressure ( BP ) control among low-income patients with hypertension . Design , Setting , and Participants A cluster r and omized trial was conducted in 18 centers for primary health care within a national public system providing free medications and health care to uninsured patients in Argentina . A total of 1432 low-income adult patients with uncontrolled hypertension were recruited between June 2013 and April 2015 and followed up to October 2016 . Interventions Nine centers ( 743 patients ) were r and omized to the multicomponent intervention , which included a community health worker – led home intervention ( health coaching , home BP monitoring , and BP audit and feedback ) , a physician intervention , and a text-messaging intervention over 18 months . Nine centers ( 689 patients ) were r and omized to usual care . Main Outcomes and Measures The co primary outcomes were the differences in systolic and diastolic BP changes from baseline to the end of follow-up of patients with hypertension . Secondary outcomes included the proportion of patients with controlled hypertension ( BP . Three BP measurements were obtained at each of 2 baseline and 2 termination visits using a st and ard protocol , the means of which were used for analyses . Results Of 1432 participants ( mean age , 55.8 years [ SD , 13.3 ] ; 772 women [ 53.0 % ] ) , 1357 ( 94.8 % ) completed the trial . Baseline mean systolic BP was 151.7 mm Hg for the intervention group and 149.8 mm Hg for the usual care group ; the mean diastolic BP was 92.2 mm Hg for the intervention group and 90.1 mm Hg for the usual care group . Systolic BP reduction from baseline to month 18 was 19.3 mm Hg ( 95 % CI , 17.9 - 20.8 mm Hg ) for the intervention group and 12.7 mm Hg ( 95 % CI , 11.3 - 14.2 mm Hg ) for the usual care group ; the difference in the reduction was 6.6 mm Hg ( 95 % CI , 4.6 - 8.6 ; P decreased by 12.2 mm Hg ( 95 % CI , 11.2 - 13.2 mm Hg ) in the intervention group and 6.9 mm Hg ( 95 % CI , 5.9 - 7.8 mm Hg ) in the control group ; the difference in the reduction was 5.4 mm Hg ( 95 % CI , 4.0 - 6.8 mm Hg ; P The proportion of patients with controlled hypertension increased from 17.0 % at baseline to 72.9 % at 18 months in the intervention group and from 17.6 % to 52.2 % in the usual care group ; the difference in the increase was 20.6 % ( 95 % CI , 15.4%-25.9 % ; P No adverse events were reported . Conclusions and Relevance Low-income patients in Argentina with uncontrolled hypertension who participated in a community health worker – led multicomponent intervention experienced a greater decrease in systolic and diastolic BP than did patients who received usual care over 18 months . Further research is needed to assess generalizability and cost-effectiveness of this intervention and to underst and which components may have contributed most to the outcome . Trial Registration clinical trials.gov Identifier :",
"Introduction In low/middle-income countries with substantial HIV and tuberculosis epidemics , health services often neglect other highly prevalent chronic conditions , such as hypertension , which as a result are poorly managed . This paper reports on a study to assess the effect on hypertension management of lay health workers ( LHW ) working in South African rural primary healthcare clinics to support the provision of integrated chronic care . Methods A pragmatic cluster r and omised trial with a process evaluation in eight rural clinics assessed the effect of adding two LHWs supporting nurses in providing chronic disease care in each intervention clinic over 18 months . Control clinics continued with usual care . The main outcome measure was the change in the difference of percentage of clinic users who had elevated cardiovascular risk associated with high blood pressure ( BP ) before and after the intervention , as measured by two cross-sectional population surveys . Results There was no improvement in BP control among users of intervention clinics as compared with control clinics . However , the LHWs improved clinic functioning , including overall attendance , and attendance on the correct day . All clinics faced numerous challenges , including rapidly increasing number of users of chronic care , unreliable BP machines and cuffs , intermittent drug shortages and insufficient space . Conclusion LHWs improved the process of providing care but improved BP control required improved clinical care by nurses which was compromised by large and increasing numbers of patients , the dominance of the vertically funded HIV programme and the poor st and ards of equipment in clinics . Trial registration number IS RCT N12128227",
"Background In the People ’s Republic of China , out patients have limited time with their physicians . Thus , compared to in patients , out patients have lower medication adherence and are less knowledgeable about their disease . Objective The objective of this study was to evaluate the effect of pharmaceutical care on clinical outcomes of out patients with type 2 diabetes mellitus ( T2DM ) . Patients and methods A r and omized , controlled , prospect i ve clinical trial was conducted recruiting a total of 240 T2DM out patients from Zhongda Hospital , Southeast University . The control group ( CG ) received only common care from medical staff , whereas the inter vention group ( IG ) received extra pharmaceutical care from clinical pharmacists . Biochemical data such as blood pressure ( BP ) , fasting blood glucose ( FBG ) , glycosylated hemoglobin A1 ( HbA1c ) , and blood lipid were collected before and after 6-month intervention . The primary end points in this study were FBG and HbA1c . Results After the intervention , most of the baseline clinical outcomes of the patients in IG significantly improved , while only body mass index , diastolic BP , low-density lipoprotein cholesterol , and total cholesterol ( TC ) improved significantly in patients in the CG . Compared to CG , in IG , there were significant improvements in FBG , HbA1c , TC , the target attainment rates of HbA1c , and BP . Conclusion Pharmaceutical care provided by clinical pharmacists could improve the control of diabetes of out patients , and clinical pharmacists could play an important role in diabetes management",
"Background Community health workers are community members who provide education and care for patients for a broad range of health issues , including diabetes mellitus . However , few community health workers are trained for diabetes education and little is known about the effectiveness of their interventions . The aim of this study is to evaluate the effect of a diabetes education program delivered to community health workers in improving the metabolic control of patients with type 2 diabetes mellitus . Methods Eight community health workers , providing care for 118 patients , were r and omized in two groups to receive a 1-month diabetes education program ( intervention , patients n = 62 ) or an education course in other health issues ( control , patients n = 56 ) . Each community health worker was responsible for transmitting the acquired knowledge to patients . Primary outcome was changed in HbA1C 3 months after the intervention . Results : participants Mean age was 61 ± 11 years , 35 % were men and 62 % were whites . HbA1c levels reduced in both groups ( intervention : 9.1 ± 2.2 vs. 7.9 ± 1.9 % ; control : 9.1 ± 2.1 vs. 8.4 ± 2.5 % , p = 0.13 ) . Total cholesterol ( intervention : 192 ± 43 vs. 182 ± 39 mg/dl ; control : 197 ± 44 vs. 191 ± 45 mg/dl , p between groups = 0.035 ) and triglycerides ( intervention : 158 [ 106–218 ] vs. 135 [ 106–215 ] ; control : 128 [ 100–215 ] mg/dl vs. 146 [ 102–203 ] mg/dl , p between groups = 0.03 ) reduced overtime only in intervention group . Conclusions In this study , a significant decrease in HbA1c was observed during patients ' follow-up , but it was similar in intervention and control groups . The diabetes mellitus education course delivered to community health workers was able to improve patients ’ lipid profile",
"INTRODUCTION Elevated blood pressure greatly contributes to cardiovascular deaths in low-income and middle-income countries . We aim ed to investigate the effectiveness of a population -level intervention led by existing community health workers in reducing the burden of hypertension in a low-income population . METHODS We did a community-based , open-label , two-group , cluster-r and omised controlled trial in Nepal . Using computer-generated codes , we r and omly assigned ( 1:1 ) 14 clusters to a lifestyle intervention led by female community health volunteers ( FCHVs ) or usual care ( control group ) . In the intervention group , 43 FCHVs provided home visits every 4 months for lifestyle counselling and blood pressure monitoring . Eligible participants had been involved in a previous population -based survey , were aged 25 - 65 years , did not have plans to migrate outside the study area , and were not severely ill or pregnant . The primary outcome was mean systolic blood pressure at 1 year . We included all participants who remained in the trial at 1 year in the primary analysis . This trial is registered with Clinical Trials.gov , number NCT02428075 . FINDINGS Between April 1 , 2015 , and Dec 31 , 2015 , we recruited 1638 participants ( 939 assigned to intervention ; 699 assigned to control ) . At 1 year , 855 participants remained in the intervention group ( 425 were normotensive , 175 were prehypertensive , and 255 had hypertension ) and 613 remained in the control group ( 305 were normotensive , 128 were prehypertensive , and 180 had hypertension ) . The mean systolic blood pressure at 1 year was significantly lower in the intervention group than in the control group for all cohorts : the difference was -2·28 mm Hg ( 95 % CI -3·77 to -0·79 , p=0·003 ) for participants who were normotensive , -3·08 mm Hg ( -5·58 to -0·59 , p=0·015 ) for participants who were prehypertensive , and -4·90 mm Hg ( -7·78 to -2·00 , p=0·001 ) for participants who were hypertensive . INTERPRETATION A simple , FCHV-led lifestyle intervention coupled with monitoring of blood pressure is effective for reduction of blood pressure in individuals with hypertension and ameliorates age-related increases in blood pressure in adults without hypertension in the general population of Nepal . FUNDING Aarhus University , Jayanti Memorial Trust",
"Background In many low-income countries , care for patients with non-communicable diseases ( NCDs ) and mental health conditions is provided by nurses . The benefits of nurse substitution and supplementation in NCD care in high-income setting s are well recognised , but evidence from low- and middle-income countries is limited . Primary Care 101 ( PC101 ) is a programme design ed to support and exp and nurses ’ role in NCD care , comprising educational outreach to nurses and a clinical management tool with enhanced prescribing provisions . We evaluated the effect of the programme on primary care nurses ’ capacity to manage NCDs . Methods and Findings In a cluster r and omised controlled trial design , 38 public sector primary care clinics in the Western Cape Province , South Africa , were r and omised . Nurses in the intervention clinics were trained to use the PC101 management tool during educational outreach sessions delivered by health department trainers and were authorised to prescribe an exp and ed range of drugs for several NCDs . Control clinics continued use of the Practical Approach to Lung Health and HIV/AIDS in South Africa ( PALSA PLUS ) management tool and usual training . Patients attending these clinics with one or more of hypertension ( 3,227 ) , diabetes ( 1,842 ) , chronic respiratory disease ( 1,157 ) or who screened positive for depression ( 2,466 ) , totalling 4,393 patients , were enrolled between 28 March 2011 and 10 November 2011 . Primary outcomes were treatment intensification in the hypertension , diabetes , and chronic respiratory disease cohorts , defined as the proportion of patients in whom treatment was escalated during follow-up over 14 mo , and case detection in the depression cohort . Primary outcome data were analysed for 2,110 ( 97 % ) intervention and 2,170 ( 97 % ) control group patients . Treatment intensification rates in intervention clinics were not superior to those in the control clinics ( hypertension : 44 % in the intervention group versus 40 % in the control group , risk ratio [ RR ] 1.08 [ 95 % CI 0.94 to 1.24 ; p = 0.252 ] ; diabetes : 57 % versus 50 % , RR 1.10 [ 0.97 to 1.24 ; p = 0.126 ] ; chronic respiratory disease : 14 % versus 12 % , RR 1.08 [ 0.75 to 1.55 ; p = 0.674 ] ) , nor was case detection of depression ( 18 % versus 24 % , RR 0.76 [ 0.53 to 1.10 ; p = 0.142 ] ) . No adverse effects of the nurses ’ exp and ed scope of practice were observed . Limitations of the study include dependence on self-reported diagnoses for inclusion in the patient cohorts , limited data on uptake of PC101 by users , reliance on process outcomes , and insufficient re sources to measure important health outcomes , such as HbA1c , at follow-up . Conclusions Educational outreach to primary care nurses to train them in the use of a management tool involving an exp and ed role in managing NCDs was feasible and safe but was not associated with treatment intensification or improved case detection for index diseases . This notwithst and ing , the intervention , with adjustments to improve its effectiveness , has been adopted for implementation in primary care clinics throughout South Africa . Trial Registration The trial is registered with Current Controlled Trials ( IS RCT N20283604",
"OBJECTIVE To evaluate the effect of a participant-customised nutrition education programme on glycated Hb ( HbA(1c ) ) , blood lipids , blood pressure , BMI and dietary behaviours in patients with type 2 diabetes mellitus . DESIGN A r and omised controlled trial . The control group ( n 41 ) received education material s. The intervention group ( n 41 ) received the same education material s and participated in eight weekly ( 2 - 2·5 h ) group nutrition education sessions and follow-up sessions . Outcomes were assessed at 6 and 12 months . An intention-to-treat analysis was conducted . ANCOVA compared the groups ( adjustments for baseline values , age , sex and clinic ) . SETTING Two community health centres , Moretele sub-district ( North West Province ) , South Africa . SUBJECTS Adults ( aged 40 - 70 years ) with type 2 diabetes , HbA(1c ) ≥8 % . RESULTS Differences in HbA(1c ) ( primary outcome ) were -0·64 % ( P=0·15 ) at 6 months and -0·63 % ( P=0·16 ) at 12 months in favour of the intervention group . Starchy-food intake was significantly lower in the intervention group , 9·3 v. 10·8 servings/d ( P=0·005 ) at 6 months and 9·9 v. 11·9 servings/d ( P=0·017 ) at 12 months . Median energy intake was significantly lower in the intervention group at 12 months ( 5988 v. 6946 kJ/d , P=0·017 ) . No significant group differences in BMI , lipid profile , blood pressure and intakes of macronutrients , vegetables and fruits were observed . CONCLUSIONS Nutrition education was not efficacious on HbA(1c ) ; however , it improved specific dietary behaviours . Group education and h and s-on activities appeared to contribute to the improvement . Optimal goal setting and self-efficacy training/ assessment could benefit future nutrition education programmes for people with type 2 diabetes mellitus in re source -limited setting",
"Introduction Diabetes self-management education ( DSME ) is a fundamental element of type 2 diabetes care . Although 75 % of adults with diabetes worldwide live in low-income and middle-income countries ( LMICs ) , limited DSME research has been conducted in LMICs . The objective of this study was to evaluate a home-based DSME intervention in rural Guatemala . Methods We conducted a prospect i ve study of a DSME intervention using a quasi-experimental , single-group pretest – posttest design . We enrolled 90 participants in the intervention , which consisted of 6 home visits ( May 2014–July 2016 ) conducted by a diabetes educator using a curriculum culturally and linguistically tailored to rural Mayan population s. Primary outcomes were changes in mean hemoglobin A1c ( HbA1c ) and mean systolic and diastolic blood pressure at baseline and at 12 months . Secondary outcomes were diabetes knowledge and self-care activities at baseline and intervention completion . Results HbA1c decreased significantly from baseline to 12 months ( absolute mean change , −1.5 % ; 95 % confidence interval [ CI ] , −1.9 % to −1.0 % ; P also improved significantly at 12 months ( −6.2 mm Hg ; 95 % CI , −10.1 to −2.2 mm Hg ; P = .002 ) ; changes in diastolic blood pressure were not significant ( −1.6 mm Hg ; 95 % CI , −3.9 to −0.7 mm Hg ; P = .17 ) . We also found significant improvements in diabetes knowledge and self-care activities from baseline to intervention completion . Conclusion DSME interventions can be successfully delivered in a setting with an underre source d health system , high poverty rate , and unique cultural characteristics like Mayan Guatemala . Our findings point to the need for more DSME research in re source -limited setting s globally",
"Background : Research in industrialized countries has demonstrated that a key factor limiting the control of hypertension is poor patient adherence and that the most successful interventions for long-term adherence employ multiple strategies . Very little data exist on this question in low-income countries , wherein medication-taking behavior may be less well developed . Method : We conducted a treatment adherence trial of 544 patients [ mean age ∼63 years , mean blood pressure ( BP ) ∼168/92 mmHg ] with previously untreated hypertension in urban and rural Nigeria . Eligible participants were r and omized to one of two arms : clinic management only , or clinic management and home visits . Both interventions included three elements : a community based , nurse-led treatment program with physician backup ; facilitation of clinic visits and health education ; and the use of diuretics and a & bgr ; blocker as needed . After initial diagnosis , the management protocol was implemented by a nurse with physician backup . Participants were evaluated monthly for 6 months . Results : Medication adherence was assessed with pill count and urine testing . Drop-out rates , by treatment group , ranged from 12 to 28 % . Among participants who completed the 6-month trial , overall adherence was high ( ∼77 % of participants took > 98 % of prescribed pills ) . Adherence did not differ by treatment arm , but was better at the rural than the urban site and among those with higher baseline BP . Hypertension control ( BP that medication adherence can be high in developing world setting s in clinic attenders",
"BACKGROUND The practice of pharmaceutical care in primary care setting s in Thail and is currently not generally accepted . OBJECTIVE To evaluate the effect of pharmacist involvement in treatment with hypertensive patients in primary care setting s. METHODS The treatment objective was to stabilize the blood pressure ( BP ) of hypertensive patients in accordance with the Joint National Committee on Prevention , Detection , Evaluation and Treatment of High Blood Pressure guidelines . Patients were r and omly assigned to a pharmacist-involved group ( treatment ) or a group with no pharmacist involvement ( control ) . Pre- and post-test BPs , tablet counts , lifestyle modifications , and pharmacists ’ recommendations were recorded . The 6-month study was carried out in Mahasarakham University pharmacy and 2 primary care units . Patients were monitored monthly by review ing their medications and supported by providing pharmaceutical care and counseling . RESULTS From a total of 235 patients , the treatment group ( n = 118 ) had a significant reduction in both systolic ( S ) and diastolic ( D ) BP compared with the 117 patients of the control group ( p = 0.037 , 0.027 , respectively ) . The 158 patients ( 76 treatment , 82 control ) with BPs 140/90 mm Hg at the beginning of the study showed significant BP reductions ( p = 0.002 SBP , 0.008 DBP ) . The proportion of 158 patients whose BP became stabilized was higher in the treatment group ( p = 0.017 ) . The treatment group showed significantly better adherence ( p = 0.014 ) and exercise control ( p = 0.012 ) at the end of the study . Physicians accepted 42.72 % of medication modifications and 5.34 % of the suggestions for additional investigations . CONCLUSIONS Hypertensive patients who received pharmacist input achieved a significantly greater benefit in BP reduction , BP control , and improvement in adherence rate and lifestyle modification ",
"Background In Africa hypertension is common and stroke is increasing . Detection , treatment and control of high blood pressure ( BP ) is limited . BP can be lowered by reducing salt intake . In Africa salt is added to the food by the consumer , as processed food is rare . A population -wide approach with programmes based on health education and promotion is thus possible . Methods We carried out a community-based cluster r and omised trial of health promotion in 1,013 participants from 12 villages ( 628 women , 481 rural dwellers ) ; mean age 55 years to reduce salt intake and BP . Average BP was 125/74 mmHg and urinary sodium ( UNa ) 101 mmol/day . A health promotion intervention was provided over 6 months to all villages . Assessment s were made at 3 and 6 months . Primary end-points were urinary sodium excretion and BP levels . Results There was a significant positive relationship between salt intake and both systolic ( 2.17 mmHg [ 95 % CI 0.44 to 3.91 ] per 50 mmol of UNa per day , p diastolic BP ( 1.10 mmHg [ 0.08 to 1.94 ] , p systolic ( 2.54 mmHg [ -1.45 to 6.54 ] ) and diastolic ( 3.95 mmHg [ 0.78 to 7.11 ] , p = 0.015 ) BP when compared to control . There was no significant change in UNa . Smaller villages showed greater reductions in UNa than larger villages ( p = 0.042 ) . Irrespective of r and omisation , there was a consistent and significant relationship between change in UNa and change in systolic BP , when adjusted for confounders . A difference in 24-hour UNa of 50 mmol was associated with a lower systolic BP of 2.12 mmHg ( 1.03 to 3.21 ) at 3 months and 1.34 mmHg ( 0.08 to 2.60 ) at 6 months ( both p West Africa the lower the salt intake , the lower the BP . It would appear that a reduction in the average salt intake in the whole community may lead to a small but significant reduction in population systolic BP",
"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 prevalence of type 2 diabetes , especially in developing countries , has grown over the past decades . We performed a controlled clinical study to determine whether a community-based , group-centered public health intervention addressing nutrition and exercise can ameliorate glycemic control and associated cardiovascular risk factors in type 2 diabetic patients in rural Costa Rica . RESEARCH DESIGN AND METHODS A total of 75 adults with type 2 diabetes , mean age 59 years , were r and omly assigned to the intervention group or the control group . All participants received basic diabetes education . The subjects in the intervention group participated in 11 weekly nutrition classes ( 90 min each session ) . Subjects for whom exercise was deemed safe also participated in triweekly walking groups ( 60 min each session ) . Glycosylated hemoglobin , fasting plasma glucose , total cholesterol , triglycerides , HDL and LDL cholesterol , height , weight , BMI , and blood pressure were measured at baseline and the end of the study ( after 12 weeks ) . RESULTS The intervention group lost 1.0 + /- 2.2 kg compared with a weight gain in the control group of 0.4 + /- 2.3 kg ( P = 0.028 ) . Fasting plasma glucose decreased 19 + /- 55 mg/dl in the intervention group and increased 16 + /- 78 mg/dl in the control group ( P = 0.048 ) . Glycosylated hemoglobin decreased 1.8 + /- 2.3 % in the intervention group and 0.4 + /- 2.3 % in the control group ( P = 0.028 ) . CONCLUSIONS Glycemic control of type 2 diabetic patients can be improved through community-based , group-centered public health interventions addressing nutrition and exercise . This pilot study provides an economically feasible model for programs that aim to improve the health status of people with type 2 diabetes",
"Background To evaluate the efficacy of Counselling and Advisory Care for Health ( COACH ) programme in managing dyslipidaemia among primary care practice s in Malaysia . This open-label , parallel , r and omised controlled trial compared the COACH programme delivered by primary care physicians alone ( PCP arm ) and primary care physicians assisted by nurse educators ( PCP-NE arm ) . Methods This was a multi-centre , open label , r and omised trial of a disease management programme ( COACH ) among dyslipidaemic patients in 21 Malaysia primary care practice s. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia ; 149 were r and omised to the COACH programme delivered by primary care physicians assisted by nurse educators ( PCP-NE ) and 148 to care provided by primary care physicians ( PCP ) alone . The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms . Secondary endpoints included mean percentage change from baseline of lipid profile ( TC , LDL-C , HDL-C , TG , TC : HDL ratio ) , Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24 . The study also assessed the sustainability of programme efficacy at week 36 . Results Both study arms demonstrated improvement in LDL-C from baseline . The least squares ( LS ) mean change from baseline LDL-C were −30.09 % and −27.54 % for PCP-NE and PCP respectively . The difference in mean change between groups was 2.55 % ( p=0.288 ) , with a greater change seen in the PCP-NE arm . Similar observations were made between the study groups in relation to total cholesterol change at week 24 . Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups , 3.01 % , 95 % CI 0.12 - 5.90 , p=0.041 , at week 24 . There was no significant difference in lipid outcomes between 2 study groups at week 36 ( 12 weeks after the programme had ended ) . Conclusion Patients who received coaching and advice from primary care physicians ( with or without the assistance by nurse educators ) showed improvement in LDL-cholesterol . Disease management services delivered by PCP-NE demonstrated a trend towards add-on improvements in cholesterol control compared to care delivered by physicians alone ; however , the improvements were not maintained when the services were withdrawn . Trial registration National Medical Research Registration ( NMRR ) Number : NMRR-08 - 287 - 1442Trial Registration Number ( Clinical Trials.gov Identifier ) :",
"Background Poor access to care and physician shortage are major barriers to hypertension control in sub-Saharan Africa . Implementation of evidence -based systems-level strategies targeted at these barriers are lacking . We conducted a study to evaluate the comparative effectiveness of provision of health insurance coverage ( HIC ) alone versus a nurse-led task shifting strategy for hypertension control ( TASSH ) plus HIC on systolic blood pressure ( SBP ) reduction among patients with uncontrolled hypertension in Ghana . Methods and findings Using a pragmatic cluster r and omized trial , 32 community health centers within Ghana ’s public healthcare system were r and omly assigned to either HIC alone or TASSH + HIC . A total of 757 patients with uncontrolled hypertension were recruited between November 28 , 2012 , and June 11 , 2014 , and followed up to October 7 , 2016 . Both intervention groups received health insurance coverage plus scheduled nurse visits , while TASSH + HIC comprised cardiovascular risk assessment , lifestyle counseling , and initiation/titration of antihypertensive medications for 12 months , delivered by trained nurses within the healthcare system . The primary outcome was change in SBP from baseline to 12 months . Secondary outcomes included lifestyle behaviors and blood pressure control at 12 months and sustainability of SBP reduction at 24 months . Of the 757 patients ( 389 in the HIC group and 368 in the TASSH + HIC group ) , 85 % had 12-month data available ( 60 % women , mean BP 155.9/89.6 mm Hg ) . In intention-to-treat analyses adjusted for clustering , the TASSH + HIC group had a greater SBP reduction ( −20.4 mm Hg ; 95 % CI −25.2 to −15.6 ) than the HIC group ( −16.8 mm Hg ; 95 % CI −19.2 to −15.6 ) , with a statistically significant between-group difference of −3.6 mm Hg ( 95 % CI −6.1 to −0.5 ; p = 0.021 ) . Blood pressure control improved significantly in both groups ( 55.2 % , 95 % CI 50.0 % to 60.3 % , for the TASSH + HIC group versus 49.9 % , 95 % CI 44.9 % to 54.9 % , for the HIC group ) , with a non-significant between-group difference of 5.2 % ( 95 % CI −1.8 % to 12.4 % ; p = 0.29 ) . Lifestyle behaviors did not change appreciably in either group . Twenty-one adverse events were reported ( 9 and 12 in the TASSH + HIC and HIC groups , respectively ) . The main study limitation is the lack of cost-effectiveness analysis to determine the additional costs and benefits , if any , of the TASSH + HIC group . Conclusions Provision of health insurance coverage plus a nurse-led task shifting strategy was associated with a greater reduction in SBP than provision of health insurance coverage alone , among patients with uncontrolled hypertension in Ghana . Future scale-up of these systems-level strategies for hypertension control in sub-Saharan Africa requires a cost – benefit analysis . Trial registration Clinical Trials.gov",
"OBJECTIVE To analyse the costs and the effectiveness of an intervention of home visits made by nurses to elderly people versus usual care given by the family medicine units . MATERIAL AND METHODS A sample of 4,777 subjects aged 60 years and over covered by the Mexican Institute of Social Security ( Instituto Mexicano del Seguro Social , IMSS ) were screened . Those with a systolic and /or diastolic blood pressure level higher or equal than 160/90 mm Hg were r and omly allocated to the intervention or control groups . The intervention consisted of visits at home by nurses who gave health and lifestyle advice to the participants . The economic evaluation was considered from a health services and patient perspective . Direct and indirect costs were calculated as incremental . Effectiveness was measured in terms of cost per millimetre of mercury reduced . RESULTS Three hundred and forty five participants were allocated to the intervention group and compared with 338 controls . At the end of the intervention period the difference in the mean change in systolic blood pressure was 3.31 mm Hg ( 95 % CI 6.32 , 0.29 ; p = 0.03 ) comparing with the control group . In diastolic blood pressure the difference was 3.67 ( 95 % CI 5.22 , 2.12 ; p total cost of the intervention was 101 901.66 pesos . The intervention cost per patient was 34.61 pesos ( US$ 3.78 ) , ( CI 95 % 34.44 , 35.46 ) . The cost-effectiveness ratios was 10.46 pesos ( US$ 1.14 ) for systolic ( CI 95 % 129.31 , 5.51 ) and 9.43 ( US$ 1.03 ) for diastolic ( CI 95 % 19.90 , 2.49 ) . CONCLUSIONS The reduction in blood pressure obtained may well justify the small incremental cost of the intervention",
"Background An aging population poses significant challenges to health care in China . Health management has been implemented to reduce the costs of care , raise health service utilization , increase health knowledge and improve quality of life . Several studies have tried to verify the effectiveness of health management in achieving these goals worldwide . However , there have been insufficient r and omized control trials ( RCTs ) to draw reliable conclusions . The few small-scale studies conducted in China include mostly the general population rather than the elderly . Our study is design ed to evaluate the impact of community-based health management on the health of the elderly through an RCT in Nanjing , China . Methods Two thous and four hundred participants , aged 60 or older and who gave informed consent , were r and omly allocated 1:1 into management and control groups , the r and omization schedule was concealed from community health service center staff until allocation . Community-based health management was applied in the former while the latter was only given usual care . After 18 months , three categories of variables ( subjective grading health indices , objective health indices and health service utilization ) were measured based on a question naire , clinical monitoring and diagnostic measurements . Differences between the two groups were assessed before and after the intervention and analyzed with t-test , χ2-test , and multiple regression analysis . Results Compared with the control group , the management group demonstrated improvement on the following variables ( P : health knowledge score , self-evaluated psychological conditions , overall self-evaluated health conditions , diet score , physical activity duration per week , regular blood pressure monitoring , waist-to-hip ratio , systolic blood pressure and fasting blood sugar . The number of outpatient clinic visits did not differ significantly ( P=0.60 ) between the two groups before intervention , while after intervention it was smaller in the management group than in the control group ( P number of hospital admissions in the preceding 6 months was not different between the two groups even after intervention ( P=0.36 ) . Multiple regression analysis showed that gender , age , education level , chronic disease status and self-evaluated psychological conditions were important factors affecting health knowledge score , BMI , and waist-to-hip ratio . Conclusion Community-based health management improved both subjective grading health indices , objective health indices and decreased the number of outpatient clinic visits , demonstrating effectiveness in improving elderly health . Trial registration",
"Background : Nurse-led interventions have proven beneficial to reduce estimated cardiovascular risk . Aim : The purpose of this study was to evaluate the effect of systematic , nurse-led individual lifestyle counseling sessions on the reduction of 10-year cardiovascular risk scores in patients with coronary artery disease ( CAD ) . Methods : This was a r and omized clinical trial of CAD patients treated at a tertiary referral hospital . The intervention group received nurse-led guidance by means of five face-to-face sessions and telephone contact over the course of one year , starting three months after hospital discharge . Exercise and dietary goals were set for each patient and monitored at each session . The control group received st and ard medical advice . Patients were stratified by Framingham risk score and compared at the end of the follow-up period . Results : The final sample comprised 74 patients , 38 in the intervention group and 36 in the control group . Mean age was 58±9 years ; 74 % of patients were male . A 1.7 point ( −13.6 % ) reduction in risk score was recorded in the intervention group , vs a 1.2 point increase in risk score ( + 11 % ) in the control group ( p=0.011 ) . Significant between-group differences were detected for weight ( intervention , 78±14 kg at baseline vs 77±14 kg at study end ; control , 78±15 kg vs 79±15 kg ; p=0.04 ) , systolic blood pressure ( intervention , 136±22 mm Hg vs 124±15 mm Hg ; control , 126±15 mm Hg vs 129±16 mm Hg ; p=0.005 ) , and diastolic blood pressure ( intervention , 82±10 mm Hg vs 77±09 mm Hg ; control , 79±09 mm Hg vs 80±10 mm Hg ; p=0.02 ) . Conclusion : Structured and systematic nurse-led lifestyle counseling effectively reduced cardiovascular risk score",
"OBJECTIVE To compare the effects of low-level facility-based interventions on patient retention rates for cardiovascular ( CV ) disease in an environment of task shifting and nurse-led care in rural health districts in Central Cameroon . METHODS This study is an open-label , three-arm , cluster-r and omised trial in nurse-led facilities . All three groups implemented a treatment contract . The control group ( group 1 ) had no additional intervention , group 2 received the incentive of 1 month of free treatment every forth month of regularly respected visits , and group 3 received reminder letters in case of a missed follow-up visit . The primary outcome was patient retention at 1 year . Secondary outcomes were adherence to follow-up visit schemes and changes in blood pressure ( BP ) and blood glucose levels . Patients ' monthly spending for drugs and transport was calculated retrospectively . RESULTS A total of 33 centres and 221 patients were included . After 1 year , 109 patients ( 49.3 % ) remained in the programme . Retention rates in groups 2 and 3 were 60 % and 65 % , respectively , against 29 % in the control group . The differences between the intervention groups and the control group were significant ( P differences in BP or fasting plasma glucose trends between retained patients in the study groups . Average monthly cost to patients for antihypertensive medication was € 1.1 ± 0.9 and for diabetics € 1.2 ± 1.1 . Transport costs to the centres were on average € 1.1 ± 1.0 for hypertensive patients and € 1.1 ± 1.6 for patients with diabetes . CONCLUSIONS Low-cost interventions suited to an environment of task shifting and nurse-led care and needing minimal additional re sources can significantly improve retention rates in CV disease management in rural Africa . The combination of a treatment contract and reminder letters in case of missed appointments was an effective measure to retain patients in care",
"PURPOSE Early detection and management of coronary heart disease ( CHD ) are embedded into many community health service and primary care practice s in western countries . The Framingham CHD risk score has been used to predict CHD and mortality for nearly 20 years , and it has predicted CHD event risk accurately in multiethnic population s. The aim of this study was to access the effect of a 6-month community-based intervention on CHD risk in individuals at high risk . METHODS A r and omized controlled trial of individuals with a high 10-year CHD risk were recruited from two communities in China . Individuals in the intervention group ( n = 53 ) received a 3-month group education and a 3-month coaching session . Physical examination and self-report question naires were used to collect both pre- and postintervention data on blood pressure , glucose , cholesterol , body mass index , smoking , depression , and health-related quality of life ( HRQoL ) . RESULTS A total of 102 participants ( 85.0 % ) completed the 6-month study . Compared with the usual care group , the intervention group had a 5 mmHg greater reduction in systolic blood pressure ( t = 2.01 , p = .047 ) , larger declines in glucose ( t = -2.49 , p = .015 ) , cholesterol ( t = -2.44 , p = .017 ) , body mass index ( t = -2.58 , p = .011 ) , and depression ( t = -2.05 , p = .043 ) , and better reports of HRQoL ( t = 3.36 , p = .001 ) . No significant group differences in smoking behaviors were reported . CONCLUSION A 6-month community-based intervention in a CHD high-risk population improved disease-related risk factors , depression , and HRQoL. Results provide preliminary evidence for primary prevention of cardiovascular disease risk in a community high-risk population",
"This study aims to develop a nurse-led hypertension management model in the community setting and pilot it to an experimental trial . A total of 73 recruited participants were r and omly allocated into two groups . The study group received a home visit and 2 - 4 telephone follow-ups from the trained community nurses assisted by nursing student volunteers . The control group received doctor-led hypertension management . Data was collected at recruitment and immediately after the 8-week program . Outcome measures included blood pressure readings , self-care adherence , self-efficacy , quality of life , and patient satisfaction . Participants from the study group led by nurses had significant improvement in self-care adherence , patient satisfaction post-intervention than those from the control group led by doctors . However , there were no statistical significant differences in blood pressure readings , quality of life and self-efficacy between the two groups . The findings show that the nurse-led hypertension management appears to be a promising way to manage hypertensive patients at the community level , particularly when the healthcare system is better integrated",
"BACKGROUND Achievement of diabetes care goals is suboptimal globally . Diabetes-focused quality improvement ( QI ) is effective but remains untested in South Asia . OBJECTIVE To compare the effect of a multicomponent QI strategy versus usual care on cardiometabolic profiles in patients with poorly controlled diabetes . DESIGN Parallel , open-label , pragmatic r and omized , controlled trial . ( Clinical Trials.gov : NCT01212328 ) . SETTING Diabetes clinics in India and Pakistan . PATIENTS 1146 patients ( 575 in the intervention group and 571 in the usual care group ) with type 2 diabetes and poor cardiometabolic profiles ( glycated hemoglobin [ HbA1c ] level ≥8 % plus systolic blood pressure [ BP ] ≥140 mm Hg and /or low-density lipoprotein cholesterol [ LDLc ] level ≥130 mg/dL ) . INTERVENTION Multicomponent QI strategy comprising nonphysician care coordinators and decision-support electronic health records . MEASUREMENTS Proportions achieving HbA1c level less than 7 % plus BP less than 130/80 mm Hg and /or LDLc level less than 100 mg/dL ( primary outcome ) ; mean risk factor reductions , health-related quality of life ( HRQL ) , and treatment satisfaction ( secondary outcomes ) . RESULTS Baseline characteristics were similar between groups . Median diabetes duration was 7.0 years ; 6.8 % and 39.4 % of participants had preexisting cardiovascular and microvascular disease , respectively ; mean HbA1c level was 9.9 % ; mean BP was 143.3/81.7 mm Hg ; and mean LDLc level was 122.4 mg/dL. Over a median of 28 months , a greater percentage of intervention participants achieved the primary outcome ( 18.2 % vs. 8.1 % ; relative risk , 2.24 [ 95 % CI , 1.71 to 2.92 ] ) . Compared with usual care , intervention participants achieved larger reductions in HbA1c level ( -0.50 % [ CI , -0.69 % to -0.32 % ] ) , systolic BP ( -4.04 mm Hg [ CI , -5.85 to -2.22 mm Hg ] ) , diastolic BP ( -2.03 mm Hg [ CI , -3.00 to -1.05 mm Hg ] ) , and LDLc level ( -7.86 mg/dL [ CI , -10.90 to -4.81 mg/dL ] ) and reported higher HRQL and treatment satisfaction . LIMITATION Findings were confined to urban specialist diabetes clinics . CONCLUSION Multicomponent QI improves achievement of diabetes care goals , even in re source -challenged clinics . PRIMARY FUNDING SOURCE National Heart , Lung , and Blood Institute and UnitedHealth Group",
"OBJECTIVE This study tests the effectiveness of motivational interviewing compared with the usual care for Chinese hypertensive patients . METHODS A r and omised controlled trial was used . One hundred and twenty eligible participants were r and omly assigned to either the control group ( usual care group ) or the intervention group ( motivational interviewing group ) . RESULTS The results of this study demonstrated that the total scores and the mean scores for each dimension of the adherence question naire were increased in the intervention group ( P systolic blood pressure and diastolic blood pressure of the hypertensive patients greatly decreased in the intervention group during the six months of the motivational interviewing counselling ( P motivational interviewing for hypertensive patients is a promising approach for sustaining the clinical benefits of adherence behaviour . PRACTICE IMPLICATION S Motivational interviewing should be provided to hypertensive patients at hospitals and community health centres to assist patients in controlling their BP and to enhance treatment adherence . A series of training courses on the motivational interviewing technique should be provided to nurses",
"AIM The aim of this study was to examine the effect of a cardiac rehabilitation programme on health behaviours and physiological risk parameters in patients with coronary heart disease in Chengdu , China . BACKGROUND Epidemiological studies indicate a dose- , level- and duration -dependent relationship exists between cardiac behavioural and physiological risks and coronary heart disease incidence as well as subsequent cardiac morbidity and mortality . Cardiac risk factor modification has become the very primary goal of modern cardiac rehabilitation programmes . DESIGN METHODS A r and omized controlled trial was conducted . Coronary heart disease patients ( n = 167 ) who met the sampling criteria in two tertiary medical centres in Chengdu , south-west China , were r and omly assigned to either an intervention group ( the cardiac rehabilitation programme ) or control group ( the routine care ) . The change of health behaviours ( walking performance , step II diet adherence , medication adherence , smoking cessation ) and physiological risk parameters ( serum lipids , blood pressure , body weight ) were assessed to evaluate the programme effect . RESULTS Patients in the intervention group demonstrated a significantly better performance in walking , step II diet adherence , medication adherence ; a significantly greater reduction in serum lipids including triglyceride , total cholesterol , low-density lipoprotein ; and significantly better control of systolic and diastolic blood pressure at three months . The majority of these positive impacts were maintained at six months . The effect of the programme on smoking cessation , body weight , serum high-density lipoprotein , was not confirmed . CONCLUSIONS A cardiac rehabilitation programme led by a nurse can significantly improve the health behaviours and cardiac physiological risk parameters in coronary heart disease patients . Nurses can fill significant treatment gaps in the risk factor management of patients with coronary heart disease . RELEVANCE TO CLINICAL PRACTICE This study raises attention regarding the important roles nurses can play in cardiac rehabilitation and the unique way for nurses to meet the rehabilitative care needs of coronary heart disease patients . Furthermore , the hospital-home bridging nature of the programme also created a model for interfacing the acute care and community rehabilitative care",
"The authors examined the effects of a comprehensive lifestyle modification intervention on blood pressure ( BP ) and other cardiovascular risk factors in hypertensive patients . A total of 70 participants were r and omly placed into either a lifestyle intervention or a control group . Four education classes and individual counseling sessions were held for the intervention group . Participants in the control group were provided with routine outpatient services and were asked to maintain their usual lifestyle . Data were gathered at baseline and at the end of 6 months . At the end of 6 months , BP , body weight , body mass index , waist circumference , and fasting lipids , apart from high-density lipoprotein cholesterol , significantly declined in the intervention group . Healthpromoting lifestyle scores of the intervention group had increased significantly compared to those of the control group . In conclusion , the results demonstrate the feasibility of comprehensive lifestyle modification and show its beneficial effects",
"OBJECTIVE This study was primarily carried out to assess the feasibility of an adapted WHO CVD risk management package in a primary care setting . METHODS A community intervention trial was conducted in eight health posts located in rural , urban , and slum areas of northern India . After a 4 day training , eight health workers implemented the package among 1010 adults > or = 30 years of age from a r and omly chosen cluster of households . Locally adapted scenario 1 WHO protocol was used for the assessment of CVD risks . The health workers inquired about smoking , alcohol , diet , physical activity , symptoms of angina , and transient ischaemic attacks ; and measured systolic blood pressure ( SBP7 ) , height , and weight . Those with a risk were counseled and referred to a physician . Hypertensives were followed at 1 , 3 , and 5-month interval to reinforce risk prevention and adherence to treatment . In a 20 % r and om sub sample , in the study and control area before and after the intervention , WHO STEPS instrument was used to evaluate effectiveness of the package . FINDINGS After training , the knowledge of health workers regarding risk factors and symptoms of CVDs increased from 47 % to 92.5 % , and their performance in detection of risks was comparable to the investigator . All health workers could pay scheduled home visits regularly . They referred 279 ( 27.6 % ) individuals having raised systolic blood pressure ( SBP ) , and 74.5 % contacted the doctor . Significant decrease in mean SBP ( 8.8 mm Hg ) was observed during follow-up . Significantly higher reports of intention to quit tobacco ( 60.3 % vs 25.5 % ) and regular intake of anti-hypertensive medication ( 58.3 % vs 34.8 % ) were observed in the intervention area compared to the control area . CONCLUSION Adapted WHO CVD risk management package can be implemented through primary care system",
"OBJECTIVE To evaluate the impact of a low-cost nutritional intervention in changing the lifestyle of adults . DESIGN R and omised clinical trial . SETTING Primary health-care centre in São José do Rio Preto , São Paulo State , Brazil . SUBJECTS We r and omly assigned 104 adults ( 83 women and 21 men aged 30 - 65 years , body mass index 24 - 35 kg m(-2 ) , non-diabetic ) into two groups : nutrition counselling and control . Each subject in the intervention group received three individualised nutritional counselling sessions during the first 6 months aim ed at increasing intakes of fruits , vegetables and olive oil , reducing saturated fat and improving physical activity . Body composition , biochemical indicators and lifestyle were assessed at baseline and at 6 months and 1 year in both groups . RESULTS After 6 months of follow-up , body weight , waist circumference , diastolic blood pressure , fasting blood glucose , total and low-density lipoprotein cholesterol , total and saturated fat , and dietary energy and cholesterol levels showed a more significant decrease among subjects in the intervention group than in the control group ( P reduced intake of saturated fat and increased intakes of fruits , vegetables , fibre and olive oil ( P low-cost nutritional intervention programme improved serum lipids profile and weight control , and appeared to be feasible for use at a primary health-care centre in a developing country ",
"AIMS The study tested the hypothesis that a theory driven Diabetes Self-Management ( DSM ) intervention delivered by trained nurses would result in a clinical ly significant improvement in glycaemic control . METHODS Patients with an HbA1c > 7.5 % ( 58mmol/mol ) and free of diabetes complications were enrolled into a r and omized controlled trial ( n=85 ) . Intervention consisted of four sessions and monthly follow up for 6 months . Biochemical tests , and diet and physical activity assessment s were done in both groups . Analysis of covariance was used to test the effectiveness of the intervention . RESULTS At 6 months , there was a significant difference ( P=0.001 ) in HbA1c between the groups controlling for baseline values and other variables . Based on the primary outcome , 28 % in the intervention group achieved the target value of 6.5 % HbA1c , compared to 8 % in the \" usual care \" group ( P The reduction in total energy intake and increase in physical activity was significant in the intervention group between baseline and follow up . CONCLUSIONS The DSM intervention has result ed in a clinical ly significant impact on glycaemia , change in diet and physical activity , and has demonstrated the feasibility of using it within existing care arrangements in a developing country setting",
"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",
"Background : High blood pressure ( BP ) is the leading attributable risk for cardiovascular disease globally . There is little information on effective and sustainable public health system strategies for managing hypertension in South Asian countries . We conducted a feasibility study to gather preliminary data to optimize BP-lowering strategies for a public health intervention in rural communities in Bangladesh , Pakistan , and Sri Lanka . Methods : A mixed method feasibility study comprised a 3-month pre and postevaluation of a multicomponent intervention ( MCI ) , including BP screening and home health education by trained government community health worker ( CHW ) ; providers trained in hypertension management , and compensation of CHW for additional services . Checklists were used to document care . Stakeholder interviews were also conducted . Individuals aged 40 years and above with high BP ( systolic ≥140 mmHg or diastolic ≥90 mmHg based on two readings from 2 separate days , or receiving antihypertensive medications ) were enrolled from rural communities in Bangladesh , Pakistan , and Sri Lanka . BP was measured at baseline and 3 months postintervention . Results : A total of 412 ( 90 % ) of the 454 eligible individuals were recruited . Of those recruited , 90 % received home health education session by trained CHWs , 80 % were referred to trained providers , of whom 83 % completed the management checklist . A follow-up rate of 95.6 % was achieved . The mean SBP declined significantly by 4.5 mmHg 95 % confidence interval ( 2.3 , 6.7 ) mmHg ( P countries . BP decline was 10.5 mmHg ( 8.1 , 13.0 mmHg ) ( P MCI strategies . Conclusion : The proposed MCI is feasible for implementation and requires long-term , large-scale evaluation in the rural public health infrastructure in South Asian countries to determine sustainability of health system changes and BP control . If these long-term effects are confirmed , MCI may be a long-term strategy for tackling rising rates of cardiovascular disease in low-re source d countries . Clintrial.gov",
"In recent years , great emphasis has been placed on the role of nonpharmacological self-management in the care of patients with diabetes . Studies have reported that nurses , compared to other healthcare professionals , are more likely to promote preventive healthcare seeking behaviors . The aim of this study was to investigate the effectiveness of a nurse-led diabetes self-management education on glycosylated hemoglobin . A two-arm parallel-group r and omized controlled trial with the blinded outcome assessors was design ed . One hundred forty-two adults with type 2 diabetes were r and omized to receive either usual diabetes care ( control group ) or usual care plus a nurse-led diabetes self-management education ( intervention group ) . Duration of the intervention was 12 weeks . The primary outcome was glycosylated hemoglobin ( HbA1c values ) . Secondary outcomes were changes in blood pressure , body weight , lipid profiles , self-efficacy ( efficacy expectation and outcome expectation ) , self-management behaviors , quality of life , social support , and depression . Outcome measures were assessed at baseline and at 12-week and 24-week postr and omizations . Patients in the intervention group showed significant improvement in HbA1c , blood pressure , body weight , efficacy expectation , outcome expectation , and diabetes self-management behaviors . The beneficial effect of a nurse-led intervention continued to accrue beyond the end of the trial result ing in sustained improvements in clinical , lifestyle , and psychosocial outcomes . This trial is registered with I RCT 2016062528627N1",
"Abstract Background Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33 % have been recorded in Cape Town . Previous studies show that quality of care and health outcomes are poor . The development of an effective education programme should impact on self-care , lifestyle change and adherence to medication ; and lead to better control of diabetes , fewer complications and better quality of life . Methods Trial design : Pragmatic cluster r and omized controlled trial Participants : Type 2 diabetic patients attending 45 public sector community health centres in Cape Town Interventions : The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style . The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room . Objective : To evaluate the effectiveness of the group diabetes education programme Outcomes : Primary outcomes : diabetes self-care activities , 5 % weight loss , 1 % reduction in HbA1c . Secondary outcomes : self-efficacy , locus of control , mean blood pressure , mean weight loss , mean waist circumference , mean HbA1c , mean total cholesterol , quality of life R and omisation : Computer generated r and om numbers Blinding : Patients , health promoters and research assistants could not be blinded to the health centre ’s allocation Numbers r and omized : Seventeen health centres ( 34 in total ) will be r and omly assigned to either control or intervention groups . A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80 % to detect the primary outcomes with 5 % precision . Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570 . Discussion The study will inform policy makers and managers of the district health system , particularly in low to middle income countries , if this programme can be implemented more widely . Trial registerPan African Clinical Trial Registry",
"Background The potential of mobile-health ( mHealth ) technology for the management of hypertension among stroke survivors in Africa remains unexplored . We assessed whether an mHealth technology-enabled , nurse-guided intervention initiated among stroke patients within one month of symptom onset is effective in improving their blood pressure ( BP ) control . Methods A two-arm pilot cluster r and omized controlled trial involving 60 stroke survivors , ≥18 years , with BP ≥140/90 mmHg at screening/enrollment visit at a medical center in Ghana . Participants in the intervention arm ( n = 30 ) received a Blue-toothed BP device and smartphone with an App for monitoring BP measurements and medication intake under nurse guidance for three months after which intervention was withdrawn . Control arm ( n = 30 ) received usual care . Primary outcome measure was proportion with clinic BP at month 9 ; secondary outcomes included medication adherence . Findings Mean ± SD age was 55 ± 13 years , 65 % males . Two participants on intervention and three in control group were lost to follow-up . At month 9 , proportion on the intervention versus controls with BP mmHg was 14/30 ( 46.7 % ) versus 12/30 ( 40.0 % ) , p = 0.79 by intention-to-treat ; systolic BP 0.035 . Mean ± SD medication possession ratio was 0.95 ± 0.16 on intervention versus 0.98 ± 0.24 in the control arm , p = 0.56 . Interpretation We demonstrate feasibility and signal of improvement in BP control among stroke survivors in a re source -limited setting via an mHealth intervention . Larger scale studies are warranted . Trial registration NCT02568137 . Registered on 13 July 2015 at Clinical Trials.gov",
"BACKGROUND A recent cluster r and omized trial evaluating a multicomponent intervention showed significant reductions in blood pressure in low-income hypertensive subjects in Argentina . OBJECTIVES To assess the cost-effectiveness of this intervention . METHODS A total of 1432 hypertensive participants were recruited from 18 primary health care centers . The intervention included home visits led by community health workers , physician education , and text messaging . Re source use and quality of life data using the three-level EuroQol five-dimensional question naire were prospect ively collected . The study perspective was that of the public health care system , and the time horizon was 18 months . Intention-to-treat analysis was used to analyze cost and health outcomes ( systolic blood pressure [ SBP ] change and quality -adjusted life-years [ QALYs ] ) . A 1 time gross domestic product per capita per QALY was used as the cost-effectiveness threshold ( US $ 14,062 ) . RESULTS Baseline characteristics were similar in the two arms . QALYs significantly increased by 0.06 ( 95 % confidence interval [ CI ] 0.04 - 0.09 ) in the intervention group , and SBP net difference favored the intervention group : 5.3 mm Hg ( 95 % CI 0.27 - 10.34 ) . Mean total costs per participant were higher in the intervention arm : US $ 304 in the intervention group and US $ 154 in the control group ( adjusted difference of US $ 140.18 ; 95 % CI US $ 75.41-US $ 204.94 ) . The incremental cost-effectiveness ratio was $ 3299 per QALY ( 95 % credible interval 1635 - 6099 ) and US $ 26 per mm Hg of SBP ( 95 % credible interval 13 - 46 ) . Subgroup analysis showed that the intervention was cost-effective in all prespecified subgroups ( age , sex , cardiovascular risk , and body mass index ) . CONCLUSIONS The multicomponent intervention was cost-effective for blood pressure control among low-income hypertensive patients",
"Background : The burden of noncommunicable diseases and their risk factors has rapidly increased worldwide , including in India . Innovative management strategies with electronic decision support and task sharing have been assessed for hypertension , diabetes mellitus , and depression individually , but an integrated package for multiple chronic condition management in primary care has not been evaluated . Methods : In a prospect i ve , multicenter , open-label , cluster-r and omized controlled trial involving 40 community health centers , using hypertension and diabetes mellitus as entry points , we evaluated the effectiveness of mWellcare , an mHealth system consisting of electronic health record storage and an electronic decision support for the integrated management of 5 chronic conditions ( hypertension , diabetes mellitus , current tobacco and alcohol use , and depression ) versus enhanced usual care among patients with hypertension and diabetes mellitus in India . At trial end ( 12-month follow-up ) , using intention-to-treat analysis , we examined the mean difference between arms in change in systolic blood pressure and glycated hemoglobin as primary outcomes and fasting blood glucose , total cholesterol , predicted 10-year risk of cardiovascular disease , depression score , and proportions reporting tobacco and alcohol use as secondary outcomes . Mixed-effects regression models were used to account for clustering and other confounding variables . Results : Among 3698 enrolled participants across 40 clusters ( mean age , 55.1 years ; SD , 11 years ; 55.2 % men ) , 3324 completed the trial . There was no evidence of difference between the 2 arms for systolic blood pressure ( & Dgr;=−0.98 ; 95 % CI , −4.64 to 2.67 ) and glycated hemoglobin ( & Dgr;=0.11 ; 95 % CI , −0.24 to 0.45 ) even after adjustment of several key variables ( adjusted differences for systolic blood pressure : – 0.31 [ 95 % CI , −3.91 to 3.29 ] ; for glycated hemoglobin : 0.08 [ 95 % CI , −0.27 to 0.44 ] ) . The mean within-group changes in systolic blood pressure in mWellcare and enhanced usual care were −13.65 mm Hg versus −12.66 mm Hg , respectively , and for glycated hemoglobin were −0.48 % and −0.58 % , respectively . Similarly , there were no differences in the changes between the 2 groups for tobacco and alcohol use or other secondary outcomes . Conclusions : We did not find an incremental benefit of mWellcare over enhanced usual care in the management of the chronic conditions studied . Clinical Trial Registration : URL : https://www . clinical trials.gov . Unique identifier : NCT02480062",
"BACKGROUND The hypertension prevalence rate is increasing but the control rate is unsatisfactory . Nurse-led healthcare may be an effective way to improve outcomes for hypertensive patients but more evidence is required especially at the community level . OBJECTIVE This study aims to establish a nurse-led hypertension management model and to test its effectiveness at the community level . DESIGN A single-blind , r and omized controlled trial was performed in an urban community healthcare center in China . Hypertensive patients with uncontrolled blood pressure ( systolic blood pressure ≥140mmHg and /or diastolic blood pressure ≥90mmHg ) were r and omly allocated into two groups : the study group ( n=67 ) and the control group ( n=67 ) . The nurse-led hypertension management model included four components ( delivery system design , decision support , clinical information system and self-management support ) . Patients in the control group received usual care . Patients in the study group received a 12-week period of hypertension management . The patient outcomes , which involved blood pressure , self-care behaviors , self-efficacy , quality of life and satisfaction , were assessed at three time points : the baseline , immediately after the intervention and 4 weeks after the intervention . RESULTS After the intervention , the blood pressure of patients in the study group decreased significantly compared to those in the control group , and the mean reduction of systolic/diastolic blood pressure in the study and control groups was 14.37/7.43mmHg and 5.10/2.69mmHg , respectively ( p improvement in self-care behaviors than those in the control group ( p higher level of satisfaction with hypertensive care than the control group ( p difference in self-efficacy and quality of life was detected between the two groups after the intervention . CONCLUSIONS The nurse-led hypertension management model is feasible and effective in improving the outcomes of patients with uncontrolled blood pressure at the community level",
"AIM The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoring for medication adherence and management of hypertension in a primary care setting , by providing education on healthy lifestyle behaviours and medication adherence . BACKGROUND Hypertension is the third most common cause of death worldwide . Prevalence of hypertension in Turkey is approximately 30 % in the general population and 45 - 50 % in population over 50 . DESIGN R and omised controlled study . METHODS This study conducted in Turkey used a study group comprised of 120 subjects ( 40 Group A , 40 Group B , 40 controls ) , all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study . The study was conducted between February-November 2006 at public primary health care facilities and homes of the study participants . Participants in Group A and B received a total of six monthly education sessions , four times during clinic visits and two home visits . Medication adherence education for Groups A and B and education about healthy lifestyle behaviours for Group B were administered in a structured and individualised format . The control group was routinely monitored in health care facilities . RESULTS Healthy lifestyle behaviours and perception of self-efficacy regarding medication adherence showed improvement after education sessions in Groups A and B. Systolic and diastolic blood pressures of subjects in Group A and B showed a significant decrease compared with those of the control group ; the blood pressure decrease in Group B was greater than in Group A. CONCLUSION Nurses play an important role in uncontrolled hypertension detection and can improve medication adherence and healthy lifestyle behaviours . RELEVANCE TO CLINICAL PRACTICE Patient education medication adherence alone and in combination with healthy lifestyle behaviour teaching is an effective tool for blood pressure reduction in the hypertensive population in primary health care setting",
"Background The burden of cardiovascular diseases ( CVDs ) remains unclear in many regions of the world . Objectives The GBD ( Global Burden of Disease ) 2015 study integrated data on disease incidence , prevalence , and mortality to produce consistent , up-to- date estimates for cardiovascular burden . Methods CVD mortality was estimated from vital registration and verbal autopsy data . CVD prevalence was estimated using modeling software and data from health surveys , prospect i ve cohorts , health system administrative data , and registries . Years lived with disability ( YLD ) were estimated by multiplying prevalence by disability weights . Years of life lost ( YLL ) were estimated by multiplying age-specific CVD deaths by a reference life expectancy . A sociodemographic index ( SDI ) was created for each location based on income per capita , educational attainment , and fertility . Results In 2015 , there were an estimated 422.7 million cases of CVD ( 95 % uncertainty interval : 415.53 to 427.87 million cases ) and 17.92 million CVD deaths ( 95 % uncertainty interval : 17.59 to 18.28 million CVD deaths ) . Declines in the age-st and ardized CVD death rate occurred between 1990 and 2015 in all high-income and some middle-income countries . Ischemic heart disease was the leading cause of CVD health lost globally , as well as in each world region , followed by stroke . As SDI increased beyond 0.25 , the highest CVD mortality shifted from women to men . CVD mortality decreased sharply for both sexes in countries with an SDI > 0.75 . Conclusions CVDs remain a major cause of health loss for all regions of the world . Sociodemographic change over the past 25 years has been associated with dramatic declines in CVD in regions with very high SDI , but only a gradual decrease or no change in most regions . Future up date s of the GBD study can be used to guide policymakers who are focused on reducing the overall burden of noncommunicable disease and achieving specific global health targets for CVD",
"OBJECTIVE This study aim ed to evaluate the cost-effectiveness of a group diabetes education program delivered by health promoters in community health centers in the Western Cape , South Africa . METHODS The effectiveness of the education program was derived from the outcomes of a pragmatic cluster r and omized controlled trial ( RCT ) . Incremental operational costs of the intervention , as implemented in the trial , were calculated . All these data were entered into a Markov micro-simulation model to simulate clinical outcomes and health costs that were expressed as an Incremental Cost Effectiveness Ratio ( ICER ) . RESULTS The only significant effect from the RCT at one year was a reduction in blood pressure ( systolic blood pressure -4.65 mmHg ( 95%CI:-9.18 to -0.12 ) and diastolic blood pressure -3.30 mmHg ( 95%CI:-5.35 to -1.26 ) ) . The ICER for the intervention , based on the assumption that the costs would recur every year and the effect could be maintained , was 1862 $ /QALY gained . CONCLUSION A structured group education program performed by mid-level trained healthcare workers at community health centers , for the management of Type II diabetes in the Western Cape , South Africa is therefore cost-effective . PRACTICE IMPLICATION S This cost-effectiveness analysis supports the more widespread implementation of this intervention in primary care within South Africa",
"Background — In rural areas in China and India , the cardiovascular disease burden is high but economic and healthcare re sources are limited . This study ( the Simplified Cardiovascular Management Study [ SimCard ] ) aims to develop and evaluate a simplified cardiovascular management program delivered by community health workers with the aid of a smartphone-based electronic decision support system . Methods and Results — The SimCard study was a yearlong cluster-r and omized , controlled trial conducted in 47 villages ( 27 in China and 20 in India ) . Recruited for the study were 2086 individuals with high cardiovascular risk ( aged ≥40 years with self-reported history of coronary heart disease , stroke , diabetes mellitus , and /or measured systolic blood pressure ≥160 mm Hg ) . Participants in the intervention villages were managed by community health workers through an And roid-powered app on a monthly basis focusing on 2 medication use and 2 lifestyle modifications . In comparison with the control group , the intervention group had a 25.5 % ( P primary outcome of the proportion of patient-reported antihypertensive medication use pre- and post-intervention . There were also significant differences in certain secondary outcomes : aspirin use ( net difference : 17.1 % ; P ) and systolic blood pressure ( –2.7 mm Hg ; P=0.04 ) . However , no significant changes were observed in the lifestyle factors . The intervention was culturally tailored , and country-specific results revealed important differences between the regions . Conclusions — The results indicate that the simplified cardiovascular management program improved quality of primary care and clinical outcomes in re source -poor setting s in China and India . Larger trials in more places are needed to ascertain the potential impacts on mortality and morbidity outcomes . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01503814"
] | 41167d1a-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Oxidative stress is prevalent in dialysis patients and has been implicated in the pathogenesis of cardiovascular disease and anaemia . We conducted a systematic review and meta- analysis to examine the effect of Excebrane , a vitamin E-coated cellulose-based dialyser , on circulating biomarkers of lipid peroxidation , as surrogate markers of oxidative stress . METHODS The primary sources used to identify c and i date studies included PubMed , the Cochrane Central Register of Controlled Trials , a bibliography provided by the dialyser manufacturer , and a manual search of abstract s from proceedings of scientific meetings and review articles . Studies were selected for analysis if their design included a comparator group ( primarily within patient comparison , i.e. pre- and post- study evaluations ) . For the meta- analysis , we computed the overall change of the outcome from baseline using a r and om-effects model . A supplemental analysis was performed in which the absolute levels of these biomarkers of lipid peroxidation were converted to a common unit by calculating st and ardized effect sizes . RESULTS Fourteen peer- review ed articles met the criteria . The studies consisted of 11 single arm , one r and omized crossover and two r and omized controlled trials , with a total of 37 to 158 evaluable patients , according to the outcome of interest analysed . Due to the paucity of r and omized trials , the meta- analysis was limited to the Excebrane arm of each study . When the studies were combined according to similar measurement units , the overall mean decrease in malondialdehyde ( MDA ) level was -0.3 mM ( 95 % CI , -0.5 to -0.1 mM ; seven studies ) and -0.8 nmol/mg low-density lipoprotein ( LDL ) ( 95 % CI , -1.3 to -0.4 nmol/mg LDL ; three studies ) , respectively . The summary estimate revealed a non-significant decrease in pre-dialysis thiobarbituric acid reactive substances ( TBARS ) level of 0.4 microM ( 95 % CI , -1.2 to 0.4 microM ; three studies ) . When the MDA and TBARS studies were combined using the st and ardized effect size , the mean decrease in these biomarkers of lipid peroxidation was statistically significant at -1.7 units ( 95 % CI , -2.7 , -0.7 units ; 13 studies ) . A meta- analysis on the effect of Excebrane on pre-dialysis levels of oxidized-LDL could not be performed due to study heterogeneity . CONCLUSION The conversion of dialysis patients to a vitamin E-coated dialyser is associated with an improvement in circulating biomarkers of lipid peroxidation , which is of potential clinical benefit | [
"Red blood cells and plasma reduced and oxidized glutathione levels , glutathione peroxidase ( GSH-Px ) activity , thiobarbituric acid reactants ( TBAR ) of both chronic ambulatory peritoneal dialysis ( CAPD ) patients and a matched control group were investigated in this study . Oxidized and reduced pyridinic nucleotides in red blood cells ( RBC ) , in which NADPH is a direct expression of hexose monophosphate shunt function , were also studied . The results obtained indicate that RBC and plasma are exposed to oxidative stress in CAPD . This condition is characterized by a decreased GSH/GSSG ratio , particularly evident in RBC as a consequence of the GSSG accumulation . Lipid peroxidation is increased , as indicated by raised TBAR levels , and reduced pyridinic nucleotides are decreased . Increased GSH-Px levels and unmodified or slightly increased GSH content were observed in the RBC but not in plasma , which showed decreased GSH and unmodified peroxidase activity . Peroxidase correlated positively with TBAR levels in the RBC lysates . In a subgroup of patients treated with erythropoietin ( vs. untreated patients and controls ) no differences were observed in the glutathione-related parameters studied . These data suggest that a mechanism for adaptation to oxidative conditions may be present in CAPD and its effects on RBC integrity are discussed in comparison with the hemodialysis conditions previously studied",
"In hemodialysis patients , oxidative stress results from an imbalance between the production of reactive oxygen species and antioxidant defense mechanisms . Recently , a new dialysis multi‐‐layer membrane has been developed , by modifying the inner surface of regenerated cellulose to support a vitamin E coating . The aim of our study was to investigate the effects of hemodialysis treatment with vitamin E‐‐modified membrane on anemia and erythropoietin requirement in a group of chronic uremic patients . Ten uremic , non diabetic , patients on st and ard bicarbonate dialysis were treated with vitamin E‐‐bonded dialysis membrane for 12 months . Hematological parameters , erythropoietin requirement , serum vitamin E and serum malonyldialdehyde ( ( MDA ) ) were evaluated before starting the study and monthly . No significant changes in hemoglobin level , RBC count , hematocrit and EPO requirement were observed . Basal vitamin E levels were in the normal range ( ( 13.0±2.88 mg//L vs. 14.79±3.12 mg//L ; NS ) ) . On the contrary , basal MDA levels were higher than those observed in the control group ( ( 1.87±0.36 vs. 1.13±0.18 mmol//mL ; p decrease of MDA levels was found after 1 month of Excebrane ® treatment ( ( 1.39±0.25 nmol//mL ; p anemia in CHD patients is still not clearly defined , but it could be of minor clinical relevance . Although the effectiveness of vitamin E‐‐coated membranes as a scavenger of ROS allows a better control of intradialytic oxidative stress , it does n't seem to contribute to clinical management of anemia in these patients",
"BACKGROUND Asymmetric dimethylarginine ( ADMA ) is an endogenous inhibitor of nitric oxide synthase and an independent predictor of overall mortality and cardiovascular outcome in haemodialysis ( HD ) patients . In the present study , we compared the effects of a vitamin E-coated polysulfone membrane ( PSE ) and a non-vitamin E-coated polysulfone membrane ( PS ) on oxidative stress markers such as ADMA . METHODS Thirty-one HD patients were enrolled to this investigation . They were allocated into two groups : in the PSE group ( n = 16 ) , PSE was used for 6 months , followed by PS for an additional 12 months ; in the PS group ( n = 15 ) , PS was used for the entire observation period . Plasma ADMA , oxidized low density lipoprotein ( Ox-LDL ) and malondialdehyde LDL ( MDA-LDL ) levels were measured at baseline , 3 , 6 , 12 and 18 months . Plasma ADMA in peritoneal dialysis ( PD ) patients and in healthy individuals was also measured . RESULTS Predialysis concentrations of ADMA ( 0.72+/- 0.13 nmol/ml ) were significantly higher in the HD group than in both PD patients ( 0.63+/-0.10 nmol/ml , P PSE for 6 months significantly reduced predialysis levels of ADMA ( 0.54+/-0.09 nmol/ml ) compared with baseline ( 0.74+/-0.12 nmol/ml ; P Predialysis levels of Ox-LDL and MDA-LDL after 6 months therapy with PSE were also significantly lower than baseline values . Treatment with PS subsequent to treatment with PSE again increased ADMA , Ox-LDL and MDA-LDL back to baseline levels . In the PS group , ADMA , Ox-LDL and MDA-LDL levels remained unchanged during the entire treatment period of 18 months . CONCLUSIONS We confirmed that use of PSE reduced ADMA that had accumulated in HD patients . This finding indicates that PSE exerts anti-oxidant activity . A r and omized controlled study will be required to determine whether PSE prevents cardiovascular diseases and other dialysis-related complications by reducing oxidative stress",
"Hemodialysis deteriorates oxidative stress . Vitamin E is an antioxidant whose regeneration is provided for by vitamin C. The authors tested the effects of a vitamin E-modified membrane ( E ) , nonmodified cellulose membrane ( O ) , and vitamin C infusion ( 500 mg , C ) into the arterial blood line during dialysis on parameters of oxidative stress . In a short-term study , 24 patients were subjected to a single dialysis session with E , O , E with C , and O with C protocol s. In a long-term study ( 12 weeks ) , 20 patients were r and omized into groups with C and without C on each dialysis , and both groups had dialysis using O , E , and again O membrane for 4 weeks each . In the short-term study , thiobarbituric acid reacting substances ( TBARS ) in plasma rose after dialysis ( p predialysis TBARS declined when using E both in the groups with C ( p TBARS returning to baseline levels . The E membrane prevented an increase in lipid peroxidation during single dialysis , and long-term use of the E membrane also result ed in a decrease in the predialysis lipid peroxidation level . The antioxidant capacity of the E membrane was not enhanced by vitamin C infusion . High doses of vitamin C administered during dialysis using a nonmodified cellulose membrane prevented an increase in lipid peroxidation , most probably due to the enhanced rate of endogenous vitamin E regeneration",
"BACKGROUND Oxidant stress has a pathogenic role in uremic anemia , possibly interfering with erythropoietin ( EPO ) function and red blood cell ( RBC ) survival . Therefore , it is expected that antioxidant therapy might exert a beneficial effect on these parameters . METHODS To test this hypothesis , we investigated some oxidant stress indices , anemia levels , and RBC survival in 47 hemodialysis ( HD ) patients r and omly assigned to three groups . Patients in groups A ( n = l8 ) and B ( n = 20 ) were on dialysis therapy using conventional cellulosic and synthetic membranes and were administered high and low doses of recombinant human EPO ( rHuEPO ) , respectively . Patients in group C ( n = 9 ) were dialyzed with vitamin E-modified membranes ( CL-Es ) and investigated in a two-step prospect i ve study . In step Cl , patients were administered rHuEPO doses similar to those of group A. In step C2 , rHuEPO doses were reduced to those of group B. As oxidant stress markers , we determined in plasma the susceptibility of lipids to undergo iron-catalyzed oxidation ( reactive oxygen molecules [ ROMs ] test ) and malondialdehyde-4-hydroxynonenal ( MDA-4HNE ) , alpha-tocopherol ( alpha-T ) , total thiol ( -SH ) , and total antioxidant activity . RBC survival was measured using the chromium 51 T/2 technique in 22 patients . RESULTS Results show that : ( 1 ) high rHuEPO doses ( groups A and C1 ) were associated with decreased ROM production , low alpha-T levels , and slightly increased -SH levels compared with corresponding groups on low rHuEPO doses ( groups B and C2 ) ; ( 2 ) treatment with CL-Es ( group C ) increased plasma alpha-T and decreased -SH levels ; these data were associated with decreased indices of lipid peroxidation , particularly MDA-4HNE 1evels , only in patients administered low rHuEPO doses ; ( 3 ) alpha-T concentration influenced RBC survival , which was remarkably decreased in HD patients ; patients treated with CL-Es showed a better degree of anemia correction ; and ( 4 ) alpha-T level correlated negatively with -SH level and seemed to be independent of the extent of peroxidation and oxidizability of plasma lipids . CONCLUSION Both EPO and CL-E can influence plasma antioxidants and , to an extent , lipid peroxidation processes . However , this study shows that even in patients treated with low rHuEPO doses , RBC survival close to normal and sufficient correction of anemia are achieved only when appropriate alpha-T levels are reached",
"Intravenous iron application to anemic patients on hemodialysis leads to an \" oversaturation \" of transferrin . As a result , non-transferrin-bound , redox-active iron might induce lipid peroxidation . To test the hypothesis that vitamin E attenuates lipid peroxidation in patients receiving 100 mg of iron(III ) hydroxide sucrose complex intravenously during a hemodialysis session , 22 patients were investigated in a r and omized cross-over design , either with or without a single oral dose of 1200 IU of all-rac-alpha-tocopheryl acetate taken 6 h before the hemodialysis session . Blood was drawn before and 30 , 60 , 90 , 135 , and 180 min after the start of the iron infusion , and areas under the curve ( AUC0 - 180 min ) of ratios of plasma malondialdehyde ( MDA ) to cholesterol and plasma total peroxides to cholesterol ( two markers of lipid peroxidation ) were determined as the outcome variables . At baseline of the session without vitamin E supplementation , plasma alpha-tocopherol concentrations ( 27.6 + /- 1.8 micromol/L ) and ratios of alpha-tocopherol to cholesterol ( 5.88 + /- 1.09 mmol/mol ) were normal , plasma MDA concentrations were above normal ( 1.20 + /- 0.28 micromol/ L ) , and bleomycin-detectable iron ( BDI ) , indicating the presence of redox-active iron , was not detectable . Upon iron infusion , BDI and MDA concentrations increased significantly ( P BDI concentrations explained the increase over baseline in MDA concentrations ( MDA = 1.29 + /- 0.075 x BDI ) . Vitamin E supplementation , leading to a 68 % increase in plasma alpha-tocopherol concentrations , significantly reduced the AUC0 - 180 min of MDA to cholesterol ( P = 0.004 ) and peroxides to cholesterol ( P = 0.002 ) . These data demonstrate that a single oral dose of vitamin E attenuates lipid peroxidation in patients on hemodialysis receiving intravenous iron . Given that intravenous iron is applied repeatedly to patients on hemodialysis , this therapeutic approach may protect against oxidative stress-related degenerative disease in the long term",
"BACKGROUND Excess cardiovascular mortality has been documented in chronic haemodialysis patients . Oxidative stress is greater in haemodialysis patients with prevalent cardiovascular disease than in those without , suggesting a role for oxidative stress in excess cardiovascular disease in haemodialysis . We investigated the effect of high-dose vitamin E supplementation on cardiovascular disease outcomes in haemodialysis patients with pre-existing cardiovascular disease . METHODS Haemodialysis patients with pre-existing cardiovascular disease ( n=196 ) aged 40 - 75 years at baseline from six dialysis centres were enrolled and r and omised to receive 800 IU/day vitamin E or matching placebo . Patients were followed for a median 519 days . The primary endpoint was a composite variable consisting of : myocardial infa rct ion ( fatal and non-fatal ) , ischaemic stroke , peripheral vascular disease ( excluding the arteriovenous fistula ) , and unstable angina . Secondary outcomes included each of the component outcomes , total mortality , and cardiovascular-disease mortality . FINDINGS A total of 15 ( 16 % ) of the 97 patients assigned to vitamin E and 33 ( 33 % ) of the 99 patients assigned to placebo had a primary endpoint ( relative risk 0.46 [ 95 % CI 0.27 - 0.78 ] , p=0.014 ) . Five ( 5.1 % ) patients assigned to vitamin E and 17 ( 17.2 % ) patients assigned to placebo had myocardial infa rct ion ( 0.3 [ 0.11 - 0.78 ] , p=0.016 ) . No significant differences in other secondary endpoints , cardiovascular disease , or total mortality were detected . INTERPRETATION In haemodialysis patients with prevalent cardiovascular disease , supplementation with 800 IU/day vitamin E reduces composite cardiovascular disease endpoints and myocardial infa rct ion",
"Adverse physiologic effects accompany hemodialysis . Biocompatible dialyzer membranes may both limit oxidative stress and decrease & bgr;2-microglobulin production , thereby reducing patient morbidity . We compared st and ard solute clearance , lipid , and antioxidant effects of a novel cellulosic membrane dialyzer modified with covalently bonded vitamin E ( Excebrane Clirans E15 , Terumo Australia ) with st and ard cellulosic and polysulphone membrane dialyzers . Stable adult hemodialysis patients taking no lipid lowering or antioxidant therapy ( n = 17 ; 9 male , 8 female ) were recruited into a 10 week , prospect i ve , unblinded study . Measurements were made at baseline on their usual dialyzer and after 2 , 4 , and 10 weeks of Excebrane use . Excebrane demonstrated good in vivo clearance of st and ard solutes relative to surface area . Predialysis & bgr;2-microglobulin levels were unchanged with time and were significantly lower postdialysis than with cellulose acetate ( p Oxidized low density lipoprotein levels as measured by nitrotyrosine residues were high predialysis , but tended to decrease with both membranes ( p > 0.05 ) . Total antioxidant status fell during dialysis ( p plasma vitamin A and E concentrations increased ( p = 0.007 and p = 0.02 , respectively ) . Baseline vitamin A levels were high in all patients and , along with vitamin E , total antioxidant status and lipid profiles did not change over time with Excebrane use . Excebrane is an efficient , biocompatible membrane with no deleterious effects on & bgr;2-microglobulin or lipids . More long-term study is merited",
"We evaluated the biocompatibility of a newly developed vitamin E hemodialyzer ( CL-EE ; Terumo Co Ltd , Tokyo , Japan ) by neutrophil function and oxidant stress in patients with end-stage renal failure in a r and omized crossover study . Ten patients underwent hemodialysis using either the CL-EE or a control dialyzer membrane identical to the CL-EE except for vitamin E binding for 12 weeks in a crossover fashion after a 1-month washout period with hemophane membranes . White blood cell counts , serum oxidized low-density lipoprotein ( Ox-LDL ) levels , and malondialdehyde ( MDA ) levels during hemodialysis sessions were measured at the initiation and end of the CL-EE and control trials . Superoxide anion production by neutrophils just before and 4 hours after starting the session also was measured . Leukocytopenia at 1 hour after starting the session was detected to a similar extent in both membranes . However , the degree of reduction was less in the CL-EE trial after repeated use . Superoxide anion production by neutrophils just before a hemodialysis session was reduced after repeated use of the CL-EE membrane . Serum Ox-LDL levels increased , whereas serum MDA levels decreased during sessions to a similar extent in both trials . However , these parameters were significantly lower in the CL-EE trial after repeated use . Serum LDL concentrations significantly decreased with repeated use of the CL-EE membrane . These data suggest that repeated use of the CL-EE membrane for 3 months improves neutrophil function , oxidant stress , and LDL concentrations in patients with renal failure . This membrane may be useful to reduce the incidence of cardiovascular events in patients with renal failure",
"Cytokine induction by dialyzer membranes has been related to several acute and chronic side effects of hemodialysis treatment , among them being immune dysfunction and progressive atherosclerosis . Surface modification of cuprophane dialyzers with the antioxidant vitamin E is a new approach to enhance biocompatibility and improve cytokine levels , as well as immune function . Twenty-one patients undergoing treatment with hemophane ( HE ) dialyzers were enrolled onto a crossover study with a vitamin E-coated ( VE ) dialyzer or a synthetic polyamide ( PA ) dialyzer . In vitro assays of lymphocyte activation and measurements of cytokine induction were performed to evaluate biocompatibility . Four weeks of treatment with either VE or PA dialyzers enhanced in vitro proliferation of peripheral blood leukocytes in comparison to treatment with HE membranes used before study entry . Enhancement of lymphocyte function was independent of dialysis efficiency , which was kept constant during the study . In the interdialytic interval , preactivation of monocytes for the production of interleukin-6 ( IL-6 ) did not differ between VE or PA dialysis . In contrast , the VE membrane reduced acute production of IL-6 during a dialysis treatment , whereas the PA membrane did not . Unlike IL-6 , the regulatory cytokine IL-10 is not inhibited by either membrane . This is important because IL-10 is believed to have a beneficial effect on immune function in dialysis patients . The VE membrane , despite being based on a cuprophane backbone , is similar to the highly biocompatible PA dialyzer in terms of its effect on lymphocyte function , whereas it exerts an additional suppressive effect on the overproduction of proinflammatory cytokines ",
"By the use of flow cytometric techniques , this prospect i ve , r and omized crossover study was design ed to analyze intradialytic granulocyte reactive oxygen species ( ROS ) formation in whole blood with complement-activating and noncomplement-activating hollow fiber membranes . Dialysis with a complement-activating membrane result ed in a 6.5-fold increase in granulocyte hydrogen peroxide production 15 min after dialysis initiation and remained significantly elevated ( P granulocyte ROS production in response to Staphylococcus aureus incubation than blood obtained either predialysis or at the same time in dialysis with a noncomplement-activating membrane . Both complement-activating and noncomplement-activating dialysis membranes caused slightly decreased granulocyte responsiveness to phorbol myristate acetate . It was concluded that hemodialysis with complement-activating membranes results in increased granulocyte ROS production and decreased responsiveness to S. aureus challenge during the dialysis procedure . These results document the potential role of ROS in hemodialysis-associated pathology and susceptibility to infection",
"A comparison of the oxyradical exposure during hemodialysis ( HD ) carried out with vitamin-E-modified cellulose ( CL-E ) or conventional membranes , study ing red blood cell ( RBC ) and plasma lipoperoxidation and RBC glutathione metabolism , was done . In this preliminary characterization of a new and original approach to the prevention of free radical damage in HD , the results obtained indicate that lipoperoxidation in plasma and RBC is decreased and therefore oxidative damage can be significantly decreased using CL-E dialysis membranes instead of conventional membranes"
] | 41167d56-06ff-11f0-808a-c43d1ab1c353 |
The aim of this work was to identify the limitations of previously published systematic review s evaluating the outcome of root canal treatment . Traditionally , periapical radiography has been used to assess the outcome of root canal treatment with the absence of a periapical radiolucency being considered a confirmation of a healthy periapex . However , a high percentage of cases confirmed as healthy by radiographs revealed apical periodontitis on cone beam computed tomography ( CBCT ) and by histology . In teeth , where reduced size of the existing radiolucency was diagnosed by radiographs and considered to represent periapical healing , enlargement of the lesion was frequently confirmed by CBCT . In clinical studies , two additional factors may have further contributed to the overestimation of successful outcomes after root canal treatment : ( i ) extraction s and re-treatments were rarely recorded as failures ; and ( ii ) the recall rate was often lower than 50 % . The periapical index ( PAI ) , frequently used for determination of success , was based on radiographic and histological findings in the periapical region of maxillary incisors . The validity of using PAI for all tooth positions might be question able , as the thickness of the cortical bone and the position of the root tip in relation with the cortex vary with tooth position . In conclusion , the serious limitations of longitudinal clinical studies restrict the correct interpretation of root canal treatment outcomes . Systematic review s reporting the success rates of root canal treatment without referring to these limitations may mislead readers . The outcomes of root canal treatment should be re-evaluated in long-term longitudinal studies using CBCT and stricter evaluation criteria | [
"The purpose of this study was to evaluate the clinical outcomes of root canal treatment in private practice and filled with Resilon . Immediate postoperative radiographs were compared to follow-up radiographs of at least 1 year in 82 r and omly selected primary endodontic cases treated according to a nonst and ardized protocol but root-filled with Resilon . The Periapical Index ( PAI ) and the Clinical Impression of Healing ( CIH ) quantification procedures were used to determine the status and change in the condition of the teeth . The PAI evaluation revealed that 90 % of the teeth that were healthy at the initial reading ( PAI , 1or 2 ) maintained the condition at follow-up evaluation . Of those teeth that were unhealthy ( PAI , 3 - 5 ) at the initial reading , 73.3 % were judged healthy ( 50 % ) or improved ( 23.3 ) at the last evaluation . In contrast , the proportion of healthy or healing with the CIH evaluation was 89.4 % . The findings of this study support the contention that regardless of treatment protocol , healing rates for Resilon-filled teeth in private practice were within the range of success rates for studies with uniform treatment techniques mostly in university setting s with gutta-percha root filling",
"AIM To describe and discuss changes in periapical and endodontic status in a general Danish population . METHODOLOGY In 1997 , 616 r and omly selected individuals had a full-mouth radiographic survey taken . In 2003 , 77 % of the participants attended for a new full-mouth radiographic examination . Information on endodontic treatment and periapical status was obtained . The periapical index ( PAI ) was used to assess apical periodontitis ( AP ) . RESULTS More participants had root filling(s ) and AP in 2003 than in 1997 . More teeth had AP and /or root fillings in 2003 . Fewer of the root-filled teeth ( RFT ) had AP in 2003 . Less than 3 % of the teeth without root fillings ( NRFT ) that in 1997 had no AP , developed AP and /or received a root filling . Of the NRFT which in 1997 had AP , more than 35 % still had AP and no root filling in 2003 . Approximately , 30 % of the NRFT with AP in 1997 received a root filling . Of the teeth that received a root filling , 40 % had healed , whereas 60 % had not . Approximately , 25 % of the NRFT that in 1997 had AP had been extracted . In 1997 there were 618 RFT , 314 of the RFT had no AP in 1997 . Almost 20 % of the RFT that in 1997 were periapically sound , developed AP . Of the 304 RFT with AP in 1997 , approximately 30 % had healed , in 60 % AP persisted , and 10 % were extracted . CONCLUSIONS The present study indicates that caution must be exercised when statements on the outcome of root canal treatment are made based on the cross-sectional studies",
"The choice of one-visit versus two-visit root canal therapy for necrotic teeth with apical periodontitis is a source of current debate . The primary objective of this r and omized controlled clinical trial was to compare radiographic evidence of periapical healing after root canal therapy completed in one visit or two visits with an interim calcium hydroxide/chlorhexidine paste dressing . Ninety-seven patients met the inclusion criteria and consented to participate in this study . Patients were r and omly assigned to either the one-visit or two-visit group , and root canal therapy was performed with a st and ardized protocol . Patients in the two-visit group received an intracanal dressing of calcium hydroxide/chlorhexidine paste . Sixty-three patients , 33 in the one-visit group and 30 in the two-visit group , were evaluated at 12 months . The primary outcome measure was change in apical bone density by using the periapical index ( PAI ) . Secondary outcome measures were proportion of teeth healed or improved in each group . Both groups exhibited equally favorable periapical healing at 12 months , with no statistically significant differences between groups",
" A prospect i ve clinical and radiographic study was conducted in order to compare Hydron and laterally condensed gutta-percha/AH-26 root canal fillings . Paralleling technique periapical radiographs were taken preoperatively , postoperatively and at recall appointments at post-treatment intervals of 6 months , 1 year , 2 years , 3 years and 5 years . Clinical examination at the recall appointments revealed no adverse signs or symptoms amongst all the patients who attended ( mean attendance 44.5 % at each interval ) . Radiographs were scored according to the periapical status of the treated root , and comparable bone healing rates were observed between the two root-filling material s. Among the patients attending recall appointments , there were no radiographic signs of failure of any of the 39 gutta-percha/AH-26 root canal fillings . However , three of the 35 canals filled with Hydron were classified as failures , and four required further assessment after the 5-year recall appointment . This study indicated that Hydron and gutta-percha/AH-26 root canal fillings were well accepted but , on the basis of radiographic assessment , success with gutta-percha/AH-26 was more predictable",
"OBJECTIVES The aim of the study was to identify risk indicators for apical periodontitis ( AP ) in the individual . A parameter was defined as a ' risk indicator ' when its presence increased the individual 's risk of exhibiting AP . Risk indicators may , but need not be directly associated with the disease . METHODS The study included full-mouth surveys of 613 r and omly selected individuals , who were 20 - 60 years old and living in Aarhus County . Logistic regression analyses were performed . The outcome variable was > or=1 AP/no AP . The independent variables were obtained from information on socioeconomic and dental status . RESULTS It was found that smoking , no usage of services from the dentist , > or=2 secondary caries lesions , > or=3 inadequate coronal fillings and the presence of root filling(s ) were statistically associated with AP . A separate analysis for individuals with no previous root fillings showed that individuals with regular dental visits as well as individuals who had all their teeth ( third three molars excluded ) were less likely to have AP , whereas individuals who had > or=3 inadequate coronal fillings were more likely to have AP . CONCLUSIONS The results from the present study of a Danish population showed that the most important risk indicator of having AP in the individual was the radiographic evidence of root fillings . The presence of several caries lesions , the quality of the dental treatment , the regularity of dental visits and smoking were also statistically associated with AP . Further , the socioeconomic status of the individual did not provide much additional information on the periapical status",
"Outcome 4 - 6 years after retreatment was assessed for Phases 3 and 4 of the Toronto Study . Of 477 teeth retreated , 333 were lost to follow-up , 18 were extracted , and 126 ( 41 % recall , excluding 124 discontinuers ) were examined for outcome of healed ( periapical index score , = 2 ; no signs or symptoms ) or diseased . When pooled with Phases 1 and 2 , 187 of 229 teeth ( 82 % ) were healed . Logistic regression identified significant ( P root filling quality ( odds ratio [ OR ] , 4.18 ; confidence interval [ CI ] , 1.72 - 10.12 ; healed : inadequate , 88 % ; adequate , 66 % ) , perforation ( OR , 4.01 ; CI , 1.28 - 12.62 ; healed : absent , 87 % ; present , 56 % ) , and radiolucency ( OR , 3.33 ; CI , 1.19 - 9.36 ; healed : absent , 93 % ; present , 80 % ) . In teeth with radiolucency , outcome predictors were number of treatment sessions ( OR , 12.08 ; CI , 1.84-infinity ; healed : one , 100 % ; > or = 2 , 77 % ) and previous root filling quality ( OR , 7.68 ; CI , 2.36 - 26.89 ; healed : inadequate , 86 % ; adequate , 50 % ) . Outcome was better in teeth with inadequate previous root filling , without perforation and radiolucency . Suggested significance of number of treatment sessions in teeth with radiolucency requires validation from r and omized controlled trials",
"AIM This study aim ed to examine clinical ly and radiographically the survival of primary root canal treatment completed in a dental teaching hospital between 10 and 20 years previously . METHODOLOGY A data collection form was used to collate all information obtained from the written patients ' records along with the results from clinical and radiographic examination of 608 teeth , out of a total of 986 r and omly selected teeth that had been root filled in the Prince Philip Dental Hospital ( PPDH ) , Hong Kong , between 1981 and 1989 . The criteria for failure were extraction s ( except for documented nonendodontic reason ) , retreatments and presence of a periapical radiolucency . The survival function of the treated teeth was plotted against the calculated date of failure using the Kaplan-Meier ( K-M ) method . Covariables were examined further by Cox Regression analysis with a backward stepwise method . RESULTS A total of 314 teeth ( 52 % ) were either documented or deemed to have failed after examination . The median survival time was 111 months . Cox Regression analysis indicated that the survival of root-filled teeth was significantly influenced by the tooth type , preoperative periapical status and the type of coronal restoration . The survival function declined with time , with a rapid drop in the first 18 months or so . The rate at which failures occurred appeared to slow down with a longer observation time . CONCLUSIONS There was a nonlinear decline in the cumulative survival probability of primary root canal treatment . Tooth type , preoperative periapical status and type of post and final restoration significantly affected the long-term survival of the treated teeth",
"OBJECTIVE Many biological variables , endodontic treatment factors , and restorative considerations have been suggested in the literature to affect the outcome of endodontic treatment . However , few attempts have been made recently to study these variables further . The purpose of this study was to identify the biologic and endodontic treatment-associated variables that are most predictive of treatment outcome for conventional endodontic therapy and to determine the magnitude of risk these variables pose on the outcome . STUDY DESIGN The population of this historical prospect i ve cohort study comprised a total of 200 teeth with 441 root canals . Diagnostic and treatment information was abstract ed from the original patient records . An endodontic follow-up examination was conducted 4 + /- 0.5 years after obturation . Each tooth/root was analyzed according to 3 indices of periradicular status at 2 time points . The main outcome measure was the presence of apical periodontitis . The criteria used for evaluation of the outcome were modified from Strindberg . Data were subjected to univariate and multivariate analysis . Logistic regression models were fit by using various clinical measures to determine which combination of biologic and treatment-associated factors best predicted treatment outcome . RESULTS The preoperative pulp diagnosis , the periapical diagnosis , the preoperative periapical radiolucency size , and the sex of the patients were revealed , by means of univariate analysis , to exert a significant influence on endodontic treatment outcome ( P postoperative healing was the presence and magnitude of preoperative apical periodontitis . In the presence of this variable , no other factor contributed value to the prediction . The correct prediction of this model was 74.7 % ( P endodontic treatment appear to be the extent of microbiological insult to the pulp and periapical tissue , as reflected by the periapical diagnosis and the magnitude of periapical pathosis",
"The objective was to evaluate the clinical efficacy of chemomechanical preparation of the root canals with sodium hypochlorite and interappointment medication with calcium hydroxide in the control of root canal infection and healing of periapical lesions . Fifty teeth diagnosed with chronic apical periodontitis were r and omly allocated to one of three treatments : Single visit ( SV group , n = 20 ) , calcium hydroxide for one week ( CH group n = 18 ) , or leaving the canal empty but sealed for one week ( EC group , n = 12 ) . Microbiological sample s were taken to monitor the infection during treatment . Periapical healing was controlled radiographically following the change in the periapical index at 52 wk and analyzed using one-way ANOVA . All cases showed microbiological growth in the beginning of the treatment . After mechanical preparation and irrigation with sodium hypochlorite in the first appointment , 20 to 33 % of the cases showed growth . At the second appointment 33 % of the cases in the CH group revealed bacteria , whereas the EC group showed remarkably more culture positive cases ( 67 % ) . Sodium hypochlorite was effective also at the second appointment and only two teeth remained culture positive . Only minor differences in periapical healing were observed between the treatment groups . However , bacterial growth at the second appointment had a significant negative impact on healing of the periapical lesion ( p clinical efficacy of sodium hypochlorite irrigation in the control of root canal infection . Calcium hydroxide dressing between the appointments did not show the expected effect in disinfection the root canal system and treatment outcome , indicating the need to develop more efficient inter-appointment dressings",
"AIM To determine the prevalence of apical periodontitis and quality of root fillings in 35-year-old citizens of Oslo , Norway in 2003 , and to compare the results with data from the same age cohort collected by repetitive cross-sectional studies in 1973 , 1984 and 1993 . METHODOLOGY A r and om sample of 250 35-year-old Oslo inhabitants was drawn from The National Bureau of Statistics Recordings . Attendance rate was 64 % . Root filled teeth and teeth with periapical pathology were detected from panoramic radiographs and additional periapical radiographs of affected teeth were processed . The preriapical status was evaluated by applying the periapical index system ( PAI ) . Chi-square and Student 's t-tests were used for the evaluation of differences between the groups . RESULTS Twenty-three per cent of the individuals examined had root filled teeth and 16 % had at least one tooth with apical periodontitis . Root filled teeth were associated with PAI values of 1 and 2 ( health ) in 57 % of cases . Prevalence of root filled teeth and apical periodontitis remained unchanged during the past 10 years . An increase in the proportion of root filled teeth with apical periodontitis from 18 % in 1973 to 43 % in 2003 was observed . CONCLUSIONS Despite continuous improvement in dental health ( reduced DMF-values ) compared with the previous Oslo studies ; there was no improvement in endodontic status from 1993 to 2003",
"OBJECTIVE The purpose of this clinical study was to determine the effect of 1- or 2-visit root canal treatment on the postoperative pain in the retreatment cases . STUDY DESIGN Two hundred eighteen cases that required retreatment were included in the study . Obturated and unfilled canal space and the status of periapical tissues were evaluated according to the PAI index . The patients were subcategorized in regard to the presence or the absence of preoperative pain . Approximately half of each category was treated in 1 appointment . After removing the previous root canal obturation material s and biomechanic preparation of root canals , the teeth in the 1-visit group were obturated at the first appointment by using AH 26 sealer and laterally compacted gutta-percha , and those in the 2-visit group were medicated with calcium hydroxide-chlorhexidine combination and then closed with a temporary filling material . One week after the initial appointment , patients were asked about the occurrence of postoperative pain . The level of discomfort was rated as no pain , mild pain , moderate pain , or severe pain ( flare-up ) . Data were statistically analyzed using the chi-squared and Fischer exact tests . RESULTS Eight patients from the 1-visit group and 2 patients from the 2-visit group had flare-ups . There was a statistical difference between the groups ( P canal treatment was more effective in completely eliminating pain than 1-visit treatment of previously symptomatic teeth ( P Two-visit endodontic treatment with intracanal medication was found to be effective in reducing postoperative pain of previously symptomatic teeth and decreased the number of flare-ups in all retreatment cases",
"This study prospect ively assessed the 4 to 8 yr outcome of apical surgery performed by graduate students in phases I and II of the Toronto Study . The study cohort included 155 teeth in 138 patients . Outcome was assessed by a blinded and calibrated examiner . Clinical and radiographic measures were used for a dichotomous outcome : healed ( no signs and symptoms , Periapical Index score scar ) , or diseased ( presence of signs and symptoms , or Periapical Index score > /= 3 ) . The recall rate was 85 % and the overall healed rate 74 % . Healed rate was significantly higher for teeth with small ( disease persistence for teeth with larger preoperative lesions ( OR = 3.81 , CI = 1.2 - 12.1 ) , and preoperative root-filling of adequate length ( OR = 3.7 , CI = 1.1 - 11.1 ) . Preoperative lesion size and root-filling length were significant predictors of outcome of apical surgery",
"Outcome 4 - 6 years after initial treatment was assessed for Phase 4 ( 2000 - 2001 ) of the Toronto Study . Of 582 teeth treated , 430 were lost to follow-up ( 99 discontinuers , 331 dropouts ) , 15 were extracted , and 137 ( 32 % recall minus 15 extracted teeth ) were examined for outcome : healed ( no apical periodontitis , signs , symptoms ) or diseased . When pooled with Phases 1 - 3 , 439 of 510 teeth ( 86 % ) were healed . Logistic regression identified 2 significant ( P radiolucency ( odds ratio [ OR ] , 2.86 ; confidence interval [ CI ] , 1.56 - 5.24 ; healed : absent , 93 % ; present , 82 % ) and number of roots ( OR , 2.53 ; CI , 1.25 - 5.13 ; healed : single , 93 % ; multiple , 84 % ) . In teeth with radiolucency , intraoperative complications ( OR , 2.27 ; CI , 1.05 - 4.89 ; healed : absent , 84 % ; present , 69 % ) and root-filling technique ( OR , 1.89 ; CI , 1.01 - 3.53 ; healed : lateral , 77 % ; vertical , 87 % ) were additional outcome predictors . A better outcome was suggested for teeth without radiolucency , with single roots , and without mid-treatment complications . The predictive value of root-filling technique in teeth with radiolucency requires validation from r and omized controlled trials",
"The purpose of this study was to examine changes in the endodontic status of selected teeth in a population over time , in order to get a long-term perspective of endodontically treated teeth . A r and om sample of the adult Swedish population was selected in 1974 and offered a clinical and radiographic examination . Eleven years later 351 of the selected persons attended a follow-up examination ( 1985 ) . In radiographs , covering the m and ibular premolar and molar regions , the status of 1974 was directly compared , tooth by tooth , with the status of 1985 . The results showed that a number of endodontically treated teeth with an apical periodontitis healed during the observation period . During the same period , approximately the same number of endodontically treated teeth presented with a new apical periodontitis . This finding suggested that cross-sectional studies could provide reliable information on the long-term success rate of endodontic treatment at the population level . The periapical lesions that persisted or developed during the observation period were strongly related to incomplete root canal obturation , which is in agreement with observations in follow-up studies from teaching and specialist clinics",
"AIM The aim of this study was to investigate the quality of endodontic and coronal restorations and the association with periapical status in a Danish population . METHODOLOGY A total of 614 r and omly selected individuals ( 20 - 60 + years of age ) from Aarhus County had a full-mouth radiographic examination . The quality of endodontic and coronal restorations and the periapical status of endodontically treated teeth were assessed by radiographic criteria . Root fillings were categorized as ' adequate ' or ' inadequate ' with regard to root filling length and lateral seal . Coronal restorations were categorized into ' adequate ' and ' inadequate ' , defined by the absence or presence of radiographic signs of overhangs or open margins . Results were analysed statistically using the chi-squared test . RESULTS The total number of endodontically treated teeth was 773 , and 52.3 % had apical periodontitis ( AP ) . Root-filled teeth with an adequate lateral seal had a lower incidence of AP than teeth with an inadequate seal ( 44.3 % vs. 57.8 % ) , and teeth with an adequate root filling length were associated with a better periapical status than teeth with inadequate length of the root filling ( 42.0 % vs. 67.6 % ) . Similarly , adequate coronal restorations were associated with better periapical status than inadequate restorations ( 48.0 % vs. 63.9 % ) . When both root filling and coronal restoration quality were assessed , the incidence of AP ranged from 31.2 % ( optimal quality ) to 78.3 % ( all parameters scored as inadequate ) . CONCLUSIONS Inadequate root canal and coronal restorations were associated with an increased incidence of AP",
"The clinical performance of three endodontic sealers , AH 26 ® , Kloroperka N-O ® and ProcoSol ® , was assessed in a prospect i ve study of endodontic treatment in 810 roots . The roots were treated by undergraduate students according to a st and ardized procedure , and were filled with laterally condensed gutta-percha and sealer . The sealer was r and omly selected just prior to filling . The patients were recalled yearly for 4 years for a clinical and radiographic control examination , and the radiographs were scored using the periapical index ( PAI ) scoring system . Ridit analysis provided optimal discrimination between subgroups of roots with regard to the radiographic status of the periapical tissues as a measure of the clinical performance of the material s. The periapical status of roots filled with AH 26 ® or ProcoSol ® was better than that of roots filled with Kloroperka ® . The difference was significant after 1 year and persisted through the 4-year observation period . The difference was also evident after stratification of the material with regard to preoperative pulpal and periapical diagnoses . It is concluded that the choice of sealer may influence the outcome of endodontic treatment , and that the perapical index is a useful discriminatory tool for assessment of treatment results in endodontics",
"AIM To assess the treatment results up to 1 year after endodontic treatment of apical periodontitis using a silicone-based sealer in comparison with Grossman 's sealer , and to compare the results at 3 months after treatment with the 12-month follow-up to assess the prognostic value of a 3-month control . METHODOLOGY A total of 199 teeth were treated at three centres . The sealer was r and omly chosen at the time of filling . Treatment results were evaluated clinical ly and radiographically 3 and 12 months after root-canal filling . The periapical status was evaluated using the periapical index ( PAI ) . RESULTS AND CONCLUSIONS Average PAI scores decreased from 3.43 at start to 2.21 at 12 months for Grossman 's sealer and from 3.40 to 2.26 for the silicon-based material . No significant difference between the groups at start or any of the follow ups was seen . The 3-month control was adequate in establishing significant healing in both groups . The improvement of the periapical condition continued at the 12-month examination",
"This study was performed to evaluate radiographic healing of teeth with apical periodontitis , treated in one visit or in two visits ( a ) with or ( b ) without calcium hydroxide as an intracanal disinfecting medicament . The patients were assigned one of the three treatment groups by the throwing of a die . The Periapical Index ( PAI ) Scoring Method was used to compare differences in periapical status from the beginning of treatment to a 52-wk follow-up evaluation . Overall , the periapical status of the treated teeth improved significantly after 52 wk ( p PAI score of 1 or 2 was considered as representing a \" good \" periapical status while 3 , 4 , or 5 was a \" bad \" status . When base line PAI scores were controlled for , the calcium hydroxide group showed the most improvement in PAI score ( 3 , 4 , or 5 to 1 or 2 ) , followed by the one-step group ( 74 % vs. 64 % ) . The teeth that were left empty between visits had clearly inferior healing results . Power statistics were conducted to determine the numbers required for significant differences between the groups , and it was shown that large experimental groups on the order of hundreds of patients would be required to show significant differences",
"The 4- to 6-year outcome of initial endodontic treatment was assessed for phase III ( 1998 - 1999 ) of the Toronto Study . Of the 532 teeth treated , 248 were from discontinuers ( excluded ) , 142 from dropouts , 10 extracted , and 132 ( 50 % recall ) examined for outcome : healed ( no apical periodontitis [ AP ] , signs , symptoms ) or diseased . Phase III was analyzed alone and combined with phases I , II ( n = 373 teeth ) . Logistic regression performed on the combined phases I-III sample identified significant ( p preoperative AP ( OR = 3.5 ; CI 1.7 - 7.2 ; healed : absent , 93 % ; present , 80 % ) , number of roots ( OR = 2.2 ; CI 1.0 - 4.7 ; healed : 1 - 92 % ; > or = 2 - 83 % ) , and intraoperative complications ( OR = 2.2 ; CI 1.1 - 4.5 ; healed : absent , 88 % ; present , 76 % ) . Treatment technique ( OR = 2.8 ; CI 1.3 - 6.1 ; healed : Schilder , 89 % ; alternative , 73 % ) was suggested as an outcome predictor in teeth with AP , requiring confirmation from r and omized controlled trials",
"In the present study , multivariate analyses were performed on clinical and treatment variables that may influence the outcome of endodontic treatment . Data collected in a previous clinical -radiographic follow-up study were used . Of 810 treated , 675 roots in 498 teeth were followed for 6 months to 4 yr . Of these , 192 ( the CAP group ) had pre-existing , chronic apical periodontitis and 483 ( the NAP group ) had not . Root canal treatment followed a st and ard procedure with one of three sealers chosen at r and om . Demographic , clinical and radiographic variables were recorded at the start of , and during treatment . The periapical index ( PAI ) score was used to record the outcome of treatment , and applied in two different endpoint modes ( END1 and END2 ) as the dependent variable for multivariate statistical analyses using logistic regression and the general model . The modes reflected increasing PAI scores ( END1 ) and conventional success/failure assessment ( END2 ) . Dropouts were largely similar to the cases followed up . A total of 10 preoperative and peroperative variables were found to be significantly associated with treatment outcome by the multivariate analyses of either the total material or the NAP or CAP subgroups . Several of these were not significant in univariate analyses ( e.g. the effect of sealer ) . Conventional success/failure analyses ( END2 ) identified fewer of the influential variables and had low explanatory power , whereas PAI scores on an ordinal scale ( END1 ) were most sensitive in identifying variables of influence on the treatment outcome"
] | 41167d9c-06ff-11f0-808a-c43d1ab1c353 |
INTRODUCTION Unexplained differences between classes of antihypertensive drugs in their effectiveness in preventing stroke might be due to class effects on intraindividual variability in blood pressure . We did a systematic review to assess any such effects in r and omised controlled trials . METHODS Baseline and follow-up data for mean ( SD ) of systolic blood pressure ( SBP ) were extracted from trial reports . Effect of treatment on interindividual variance ( SD2 ) in blood pressure ( a surrogate for within-individual variability ) , expressed as the ratio of the variances ( VR ) , was related to effects on clinical outcomes . Pooled estimates were derived by use of r and om-effects meta- analysis . FINDINGS Mean ( SD ) SBP at follow-up was reported in 389 ( 28 % ) of 1372 eligible trials . There was substantial heterogeneity between trials in VR ( p interindividual variation in SBP was reduced by calcium-channel blockers ( VR 0.81 , 95 % CI 0.76 - 0.86 , p non-loop diuretic drugs ( 0.87 , 0.79 - 0.96 , p=0.007 ) , and increased by angiotensin-converting enzyme ( ACE ) inhibitors ( 1.08 , 1.02 - 1.15 , p=0.008 ) , angiotensin-receptor blockers ( 1.16 , 1.07 - 1.25 , p=0.0002 ) , and beta blockers ( 1.17 , 1.07 - 1.28 , p=0.0007 ) . Compared with placebo only , interindividual variation in SBP was reduced the most by calcium-channel blockers ( 0.76 , 0.67 - 0.85 , p VR of SBP ( r2=0.372 , p=0.0006 ) and on mean SBP ( r2=0.328 , p=0.0015 ) accounted for effects on stroke risk ( eg , odds ratio 0.79 , 0.71 - 0.87 , p blood pressure can account for differences in effects of antihypertensive drugs on risk of stroke independently of effects on mean SBP . FUNDING None | [
"Background The results of angiographic studies have suggested that calcium channel – blocking agents may prevent new coronary lesion formation , the progression of minimal lesions , or both . Methods and Results The Prospect i ve R and omized Evaluation of the Vascular Effects of Norvasc Trial ( PREVENT ) was a multicenter , r and omized , placebo-controlled , double-masked clinical trial design ed to test whether amlodipine would slow the progression of early coronary atherosclerosis in 825 patients with angiographically documented coronary artery disease . The primary outcome was the average 36-month angiographic change in mean minimal diameters of segments with a baseline diameter stenosis of 30 % . A secondary hypothesis was whether amlodipine would reduce the rate of atherosclerosis in the carotid arteries as assessed with B-mode ultrasonography , which measured intimal-medial thicknesses ( IMT ) . The rates of clinical events were also monitored . The placebo and amlodipine groups had nearly identical average 36-month reductions in the minimal diameter : 0.084 versus 0.095 mm , respectively ( P = 0.38 ) . In contrast , amlodipine had a significant effect in slowing the 36-month progression of carotid artery atherosclerosis : the placebo group experienced a 0.033-mm increase in IMT , whereas there was a 0.0126-mm decrease in the amlodipine group ( P = 0.007 ) . There was no treatment difference in the rates of all-cause mortality or major cardiovascular events , although amlodipine use was associated with fewer cases of unstable angina and coronary revascularization . Conclusions Amlodipine has no demonstrable effect on angiographic progression of coronary atherosclerosis or the risk of major cardiovascular events but is associated with fewer hospitalizations for unstable angina and revascularization",
"The aim of our study was to assess the effects of lacidipine , a long-acting calcium antagonist , on 24-hour average blood pressure , blood pressure variability , and baroreflex sensitivity . In 10 mildly to moderately hypertensive patients with type II diabetes mellitus ( aged 18 to 65 years ) , 24-hour ambulatory blood pressure was continuously monitored noninvasively ( Portapres device ) after a 3-week pretreatment with placebo and a subsequent 4-week once daily lacidipine ( 4 mg ) or placebo treatment ( double-blind crossover design ) . Systolic blood pressure , diastolic blood pressure , and heart rate means were computed each hour for 24 hours ( day and night ) at the end of each treatment period . Similar assessment s were also made for blood pressure and heart rate variability ( st and ard deviation and variation coefficient ) and for 24-hour baroreflex sensitivity , which was quantified ( 1 ) in the time domain by the slope of the spontaneous sequences characterized by progressive increases or reductions of systolic blood pressure and RR interval and ( 2 ) in the frequency domain by the squared ratio of RR interval and systolic blood pressure spectral power ≈0.1 and 0.3 Hz over the 24 hours . Compared with placebo , lacidipine reduced the 24-hour , daytime , and nighttime systolic and diastolic blood pressure ( P significant change in heart rate . It also reduced 24-hour , daytime , and nighttime st and ard deviation ( −19.6 % , −14.4 % , and −24.0 % , respectively;P The 24-hour average slope of all sequences ( 7.7±1.7 ms/mm Hg ) seen during placebo was significantly increased by lacidipine ( 8.7±1.8 ms/mm Hg , P diabetic hypertensive patients , lacidipine reduced not only 24-hour blood pressure means but also blood pressure variability . This reduction was accompanied by an improvement of baroreflex sensitivity . Computer analysis of beat-to-beat 24-hour noninvasive blood pressure monitoring may offer valuable information about the effects of antihypertensive drugs on hemodynamic and autonomic parameters in daily life",
"The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ( ALLHAT ) , sponsored by the National Heart , Lung , and Blood Institute ( NHLBI ) , is the largest outcome trial of antihypertensive treatment ever carried out and the only large blood pressure ( BP ) trial to be carried out in a US population in the past decade.1 The rationale for ALLHAT , which was design ed in the early 1990s , was the urgent need to determine which of the several classes of antihypertensive drugs that had been developed and released for clinical use was most effective in preventing coronary heart disease ( CHD ) , defined as fatal CHD and nonfatal myocardial infa rct ion.2 The only r and omized trials that had previously compared representatives of the antihypertensive drug classes , the Department of Veterans Affairs Cooperative Study Group on Antihypertensive Agents3 and the Treatment of Mild Hypertension Study (TOMHS),4 showed BP reductions with all classes but were not powered to evaluate CHD outcomes . Further , prior outcome trials had shown that the reduction in CHD event rates with antihypertensive treatment was less than expected based on epidemiologic data .5 Adverse effects of study drugs , particularly diuretics , including hypokalemia , hypomagnesemia , hyperuricemia , hyperlipidemia , insulin resistance , and ventricular ectopic activity , had been adduced to account for the disappointing outcomes of earlier trials by off setting the beneficial effects of BP reduction.6,7 To further complicate the picture , benefits beyond BP reduction had been attributed to some antihypertensive drug classes , ie , improved survival and reduced morbidity in persons with heart failure or left ventricular dysfunction treated with angiotensin-converting enzyme ( ACE ) inhibitors8–10 and improved insulin sensitivity and lipid profiles with α-blocker treatment.11 In contrast , another antihypertensive drug class , the dihydropyridine calcium channel blockers ( CCBs ) , had been associated with unfavorable outcomes in patients with acute myocardial infa rct ion or unstable angina.12 There were no data",
"Although the benefits of antihypertensive treatment in \" young \" elderly ( under 70 years ) hypertensive patients are well established , the value of treatment in older patients ( 70 - 84 years ) is less clear . The Swedish Trial in Old Patients with Hypertension ( STOP-Hypertension ) was a prospect i ve , r and omised , double-blind , intervention study set up to compare the effects of active antihypertensive therapy ( three beta-blockers and one diuretic ) and placebo on the frequency of fatal and non-fatal stroke and myocardial infa rct ion and other cardiovascular death in hypertensive Swedish men and women aged 70 - 84 years . We recruited 1627 patients at 116 health centres throughout Sweden , who were willing to participate , and who met the entry criteria of three separate recordings during a 1-month placebo run-in period of systolic blood pressure between 180 and 230 mm Hg with a diastolic pressure of at least 90 mm Hg , or a diastolic pressure between 105 and 120 mm Hg irrespective of the systolic pressure . The total duration of the study was 65 months and the average time in the study was 25 months . 812 patients were r and omly allocated active treatment and 815 placebo . The mean difference in supine blood pressure between the active treatment and placebo groups at the last follow-up before an endpoint , death , or study termination was 19.5/8.1 mm Hg . Compared with placebo , active treatment significantly reduced the number of primary endpoints ( 94 vs 58 ; p = 0.0031 ) and stroke morbidity and mortality ( 53 vs 29 ; p = 0.0081 ) . Although we did not set out to study an effect on total mortality , we also noted a significantly reduced number of deaths in the active treatment group ( 63 vs 36 ; p = 0.0079 ) . The benefits of treatment were discernible up to age 84 years . We conclude that antihypertensive treatment in hypertensive men and women aged 70 - 84 confers highly significant and clinical ly relevant reductions in cardiovascular morbidity and mortality as well as in total mortality",
"Background and Purpose — In hypertensive stroke patients , for the same level of blood pressure control , eprosartan will be more effective than nitrendipine in reducing cerebrovascular and cardiovascular morbidity and mortality . Methods — A total of 1405 well-defined , high-risk hypertensives with cerebral event during the last 24 months ( proven by cerebral computed tomography scan or nuclear magnetic resonance ) were r and omized to eprosartan or nitrendipine ( mean follow-up 2.5 years ) . Primary end point was the composite of total mortality and all cardiovascular and cerebrovascular events , including all recurrent events . Results — R and omization was successful without significant differences in the baseline characteristics . Blood pressure was reduced to a comparable extent without any significant differences between the 2 groups during the whole study period ( 150.7/84 mm Hg and 152.0/87.2 mm Hg with eprosartan and nitrendipine therapy to 137.5/80.8 mm Hg and 136.0/80.2 mm Hg , respectively , confirmed by ambulatory blood pressure monitoring ) . Moreover , already after 3 months , normotensive mean values were achieved , and 75.5 % reached values eprosartan regimen and 77.7 % with the nitrendipine regimen . During follow-up , in total , 461 primary events occurred : 206 eprosartan and 255 nitrendipine ( incidence density ratio [ IDR ] , 0.79 ; 95 % CI , 0.66 to 0.96 ; P=0.014 ) . Cardiovascular events were : 77 eprosartan and 101 nitrendipine ( IDR , 0.75 ; 95 % CI , 0.55 to 1.02 ; P=0.06 ) ; cerebrovascular events : 102 eprosartan and 134 nitrendipine ( IDR , 0.75 ; 95 % CI , 0.58 to 0.97 ; P=0.03 ) . Conclusions — The Morbidity and Mortality After Stroke , Eprosartan Compared With Nitrendipine for Secondary Prevention ( MOSES ) study was the first to compare an angiotensin II type 1 receptor antagonist with a calcium antagonist in secondary stroke prevention . In these high-risk hypertensive stroke patients , an early normotensive and comparable blood pressure was achieved . The combined primary end point was significantly lower in the eprosartan group",
"Although diuretics are recommended for the treatment of hypertension , decreased diuretic use and increased calcium antagonist use necessitate a comparison of the efficacy of these drugs in preventing cardiovascular events . Patients > /=60 years of age with systolic blood pressure of 160 to 220 mm Hg and diastolic blood pressure Patients were r and omly assigned to 20 mg of sustained-release nicardipine hydrochloride twice daily or 2 mg of trichlormethiazide once daily by the double-dummy method and followed up for 5 years . A total of 414 patients were analyzed : 204 in the nicardipine group and 210 in the diuretic group . Blood pressure at entry was 172/94 mm Hg and 173/93 mm Hg , respectively , and decreased to 147/81 mm Hg and 147/79 mm Hg , respectively . Cardiovascular morbidity rates per 1000 persons per year were similar in the nicardipine and diuretic groups ( 27.8 and 26.8 , respectively ; P=0.923 ) . The sex- and age-adjusted risk ratio for the nicardipine group was 0.973 ( 95 % confidence interval , 0.514 to 1.839 , P=0.932 ) . The calcium antagonist and diuretic groups had a similarly decreased rate of cardiovascular events",
"Background —Microalbuminuria is associated with increased risk of cardiovascular events . We assessed whether therapeutic intervention aim ed at lowering urinary albumin excretion would reduce cardiovascular events in microalbuminuric subjects ( 15 to 300 mg/24 hours ) . Methods and Results —From the Prevention of Renal and Vascular Endstage Disease ( PREVEND ) cohort ( n=8592 ) , 1439 subjects fulfilled the inclusion criteria of the PREVEND Intervention Trial ( PREVEND IT ) . Of these subjects , 864 were r and omized to fosinopril 20 mg or matching placebo and to pravastatin 40 mg or matching placebo . The mean follow-up was 46 months , and the primary end point was cardiovascular mortality and hospitalization for cardiovascular morbidity . Mean age was 51±12 years ; 65 % of subjects were male , and 3.4 % had a previous cardiovascular event . Mean cholesterol level was 5.8±1.0 mmol/L , mean systolic/diastolic blood pressure was 130±18/76±10 mm Hg , and median urinary albumin excretion was 22.8 ( 15.8 to 41.3 ) mg/24 hours . The primary end point occurred in 45 subjects ( 5.2 % ) . Fosinopril reduced urinary albumin excretion by 26 % ( P with fosinopril showed a 40 % lower incidence of the primary end point ( hazard ratio 0.60 [ 95 % CI 0.33 to 1.10 ] , P=0.098 , log-rank ) . Pravastatin did not reduce urinary albumin excretion , and subjects treated with pravastatin showed a 13 % lower incidence of the primary end point than subjects in the placebo group ( 0.87 [ 0.49 to 1.57 ] , P=0.649 , log-rank ) . Conclusions —In microalbuminuric subjects , treatment with fosinopril had a significant effect on urinary albumin excretion . In addition , fosinopril treatment was associated with a trend in reducing cardiovascular events . Treatment with pravastatin did not result in a significant reduction in urinary albumin excretion or cardiovascular events ",
"BACKGROUND Blood pressure is a determinant of the risk of stroke among both hypertensive and non-hypertensive individuals with cerebrovascular disease . However , there is uncertainty about the efficacy and safety of blood-pressure-lowering treatments for many such patients . The perindopril protection against recurrent stroke study ( PROGRESS ) was design ed to determine the effects of a blood-pressure-lowering regimen in hypertensive and non-hypertensive patients with a history of stroke or transient ischaemic attack . METHODS 6105 individuals from 172 centres in Asia , Australasia , and Europe were r and omly assigned active treatment ( n=3051 ) or placebo ( n=3054 ) . Active treatment comprised a flexible regimen based on the angiotensin- converting-enzyme inhibitor perindopril ( 4 mg daily ) , with the addition of the diuretic indapamide at the discretion of treating physicians . The primary outcome was total stroke ( fatal or non-fatal ) . Analysis was by intention to treat . FINDINGS Over 4 years of follow up , active treatment reduced blood pressure by 9/4 mm Hg . 307 ( 10 % ) individuals assigned active treatment suffered a stroke , compared with 420 ( 14 % ) assigned placebo ( relative risk reduction 28 % [ 95 % CI 17 - 38 ] , p risk of total major vascular events ( 26 % [ 16 - 34 ] ) . There were similar reductions in the risk of stroke in hypertensive and non-hypertensive subgroups ( all p perindopril plus indapamide reduced blood pressure by 12/5 mm Hg and stroke risk by 43 % ( 30 - 54 ) . Single-drug therapy reduced blood pressure by 5/3 mm Hg and produced no discernable reduction in the risk of stroke . INTERPRETATION This blood-pressure-lowering regimen reduced the risk of stroke among both hypertensive and non-hypertensive individuals with a history of stroke or transient ischaemic attack . Combination therapy with perindopril and indapamide produced larger blood pressure reductions and larger risk reductions than did single drug therapy with perindopril alone . Treatment with these two agents should now be considered routinely for patients with a history of stroke or transient ischaemic attack , irrespective of their blood pressure",
"BACKGROUND Blood pressure reduction achieved with beta-blockers and diuretics is the best recorded intervention to date for prevention of cardiovascular morbidity and death in patients with hypertension . Left ventricular hypertrophy ( LVH ) is a strong independent indicator of risk of cardiovascular morbidity and death . We aim ed to establish whether selective blocking of angiotensin II improves LVH beyond reducing blood pressure and , consequently , reduces cardiovascular morbidity and death . METHODS We did a double-masked , r and omised , parallel-group trial in 9193 participants aged 55 - 80 years with essential hypertension ( sitting blood pressure 160 - 200/95 - 115 mm Hg ) and LVH ascertained by electrocardiography ( ECG ) . We assigned participants once daily losartan-based or atenolol-based antihypertensive treatment for at least 4 years and until 1040 patients had a primary cardiovascular event ( death , myocardial infa rct ion , or stroke ) . We used Cox regression analysis to compare regimens . FINDINGS Blood pressure fell by 30.2/16.6 ( SD 18.5/10.1 ) and 29.1/16.8 mm Hg ( 19.2/10.1 ) in the losartan and atenolol groups , respectively . The primary composite endpoint occurred in 508 losartan ( 23.8 per 1000 patient-years ) and 588 atenolol patients ( 27.9 per 1000 patient-years ; relative risk 0.87 , 95 % CI 0.77 - 0.98 , p=0.021 ) . 204 losartan and 234 atenolol patients died from cardiovascular disease ( 0.89 , 0.73 - 1.07 , p=0.206 ) ; 232 and 309 , respectively , had fatal or non-fatal stroke ( 0.75 , 0.63 - 0.89 , p=0.001 ) ; and myocardial infa rct ion ( non-fatal and fatal ) occurred in 198 and 188 , respectively ( 1.07 , 0.88 - 1.31 , p=0.491 ) . New-onset diabetes was less frequent with losartan . Interpretation Losartan prevents more cardiovascular morbidity and death than atenolol for a similar reduction in blood pressure and is better tolerated . Losartan seems to confer benefits beyond reduction in blood pressure",
"Objective To compare the incidence of stroke and other cardiovascular events in hypertensive patients receiving a low-dose diuretic and low-dose calcium antagonist combination with those receiving low-dose diuretic monotherapy , and assess the effects of a small blood pressure difference at achieved levels lower than those achieved in previous placebo-controlled trials . Methods The Felodipine Event Reduction ( FEVER ) trial was an investigator- design ed , prospect i ve , multicentre , double-blind , r and omized , placebo-controlled , parallel group trial . It enrolled 9800 Chinese patients , of either sex , aged 50–79 years , with one or two additional cardiovascular risk factors or disease , whose blood pressure , 6 weeks after switching from previous antihypertensive therapy to low-dose ( 12.5 mg a day ) hydrochlorothiazide , was in the range 140–180 mmHg ( systolic ) or 90–100 mmHg ( diastolic ) . These patients were r and omly assigned either to low-dose felodipine extended release or placebo , and followed at 3-month intervals for an average of 40 months . Results The intention-to-treat analysis included 9711 r and omly selected patients with only 30 ( 0.3 % ) lost to follow-up . A total of 31 842 patient-years of follow-up were accumulated , with 85.9 % of patients remaining on blinded r and omized treatment . Add-on therapy was given to 33.9 % of the hydrochlorothiazide – felodipine patients and to 42.3 % of the hydrochlorothiazide – placebo patients . In the felodipine group , systolic blood pressure (SBP)/diastolic blood pressure ( DBP ) decreased ( from r and omization to study end ) from 154.2/91.0 to 137.3/82.5 mmHg , and in the placebo group from 154.4/91.3 to 142.5/85.0 mmHg , with an average difference throughout the trial of 4.2/2.1 mmHg . In the felodipine group , the primary endpoint ( fatal and non-fatal stroke ) was reduced by 27 % ( P = 0.001 ) . Among secondary endpoints , all cardiovascular events were reduced by 27 % ( P by 35 % ( P = 0.012 ) , death by any cause by 31 % ( P = 0.006 ) , coronary events by 32 % ( P = 0.024 ) , heart failure by 30 % ( P = 0.239 ) , cardiovascular death by 33 % ( P = 0.019 ) , cancer by 36 % ( P = 0.017 ) in the felodipine group . No significant differences were found in new-onset diabetes . Both treatments were very well tolerated . Conclusions In moderately complicated hypertensive patients from China even a difference in SBP/DBP as small as 4/2 mmHg , such as that induced by adding low-dose felodipine to low-dose hydrochlorothiazide , is associated with very substantial reductions in the incidence of most types of cardiovascular events . As the SBP achieved in the felodipine group was below the recommended goal of less than 140 mmHg , and SBP in the placebo group was slightly above that level , FEVER provides the required evidence in support of the guidelines recommended goal , even for a hypertensive population not entirely consisting of patients with diabetes or previous cardiovascular events ",
"Background The prognostic benefits of blood pressure lowering treatment in elderly hypertensive patients were established more than a decade ago , but are less clear in those with mildly to moderately elevated blood pressure . Objective To assess whether c and esartan-based antihypertensive treatment in elderly patients with mildly to moderately elevated blood pressure confers a reduction in cardiovascular events , cognitive decline and dementia . Design Prospect i ve , double-blind , r and omized , parallel-group study conducted in 1997–2002 . Setting and participants The study was of 4964 patients aged 70–89 years , with systolic blood pressure 160–179 mmHg , and /or diastolic blood pressure 90–99 mmHg , and a Mini Mental State Examination ( MMSE ) test score ⩾ 24 . A total of 527 centres in 15 countries participated in the study . Intervention Patients were assigned r and omly to receive the angiotensin receptor blocker c and esartan or placebo , with open-label active antihypertensive therapy added as needed . As a consequence , active antihypertensive therapy was extensively used in the control group ( 84 % of patients ) . Mean follow-up was 3.7 years . Main outcome measures The primary outcome measure was major cardiovascular events , a composite of cardiovascular death , non-fatal stroke and non-fatal myocardial infa rct ion . Secondary outcome measures included cardiovascular death , non-fatal and fatal stroke and myocardial infa rct ion , cognitive function measured by the MMSE and dementia . Results Blood pressure fell by 21.7/10.8 mmHg in the c and esartan group and by 18.5/9.2 mmHg in the control group . A first major cardiovascular event occurred in 242 c and esartan patients and in 268 control patients ; risk reduction with c and esartan was 10.9 % [ 95 % confidence interval ( CI ) , −6.0 to 25.1 , P = 0.19 ] . C and esartan-based treatment reduced non-fatal stroke by 27.8 % ( 95 % CI , 1.3 to 47.2 , P = 0.04 ) , and all stroke by 23.6 % ( 95 % CI , −0.7 to 42.1 , P = 0.056 ) . There were no significant differences in myocardial infa rct ion and cardiovascular mortality . Mean MMSE score fell from 28.5 to 28.0 in the c and esartan group and from 28.5 to 27.9 in the control group ( P = 0.20 ) . The proportions of patients who had a significant cognitive decline or developed dementia were not different in the two treatment groups . Conclusions In elderly hypertensive patients , a slightly more effective blood pressure reduction during c and esartan-based therapy , compared with control therapy , was associated with a modest , statistically non-significant , reduction in major cardiovascular events and with a marked reduction in non-fatal stroke . Cognitive function was well maintained in both treatment groups in the presence of substantial blood pressure reductions . Both treatment regimens were generally well tolerated",
"The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ( ALLHAT ) was a r and omized , double-blind , active , controlled clinical trial conducted to determine whether newer antihypertensive agents , including doxazosin , an alpha-blocker , differ from chlorthalidone , a diuretic , with respect to coronary heart disease ( CHD ) and other cardiovascular disease ( CVD ) events in hypertensive patients at high risk of CHD . In February 2000 , the doxazosin treatment arm was discontinued , and findings through December 1999 were reported . This report includes an additional 9232 participant-years and 939 CVD events . At 623 clinical centers , patients ( aged > or=55 years ) with hypertension and at least 1 other CHD risk factor were r and omly assigned to either chlorthalidone or doxazosin . The primary outcome measure was the combined occurrence of fatal CHD or nonfatal myocardial infa rct ion ( MI ) , analyzed by intent to treat ; prespecified secondary outcome measures included all-cause mortality , stroke , combined CHD ( fatal CHD , nonfatal MI , hospitalized angina , and coronary revascularization ) , and combined CVD ( combined CHD , stroke , angina treated outside the hospital , heart failure , and peripheral arterial disease ) . Mean follow-up was 3.2 years . There was no difference in primary outcome between the arms ( relative risk [ RR ] , 1.02 ; 95 % confidence interval [ CI ] , 0.92 to 1.15 ) . All-cause mortality also did not differ ( RR , 1.03 ; 95 % CI , 0.94 to 1.13 ) . However , the doxazosin arm compared with the chlorthalidone arm had a higher risk of stroke ( RR , 1.26 ; 95 % CI , 1.10 to 1.46 ) and combined CVD ( RR 1.20 ; 95 % CI , 1.13 to 1.27 ) . These findings confirm the superiority of diuretic-based over alpha-blocker-based antihypertensive treatment for the prevention of CVD",
"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",
"OBJECTIVE To assess the ability of antihypertensive drug treatment to reduce the risk of nonfatal and fatal ( total ) stroke in isolated systolic hypertension . DESIGN Multicenter , r and omized , double-blind , placebo-controlled . SETTING Community-based ambulatory population in tertiary care centers . PARTICIPANTS 4736 persons ( 1.06 % ) from 447,921 screenees aged 60 years and above were r and omized ( 2365 to active treatment , 2371 to placebo ) . Systolic blood pressure ranged from 160 to 219 mm Hg and diastolic blood pressure was less than 90 mm Hg . Of the participants , 3161 were not receiving antihypertensive medication at initial contact , and 1575 were . The average systolic blood pressure was 170 mm Hg ; average diastolic blood pressure , 77 mm Hg . The mean age was 72 years , 57 % were women , and 14 % were black . INTERVENTIONS -- Participants were stratified by clinical center and by antihypertensive medication status at initial contact . For step 1 of the trial , dose 1 was chlorthalidone , 12.5 mg/d , or matching placebo ; dose 2 was 25 mg/d . For step 2 , dose 1 was atenolol , 25 mg/d , or matching placebo ; dose 2 was 50 mg/d . MAIN OUTCOME MEASURES Primary . Nonfatal and fatal ( total ) stroke . Secondary . Cardiovascular and coronary morbidity and mortality , all-cause mortality , and quality of life measures . RESULTS Average follow-up was 4.5 years . The 5-year average systolic blood pressure was 155 mm Hg for the placebo group and 143 mm Hg for the active treatment group , and the 5-year average diastolic blood pressure was 72 and 68 mm Hg , respectively . The 5-year incidence of total stroke was 5.2 per 100 participants for active treatment and 8.2 per 100 for placebo . The relative risk by proportional hazards regression analysis was 0.64 ( P = .0003 ) . For the secondary end point of clinical nonfatal myocardial infa rct ion plus coronary death , the relative risk was 0.73 . Major cardiovascular events were reduced ( relative risk , 0.68 ) . For deaths from all causes , the relative risk was 0.87 . CONCLUSION In persons aged 60 years and over with isolated systolic hypertension , antihypertensive stepped-care drug treatment with low-dose chlorthalidone as step 1 medication reduced the incidence of total stroke by 36 % , with 5-year absolute benefit of 30 events per 1000 participants . Major cardiovascular events were reduced , with 5-year absolute benefit of 55 events per 1000",
"The associations of diastolic blood pressure ( DBP ) with stroke and with coronary heart disease ( CHD ) were investigated in nine major prospect i ve observational studies : total 420,000 individuals , 843 strokes , and 4856 CHD events , 6 - 25 ( mean 10 ) years of follow-up . The combined results demonstrate positive , continuous , and apparently independent associations , with no significant heterogeneity of effect among different studies . Within the range of DBP studied ( about 70 - 110 mm Hg ) , there was no evidence of any \" threshold \" below which lower levels of DBP were not associated with lower risks of stroke and of CHD . Previous analyses have described the uncorrected associations of DBP measured just at \" baseline \" with subsequent disease rates . But , because of the diluting effects of r and om fluctuations in DBP , these substantially underestimate the true associations of the usual DBP ( ie , an individual 's long-term average DBP ) with disease . After correction for this \" regression dilution \" bias , prolonged differences in usual DBP of 5 , 7.5 , and 10 mm Hg were respectively associated with at least 34 % , 46 % , and 56 % less stroke and at least 21 % , 29 % , and 37 % less CHD . These associations are about 60 % greater than in previous uncorrected analyses . ( This regression dilution bias is quite general , so analogous corrections to the relations of cholesterol to CHD or of various other risk factors to CHD or to other diseases would likewise increase their estimated strengths . ) The DBP results suggest that for the large majority of individuals , whether conventionally \" hypertensive \" or \" normotensive \" , a lower blood pressure should eventually confer a lower risk of vascular disease",
"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 This long-term , multicenter , r and omized , double-blind , placebo-controlled , 2 × 2 factorial , angiographic trial evaluated the effects of cholesterol lowering and angiotensin-converting enzyme inhibition on coronary atherosclerosis in normocholesterolemic patients . Methods and Results There were a total of 460 patients : 230 received simvastatin and 230 , a simvastatin placebo , and 229 received enalapril and 231 , an enalapril placebo ( some subjects received both drugs and some received a double placebo ) . Mean baseline measurements were as follows : cholesterol level , 5.20 mmol/L ; triglyceride level , 1.82 mmol/L ; HDL , 0.99 mmol/L ; and LDL , 3.36 mmol/L. Average follow-up was 47.8 months . Changes in quantitative coronary angiographic measures between simvastatin and placebo , respectively , were as follows : mean diameters , −0.07 versus −0.14 mm ( P = 0.004 ) ; minimum diameters , −0.09 versus −0.16 mm ( P = 0.0001 ) ; and percent diameter stenosis , 1.67 % versus 3.83 % ( P = 0.0003 ) . These benefits were not observed in patients on enalapril when compared with placebo . No additional benefits were seen in the group receiving both drugs . Simvastatin patients had less need for percutaneous transluminal coronary angioplasty ( 8 versus 21 events;P = 0.020 ) , and fewer enalapril patients experienced the combined end point of death/myocardial infa rct ion/stroke ( 16 versus 30;P = 0.043 ) than their respective placebo patients . Conclusions This trial extends the observation of the beneficial angiographic effects of lipid-lowering therapy to normocholesterolemic patients . The implication s of the neutral angiographic effects of angiotensin-converting enzyme inhibition are uncertain , but they deserve further investigation in light of the positive clinical benefits suggested here and seen elsewhere",
"Myocardial infa rct ion , sudden cardiac death , cerebrovascular accidents , blood pressure control and treatment tolerability were studied in a r and omized double-blind trial conducted in 6357 men and women aged 40 - 64 years with uncomplicated essential hypertension ( diastolic blood pressures 100 - 125 mmHg ) . At the start of the trial 3185 patients received treatment based on a beta-blocker ( oxprenolol ) , while in the remaining 3172 placebo replaced oxprenolol . Supplementary drugs , excluding beta-blockers , were used as necessary in both treatment groups , with the aim of reducing diastolic pressure to 95 mmHg or less . Patients were followed for 3 - 5 years , a total of 25 651 patient years at risk . In most respects the two groups fared equally well ; sudden death ( relative risk [ RR ] 1.08 ; 95 % confidence interval [ Cl ] 0.68 and 1.72 ) , myocardial infa rct ion ( RR 0.83 ; Cl 0.59 and 1.16 ) and cerebrovascular accident ( RR 0.97 ; Cl 0.64 and 1.47 ) rates were similar . Beta-blocker based therapy was associated with significantly lower average blood pressures , earlier ECG normalization , less hypokalaemia and fewer withdrawals from double-blind treatment for uncontrolled hypertension . Doctor-elicited and patient-assessed unwanted effects demonstrated overall good tolerability . In smokers the cardiac event rate was doubled . We propose that beta-blocker treatment effects depend on smoking status , with a significant interaction benefiting non-smoking men . Lower blood pressures during treatment were associated with substantially lower rates for cardiac as well as cerebrovascular events . Proportional hazards analysis also underlines the importance of other cardiovascular risk factors . The IPPPSH stresses the need for a comprehensive approach to the management of blood pressure and other risk factors in hypertensive patients",
"Summary The latter was due to a reduction in cardiac mortality ( −38 % , p=0.036 ) and a nonsignificant decrease in cerebrovascular mortality ( −32 % , p=0.16 ) . In the double-blind part of the trial , the total mortality rate was not significantly reduced ( −26 % , p=0.077 ) . However , cardiovascular mortality was reduced in the actively treated group ( −38 % , p=0.023 ) , owing to a reduction in cardiac deaths ( −47 % , p=0.048 ) and a non-significant decrease in cerebrovascular mortality ( −43 % , p=0.15 ) . Deaths from myocardial infa rct ion were reduced ( −60 % , p=0.043 ) , and study -terminating morbid cardiovascular events were significantly reduced by active treatment ( −60 % , p=0.0064 ) . Non-terminating cerebrovascular events were reduced ( −52 % , p=0.026 ) , but the non-terminating cardiac events were not ( + 3 % , p=0.98 ) . In the patients r and omised to active treatment there were 29 fewer cardiovascular events and 14 fewer cardiovascular deaths per 1000 patient years during the double-blind part of the trial . A double-blind r and omised placebo-controlled trial of antihypertensive treatment was conducted in patients over the age of 60 . Entry criteria included both a sitting diastolic blood pressure on placebo treatment in the range 90 to 119 mm Hg and a systolic pressure in the range 160 to 239 mm Eg . 840 patients were r and omised either to active treatment ( hydrochlorothiazide and triamterene ) or to matching placebo . If the blood pressure remained raised , methyldopa was added to the active regimen and matching placebo in the placebo group . An overall intention-to-treat analysis , combining the double-blind part of the trial and all subsequent follow-up , revealed a non-significant change in total mortality rate ( −9 % , p=0.41 ) but a significant reduction in cardiovascular mortality rate ( −27 % , p=0.037 )",
"Men aged 40 - 64 years with mild to moderate hypertension [ diastolic blood pressure ( DBP ) 100 - 130 mmHg ] were r and omized to treatment with a diuretic ( n = 3272 ) or a beta-blocker ( n = 3297 ) , with additional drugs if necessary , to determine whether a beta-blocker based treatment differs from thiazide diuretic based treatment with regard to the prevention of coronary heart disease ( CHD ) events and death . Patients with previous CHD , stroke or other serious diseases , or with contraindications to diuretics or beta-blockers were excluded . If normotension ( DBP less than 95 mmHg ) was not achieved by monotherapy , other antihypertensive drugs were added , but the two basic drugs were not crossed over . Patients were assessed at 6-monthly intervals . The mean follow-up for end-points was 45.1 months . Blood pressure ( BP ) side effects and end-points were recorded in a st and ardized manner . Entry characteristics and the BP reduction achieved were very similar in both treatment groups . All analyses were made on an intention-to-treat basis . The incidence of CHD did not differ between the two treatment groups . The incidence of fatal stroke tended to be lower in the beta-blocker treated group than in the diuretic treated group . Total mortality and the total number of end-points were similar in both groups . The percentage of patients withdrawn due to side effects was similar , whereas the number of reported symptoms , according to a question naire , was higher for patients on beta-blockers . The incidence of diabetes did not differ between the two groups . Subgroup analyses did not detect a difference in the effect of beta-blockers compared with diuretics in smokers as opposed to non-smokers , and beta-blockers also had the same effects as diuretics in the quartile with the highest predicted risk for CHD . Beta-blockers and thiazide diuretics were approximately equally well tolerated . The two drugs had a similar BP reducing effect although additional drugs had to be given more often in the diuretic group . Antihypertensive treatment based on a beta-blocker or on a thiazide diuretic could not be shown to affect the prevention of hypertensive complications , including CHD , to a different extent"
] | 41167de2-06ff-11f0-808a-c43d1ab1c353 |
Several theories have been proposed to explain the 3- to 6-fold gender difference in the incidence of anterior cruciate ligament injuries . One potential theory for the increased incidence is based on gender-related hormonal differences between men and women , especially after puberty and the onset of menses in the female athlete . The purpose of this systematic review was to compile and systematic ally analyze the published literature to determine if the menstrual cycle is associated with anterior cruciate ligament injury risk and to provide an objective comparison of the published results . Investigations were included in the systematic review if the report included associations between the menstrual cycle and noncontact anterior cruciate ligament injuries in female athletes . Abstract s and unpublished studies were excluded . Seven articles were identified that met the systematic review inclusion criteria . The 7 review ed studies favored an effect of the first half , or preovulatory phase , of the menstrual cycle for increased anterior cruciate ligament injuries . The 6 studies that separated the non — oral contraceptive and oral contraceptive data also favored an effect of the first half of the menstrual cycle for increased anterior cruciate ligament injuries . The clinical relevance of this finding is that female athletes may be more predisposed to anterior cruciate ligament injuries during the preovulatory phase of the menstrual cycle . These findings may lead to potential interventions targeted toward this phase of the menstrual cycle to reduce the incidence of anterior cruciate ligament injury | [
"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",
"OBJECTIVE : To determine if anterior cruciate ligament ( ACL ) injuries in female athletes occur r and omly or correlate with a specific phase of the menstrual cycle . DESIGN AND SETTING : Female athletes who sustained ACL injuries reported the days of their menstrual cycles and provided saliva sample s for sex-hormone determination . Salivary sex-hormone profiles were assessed to confirm the self-reported menstrual histories . SUBJECTS : A total of 38 female athletes ( 20 college , 15 high school , 1 middle school , 2 recreational ) with recent ACL injuries participated in the study over a 3-year period . MEASUREMENTS : Athletes with recent ACL injuries completed a question naire defining the injury , the last menstrual cycle , prior knee injury , school , and type of birth control used ( if any ) . Each subject provided a 30-cc saliva sample within 72 hours of injury . Saliva sample s were placed into sealed containers and frozen at -20 degrees C. We obtained 13 additional control sample s from uninjured females to test the correlation between saliva and serum sex-hormone levels . Progesterone and estrogen were assayed by radioimmunoassay . Physical examination , magnetic resonance imaging , or surgery confirmed the injury in all subjects . RESULTS : The correlations between saliva and serum estrogen and progesterone were 0.73 ( alpha = .01 ) and 0.72 ( alpha = .01 ) , respectively . Ten of 27 athletes who reported their cycle day at time of injury sustained an ACL injury immediately before or 1 to 2 days after the onset of menses . We rejected the None hypothesis that such high frequency was due to r and om chance . CONCLUSIONS : A significantly greater number of ACL injuries occurred on days 1 and 2 of the menstrual cycle . Salivary sex-hormone levels correlated with the reported cycle day",
"An increased incidence of sports related injuries in the premenstrual phase as well as in the menstrual phase of the menstrual cycle has been described . This may be explained by alterations in proprioception and neuromuscular coordination due to hormonal variations . Prospect i ve , within women analysis of knee joint kinesthesia and neuromuscular coordination were performed by repeated measures analysis of variance in three hormonally verified phases of three consecutive menstrual cycles . Thirty-two healthy , moderately active female subjects volunteered to participate in the study . Twenty-five of the subjects performed at least one hormonally verified menstrual cycle . A specially design ed device was used to investigate knee joint kinaesthesia and neuromuscular coordination was measured with the square hop test . These tests were carried out in the menstrual phase , ovulation phase and premenstrual phase determined by hormone analyses in three consecutive menstrual cycles . An impaired knee joint kinaesthesia was detected in the premenstrual phase and the performance of square hop test was significantly improved in the ovulation phase compared to the other two phases . The results of this study indicate that the variation of sex hormones in the menstrual cycle has an effect on performance of knee joint kinaesthesia and neuromuscular coordination",
"The purpose of this study was to examine gender differences in the incidence of anterior cruciate ligament ( ACL ) injuries in a population of high-level team h and ball players . We also wanted to examine injury mechanisms and possible risk factors for ACL injuries , including menstrual status . The study was done prospect ively during the 1993 - 94 , 1994 - 95 , and 1995 - 96 seasons . We found 28 ACL injuries , 23 among women ( incidence : 0.31 + /- 0.06 injuries per 1000 player hours ) and 5 among men ( 0.06 + /- 0.03 inj./1000 h ; P 23 cases among females . Five of the injuries occurred in the menstrual phase , 2 in the follicular phase , 1 in the early luteal phase and 9 in the late luteal phase ( chi-square3 d.f . = 13.2 ; P risk of ACL injury during the week prior to or after the start of the menstrual period",
"BACKGROUND No definitive explanation for the difference in rate of male and female noncontact ACL injury has been found . The hormonal environment , known to be different in men and women has been hypothesized as a possible source for this difference in injury rate . PURPOSE To confirm earlier work looking at periodicity of noncontact ACL injury . To increase sample size by adding ankle sprains . To determine the rate of noncontact ACL injury and ankle sprains in collegiate basketball and soccer . To determine if the use of oral contraceptives affects the rate of noncontact ACL injury and ankle sprains . METHODS Data was collected from a sample of NCAA schools over the 2000 - 2001 basketball and the 2001 - 2002 basketball and soccer seasons . RESULTS Recall and prospect i ve data collection of length of menstrual cycle did not produce equivalent results . Periodicity was present only in the recall group of \" off pill \" users . The rate of noncontact ACL injury and noncontact ankle sprains was twice as high in basketball as in soccer . There was no difference in rate of injuries between those athletes using hormonal therapy and those athletes not using hormonal therapy . CONCLUSIONS Noncontact ACL injuries and ankle sprains occurred at significantly higher rates in basketball than in soccer but this rate difference was not linked to hormonal therapy usage . The overall rate of noncontact ACL injury and ankle sprain to women 's collegiate basketball and soccer players is very low",
"Objective To identify a significant change in the laxity of the anterior cruciate ligament ( ACL ) in the competitive adolescent female athlete throughout the different phases of the menstrual cycle . Design Prospect i ve , single-blinded 8-week study set during a winter sports season . Setting Suburban Ohio Division I high school . Participants 26 members of gymnastics , soccer , track , tennis , and basketball teams . All participants were screened for normal menstrual cycles ( 26–30 days , menses 4–7 days long ) . Main Outcome Measures KT-1000 arthrometer was used to measure laxity by performing repeated measures throughout an 8-week period . Measurements were taken before the athletes ' workouts . The athlete charted the menstrual periods on a monthly calendar . The measurements were then grouped into the three phases of the menstrual cycle ( follicular , ovulatory , and luteal ) and averaged . Results Right knee laxity measured 4.98 mm follicular phase , 5.24 mm ovulatory , and 5.09 mm luteal . Left knee laxity measured 4.51 mm follicular , 4.43 mm ovulatory , and 4.62 mm luteal . There was no statistical difference among the three phases in the left ( p = 0.9 ) and right ( p = 0.7977 ) . Additionally , left ACL laxity was significantly less in all three phases . We found no statistically significant variability in laxity among the five sports sample d ( p > 0.63 to 0.10 ) and different ages ( p = 0.404 ) Conclusions We found an insignificant change in ACL laxity from follicular to luteal phases of the menstrual cycle . This indicates that no single phase of the menstrual cycle clinical ly affects the ACL more than the next . Although the presence of sex hormones — particularly estrogen — may indeed predispose females to higher ACL injury rates , we did not find any evidence that hormonal level changes equate with significant ACL laxity changes . We conclude that the menstrual cycle does not significantly affect ACL laxity in the competitive adolescent female athlete",
"The incidence of severe anterior cruciate ligament sprains was once only a third the current rate . This fact led the authors to believe a means to help reduce the risk of anterior cruciate ligament injury among skiers might be found . Using videotapes of the occurrences of anterior cruciate ligament sprains in alpine skiers and the data associated with more than 1400 anterior cru ciate ligament injuries observed in a 22-year study , the authors identified two common mechanisms of anterior cruciate ligament injury . From this information , a study was design ed to determine if training could help reduce the risk of anterior cruciate ligament sprains . During the 1993 to 1994 season , the on-slope staff from 20 ski areas participated in a training program involving view ing videotaped scenes where knee injuries occurred . Data from 22 ski areas , where staff were not exposed to the training , were assembled to form a control group . Data concerning anterior cruciate ligament injuries were collected from both groups for the three seasons 1991 to 1994 . A total of 179 serious knee sprains were evalu ated . Serious knee sprains declined by 62 % among trained patrollers and instructors compared with the two previous seasons , but no decline occurred in the control group",
"Background Female athletes participating in high-risk sports suffer anterior cruciate ligament injury at a 4- to 6-fold greater rate than do male athletes . Hypothesis Prescreened female athletes with subsequent anterior cruciate ligament injury will demonstrate decreased neuromuscular control and increased valgus joint loading , predicting anterior cruciate ligament injury risk . Study Design Cohort study ; Level of evidence , 2 . Methods There were 205 female athletes in the high-risk sports of soccer , basketball , and volleyball prospect ively measured for neuromuscular control using 3-dimensional kinematics ( joint angles ) and joint loads using kinetics ( joint moments ) during a jump-l and ing task . Analysis of variance as well as linear and logistic regression were used to isolate predictors of risk in athletes who subsequently ruptured the anterior cruciate ligament . Results Nine athletes had a confirmed anterior cruciate ligament rupture ; these 9 had significantly different knee posture and loading compared to the 196 who did not have anterior cruciate ligament rupture . Knee abduction angle ( P knee abduction moment ( P ground reaction force ( P stance time was 16 % shorter ; hence , increased motion , force , and moments occurred more quickly . Knee abduction moment predicted anterior cruciate ligament injury status with 73 % specificity and 78 % sensitivity ; dynamic valgus measures showed a predictive r2 of 0.88 . Conclusion Knee motion and knee loading during a l and ing task are predictors of anterior cruciate ligament injury risk in female athletes . Clinical Relevance Female athletes with increased dynamic valgus and high abduction loads are at increased risk of anterior cruciate ligament injury . The methods developed may be used to monitor neuromuscular control of the knee joint and may help develop simpler measures of neuromuscular control that can be used to direct female athletes to more effective , targeted interventions",
" During 1984 , 86 women soccer players answered detailed question naires concerning contraceptive use , menstruation data , premenstrual and menstrual symptoms , and data concerning soccer activities including injuries . This prospect i ve study showed that women soccer players were more susceptible to traumatic injuries during the premenstrual and menstrual period compared to the rest of the menstrual cycle ( P less than 0.05 ) , especially among players with premenstrual symptoms such as irritability/irascibility , swelling/discomfort in the breasts , and swelling/congestion in the abdomen . It was also found that women using contraceptive pills had a lower rate of traumatic injuries ( P less than 0.05 ) compared to women who were not on the Pill . The results can be explained by the fact that oral contraceptives ameliorate some symptoms of the premenstrual and menstrual period which might also affect coordination and hence the risk of injury"
] | 41167e28-06ff-11f0-808a-c43d1ab1c353 |
Background Health state utility values ( HSUVs ) are required to calculate quality -adjusted life-years ( QALYs ) . They are frequently derived from generic preference-based measures of health . However , such generic measures may not capture health attributes of relevance to specific conditions . In such cases , a condition-specific preference-based measure ( CSPBM ) may be more appropriate . Objective This systematic review aim ed to identify all published accounts of developing CSPBMs to describe and appraise the methods used . Method We undertook a systematic search ( of Embase , MEDLINE , PsycINFO , Web of Science , the Cochrane Library , CINAHL , EconLit , ASSIA and the Health Management Information Consortium data base ) to identify published accounts of CSPBM development up to July 2015 . Studies were review ed to investigate the methods used to design classification systems , estimate HSUVs , and vali date the measures . Results A total of 86 publications were identified , describing 51 CSPBMs . Around two-thirds of these were QALY measures ; the remainder were design ed for clinical decision making only . Classification systems for 33 CSPBMs were derived from existing instruments ; 18 were developed de novo . HSUVs for 34 instruments were estimated using a ‘ composite ’ approach , involving statistical modelling ; the remainder used a ‘ decomposed ’ approach based on multi-attribute utility theory . Half of the papers that described the estimation of HSUVs did not report validating their measures . Conclusion Various methods have been used at all stages of CSPBM development . The choice between developing a classification system de novo or from an existing instrument may depend on the availability of a suitable existing measure , while the choice between a decomposed or composite approach appears to be determined primarily by the purpose for which the instrument is design ed . The validation of CSPBMs remains an area for further development | [
"Objective To evaluate the psychometric properties of the National Eye Institute Visual Function Question naire-25 ( NEI VFQ-25 ) and Visual Function Question naire Utility Index ( VFQ-UI ) in patients with non-infectious intermediate and posterior uveitis . Methods Secondary analysis of pooled data from a 26-week , multicenter , masked , r and omized , sham-controlled Phase 3 clinical trial . Health-related quality of life was assessed using the NEI VFQ-25 , the EQ-5D , and SF-36 . Internal consistency reliability , reproducibility , convergent validity , and known groups of BCVA and vitreous haze severity were assessed . Clinical ly significant difference was assessed using anchor-based and distribution-based methods . Results The study included 224 subjects with non-infectious intermediate ( 80.4 % ) or posterior uveitis ( 19.6 % ) . The NEI VFQ-25 and the VFQ-UI demonstrated good internal consistency ( Cronbach ’s alpha 0.87–0.94 ) and test – retest reliability ( ICCs 0.58–0.88 ) . Spearman ’s product – moment rank correlations between the NEI VFQ-25 and VFQ-UI scores and the SF-6D , EQ-5D , and BCVA ranged from small to moderate . There was a significant association between visual functioning and known groups of visual acuity ( p NEI VFQ-25 and the VFQ-UI are reliable and valid measures of vision-related functioning and preference-based status in patients with non-infectious intermediate and posterior uveitis",
"BACKGROUND Cost-effectiveness/cost-utility analyses are increasingly needed to inform decisions about care . Algorithms have been developed using the Functional Assessment of Cancer Therapy ( FACT ) quality of life instrument to estimate utility weights for cost analyses . This study was design ed to compare these algorithms in the setting of ovarian cancer . METHODS GOG-0152 was a 550-patient r and omized phase III trial of interval cytoreduction , and GOG-0172 was a 415-patient r and omized phase III trial comparing intravenous versus intraperitoneal therapy among women with advanced ovarian cancer . QOL data were collected via the FACT at four time points in each study . Two published mapping algorithms ( Cheung and Dobrez ) and a linear transformation method were applied to these data . The agreement between measures was assessed by the concordance correlation coefficient ( r(CCC ) ) , and paired t-tests were used to compare means . RESULTS While agreement between the estimation algorithms was good ( ranged from 0.72 to 0.81 ) , there were statistically significant ( p mean scores were higher with Dobrez than with Cheung or the linear transformation method . Scores were also statistically significantly different ( p<0.001 ) between studies . CONCLUSIONS In the absence of prospect ively collected utility data , the use of mapping algorithms is feasible , however , the optimal algorithm is not clear . There were significant differences between studies , which highlight the need for validation of these algorithms in specific setting s. If cost analyses incorporate mapping algorithms to obtain utility estimates , investigators should take the variability into account",
"Background . Currently there are no reported cancer-specific health state valuations in low- and middle-income countries using a vali date d preference-based measure . The EORTC-8D , a cancer-specific preference-based measure , has 81,920 health states and is useful for economic evaluations in cancer care . The aim of this study was to develop a utility algorithm to value EORTC-8D health states using preferences derived from a representative population sample in Sri Lanka . Methods . The time-tradeoff method was used to elicit preferences from a general population sample of 780 in Sri Lanka . A block design of 85 health states , with a time horizon of 10 years , was used for the direct valuation . Data were analyzed using generalized least squares with r and om effects . All respondents with at least one logical inconsistency were excluded from the analysis . Results . After logical inconsistencies were excluded , 4520 observations were available from 717 respondents for the analysis . The preferred model specified main effects with an interaction term for any level 4 or worse descriptor within a health state . Worsening of physical functioning had a substantially greater utility decrement than any other dimension in this population . Limitations are that the data collection could not include the whole country and that females formed a large part of the sample . Conclusions . Preference weights for EORTC-8D health states for Sri Lanka have been derived : These will be very useful in economic evaluations of cancer-related interventions in a range of low- and middle-income countries",
"Background The aim of the study was to develop a menopause-specific , preference-based health-related quality -of-life ( HRQoL ) index reflecting both menopausal symptoms and potential side-effects of Hormone Replacement Therapy ( HRT ) . Methods The study had three phases : the development of a health state classification , a prospect i ve valuation survey and the estimation of a model to interpolate HRQoL indices for all remaining health states as defined by the classification . A menopausal health state classification was developed with seven dimensions : hot flushes , aching joints/muscles , anxious/frightened feelings , breast tenderness , bleeding , vaginal dryness and undesirable and rogenic signs . Each dimension contains between three and five levels and defines a total of 6,075 health states . A sample of 96 health states was selected for the valuation survey . These states were valued by a sample of 229 women aged 45 to 60 , r and omly selected from 6 general practice lists in Sheffield , UK . Respondents were asked to complete a time trade-off ( TTO ) task for nine health states , result ing in an average of 16.5 values for each health state . Results Mean health states valued range from 0.48 to 0.98 ( where 1.0 is full health and zero is for states regarded as equivalent to death ) . Symptoms , as described by the classification system , can be rank-ordered in terms of their impact ( from high to low ) on menopausal HRQoL as follows : aching joints and muscles , bleeding , breast tenderness , anxious or frightened feelings , vaginal dryness , and rogenic signs . Hot flushes did not significantly contribute to model fit . The preferred model produced a mean absolute error of 0.053 , but suffered from bias at both ends of the scale . Conclusion This article presents an attempt to directly value a condition specific health state classification . The overall fit was disappointing , but the results demonstrate that menopausal symptoms are perceived by patients to have a significant impact on utility . The overall effect is modest compared to the more generic health state descriptions such as the EQ-5D . The result ant algorithm generates a preference-based index that can be used economic evaluation and that reflects the impact of this condition",
"We developed a preference‐based measure , the Amyotrophic Lateral Sclerosis Utility Index ( ALSUI ) , allowing computation of US population ‐based utility weights for the wide range of health states observed among ALS patients . A multi‐attribute utility approach was used . An ALS Health State Classification System was developed comprising the following attributes with different severity levels : Speech and Swallowing ( A1 ) ; Eating , Dressing , and Bathing ( A2 ) ; Leg Function ( A3 ) ; and Respiratory Function ( A4 ) . An internet‐based survey was administered to a r and om sample of the US population to assess preferences for ALS health states based on this system using visual analog scale ( VAS ) and st and ard gamble ( SG ) questions . Using the VAS and SG data from 1374 individuals in the general population , utility functions were computed that corresponded to each severity level within A1 , A2 , A3 , and A4 . ALSUI scores for a given patient are computed by inputting his corresponding utility functions into the following multiplicative formula : ALSUI score = 1.06 × (A1 × A2 × A3 × A4)−0.06 on a scale where 0.0 reflects death and 1.0 reflects healthy . This study provides a useful tool for classifying ALS patients and determining a general public‐based utility score for ALS health states",
"STUDY OBJECTIVE To develop and evaluate a brief , easy-to-administer symptom assessment scale for use as a preference-based outcome measure in clinical trials and cost-effectiveness studies in asthma . DESIGN Cross-sectional survey with 2-week reproducibility assessment . SETTING Ambulatory care : university asthma and allergy center . PARTICIPANTS One hundred sixty-one adults with asthma , 59 % female , mean age 35+/-11 years . Mean FEV1 percent predicted was 86+/-17 % . INTERVENTIONS The 11-item Asthma Symptom Utility Index ( ASUI ) . MEASUREMENTS AND RESULTS Mean ASUI score for this sample was 0.71+/-0.23 , with a range from 0.02 to 1.0 . The ASUI was reproducible ( intraclass correlation coefficient = 0.74 ) and able to distinguish patients known to differ on disease severity according to clinician ratings ( p asthma disease severity scale score ( p FEV1 percent predicted ( r = 0.27 , p Asthma Quality of Life Question naire ( r = 0.77 , p Health Utilities Index Mark 2 ( r = 0.36 , p < 0.001 ) . CONCLUSION The results of this study support the reliability and validity of the ASUI , suggesting it will be a useful , complementary patient outcome measure for clinical trials and cost-effectiveness studies comparing treatment alternatives for persons with asthma",
"Purpose Condition-specific preference-based measures can offer utility data where they would not otherwise be available or where generic measures may lack sensitivity , although they lack comparability across conditions . This study aim ed to develop an algorithm for estimating utilities from the short bowel syndrome health-related quality of life scale ( SBS-QoL ™ ) . Methods SBS-QoL ™ items were selected based on factor and item performance analysis of a European SBS-QoL ™ data set and consultation with 3 SBS clinical experts . Six-dimension health states were developed using 8 SBS-QoL ™ items ( 2 dimensions combined 2 SBS-QoL ™ items ) . SBS health states were valued by a UK general population sample ( N = 250 ) using the lead-time time trade-off method . Preference weights or ‘ utility decrements ’ for each severity level of each dimension were estimated by regression models and used to develop the scoring algorithm . Results Mean utilities for the SBS health states ranged from −0.46 ( worst health state , very much affected on all dimensions ) to 0.92 ( best health state , not at all affected on all dimensions ) . The r and om effects model with maximum likelihood estimation regression had the best predictive ability and lowest root mean squared error and mean absolute error , and was used to develop the scoring algorithm . Conclusions The preference-weighted scoring algorithm for the SBS-QoL ™ developed is able to estimate a wide range of utility values from patient-level SBS-QoL ™ data . This allows estimation of SBS HRQL impact for the purpose of economic evaluation of SBS treatment benefits",
"BACKGROUND Condition-specific measures are frequently used to assess the health-related quality of life of people with multiple sclerosis ( MS ) . Such measures are unsuitable for use in economic evaluations that require estimates of cost per quality -adjusted life-year because they are not based on preferences . OBJECTIVES To report the estimation of a preference-based single index for an eight-dimensional instrument for MS , the Multiple Sclerosis Impact Scale - Eight Dimensions ( MSIS-8D ) , derived from an MS-specific measure of health-related quality of life , the 29-item Multiple Sclerosis Impact Scale ( MSIS-29 ) . METHODS We elicited preferences for a sample of MSIS-8D states ( n = 169 ) from a sample ( n = 1702 ) of the UK general population . Preferences were elicited using the time trade-off technique via an Internet-based survey . We fitted regression models to these data to estimate values for all health states described by the MSIS-8D . Estimated values were assessed against MSIS-29 scores and values derived from generic preference-based measures in a large , representative sample of people with MS . RESULTS Participants reported that the time trade-off questions were easy to underst and . Observed health state values ranged from 0.08 to 0.89 . The best-performing model was a main effects , r and om effects model ( mean absolute error = 0.04 ) . Validation analyses support the performance of the MSIS-8D index : it correlated more strongly than did generic measures with MSIS-29 scores , and it discriminated effectively between subgroups of people with MS . CONCLUSIONS The MSIS-8D enables health state values to be estimated from the MSIS-29 , adding to the methods available to assess health outcomes and to estimate quality -adjusted life-years for MS for use in health technology assessment and decision-making context",
"Background . The Clinical Outcomes in Routine Evaluation– Outcome Measure ( CORE-OM ) is used to evaluate the effectiveness of psychological therapies in people with common mental disorders . The objective of this study was to estimate a preference-based index for this population using CORE-6D , a health state classification system derived from the CORE-OM consisting of a 5-item emotional component and a physical item , and to demonstrate a novel method for generating states that are not orthogonal . Methods . Rasch analysis was used to identify 11 emotional health states from CORE-6D that were frequently observed in the study population and are , thus , plausible ( in contrast , conventional statistical design might generate implausible states ) . Combined with the 3 response levels of the physical item of CORE-6D , they generate 33 plausible health states , 18 of which were selected for valuation . A valuation survey of 220 members of the public in South Yorkshire , United Kingdom , was undertaken using the time tradeoff ( TTO ) method . Regression analysis was subsequently used to predict values for all possible states described by CORE-6D . Results . A number of multivariate regression models were built to predict values for the 33 health states of CORE-6D , using the Rasch logit value of the emotional state and the response level of the physical item as independent variables . A cubic model with high predictive value ( adjusted R2 = 0.990 ) was selected to predict TTO values for all 729 CORE-6D health states . Conclusion . The CORE-6D preference-based index will enable the assessment of cost-effectiveness of interventions for people with common mental disorders using existing and prospect i ve CORE-OM data sets . The new method for generating states may be useful for other instruments with highly correlated dimensions",
"Background Limited utility data on patients suffering from overactive bladder ( OAB ) are available in the literature . The objectives of this study were to estimate utility values in patients with OAB using the generic EQ-5D question naire and the OAB-5D disease specific question naire , to investigate the relationship between utilities and symptoms , and to evaluate the sensitivity of the two instruments to changes in symptom severity . Methods Analyses were based on pooled data from three large multicenter r and omized 12-week placebo-controlled trials ( SCORPIO , ARIES , CAPRICORN ) . Patients completed a micturition diary , EQ-5D and OAB-q ( a quality of life question naire from which OAB-5D is derived ) at baseline and at weeks 4 , 8 and 12 . Time trade-off tariffs elicited from UK population were applied to obtain utilities from both instruments . Repeated measures regressions were used to estimate EQ-5D and OAB-5D utilities by micturition frequency and incontinence severity level . As a test of sensitivity of the instruments , utility changes from baseline to week 12 were estimated by symptomatic response ( improvement , stable or worsening ) . Results The sample included 4427 patients . Mean utilities ( ± st and ard deviation ) across all visits were 0.82 ( ±0.21 ) for EQ-5D and 0.86 ( ±0.09 ) for OAB-5D . Correlation between EQ-5D and OAB-5D was 0.34 ( p Both OAB-5D and EQ-5D utilities increased as OAB symptoms improved . Utility values were similar for severe levels of symptoms , but higher with OAB-5D than with EQ-5D for mild cases . Micturitions and incontinence had similar impact on EQ-5D utilities , but micturitions had greater impact on OAB-5D utilities than incontinence . Changes from baseline in OAB-5D utilities differed significantly according to symptomatic response . Changes in EQ-5D utilities were not significantly associated with changes in micturition frequency and weakly associated with changes in incontinence severity among patients with mild symptoms at baseline . Conclusions This study showed that both EQ-5D and OAB-5D can detect changes in severity of OAB , especially in severe cases . However , OAB-5D is more sensitive than EQ-5D in measuring differences between treatments in milder cases . Both OAB-5D and EQ-5D – although leading to different results –may be useful to derive utilities from clinical trial data and perform cost-effectiveness analyses . Trial registration Clinical Trials NCT00689104 , NCT00662909 , NCT00912964",
"Purpose This study aim ed to develop a utility index ( the ABC-UI ) from the Aberrant Behavior Checklist-Community ( ABC-C ) , for use in quantifying the benefit of emerging treatments for fragile X syndrome ( FXS ) . Methods The ABC-C is a proxy-completed assessment of behaviour and is a widely used measure in FXS . A subset of ABC-C items across seven dimensions was identified to include in health state descriptions . This item reduction process was based on item performance , factor analysis and Rasch analysis performed on an observational study data set , and consultation with five clinical experts and a method ological expert . Dimensions were combined into health states using an orthogonal design and valued using time trade-off ( TTO ) , with lead-time TTO methods used where TTO indicated a state valued as worse than dead . Preference weights were estimated using mean , individual level , ordinary least squares and r and om-effects maximum likelihood estimation [ RE ( MLE ) ] regression models . Results A representative sample of the UK general public ( n = 349 ; mean age 35.8 years , 58.2 % female ) each valued 12 health states . Mean observed values ranged from 0.92 to 0.16 for best to worst health states . The RE ( MLE ) model performed best based on number of significant coefficients and mean absolute error of 0.018 . Mean utilities predicted by the model covered a similar range to that observed . Conclusions The ABC-UI estimates a wide range of utilities from patient-level FXS ABC-C data , allowing estimation of FXS health-related quality of life impact for economic evaluation from an established FXS clinical trial instrument",
"BACKGROUND Conventionally , parametric models were used for health state valuation data . Recently , research ers started to explore the use of nonparametric Bayesian methods in this area . OBJECTIVES We present a nonparametric Bayesian model to estimate a preference-based index for two condition-specific five-dimensional health state classifications , one for asthma ( five-dimensional Asthma Quality of Life Utility Index ) and the other for overactive bladder ( five-dimensional Overactive Bladder Quality of Life-Utility Index ) . METHODS Sample s of 307 and 311 members of the UK general population valued 99 health states selected from a total of 3125 health states defined by each of the measures using the time trade-off technique . The article presents the results of the nonparametric model and compares it with the original model estimated using a conventional parametric r and om-effects model . The different methods are compared theoretically and in terms of empirical performance across the two data sets . It also reports the effect of respondent characteristics on health state valuations . RESULTS The nonparametric models were found to be better at predicting health state values within the estimation sample than without in terms of root mean square error and the patterns of st and ardized residuals . Some respondent characteristics were found to explain variation in health state values , but these did not have a significant effect on the health states values when estimates were adjusted for sample differences with the general population . CONCLUSIONS The nonparametric Bayesian models are theoretically more appropriate than previously used parametric models and provide better utility estimates from the two condition-specific measures . Furthermore , the model is more flexible in estimating the effect of covariates",
"OBJECTIVE The goal of this study was to estimate an algorithm to convert responses to the Functional Assessment of Cancer Therapy - General ( FACT-G ) to time trade-off ( TTO ) utilities based on utilities for current health elicited from cancer patients . METHODS Data for 1433 cancer patients were r and omly separated into construction and validation sample s. Four FACT-G questions were selected for inclusion based on correlation with Eastern Clinical Oncology Group - Performance Status ( ECOG-PS ) scores and TTO utilities . Item response theory was used to collapse response categories . Ordinary least squares regression with the constant constrained to one was used to estimate the algorithm . RESULTS The algorithm estimated mean utility for the full validation sample within three points of observed mean utility ( 0.805 vs. 0.832 , P Mean utilities were well predicted ( mean absolute difference 0.05 ) for most subgroups defined by ECOG-PS and Short Form-36 physical functioning scores , and responses to the FACT-G overall quality of life item . Nevertheless , the algorithm systematic ally overpredicted utilities for poorer health states . CONCLUSIONS A FACT-G-based algorithm of cancer patient utilities was developed that estimates group mean utility scores with accuracy comparable to other indirect preference-based measures of health-related quality of life . Patient-based preferences for health outcomes of cancer treatment may be useful in multiple situations , such as managing re sources within cancer centers and in underst and ing health states preferences among cancer experienced patients before and after treatment",
"BACKGROUND The exacerbations of chronic obstructive pulmonary disease tool ( EXACT ) is a condition-specific daily diary recently developed to evaluate the frequency , severity , and duration of chronic obstructive pulmonary disease ( COPD ) exacerbations . A preference-based algorithm for the EXACT would allow utilities to be reported from patients during an exacerbation when EQ-5D data are not available . OBJECTIVE To develop the exacerbations of chronic obstructive pulmonary disease tool-utility ( EXACT-U ) , a condition-specific preference-based measure to report utilities from the EXACT for use in cost-effectiveness studies . METHODS Five items with three to five levels comprise the EXACT-U. Two groups of health states and respondents were constructed to allow for model development ( Development group ) and predictive validity testing ( Validation group ) using independent sample s. Members of the UK general public each valued 11 r and omized health states using time trade-offs ( TTOs ) scaled from full health/dead with 10-year duration s. Regression models estimated from the Development group using individual data , mean data , and panel design s. Models assessed by number of inconsistent coefficients estimated and R(2 ) and tested against observed utilities from the Validation group using mean absolute error ( MAE ) and root mean squared error ( RMSE ) . RESULTS A total of 55 health states , including the best and worst states , were valued in TTO interviews conducted with 400 respondents . Ten models were developed . The final preferred model contained no logical inconsistencies and found MAE = 0.04 and RMSE = 0.05 with a predicted utility range from 0.09 to 0.95 . CONCLUSIONS The EXACT-U is a condition-specific preference-based measure with strong predictive validity to report daily utilities during an exacerbation",
"BACKGROUND The evaluation of asthma symptoms is a core outcome measure in asthma clinical research . The Asthma Symptom Utility Index ( ASUI ) was developed to assess the frequency and severity of asthma symptoms . The psychometric properties of the ASUI are not well characterized , and a minimal important difference ( MID ) is not established . OBJECTIVES We assessed the reliability , validity , and responsiveness to change of the ASUI in a population of adult asthmatic patients . We also sought to determine the MID for the ASUI . METHODS Adult asthmatic patients ( n = 1648 ) from 2 previously completed multicenter r and omized trials were included . Demographic information , spirometric results , ASUI scores , and other asthma question naire scores were obtained at baseline and during follow-up visits . Participants also kept a daily asthma diary . RESULTS The internal consistency reliability of the ASUI was 0.74 ( Cronbach α ) . Test-retest reliability was 0.76 ( intraclass correlation ) . Construct validity was demonstrated by significant correlations between ASUI scores and Asthma Control Question naire scores ( Spearman correlation r = -0.79 ; 95 % CI , -0.85 to -0.75 ; P .001 ) and Mini Asthma Quality of Life Question naire scores ( r = 0.59 ; 95 % CI , 0.51 - 0.61 ; P ) . Responsiveness to change was demonstrated , with significant differences between mean changes in ASUI scores across groups of participants differing by 10 % in percent predicted FEV(1 ) ( P Asthma Control Question naire scores ( P reliable , valid , and responsive to changes in asthma control over time . The MID of the ASUI ( range of scores , 0 - 1 ) is 0.09",
"Background and purpose An internet-based discrete choice experiment ( DCE ) was conducted to elicit preferences for a wide range of Dupuytren ’s contracture (DC)-related health states . An algorithm was subsequently developed to convert these preferences into health state utilities that can be used to assess DC ’s impact on quality of life and the value of its treatments . Methods Health state preferences for varying levels of DC h and severity were elicited via an internet survey from a sample of the UK adult population . Severity levels were defined using a combination of contractures ( 0 , 45 , or 90 degrees ) in 8 proximal interphalangeal and metacarpophalangeal joints of the index , middle , ring , and little fingers . Right-h and ed , left-h and ed , and ambidextrous respondents indicated which h and was preferable in each of the 10 r and omly-selected h and -pairings comparing different DC severity levels . For consistency across comparisons , anatomically precise digital h and drawings were used . To anchor preferences onto the traditional 0–1 utility scale used in health economic evaluations , unaffected h and s were assigned a utility of 1.0 whereas the utility for a maximally affected h and ( i.e. , all 8 joints set at 90 degrees of contracture ) was derived by asking respondents to indicate what combination of attributes and levels of the EQ-5D-5L profile most accurately reflects the impact of living with such h and . Conditional logistic models were used to estimate indirect utilities , then rescaled to the anchor points on the EQ-5D-5L . Results Estimated utilities based on the responses of 1,745 qualified respondents were 0.49 , 0.57 , and 0.63 for completely affected dominant h and s , non-dominant h and s , or ambidextrous h and s , respectively . Utility for a dominant h and with 90-degree contracture in t h e metacarpophalangeal joints of the ring and little fingers was estimated to be 0.89 . Separately , reducing the contracture of metacarpophalangeal joint for a little finger from 50 to 12 degrees would improve utility by 0.02 . Interpretation DC is associated with substantial utility decre- ments . The algorithms presented herein provide a robust and flexible framework to assess utility for varying degrees of DC severity ",
"Background . Generic preference-based measures of health may not adequately cover the impact of some conditions . There is therefore increasing interest in developing condition-specific preference-based measures . Objectives . The purpose of this study was to estimate a preference-based measure from a condition-specific measure of health for urinary incontinence , the 21-item King 's Health Question naire , for use in economic evaluation . Methods . The King 's Health Question naire ( KHQ ) was revised into a 5-dimensional health state classification amenable to valuation using items selected using psychometric evidence . Forty-nine states were valued using st and ard gamble by a representative sample of patients with urinary incontinence attending UK hospital outpatient clinics . Each respondent was asked to value 9 health states . Models have been estimated for predicting health state valuations for all 1024 states defined by the KHQ classification . The modeling had to cope with the clustering of data by respondent and its skewed distribution . Results . In total , 110 usable interviews were obtained from 169 patients approached to participate in the study . These responders generated 959 health state valuations . Mean health state values ranged from 0.77 to 0.98 . Models were estimated using mean health state values and r and om effects models of individual-level health state values . These models generated robust estimates of the ` main effects , ` and in general , the results support the ordinality of the KHQ health state classification . There were problems modeling interaction effects , and a number of alternatives were explored . Conclusion . The recommended model for estimating a preference-based measure from the condition-specific KHQ is presented",
"PURPOSE Multi-attribute utility instruments ( MAUIs ) , which contain a descriptive system , including several health dimensions with associated levels of increasing severity , are used commonly to measure utilities . However , the validity of the descriptive systems rarely is examined using modern psychometric theory . Therefore , we evaluated the psychometric properties of the German version of the Vision and Quality of Life Index ( VisQol ) , a six-item vision-related MAUI . METHODS The German VisQol was self-administered to 340 patients and 280 controls . All subjects underwent a full ophthalmologic examination , including best-corrected visual acuity ( VA ) testing . The psychometric properties of the VisQoL were assessed using Rasch analysis . RESULTS The VisQoL 's descriptive system did not function in controls . In patients , after collapsing response categories to resolve disordered thresholds and omitting misfitting persons , the measurement properties ( i.e. , precision , unidimensionality , and targeting ) of the German VisQoL were satisfactory . Most person misfit related to unexpected responses to item 4 ( \" organizing assistance \" ) . Rasch-generated person estimates were not different between age categories , sex , or underlying ocular condition , but decreased significantly with presence of visual impairment in the better eye ( LogMAR ≥ 0.5 , 1.20 ± 4.62 compared to 3.46 ± 3.52 , P VisQoL 's descriptive system displayed adequate fit to the Rasch model after removal of a large proportion of patients with poor fit statistics . However , the wording of item four should be revised to reduce respondent confusion and measurement \" noise . \" The scale 's descriptive system does not function in a sample of visually unimpaired persons , most likely due to a lack of variance in the measured trait",
"OBJECTIVES The aim of the study is to estimate a preference-based single index for calculating quality -adjusted life years for patients with overactive bladder ( OAB ) , based on a survey of the UK general population using the 5-dimensional health classification system OAB-5D , derived from the vali date d Overactive Bladder Question naire ( OAB-q ) . METHODS An interview valuation survey of members of public in the South Yorkshire , UK was undertaken using the time-trade-off method . Each respondent was r and omly allocated to one of 14 blocks , and valued seven states each plus the \" pits \" state , so that a total of 99 states were valued . A number of multivariate regression models were estimated for predicting a total of 3125 health state values defined by the classification . Models were compared and selected using a set of criteria , including overall diagnosis by adjusted R-squared , the sign and significance of individual parameter estimates , the relative size of coefficients within a given dimension and predictive ability . RESULTS The mean model was recommended for use in economic evaluation . CONCLUSION This will permit the cost-effectiveness of new interventions to be assessed in patients with OAB using existing and future OAB-q data sets"
] | 41167e6e-06ff-11f0-808a-c43d1ab1c353 |
Background Cardiac resynchronisation therapy ( CRT ) is beneficial in selected patients with heart failure ( HF ) in normal sinus rhythm ( NSR ) . We sought to evaluate the impact of CRT with or without atrioventricular junction ( AVJ ) ablation in patients with HF with concomitant atrial fibrillation ( AF ) Methods and results Literature was search ed ( inception through 30 August 2017 ) for observational studies that reported outcomes in patients with HF with CRT and AF that reported all-cause and cardiovascular mortality . Thirty-one studies with 83 , 571 patients were included . CRT did not decrease mortality compared with internal cardioverter defibrillator or medical therapy alone in patients with HF and AF with indications for CRT ( OR : 0.851 , 95 % CI 0.616 to 1.176 , p=0.328 , I2=86.954 ) . CRT-AF patients had significantly higher all-cause and cardiovascular mortality than CRT-NSR patients ( [ OR : 1.472 , 95 % CI 1.301 to 1.664 , p=0.000 ] and [ OR : 1.857 , 95 % CI 1.350 to 2.554 , p=0.000 ] respectively ) . Change in left ventricular ejection fraction was not different between CRT patients with and without AF ( p=0.705 ) . AVJ ablation , however , improved all-cause mortality in CRT-AF patients when compared with CRT-AF patients without AVJ ablation ( OR : 0.485 , 95 % CI 0.247 to 0.952 , p=0.035 ) . With AVJ ablation , there was no difference in all-cause mortality in CRT-AF patients compared with CRT-NSR patients ( OR : 1.245 , 95 % CI 0.914 to 1.696 , p=0.165 ) . Conclusion The results of our meta- analysis suggest that AF was associated with decreased CRT benefits in patients with HF . CRT , however , benefits patients with AF with AVJ ablation | [
"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 —Cardiac resynchronization ( CRT ) prolongs survival in patients with systolic heart failure and QRS prolongation . However , most trials excluded patients with permanent atrial fibrillation . Methods and Results —The Resynchronization for Ambulatory Heart Failure Trial ( RAFT ) r and omized patients to an implantable cardioverter defibrillator ( ICD ) or ICD+CRT , stratified by the presence of permanent atrial fibrillation . Patients with permanent atrial fibrillation were r and omized to CRT-ICD ( n=114 ) or ICD ( n=115 ) . Patients receiving a CRT-ICD were similar to those receiving an ICD : age ( 71.6±7.3 versus 70.4±7.7 years ) , left ventricular ejection fraction ( 22.9±5.3 % versus 22.3±5.1 % ) , and QRS duration ( 151.0±23.6 versus 153.4±24.7 ms ) . There was no difference in the primary outcome of death or heart failure hospitalization between those assigned to CRT-ICD versus ICD ( hazard ratio , 0.96 ; 95 % CI , 0.65–1.41 ; P=0.82 ) . Cardiovascular death was similar between treatment arms ( hazard ratio , 0.97 ; 95 % CI , 0.55–1.71 ; P=0.91 ) ; however , there was a trend for fewer heart failure hospitalizations with CRT-ICD ( hazard ratio , 0.58 ; 95 % CI , 0.38–1.01 ; P=0.052 ) . The change in 6-minute hall walk duration between baseline and 12 months was not different between treatment arms ( CRT-ICD : 19±84 m versus ICD : 16±76 m ; P=0.88 ) . Patients treated with CRT-ICD showed a trend for a greater improvement in Minnesota Living with Heart Failure score between baseline and 6 months ( CRT-ICD : 41±21 to 31±21 ; ICD : 33±20 to 28±20 ; P=0.057 ) . Conclusions — Patients with permanent atrial fibrillation who are otherwise CRT c and i date s appear to gain minimal benefit from CRT-ICD compared with a st and ard ICD . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00251251",
"BACKGROUND Controlled clinical trial data are lacking for cardiac resynchronization therapy ( CRT ) outcomes in patients with advanced heart failure ( HF ) from reduced left ventricular ejection fraction ( HFrEF ) and intermittent atrial fibrillation or flutter ( IAF/AFL ) . OBJECTIVE The purpose of this study was to describe CRT outcomes in patients with IAF/AFL and advanced HF . METHODS HF outcomes in patients in the COMPANION ( Comparison of Medical Therapy , Pacing , and Defibrillation in Heart Failure ) trial with New York Heart Association class III or IV HFrEF , left ventricular ejection fraction ≤0.35 , sinus rhythm at r and omization , and no history of baseline arrhythmia were compared with those with a history of IAF/AFL . RESULTS In those with no history of baseline arrhythmia ( n = 887 ) , compared with optimal pharmacological therapy ( OPT ) with no CRT , the CRT + OPT arms exhibited a significant reduction in the end points of death or any hospitalization ( hazard ratio [ HR ] 0.73 [ 95 % Confidence Interval ( CI ) : 0.60 to 0.89 ] ; P = .002 ) and death or HF hospitalization ( HR 0.53 [ 95 % CI : 0.41 to 0.68 ] ; P IAF/AFL subgroup ( n = 293 ) , CRT did not result in improved outcomes compared with OPT ( death or any hospitalization : HR 1.16 [ 95 % CI : 0.83 to 1.63 ] ; P = .38 ; death or HF hospitalization : HR 0.97 [ 95 % CI : 0.64 to 1.46 ] ; P = .88 ) . The interaction between history of AF/AFL and CRT was statistically significant for both outcomes ( P patients with moderate to severe HFrEF and a history of IAF/AFL had no benefit from CRT",
"OBJECTIVES The main objective of this study was to assess if the benefits of biventricular ( BiV ) pacing observed during the crossover phase were sustained over 12 months . BACKGROUND MUltisite STimulation In Cardiomyopathies ( MUSTIC ) is a r and omized controlled study intended to evaluate the effects of BiV pacing in patients with New York Heart Association ( NYHA ) class III heart failure and intraventricular conduction delay . METHODS Of 131 patients included , 42/67 in sinus rhythm ( SR ) and 33/64 in atrial fibrillation ( AF ) were followed up longitudinally at 9 and 12 months by 6-min walked distance , peak oxygen uptake ( peak VO(2 ) ) , quality of life by the Minnesota score , NYHA class , echocardiography , and left ventricular ejection fraction by radionuclide technique . RESULTS At 12 months , all SR and 88 % of AF patients were programmed to BiV pacing . Compared with baseline , the 6-min walked distance increased by 20 % ( SR ) ( p = 0.0001 ) and 17 % ( AF ) ( p = 0.004 ) ; the peak VO(2 ) by 11 % ( SR ) and 9 % ( AF ) ; quality of life improved by 36 % ( SR ) ( p = 0.0001 ) and 32 % ( AF ) ( p = 0.002 ) ; NYHA class improved by 25 % ( SR ) ( p = 0.0001 ) and 27 % ( AF ) ( p = 0.0001 ) . The ejection fraction improved by 5 % ( SR ) and 4 % ( AF ) . Mitral regurgitation decreased by 45 % ( SR ) and 50 % ( AF ) . CONCLUSIONS The clinical benefits of BiV pacing appeared to be significantly maintained over a 12-month follow-up period",
"Background —Whether adding cardiac resynchronization therapy ( CRT-D ) to an implanted cardioverter – defibrillator alters the risk of atrial fibrillation or other atrial tachyarrhythmias ( AF/AT ) , or if postimplantation AF/AT modulate the benefits of CRT-D , remain unknown . Methods and Results —We studied 972 Resynchronization/Defibrillation in Ambulatory Heart Failure Trial ( RAFT ) participants without permanent AF , who were r and omized to CRT-D ( n=495 ) versus nonresynchronization defibrillator ( implanted cardioverter – defibrillator ; n=477 ) within the predefined stratum eligible for an atrial lead . Occurrence of postr and omization AF/AT was prospect ively assessed , and Cox models were used to test the independent association between the postr and omization AF/AT and the RAFT primary composite outcome of all-cause mortality or hospitalization for heart failure . Over 41 ( ±19 ) months , postr and omization AF/AT occurred in 216 ( 45.3 % ) patients r and omized to implanted cardioverter – defibrillator and 249 ( 50.3 % ) r and omized to CRT-D. After adjusting for competing risk of death , r and omization to CRT-D increased risk of postr and omization AF/AT ( hazard ratio , 1.20 ; 95 % confidence interval , 1.00–1.42 ; P=0.045 ) . Postr and omization AF/AT , which remained paroxysmal in 69.5 % , did not reduce biventricular pacing percentage . In adjusted models , postr and omization AF/AT was not associated with the primary outcome ( hazard ratio , 1.04 ; 95 % confidence interval , 0.84–1.30 ) . However , AF/AT was associated with a borderline decreased risk of mortality ( hazard ratio , 0.75 ; 95 % confidence interval , 0.58–1.00 ) but increased risk of heart failure hospitalization ( hazard ratio , 1.43 ; 95 % confidence interval , 1.08–1.90 ) . Conclusions —In RAFT , nearly half of the patients developed postr and omization AF/AT , and those r and omized to CRT-D had borderline significant higher risk . Postr and omization AF/AT was associated with risk of heart failure hospitalization , but not with the primary composite outcome . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00251251",
"Background — Atrial fibrillation/flutter ( AF ) and heart failure often coexist ; however , the effect of cardiac resynchronization therapy ( CRT ) on the incidence of AF and on the outcome of patients with new-onset AF remains undefined . Methods and Results — In the CArdiac REsynchronisation in Heart Failure ( CARE-HF ) trial , 813 patients with moderate or severe heart failure were r and omly assigned to pharmacological therapy alone or with the addition of CRT . The incidence of AF was assessed by adverse event reporting and by ECGs during follow-up , and the impact of new-onset AF on the outcome and efficacy of CRT was evaluated . By the end of the study ( mean duration of follow-up 29.4 months ) , AF had been documented in 66 patients in the CRT group compared with 58 who received medical therapy only ( 16.1 % versus 14.4 % ; hazard ratio 1.05 ; 95 % confidence interval , 0.73 to 1.50 ; P=0.79 ) . There was no difference in the time until first onset of AF between groups . Mortality was higher in patients who developed AF , but AF was not a predictor in the multivariable model ( hazard ratio 1.17 ; 95 % confidence interval , 0.82 to 1.67 ; P=0.37 ) . In patients with new-onset AF , CRT significantly reduced the risk for all-cause mortality and all other predefined end points and improved ejection fraction and symptoms ( no interaction between AF and CRT ; all P>0.2 ) . Conclusions — Although CRT did not reduce the incidence of AF , CRT improved the outcome regardless of whether AF developed",
"Objective : To compare the effects of cardiac resynchronisation therapy ( CRT ) in patients with heart failure ( HF ) in either atrial fibrillation ( AF ) or sinus rhythm ( SR ) . Design : Prospect i ve observational study . Patients : 295 consecutive patients with HF ( permanent AF in 66 , paroxysmal AF in 20 , SR in 209 ; New York Heart Association ( NYHA ) class III or IV ; left ventricular ejection fraction ( LVEF ) ⩽35 % , QRS ⩾120 ms ) . Interventions : All patients underwent CRT without atrioventricular junction ablation . Main outcome measures : The primary end point was the composite of cardiovascular death or unplanned hospitalisation for major cardiovascular events . Secondary end points included the composite of cardiovascular death or hospitalisation for worsening HF . Cardiovascular mortality , total mortality and changes in NYHA class , 6-minute walking distance , quality of life ( Minnesota Living with Heart Failure question naire ) and echocardiographic variables were also considered . Results : Over a follow-up period of up to 6.8 years , no differences emerged between patients in AF or SR in any of the mortality or morbidity end points . The AF and SR groups derived similar improvements in mean NYHA class ( −1.3 vs –1.2 ) , 6-minute walking distance ( 92.3 vs 78.4 m ) and quality of life scores ( −25.2 vs –18.7 ) ( all p seen in left ventricular end-systolic ( −25.9 vs –34.5 ml , both p ) and end-diastolic ( −20.2 ml , p = 0.001 vs 26.2 ml , p ) volumes and improvements in LVEF ( 4.69 % vs 7.86 % , both p Conclusions : Cardiac resynchronisation therapy leads to similar prognostic and symptomatic benefits in patients in AF and SR , even without atrioventricular junction ablation . Echocardiographic improvements are also comparable",
"AIMS AND OBJECTIVE Outcome data of patients with implantable cardioverter defibrillators ( ICD ) and atrial fibrillation ( AF ) are conflicting . The German DEVICE registry aims to add further information on this particular cohort . METHODS AND RESULTS The German DEVICE registry is a nationwide prospect i ve multicenter data base of ICD implantations . 3261 patients are included ( 81 % males , 2701 ( 82.8 % ) first ICD implantations , 560 ( 17.2 % ) ICD replacements ) . Cardiac resynchronization therapy ( CRT-D ) was performed in 882 patients ( 27.0 % ) . Sinus rhythm ( SR ) was present in 2654 ( 81.4 % ) and atrial fibrillation ( AF ) in 607 ( 18.6 % ) . Left ventricular ejection fraction ( LVEF ) did not differ between groups ( SR 32.3 % , AF 30.4 % ; p = 0.09 ) . AF patients were older ( AF 70.9 versus SR 63.9 years ; p co-morbidities ( diabetes , hypertension , chronic kidney disease ; all p In-hospital complications were not significantly different between groups ( p = 0.58 ) . Follow-up information after one year was available in 2967 patients ( 91 % ) . One-year overall mortality after first ICD implantation was 4.9 % for SR and 11.2 % for AF patients ( p mortality one year after ICD replacement was 8.4 % for SR and 12.0 % for AF ( p = 0.34 ) . No statistically significant difference between SR and AF patients receiving a CRT device was observed ( SR 6.9 % , AF 10.7 % , p = 0.16 ) in terms of one-year mortality . CONCLUSION The German DEVICE registry demonstrates that patients with AF who receive ICD devices are older , have more co-morbidity and more severe heart failure . AF carries an independent 1.39 fold risk ( 95 % CI 1.02 - 1.89 ) of death after one year in patients only with first ICD implantation",
"BACKGROUND Cardiac resynchronization therapy ( CRT ) benefits patients with advanced heart failure . The role of atrioventricular nodal ( AVN ) ablation in improving CRT outcomes , including survival benefit in CRT recipients with atrial fibrillation , is uncertain . OBJECTIVE The purpose of this study was to assess the impact of AVN ablation on clinical and survival outcomes in a large atrial fibrillation and heart failure population that met the current indication for CRT and to determine whether AVN ablation is an independent predictor of survival in CRT recipients . METHODS Of 154 patients with atrial fibrillation who received CRT-D , 45 ( 29 % ) underwent AVN ablation ( + AVN-ABL group ) , whereas 109 ( 71 % ) received drug therapy for rate control during CRT ( -AVN-ABL group ) . New York Heart Association ( NYHA ) class , electrocardiogram , and echocardiogram were assessed before and after CRT . Survival data were obtained from the national death and location data base ( Accurint ) . RESULTS CRT comparably improved left ventricular ejection fraction ( 8.1 % + /- 10.7 % vs 6.8 % + /- 9.6 % , P = .49 ) and left ventricular end-diastolic diameter ( -2.1 + /- 5.9 mm vs -2.1 + /- 6.7 mm , P = .74 ) in both + AVN-ABL and -AVN-ABL groups . Improvement in NYHA class was significantly greater in the + AVN-ABL group than in -AVN-ABL group ( -0.7 + /- 0.8 vs -0.4 + /- 0.8 , P = .04 ) . Survival estimates at 2 years were 96.0 % ( 95 % confidence interval [ CI ] 88.6%-100 % ) for + AVN-ABL group and 76.5 % ( 95 % CI 68.1%-85.8 % ) for-AVN-ABL group ( P = .008 ) . AVN ablation was independently associated with survival benefit from death ( hazard ratio [ HR ] 0.13 , 95 % CI 0.03 - 0.58 , P = .007 ) and from combined death , heart transplant , and left ventricular assist device ( HR 0.19 , 95 % CI 0.06 - 0.62 , P = .006 ) after CRT . CONCLUSION Among patients with atrial fibrillation and heart failure receiving CRT , AVN ablation for definitive biventricular pacing provides greater improvement in NYHA class and survival benefit . Larger-scale r and omized trials are needed to assess the clinical and survival outcomes of this therapy",
"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 .",
"The prevalence of atrial fibrillation ( AF ) in patients with heart failure is high , but data about the effects of cardiac resynchronization therapy ( CRT ) in patients with chronic AF are scarce . In this prospect i ve observational study of 263 consecutive patients , CRT was performed in 96 patients ( 37 % ) with chronic AF and 167 patients ( 63 % ) with sinus rhythm ( SR ) . Echocardiographic and clinical parameters were evaluated at baseline and 3 and 12 months . Reverse left ventricular ( LV ) remodeling is defined as LV end-systolic volume decrease > or = 10 % . Hospitalization rates for heart failure in the year before and after implantation were compared . Baseline characteristics between patients with and without AF were similar , but the AF group had smaller LV end-systolic and end-diastolic volumes and larger left atrial dimensions . New York Heart Association class , 6-minute walking distance , quality -of-life score , LV ejection fraction , and mitral regurgitation improved significantly at 3 and 12 months in both groups , and the changes were similar . Reverse LV remodeling after 3 and 12 months was 74 % and 82 % ( AF group ) versus 77 % and 83 % , respectively ( SR group , p = 0.79 ) . After 1 year , cardioversion had occurred in 25 % of patients with AF . In the year after implantation , significant decreases in hospitalizations for heart failure in both groups ( 84 % and 90 % ) were documented . Long-term mortality was almost equal in both groups . In conclusion , this large-scale study shows that the benefit of CRT in patients with chronic AF and heart failure is similar to that in patients with SR . Patients with chronic AF and heart failure should be considered c and i date s for CRT",
"BACKGROUND Cardiac resynchronization therapy ( CRT ) is an established method in patients with severe heart failure and wide QRS configuration , particularly during sinus rhythm ( SR ) . In CRT patients with permanent atrial fibrillation ( AF ) , there is no general consensus regarding the need for atrioventricular node ( AVN ) ablation . The aim of this study was to evaluate the benefit of CRT in permanent AF with and without AVN ablation . METHODS New York Heart Association classification , QRS duration , and echocardiographic parameters were assessed before and after CRT with a follow-up of 12 ± 3 months . Two hundred thirty patients in SR and 46 patients with permanent AF of 2.1 ± 0.5 years duration were studied . AVN ablation was performed only in AF patients with insufficient pharmacological rate control evidence d by ≤80 % ventricular stimulation . RESULTS Fifteen AF patients underwent AVN ablation . Biventricular pacing comparably improved functional status , left ventricular ejection fraction , and left ventricular end-diastolic dimensions in all treated groups . Biventricular stimulation percentage was 10 % lower in pharmacologically treated AF patients over 1 year as compared to patients in SR and to AF patients undergoing AVN ablation , which did not affect outcome in this patient population . CONCLUSION In patients with permanent AF and CRT , an AVN ablation strategy might not be strictly required in all patients",
"INTRODUCTION Atrial fibrillation ( AF ) is the most common arrhythmia in patients with heart failure ( HF ) and represents an important comorbidity in these patients . Cardiac resynchronization therapy ( CRT ) has been shown to be beneficial in patients with HF . Whether patients with AF benefit similarly from CRT as their counterparts in sinus rhythm is controversial . METHODS AND RESULTS We conducted a cohort analysis of 175 patients ( 138 men ; age range 57 - 79 years ) who underwent CRT implantation during 2004 - 2008 in our institution . AF was documented in 66 patients ( 37.7 % of patients , 52 men ) . There were no differences in 1- or 2-year mortality between patients with and without AF ( 13.6 % vs 11.79 % , P = 0.7 ; 25.8 % vs 16.9 % , P = 0.2 , respectively ) . There were no differences between the groups in the rate of complications after CRT implantation or in the rate of appropriate electrical shocks . In the subgroup of AF patients with cardiac resynchronization therapy defibrillator ( CRT-D ) ( n = 32 , 48.5 % ) , the 1-year mortality was 3.1 % as compared to 23.5 % in AF patients with cardiac resynchronization therapy pacemaker ( P = 0.03 ) . This difference was no longer evident after 2 years ( 25.0 % vs 26.5 % , P = 0.8 , respectively ) . Ten patients ( 15.2 % ) with AF underwent atrioventricular ( AV ) node ablation . The 2-year mortality of these patients was 10.0 % as compared to 28.6 % in AF patients who did not undergo AV-node ablation ( P = 0.4 ) . CONCLUSIONS In this study , no difference in mortality appears to exist between patients with or without AF and who undergo CRT implantation . Our findings of the beneficial effects of AV-node ablation and CRT-D in AF patients deserve further investigation",
"OBJECTIVES We evaluated the incidence and predictors of sudden death after atrioventricular ( AV ) node ablation and pacemaker implantation . BACKGROUND Sudden death may occur after radiofrequency catheter ablation of the AV node and pacemaker implantation in patients with atrial fibrillation ( AF ) . Whether it is related to the procedure or to pre-existing heart disease remains unclear . METHODS All patients who had radiofrequency catheter ablation of the AV node and pacemaker implantation for rate control of medically refractory AF were identified retrospectively and observed prospect ively . All patients with sudden death after ablation were identified . The relationship between the procedure and sudden death was defined on the basis of the time between the two as \" likely , \" \" possibly \" or \" unlikely . \" RESULTS Of 334 consecutive patients with AF who underwent AV node ablation , nine had sudden death after the ablation . Four patients ( 1.2 % ) had sudden death likely related to the procedure : in 3 patients , arrest occurred within 48 h after the procedure ; in one patient , arrest occurred four days after the procedure . In three other patients ( 0.9 % ) , sudden death was possibly related to the procedure because the event occurred within three months afterward . The remaining two deaths were unrelated to the procedure . Diabetes , New York Heart Association functional class ( > or = II ) , preprocedure ventricular arrhythmia , mitral or aortic stenosis , aortic regurgitation and chronic obstructive pulmonary disease were independent predictors for sudden death . CONCLUSIONS Sudden death likely or possibly related to catheter ablation occurred in 7 of 334 patients ( 2.1 % ) . Risk of sudden death is highest within two days after the procedure",
"BACKGROUND Cardiac-resynchronization therapy ( CRT ) benefits patients with left ventricular systolic dysfunction and a wide QRS complex . Most of these patients are c and i date s for an implantable cardioverter-defibrillator ( ICD ) . We evaluated whether adding CRT to an ICD and optimal medical therapy might reduce mortality and morbidity among such patients . METHODS We r and omly assigned patients with New York Heart Association ( NYHA ) class II or III heart failure , a left ventricular ejection fraction of 30 % or less , and an intrinsic QRS duration of 120 msec or more or a paced QRS duration of 200 msec or more to receive either an ICD alone or an ICD plus CRT . The primary outcome was death from any cause or hospitalization for heart failure . RESULTS We followed 1798 patients for a mean of 40 months . The primary outcome occurred in 297 of 894 patients ( 33.2 % ) in the ICD-CRT group and 364 of 904 patients ( 40.3 % ) in the ICD group ( hazard ratio in the ICD-CRT group , 0.75 ; 95 % confidence interval [ CI ] , 0.64 to 0.87 ; P died , as compared with 236 in the ICD group ( hazard ratio , 0.75 ; 95 % CI , 0.62 to 0.91 ; P = 0.003 ) , and 174 patients were hospitalized for heart failure , as compared with 236 in the ICD group ( hazard ratio , 0.68 ; 95 % CI , 0.56 to 0.83 ; P adverse events had occurred in 124 patients in the ICD-CRT group , as compared with 58 in the ICD group ( P patients with NYHA class II or III heart failure , a wide QRS complex , and left ventricular systolic dysfunction , the addition of CRT to an ICD reduced rates of death and hospitalization for heart failure . This improvement was accompanied by more adverse events . ( Funded by the Canadian Institutes of Health Research and Medtronic of Canada ; Clinical Trials.gov number , NCT00251251 . )",
"OBJECTIVES We sought to investigate the effect of intrinsic conduction over the right bundle on the maximum rate of left ventricular pressure rise ( LVdP/dt(max ) ) during left ventricular ( LV ) pacing compared to biventricular ( BiV ) pacing . BACKGROUND Simultaneous BiV pacing and LV pacing both improve LV function in patients with heart failure and LV asynchrony . We studied the hemodynamic effect of intrinsic conduction leading to ventricular fusion during LV pacing . METHODS In 34 patients with New York Heart Association functional class III or IV , sinus rhythm with normal atrioventricular ( AV ) conduction , left bundle branch block , QRS > 130 ms , and optimal medical therapy , LVdP/dt(max ) was measured invasively during LV and simultaneous BiV pacing . The AV interval was varied in four steps starting ( AV1 ) with an AV interval 40 ms shorter than the intrinsic PQ time and decreased with 25 % for each step . RESULTS At AV1 , LVdP/dt(max ) was 996 + /- 194 mm Hg/s for LV pacing and 960 + /- 200 mm Hg/s for BiV pacing ( p = 0.0009 ) , with all patients showing ventricular fusion during LV pacing . At AV2 , 21 patients had ventricular fusion with a LVdP/dt(max ) of 983 + /- 213 mm Hg/s and 957 + /- 202 mm Hg/s for LV and BiV pacing , respectively . In the remaining 13 patients without fusion these values were 919 + /- 164 mm Hg/s and 957 + /- 174 mm Hg/s , respectively . The difference between LV and BiV at AV2 is significantly higher when fusion is present ( p = 0.01 ) . CONCLUSIONS The LVdP/dt(max ) is higher in LV than in BiV pacing provided that LV pacing is associated with ventricular fusion caused by intrinsic activation",
"Aim : Recently , digoxin use has been found to associate with higher mortality . Yet , potential mechanisms by which digoxin use increases mortality remain unclear . Increased arrhythmogenicity from digoxin use is one possibility . Thus , we aim ed to evaluate the relation between digoxin and shock events in patients with implantable cardioverter defibrillators ( ICDs ) . Methods : We performed a retrospective chart review of all patients with ICDs and at least 1 device interrogation at our institution between January 1 , 2012 , and January 1 , 2015 . We aim ed to cover 1 year of interrogation period . Patients with heart failure , atrial fibrillation , or both were included in the analysis . Patients were divided into 2 groups based on digoxin use , defined as use of digoxin for any period of time during ICD interrogation period . Incidence of ICD shock events and electrical storms and hospitalizations were compared between the 2 groups . Results : The study included 202 patients . Of those , 55 patients were on digoxin and 147 were not on digoxin . Patients on digoxin were more likely to receive ICD shocks ( odds ratio [ OR ] = 2.5 , 95 % confidence interval [ 95 % CI ] = 1.01 - 6.18 , P = .04 ) and have increased risk of electrical storms ( P = .02 ) . Moreover , total hospitalizations were higher in digoxin users ( P = .02 ) . Multivariate logistic regression analysis also showed that digoxin use was an independent predictor of shock events ( OR = 4.07 , 95 % CI = 1.43 - 11.58 , P = .009 ) . Conclusion : Digoxin is associated with increased shock events and electrical storms in patients with ICDs ; however , large r and omized controlled studies are needed to confirm our findings"
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Background A sedentary lifestyle and an unhealthy diet are major factors in the increasing prevalence of obesity among Malaysian adolescents . The purpose of this systematic review is to compile the evidence from observational and intervention studies among Malaysian adolescents to evaluate the associations between diet and physical activity ( PA ) as determinants of cardio-metabolic risk factors . Methods A systematic search of Medline via the PubMed , Science Direct , Cochrane Review and Web of Science data bases was conducted for studies on the associations between diet and PA factors and cardio-metabolic risk factors among Malaysian adolescents aged 13–18 years that were published until 31 August 2017 . The search results were independently screened and extracted by two review ers . Results From over 2,410 references retrieved , 20 full texts articles were screened as potentially relevant . Seventeen ( 16 cross-sectional and one intervention ) met the inclusion criteria for data extraction and analysis . All 17 studies were rated as poor quality and the majority had made insufficient adjustment for confounders . As regards the effect of diet and PA on cardio-metabolic health , the intakes of energy ( n = 4 ) and macronutrients ( n = 3 ) and meal frequency ( n = 5 ) were the most commonly studied dietary factors , while the PA score and level were the most commonly studied PA factors . In addition , BMI and body weight were the most common cardio-metabolic health outcomes . The studies showed that obese and overweight adolescents consume significantly more energy and macronutrients . They are also more likely to skip their daily meals compared to their normal weight peers . In most studies , the direction of the PA effect on body weight was unclear . Some studies found that higher PA is associated with a lower risk of overweight and obesity . However , the associations are often small or inconsistent , with few studies controlling for confounding factors . Conclusions This review identified a lack of evidence and well-conducted prospect i ve studies on the effect of diet and PA on cardio-metabolic health of Malaysian adolescents | [
"INTRODUCTION We aim ed to determine the risk factors associated with abdominal obesity ( AO ) in suburban adolescents . METHODS This cross-sectional study included adolescents aged 15 - 17 years from five r and omly selected secondary schools in the Hulu Langat district of Selangor state , Malaysia . Waist circumference ( WC ) was measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest . Information on sociodemographic data , dietary habits , physical activity levels and duration of sleep was obtained via interviewer-administered question naires . Participants ' habitual food intake was determined using a 73-item Food Frequency Question naire . RESULTS Among 832 participants , 56.0 % were girls ; 48.4 % were Malay , 40.5 % Chinese , 10.2 % Indian and 0.8 % of other ethnic groups . Median age and WC were 16 ( interquartile range [ IQR ] 15 - 16 ) years and 67.9 ( IQR 63.0 - 74.6 ) cm , respectively . Overall prevalence of AO ( > 90th percentile on the WC chart ) was 11.3 % . A higher proportion ( 22.4 % ) of Indian adolescents were found to have AO compared with Malay and Chinese adolescents . Logistic regression analysis showed that female gender ( adjusted odds ratio [ OR ] 7.064 , 95 % confidence interval [ CI ] 2.087 - 23.913 ; p = 0.002 ) , Indian ethnicity ( adjusted OR 10.164 , 95 % CI 2.182 - 47.346 ; p = 0.003 ) , irregular meals ( adjusted OR 3.193 , 95 % CI 1.043 - 9.774 ; p = 0.042 ) and increasing body mass index ( BMI ) ( adjusted OR 2.867 , 95 % CI 2.216 - 3.710 ; p AO . CONCLUSION AO was common among Malaysian adolescents . Female gender , Indian ethnicity , irregular meals and increasing BMI were significant risk factors",
"The relationship between dietary intake and obesity is complex , and dietary pattern analysis may offer new insight . We examined associations between dietary patterns identified in a diverse cohort of adolescents and weight status cross-sectionally and over a 5-year period . Project EAT ( Eating Among Teens ) ( Time 1 ) collected data on 4746 middle ( younger cohort ) and high school ( older cohort ) students in 1998 - 9 . EAT-II ( Time 2 ) resurveyed 2516 of the original cohort in 2003 - 4 . All analyses were run separately by age cohort and sex . The relationship between dietary patterns identified previously ( vegetable , fruit , vegetable & fruit , starchy food , sweet & salty snack food , and fast food ) and weight status was examined using logistic regression . All analyses were adjusted for socioeconomic status , race/ethnicity and activity level ( longitudinal analyses were also adjusted for baseline weight status ) . In cross-sectional analyses , higher adherence to dietary patterns loading heavily on vegetables was associated with lower risk of overweight/obese weight status in older and younger girls , whereas higher adherence to a ' sweet & salty snack food ' pattern was associated with lower risk in older and younger boys . These associations were found prospect ively in older boys and girls , but were no longer significant in analyses adjusting for baseline weight status . We did not find consistent or intuitive associations between dietary patterns and weight status . Identified patterns may not capture the elements of diet that are truly important in determining adolescent weight , or diet may not be the primary driver in determining weight status at this age . Method ological difficulties in assessing diet must also be taken into consideration",
"Unhealthy dietary pattern increases the risk of obesity and metabolic disorders in growing children and adolescents . However , the way the habitual pattern of breakfast consumption influences body composition and risk of obesity in adolescents is not well defined . Thus , the aim of the present study was to assess any associations between breakfast consumption practice s and body composition profiles in 236 apparently healthy adolescents aged 12 to 19 years . A self-administered question naire on dietary behaviour and lifestyle practice s and a dietary food frequency question naire were used . Body composition and adiposity indices were determined using st and ard anthropometric measurement protocol s and dual energy χ-ray absorptiometry ( DXA ) . Mean age of the participants was 15.3±1.9 years . The majority of participants ( 71.2 % ) fell in the normal body mass index ( BMI ) ranges . Breakfast consumption patterns showed that only half of the participants ( 50 % ) were consuming breakfast daily . Gender-specific multivariate analyses ( ANCOVA ) showed that in both boys and girls , those eating breakfast at least 5 times a week had significantly lower body weight , body mass index ( BMI ) , BMI z-scores , waist circumference , body fat mass and percent body fat ( % BF ) compared to infrequent breakfast eaters , after adjustment for age , household income , pubertal status , eating-out and snacking practice s , daily energy intakes , and daily physical activity levels . The present findings indicate that infrequent breakfast consumption is associated with higher body adiposity and abdominal obesity . Therefore , daily breakfast consumption with healthy food choices should be encouraged in growing children and adolescents to prevent adiposity during these critical years of growth",
"INTRODUCTION Paediatric obesity is a public health concern worldwide as it can track into adulthood and increase the risk of adult morbidity and mortality . While the aetiology of obesity is multi-factorial , the roles of diet and physical activity are controversial . Thus , the purpose of this study was to report on the differences in energy intake , diet composition , time spent doing physical activity and energy expenditure among underweight ( UW ) , normal weight ( NW ) and at-risk of overweight ( OW ) Malaysian adolescents ( 317 females and 301 males ) aged 11 - 15 years . METHODS This was a cross-sectional study with 6,555 adolescents measured for weights and heights for body mass index ( BMI ) categorisation . A total of 618 subjects were r and omly selected from each BMI category according to gender . The subjects ' dietary intake and physical activity were assessed using self-reported three-day food and activity records , respectively . Dietary intake components included total energy and macronutrient intakes . Energy expenditure was calculated as a sum of energy expended for basal metabolic rate and physical activity . Time spent ( in minutes ) in low , medium and high intensity activities was also calculated . RESULTS The OW adolescents had the highest crude energy intake and energy expenditure . However , after adjusting for body weight , the OW subjects had the lowest energy intake and energy expenditure ( p-value is less than 0.001 ) . The study groups did not differ significantly in time spent for low , medium and high intensity activities . Macronutrient intakes differed significantly only among the girls where the OW group had the highest intakes compared to UW and NW groups ( p-value is less than 0.05 ) . All study groups had greater than 30 percent and less than 55 percent of energy intake from fat and carbohydrate , respectively . CONCLUSION The data suggested that a combination of low energy expenditure adjusted for body weight and high dietary fat intake may be associated with overweight and obesity among adolescents . To prevent overweight and obesity among children and adolescents , strategies that address eating behaviours and physical activity are required . Various segments of the society must be involved in efforts to promote healthful dietary intakes and active lifestyle in children and adolescents",
"INTRODUCTION A cross-sectional study was conducted to determine physical activity , eating behaviour , body weight management knowledge , perception of body image and their association with body weight status of adolescents . METHODS Respondents were 360 adolescents , aged between 13 to 14 years , from six r and omly selected secondary schools in Kuantan , Pahang . Physical activity , eating behaviour , body weight management knowledge and perception of body image were measured by the Physical Activity Question naire for Older Children ( PAQ-C ) , Eating Attitude Test-26 ( EAT-26 ) , Weight Management Knowledge Inventory ( WMKI ) and Contour Drawing Rating Scale ( CDRS ) , respectively . RESULTS Almost half of the respondents were categorised as having a normal BMI , while 30.3 % were severely thin and thin and 20.3 % were overweight and obese . Mean physical activity score was 2.06 + /- 0.45 with more males ( 35.0 % ) being physically active than females ( 17.3 % ) . Mean eating behaviour score was 15.41 + /- 10.37 , with 27.8 % of the respondents being at-risk for eating disorders . Mean weight management knowledge score was 5.35 + /- 1.80 , with more females ( 77.7 % ) having higher mean scores than males ( 42.3 % ) . Further , mean discrepancy score for body image perception was 1.24 + /- 0.99 , with 78.1 % of the respondents being dissatisfied with their current body size . Positive associations were found between eating behaviour ( r = 0.28 , p body image ( r = 0.35 , p BMI . Respondents with high eating behaviour scores and body image discrepancy scores were more likely to have greater BMI . CONCLUSION This study shows the need for healthy eating and body image intervention programmes to prevent overweight and obesity problems among adolescents"
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Although physical activity performed after bariatric surgery is associated with enhanced weight loss outcomes , there is limited information on patients ' physical activity behaviour in this context . This systematic review and meta- analysis assessed pre-operative to post-operative changes in physical activity and physical function outcomes among obese adults undergoing bariatric surgery . A total of 50 studies met inclusion criteria with 26 papers reporting data for meta- analysis . Increases in both objective ly recorded and self-reported physical activity at 12 months were demonstrated . Studies indicated that there was a shift towards a greater amount of active time , but of a lower intensity within the first 6 months of bariatric surgery , suggested by a reduction in moderate to vigorous physical activity but an increase in step count . A st and ardized mean difference ( SMD ) of 1.53 ( 95 % CI : 1.02 - 2.04 ) based on nine studies indicated improved walking performance at 12 months . Similarly , analysis of five studies demonstrated increased musculoskeletal function at 3 - 6 months ( SMD : 1.51 ; 95 % CI : 0.60 - 2.42 ) . No relationship was identified between changes in weight and walking performance post-surgery . More studies assessing physical activity , physical function and weight loss would help underst and the role of physical activity in optimizing post-operative weight and functional outcomes | [
"Background : This study aim ed to determine whether morbidly obese women have an alteration of heart rate ( HR ) kinetics and HR variability ( HRV ) during the 6-min walk test ( 6MWT ) and if an aerobic exercise training can modify these indexes after gastric bypass surgery ( GBS ) . Design and methods : Nineteen morbidly obese women were r and omized to a trained ( TG ) or control group and 12 women of eutrophic group ( EG ) were also evaluated . The obese women were tested on two occasions : 1 week before and 4 months after GBS through record of HR and R-R intervals during 6MWT for analysis HR kinetics . The TG underwent an aerobic exercise training program on a treadmill ( 1-h session , totaling 36 sessions over 12-week ) . Results : Both obese groups demonstrated a significant reduction of rMSSD and slower HR kinetics during the 6MWT when compared to the EG . In addition , only the TG demonstrated a significant improvement in HRV indexes , walking distance , faster time constant and mean response time of HR during 6MWT after training ( p Morbidly obese women have slower HR kinetics and altered cardiac modulation during submaximal exercise . However , aerobic exercise training can produce beneficial adaptations in HRV and faster HR kinetics following GBS . Implication s for Rehabilitation The obesity is one of the most important threats to health in developed countries and bariatric surgery is an option for treatment of morbid obesity . Exercise is an effective means of improving health after this procedure due alterations of autonomic nervous system in this population . This study showed that a program of aerobic physical training after bariatric surgery was able to improve the kinetics of heart rate and the cardiac autonomic modulation , both evaluated during submaximal exercise",
"Background Patients undergoing bariatric surgery do not seem to increase objective ly measured physical activity ( PA ) after surgery , despite substantial weight loss . The aims of the present study were ( i ) to objective ly characterize 3 months pre-surgery to 9 months postsurgery PA and sedentary behavior changes in women undergoing Roux-en-Y gastric bypass ( RYGB ) using tri-axial accelerometers and ( ii ) to examine associations between pre-surgery versus postsurgery PA and sedentary behavior with anthropometric measures taken in home environment . Methods Fifty-six women , with an average pre-surgery body mass index ( BMI ) of 37.6 ( SD 2.6 ) and of age 39.5 years ( SD 5.7 ) , were recruited at five Swedish hospitals . PA was measured for 1 week by the Actigraph GT3X+ accelerometer , and anthropometric measures were taken at home visits 3 months pre-surgery and 9 months postsurgery , thus limiting seasonal effects . Results Average BMI loss , 9 months postsurgery , was 11.7 ( SD 2.7 ) BMI units . There were no significant pre- to postsurgery differences in PA or sedentary behavior . However , pre-surgery PA showed negative association with PA change and positive association with postsurgery PA . Adjustments for pre-surgery BMI had no impact on these associations . Conclusions No significant differences were observed in objective ly measured changes in PA or time spent sedentary from 3 months pre-surgery to 9 months postsurgery among women undergoing RYGB . However , women with higher pre-surgery PA decreased their PA postsurgery while women with lower pre-surgery PA increased their PA",
"OBJECTIVES To estimate the magnitude of small meaningful and substantial individual change in physical performance measures and evaluate their responsiveness . DESIGN Secondary data analyses using distribution- and anchor-based methods to determine meaningful change . SETTING Secondary analysis of data from an observational study and clinical trials of community-dwelling older people and subacute stroke survivors . PARTICIPANTS Older adults with mobility disabilities in a strength training trial ( n=100 ) , subacute stroke survivors in an intervention trial ( n=100 ) , and a prospect i ve cohort of community-dwelling older people ( n=492 ) . MEASUREMENTS Gait speed , Short Physical Performance Battery ( SPPB ) , 6-minute-walk distance ( 6MWD ) , and self-reported mobility . RESULTS Most small meaningful change estimates ranged from 0.04 to 0.06 m/s for gait speed , 0.27 to 0.55 points for SPPB , and 19 to 22 m for 6MWD . Most substantial change estimates ranged from 0.08 to 0.14 m/s for gait speed , 0.99 to 1.34 points for SPPB , and 47 to 49 m for 6MWD . Based on responsiveness indices , per-group sample sizes for clinical trials ranged from 13 to 42 for substantial change and 71 to 161 for small meaningful change . CONCLUSION Best initial estimates of small meaningful change are near 0.05 m/s for gait speed , 0.5 points for SPPB , and 20 m for 6MWD and of substantial change are near 0.10 m/s for gait speed , 1.0 point for SPPB , and 50 m for 6MWD . For clinical use , substantial change in these measures and small change in gait speed and 6MWD , but not SPPB , are detectable . For research use , these measures yield feasible sample sizes for detecting meaningful change",
"The purpose of this study was to determine whether pre- to postoperative increases in physical activity ( PA ) are associated with weight loss and health-related quality of life ( HRQoL ) following bariatric surgery . Participants were 199 Roux-en-Y gastric bypass ( RYGB ) surgery patients . The International Physical Activity Question naire ( IPAQ ) was used to categorize participants into three groups according to their preoperative and /1-year postoperative PA level : ( i ) Inactive/Active ( or=200-min/week ) , ( ii ) Active/Active ( > or=200-min/week/>or=200-min/week ) and ( iii ) Inactive/Inactive ( ) . The Medical Outcomes Study Short Form-36 ( SF-36 ) was used to assess HRQoL. Analyses of covariance were conducted to examine the effects of PA group on weight and HRQoL changes . Inactive/Active participants , compared with Inactive/Inactive individuals , had greater reductions in weight ( 52.5 + /- 15.4 vs. 46.4 + /- 12.8 kg ) and BMI ( 18.9 + /- 4.6 vs. 16.9 + /- 4.2 kg/m(2 ) ) . Weight loss outcomes in the Inactive/Active and Active/Active groups were similar to each other . Inactive/Active and Active/Active participants reported greater improvements than Inactive/Inactive participants on the mental component summary ( MCS ) score and the general health , vitality and mental health domains ( P RYGB patients who become active postoperatively achieve weight losses and HRQoL improvements that are greater than those experienced by patients who remain inactive and comparable to those attained by patients who stay active . Future r and omized controlled trials should examine whether assisting patients who are inactive preoperatively to increase their PA postoperatively contributes to optimization of weight loss and HRQoL outcomes",
"Obesity and high blood pressure ( BP ) often coexist . Weight reduction lowers resting BP but its effect on BP during exercise ( a predictor of target organ damage ) has not been evaluated . Blood pressure was measured at rest and during cycling , before and after weight reduction induced by gastric restriction . Nineteen subjects ( 4 male ) , 41 + /-2 ( SEM ) years of age and body mass index ( BMI ) of 43 + /- 0.9 kg/m2 , were studied . On each occasion BP was measured at rest , at a steady state of 0 and 25 watts , at peak exercise and 1 min into recovery . Body weight was reduced by 28 % + /- 6 % and BMI decreased from 43.3 + /- 0.9 to 31.5 + /- 0.7 kg/m2 ( P BP and heart rate , at rest and at all exercise intensities , were significantly lower after weight reduction . Resting BP decreased from 133 + /-4/87 + /- 3 mm Hg to 115 + /- 4/77 + /- 2 mm Hg ( P BP at peak exercise decreased from 181 + /- 8/98 + /- 4 to 162 + /- 6/83 + /- 5 mm Hg ( P resting systolic BP did not correlate with the change in body weight or with the change in heart rate , but it correlated with the baseline systolic BP ( R = 0.61 ; P BP at rest and at all exercise intensities . Gastroplasty should be considered as an option in morbidly obese hypertensive patients who are not well controlled with conventional treatment , and who fail to lose or to maintain a reduced weight by calorie restriction alone",
"Background : The six-minute walk test ( 6mWT ) is a simple index of functional capacity in healthy people , and it has been used to estimate exercise capacity in obese subjects . The aim of this study was to determine whether weight reduction induced by laparoscopic adjustable gastric b and ing ( LAGB ) improves the functional capacity in the severely obese on the 6mWT . Methods : A prospect i ve 1-year study was carried out at the Hospital Casoria , Naples , involving 15 consecutive severely obese patients who underwent the 6mWT before and 1 year after LAGB . BMI , walking distance , heart rate , dyspnea , and respiratory function tests were also measured . Patients served as their own controls . Results : 15 patients ( all females ) were evaluated . Mean BMI decreased from 42.1 ( range 39 - 49 ) before to 31.9 ( range 25 - 38 ) postoperatively . The distance walked increased from 475.7 meters ( range 380 - 580 ) before LAGB to 626.3 meters ( range 435 - 880 ) 1 year postoperatively ( P dyspnea score after the 6mWT was significantly reduced postoperatively . All functional variables after the 6mWT showed improvement postoperatively at 1 year study . Conclusion : Weight reduction in the obese increases the functional capacity during walking . The improvements are refected in the patients ' own assessment",
"BACKGROUND Physical , emotional , and social functioning are impaired in obesity . It is unknown whether and , if so , to what extent and in which domain obese subjects who lose weight may catch up to normal-weight levels . Our objective was to compare the health-related quality -of-life ( HRQL ) of obese subjects with that of a normal-weight reference group before and 1 year after a weight loss program that centered around laparoscopic and open gastric b and ing . METHODS An HRQL question naire consisting of a battery of both generic and specific measures was administered to 50 morbidly obese subjects on 2 occasions and to 100 healthy , normal-weight subjects , matched for age , gender , education , and vocational training . In addition to weight loss and health gain , the influences of achieved weight loss goals , satisfaction with outcome and operative approach ( laparoscopy/laparotomy ) were assessed . RESULTS Quality -of-life was significantly impaired in obese subjects . With a substantial weight loss of 35 kg and 42 % loss of excessive weight , and correction of disturbed metabolic parameters , they significantly improved in general well-being , health distress , and perceived attractiveness , approaching halfway the values of a normal-weight reference group . Improvement in values for depression and self-regard lagged behind . In physical activity , they bypassed the reference group . Days of sick leave decreased to the level of the reference group . Improvements in HRQL paralleled the rate of weight loss . Personal satisfaction and surgical approach were of minor influence . CONCLUSIONS The obese subjects ' impaired physical and social functioning improved considerably , catching up midway to normal-weight reference values after weight loss . Psychologic amelioration lagged behind . Whether the latter will catch up later and physical/social improvements will be maintained is the subject of further studies",
"BACKGROUND Joint pain is a common musculoskeletal complaint of morbidly obese patients that can result in gait abnormalities , perceived mobility limitations , and declining quality of life ( QOL ) . It is not yet known whether weight loss 3 months after bariatric surgery can induce favorable changes in joint pain , gait , perceived mobility , and QOL . Our objectives were to examine whether participants who had undergone bariatric surgery ( n = 25 ; laparoscopic Roux-en-Y gastric bypass or laparoscopic adjustable gastric b and ing ) demonstrate improvements in joint pain , gait ( speed , stride/step length , width of base of support , toe angles , single/double support , swing and stance time , functional ambulatory profile ) , mobility , and QOL by 3 months compared with nonsurgical controls ( n = 20 ) . The setting was an orthopedics laboratory at a university hospital in the United States . METHODS The present study was a prospect i ve , comparative study . Numeric pain scales ( indicating the presence and severity of pain ) , mobility-related surveys , and the Medical Outcomes Study short-form 36-item question naire ( SF-36 ) were completed , and gait and walking speed were assessed at baseline and at month 3 . RESULTS The bariatric group lost an average of 21.6 ± 7.7 kg . Significant differences existed between the 2 groups at month 3 in step length , heel to heel base of support , and the percentage of time spent in single and double support during the gait cycle ( all P The severity of low back pain and knee pain decreased by 54 % and 34 % , respectively , with no changes in the control group ( P = .05 ) . The walking speed increased by 15 % in the bariatric group ( 108 - 123 cm/s ; P limitations with walking and stair climbing by month 3 . The bariatric group had a 4.8-cm increase in step length , 2.6 % increase in single support time during the gait cycle , and 2.5-cm reduction in the base of support ( all P The SF-36 physical component scores increased 11.8 points in the bariatric group compared with the control group , which showed no improvement by month 3 ( P gait parameters , walking speed , and QOL and of perceived functional limitations occur by 3 months after a bariatric procedure",
"Severe obesity has been associated with adverse effects on physical capacity . In a prospect i ve study , the aerobic capacity of severely obese patients was measured in order to observe the physiological response to weight loss from bariatric surgery . Sixty-five consecutive patients ( 40.4 ± 8.4 years old ; 93.8 % female ; body mass index = 49.4 ± 5.4 kg/m2 ) were evaluated before bariatric surgery and then 6 and 12 months after surgery . Aerobic capacity was assessed with a scientific treadmill to measure maximal oxygen consumption ( VO2max ) , heart rate , blood pressure , time on the treadmill , and distance walked ( modified Bruce test ) . For the three observational periods , VO2max was 25.4 ± 9.3 , 29.8 ± 8.1 , and 36.7 ± 8.3 ml/kg/min ; time on the treadmill was 5.4 ± 1.4 , 6.4 ± 1.6 , and 8.8 ± 1.0 min ; and distance walked was 401.8 ± 139.1 , 513.4 ± 159.9 , and 690.5 ± 76.2 m. For these variables , significant results ( p = 0.0000 ) were observed for the two postoperative periods in relation to the preoperative period . Severely obese individuals increased their aerobic capacity after successful bariatric surgery . The data also suggests that a positive and progressive relationship between weight loss and improvement in fitness as a moderate loss of weight 6 months after surgery already showed some benefit and an additional reduction in weight was associated with a better performance in the aerobic capacity tests at the 12-month follow-up",
"Background Laparoscopic sleeve gastrectomy ( LSG ) has shown to be effective in serum triglycerides reduction and HDL cholesterol increase , but with little effect on total cholesterol and LDL cholesterol . Physical activity is recognized as an effective non-pharmacological intervention to reduce body fat mass and hypercholesterolemia . Methods A prospect i ve observational study of all the patients undergoing LSG as bariatric technique between 2007 and 2012 was performed . All patients completed the Spanish Version of the Modifiable Physical Activity Question naire at two time points : baseline ( pre-intervention ) and 1 year after surgery , both in face-to-face interviews . Lipid profiles were monitored at the same time points . Results A total of 50 patients were included in the study , 44 females ( 88 % ) and six males ( 12 % ) with a mean age of 42.7 ± 10.3 years . Comorbidities included dyslipidemia in 50 % ( 40 % hypercholesterolemia and 10 % hypertriglyceridemia ) . Preoperatively , four patients ( 8 % ) reported moderately active physical activity and one patient ( 2 % ) active physical exercise . The rest of the patients were sedentary . One year after surgery , 30 patients ( 60 % ) performed any kind of active physical activity , while the rest were sedentary . Lipid profile 12 months after surgery showed significantly lower total cholesterol levels in the active group ( 182.8 mg/dl vs 220 mg/dl in the sedentary group ; p = 0.003 ) . LDL cholesterol levels were also lower in the active group ( 103.2 vs 133 mg/dl in the sedentary group ; p = 0.015 ) . Conclusion The performance of routine moderate physical activity in addition to LSG achieves a significant improvement in all parameters of the lipid profile",
"OBJECTIVE Bariatric surgery is an effective method for acute weight loss . While the impact of bariatric surgery on general medical conditions ( e.g. , type 2 diabetes ) is well documented , few studies focus on physical functional outcomes following weight-loss induced by bariatric surgery . DESIGN AND METHODS We report on 50 women aged 20 - 74 scheduled for Roux-en-Y gastric bypass ( RYGB ) procedure who were enrolled for a prospect i ve 1-year study . Height , weight , and waist circumference were recorded preoperatively and at 6 and 12 months , postoperatively . To track musculoskeletal/physical function changes , the timed-get-up- and -go ( TGUG ) and short-form health survey-36 ( SF-36 ) and short musculoskeletal function assessment ( SFMA ) question naires were administered . RESULTS Patients had significant weight loss and functional improvement . At 1 year mean weight loss was 48.5 kg and mean TGUG improvement was 3.1 s. SMFA and SF-36 also showed improvement in functional components with weight loss at 6 months and 1-year post surgery . Significant associations were observed between TGUG and SMFA measures at all time points . Final weight at 1 year post bariatric surgery was also significantly correlated with most functional outcomes and changes in these outcomes . Partial correlations controlling for age revealed additional associations between body weight and functional outcomes , especially at the 6-month visit . CONCLUSION Our results suggest that significant rapid weight loss , such as that attained by bariatric surgery , acutely improves musculoskeletal function in morbidly obese patients . Additionally , for patients with musculoskeletal disease or injury , weight loss result ing from bariatric surgery may serve as an adjunct for improving global functional outcome , and enhancing the rehabilitation potential",
"Background Obesity is a major public health concern on a global scale . Bariatric surgery is among the treatment options , result ing in significant and sustainable weight loss as well as amelioration of comorbidities . The purpose of this study was to evaluate whether a 12-week aerobic exercise program positively impacts heart rate variability ( HRV ) and functional capacity after gastric bypass surgery ( GBS ) in a female cohort . Methods Of the 52 patients initially recruited , 21 were r and omized to a training group ( TG ) or control group and successfully completed the study . Patients were tested on two occasions : 1 week before GBS and 4 months after GBS . Anthropometric variables , body composition , record of heart rate and R-R intervals , and 6-min walk test ( 6MWT ) were assessed at both time points . The TG underwent an aerobic exercise training program on a treadmill ( 1-h session , totaling 36 sessions over 12 weeks ) . Results The main findings from this study were : ( 1 ) only the TG demonstrated a significant increase ( p indexes of heart rate variability ( HRV ) after 12 weeks of aerobic exercise training and ( 2 ) only the TG demonstrated a significant increase ( p 6MWT distance and decrease in diastolic blood pressure after aerobic exercise training . Conclusions We conclude that 12 weeks of aerobic exercise training improves cardiac autonomic modulation and functional capacity 4 months after GBS",
"BACKGROUND Weight loss is associated with short-term amelioration and prevention of metabolic and cardiovascular risk , but whether these benefits persist over time is unknown . METHODS The prospect i ve , controlled Swedish Obese Subjects Study involved obese subjects who underwent gastric surgery and contemporaneously matched , conventionally treated obese control subjects . We now report follow-up data for subjects ( mean age , 48 years ; mean body-mass index , 41 ) who had been enrolled for at least 2 years ( 4047 subjects ) or 10 years ( 1703 subjects ) before the analysis ( January 1 , 2004 ) . The follow-up rate for laboratory examinations was 86.6 percent at 2 years and 74.5 percent at 10 years . RESULTS After two years , the weight had increased by 0.1 percent in the control group and had decreased by 23.4 percent in the surgery group ( P weight had increased by 1.6 percent and decreased by 16.1 percent , respectively ( P Energy intake was lower and the proportion of physically active subjects higher in the surgery group than in the control group throughout the observation period . Two- and 10-year rates of recovery from diabetes , hypertriglyceridemia , low levels of high-density lipoprotein cholesterol , hypertension , and hyperuricemia were more favorable in the surgery group than in the control group , whereas recovery from hypercholesterolemia did not differ between the groups . The surgery group had lower 2- and 10-year incidence rates of diabetes , hypertriglyceridemia , and hyperuricemia than the control group ; differences between the groups in the incidence of hypercholesterolemia and hypertension were undetectable . CONCLUSIONS As compared with conventional therapy , bariatric surgery appears to be a viable option for the treatment of severe obesity , result ing in long-term weight loss , improved lifestyle , and , except for hypercholesterolemia , amelioration in risk factors that were elevated at baseline",
"Bariatric surgery ameliorates obesity‐associated diseases , result ing in psychological and social benefits . Long‐term studies of its effects on quality of life ( QOL ) assessed with well established instruments are lacking . This prospect i ve study investigated the long‐term effects of gastric b and ing on health‐related QOL using an obesity‐specific vali date d measure",
"OBJECTIVE To find out whether weight reduction induced by vertical b and ed gastroplasty ( VBG ) alters the energy expenditure in severely obese women during treadmill walking . DESIGN A prospect i ve one year follow-up study , patients being their own controls . SETTING University hospital , Sweden . SUBJECTS A consecutive series of 11 women who had VBG . MAIN OUTCOME MEASURES Indirect calorimetry , body mass index ( BMI ) , preset and comfortable walking speeds , heart rate , perceived exertion , and quality of life . RESULTS 11 patients were evaluated . Mean BMI ( kg/ml ) decreased from 41 ( range 36 - 46 ) before to 32 ( range 25 - 37 ) 12 months postoperatively . The energy expenditure decreased significantly both at comfortable and preset walking speeds . The comfortable walking speed increased from 2.7 km x h(-1 ) ( range 1.3 - 3.4 ) before operation to 3.8 ( range 2.0 - 4.2 ) one year postoperatively ( p = 0.003 ) . All bodily variables in the SF-36 question naire showed improvement from 6 months onwards . CONCLUSION Weight reduction in women reduces the energy expenditure during walking both at comfortable and preset speeds . The comfortable walking speed is increased . The improvements are reflected in the patients ' own assessment",
"Background Decrease in fat mass and fat-free mass have been observed with weight loss induced by a dietary intervention or surgery . There are concerns that fat-free mass decrease could have some negative functional consequences . The aim of this study was to examine how weight loss affects strength and force control in obese and morbidly obese men . Methods Weight loss was obtained in obese individuals by a hypocaloric diet program until resistance to lose fat and in morbidly obese individuals by bariatric surgery . Maximal force was measured for upper and lower limb and the ability to maintain 15 % and 40 % of that force . These measures were taken at baseline , in those dieting once resistant to weight loss and 1 year after surgery for those operated on . Normal weight individuals used for control were evaluated twice ( 6 to 12 months apart ) . Results At baseline , there was no significant difference between groups for maximal forces and capabilities to maintain force levels . Weight loss averaged 11.1 % of the initial body weight after dieting and 46.3 % 1 year after surgery . At the same time , there was for the lower limb a loss of 10.1 % in maximal force after dieting and 33.5 % after surgery . For the upper limb , there was no change in maximal force after dieting whereas a decrease of 14.4 % was observed after surgery . When transformed in force related to body weight , there was no change in relative force for the lower limb after dieting whereas an increased relative force after surgery . There was no significant difference for the ability for maintaining force levels . Conclusion Despite a large force loss , particularly for the lower limbs in morbidly obese individuals after surgery , this loss is relatively well tolerated because the relation between force and body weight is even improved and the ability to maintain that force is preserved",
"OBJECTIVE To investigate the effects of surgically induced weight loss on exercise capacity in patients with morbid obesity ( MO ) . RESEARCH METHODS AND PROCEDURES A prospect i ve 1-year follow-up study was carried out , with patients being their own controls . A symptom-limited cardiopulmonary exercise stress test was performed in 31 MO patients ( BMI > 40 kg/m2 ) before and 1 year after undergoing bariatric surgery . RESULTS At 1 year after surgery , weight was reduced from 146 + /- 33 to 95 + /- 19 kg ( p BMI went from 51 + /- 4 to 33 + /- 6 kg/m2 ( p oxygen consumption , heart rate , systolic arterial pressure , and ventilatory volume ( p energy expenditure allowed them to increase the duration of their effort test from 13.8 + /- 3.8 to 21 + /- 4.2 minutes ( p maximal heart rate , and their respiratory exchange ratio was 0.87 + /- 0.06 . After weight loss , those values were 90 % and 1 + /- 0.08 , respectively ( p peak O2 pulse corrected by fat free mass before and after surgery , no significant differences between the groups were found . DISCUSSION After surgically induced weight loss , MO patients markedly improved their exercise capacity . This is due to the fact that they were able to perform the external work with lower energy expenditure and also to increase cardiovascular stress , optimizing the use of cardiac reserve . There were no differences in cardiac function before and after surgery",
"Background : The Netherl and s has a population of 20,000 morbidly obese patients , an average of 350 of whom per year undergo a stomach reduction operation involving the surgical placement of a Lap-B and ® . The quality of life ( QOL ) of a sample of female patients who underwent this operation was studied in a 1-year postoperative study . Methods : The Medical Outcome Study Short Form-36 ( MOS SF-36 ) was used to assess 1-year postoperative quality of life among a sample of 39 female patients aged 19 - 53 years . QOL was measured at most 20 h preoperatively and 1 year postoperatively using a r and omized pretest/posttest design . Statistical data , after transformation , were analyzed with SPSS Version 7.5 for Windows 95 . Results : The response rate of 92.9 % of patients polled was good , in contrast to earlier findings with this measuring instrument . Mean body mass index ( BMI ) declined from 40.86 kg/m2 preoperatively to 33.14 kg/m2 1 year postoperatively . QOL improved on all scores in the MOS SF-36 . Internal consistency of the scales used was high . Conclusions : The response rate to the MOS SF-36 question naire was high . The surgical placement of a Lap-B and ® result ed in a significant improvement of QOL ( 1 year postoperatively ) on all scores used . The internal consistency of the scales used was high"
] | 41167f36-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE To systematic ally review the literature on the metabolic costs of activities of daily living ( ADL ) in persons with a lower limb amputation ( LLA ) . DATA SOURCES A literature search was undertaken in the Pubmed , Embase , CINAHL , CENTRAL , and PsycINFO data bases using keywords and synonyms for LLA , metabolic costs , and ADL . The last search was performed on November 29th , 2017 . STUDY SELECTION Studies were included if they met the following 2 criteria : participants were adults with a ( unilateral or bilateral ) LLA and metabolic costs were measured while participants performed a physical activity or ADL . DATA EXTRACTION AND SYNTHESIS Data of 1,912 participants from 61 studies were included in the systematic review and meta- analysis . The studies used different terms to describe metabolic costs . Participants were recruited in different setting s , relatively healthy , with few comorbidities . Limited data were available on metabolic costs of other activities than walking with a prosthesis . A linear mixed model analysis was performed based on the means reported , with study as unit of analysis and test results of different groups and measurement conditions as repeated measures within the unit of analysis . Predictors entered in the analysis were e.g. level and reason of amputation , age , weight , and height . During walking , oxygen consumption ( ml O2/kg/min ) and heart rate ( beats/min ) increased with a higher walking speed and a more proximal amputation . Additionally , oxygen consumption was determined by the interaction terms walking speed x amputation level and walking speed squared . Heart rate was determined by the interaction term walking speed squared . CONCLUSION During walking , oxygen consumption ( ml O2/kg/min ) and heart rate ( beats/min ) increased with a higher walking speed and a more proximal amputation . Data on metabolic costs of other activities were limited . The poor quality of the studies and the relatively healthy participants limited generalizability of the results of the meta- analysis | [
"Objective : To determine whether there are changes in level walking performance for people using a powered ankle prosthesis that was tuned by an independent , manufacturer-certified prosthetist in accordance with device recommendations . Design : Intervention study with cross-over design . Setting : Laboratory . Participants : Convenience sample of 10 individuals with unilateral , transtibial amputation , and 10 age- and gender-matched control participants . Interventions : Powered ankle prosthesis ( BiOM T2 Ankle System ) . Main outcome metrics : Metabolic costs of walking , preferred walking speed . Results : There were no significant differences in oxygen consumption ( 2.9 % difference ; P = 0.606 , d = 0.26 ) , cost of transport ( ~1 % difference ; P = 0.652 , d = 0.23 ) , or preferred walking speed ( ~1 % difference ; P = 0.147 , d = 0.76 ) when using the powered ankle compared to unpowered prostheses . Secondary analyses of user characteristics revealed that participants who were classified as having the highest function ( K4 on Medicare ’s 5-point scale from K0 to K4 ) were significantly more likely to exhibit energy cost savings than those classified as having lower function ( K3 ; P = 0.014 , d = 2.36 ) . Conclusions : Participants did not demonstrate significant improvements in energetics or preferred speed when wearing a clinical ly tuned powered ankle prosthesis compared to their non-powered prostheses . Prescribers of powered devices should underst and that not all users will show an immediate reduction in energy expenditure",
"Twenty unilateral trans-femoral amputees fitted with either the Contoured Adducted Trochanteric-Controlled Alignment Method ( CAT-CAM ) socket ( n=10 ) or the quadrilateral ( QUAD ) socket ( n=10 ) , and a “ non-amputee ” control group ( n=10 ) participated in the study . Subjects meeting the following criteria were studied : healthy males between the ages of 18 and 55 years , amputation due to non-vascular pathology , an unaffected sound limb , at least six months use of the test prosthesis , and a minimal stump length of 15 cm . Subjects ambulated in two r and omized trials separated by 20 minutes of rest at 2 assigned speeds : a pace reflecting normal walking speed ( 97 m/min=2.5 mph ) or a slower speed ( 48.5 m/min=1.25 mph ) . Heart rate ( HR ) and Oxygen uptake ( VO2 ) measured during steady state walking were analyzed via two-way ANOVA . Differences among means were further analyzed using Tukey post hoc and simple effects tests . Significant differences were observed between the control group and CAT-CAM subjects with respect to VO2 ( p HR ( p QUAD socket also differed with respect to VO2 ( p 0.01 ) and HR ( p more energy expenditure ( p higher HR ( p higher energy expenditure in the QUAD than the CAT-CAM group was observed ( p CAT-CAM socket design uses less energy than when using a QUAD socket design",
"Abstract Purpose : The purpose of this study was to clinical ly evaluate the automatic stance-phase lock ( ASPL ) knee mechanism against participants ’ existing weight-activated braking ( WAB ) prosthetic knee joint . Method : This prospect i ve crossover study involved 10 young adults with an above-knee amputation . Primary measurements consisted of tests of walking speeds and capacity . Heart rate was measured during the six-minute walk test and the Physiological Cost Index ( PCI ) which was calculated from heart rate estimated energy expenditure . Activity was measured with a pedometer . User function and quality of life were assessed using the Lower Limb Function Question naire ( LLFQ ) and Prosthetic Evaluation Question naire ( PEQ ) . Long-term follow-up over 12 months were completed . Results : Walking speeds were the same for WAB and APSL knees . Energy expenditure ( PCI ) was lower for the ASPL knees ( p = 0.007 ) . Step counts were the same for both knees , and question naires indicated ASPL knee preference attributed primarily to knee stability and improved walking , while limitations included terminal impact noise . Nine of 10 participants chose to keep using the ASPL knee as part of the long-term follow-up . Conclusions : Potential benefits of the ASPL knee were identified in this study by functional measures , question naires and user feedback , but not changes in activity or the PEQ . Keywords : Amputee ; artificial knee joint ; energy expenditure ; prosthesis ; stance-phase control ; transfemoral amputation , stance-phase",
"BACKGROUND Energy expenditure and walking speed are generally recommended for use as measures of status and outcome for walking . The objective of this study was to measure the physiological cost index ( PCI ) and comfort walking speed ( CWS ) at three levels of lower limb amputation : transfemoral , transtibial and Syme level , and the relationship of these physiological variables to prosthetic ambulation supported with walking aids and stump length . MATERIAL AND METHODS This study was a prospect i ve cross-sectional study .Eighty-nine individuals with lower limb amputation for reasons other than peripheral vascular disease ( PVD ) were recruited among patients at the Department of Prosthetics and Orthotics in University Clinical Center of Kosovo . PCI was assessed by five minutes of continuous indoor walking at CWS . RESULTS Significant differences were found in PCI ( F=29.87 , P CWS ( F=19.33 , P crutches showed an important impact on PCI ( F=35.1 , P CWS ( F=28.42 , P PCI ( r=0.53 , P = 0.02 ) and reduced CWS ( r=0.58 , P = 0.004 ) in transfemoral amputees . CONCLUSIONS 1 . A higher level of amputation is associated with less energy-efficient walking and with lower walking speed . 2 . Prosthetic ambulation supported with crutches has significant impact on increasing of energy expenditure and decreasing walking speed . 3 . Stump length is shown to have a major impact on PCI and CWS in transfemoral amputees",
"Background : The Physiological Cost Index ( PCI ) was introduced by MacGregor to estimate the energy cost in walking of healthy people , also it has been reported for persons with lower limb amputation , walking with prosthesis . Objective : To assess energy cost and walking speed in two level lower limb amputation : transfemoral and transtibial amputation and to determine if the age and prosthetic walking supported with walking aids have impact on energy cost and walking speed . Methods : A prospect i ve cross sectional study was performed in two level lower limb amputees with no vascular disease who were rehabilitated at the Department of Prosthetics and Orthotics at the University Clinical Center of Kosovo . The Physiological Cost Index ( PCI ) was assessed by five minutes of continuous indoor walking at Comfort Walking Speed ( CWS ) . Results : Eighty three lower limb amputees were recruited . It is shown relevant impact of level of amputation in PCI ( t=6.8 , p CWS ( T=487 , p using crutches during prosthetic walking in PCI ( ANOVA F= 39.5 P CWS ( ANOVA F=32.01 , P age with PCI and CWS in both groups of amputation . Conclusions : Walking with transfemoral prosthesis or using walking aids during prosthetic ambulation is matched with higher cost of energy and slower walking speed . Advanced age was shown with high impact on PCI and CWS in both groups of amputees",
"Background : Walking energy expenditure , calculated as the percent utilization of the maximal aerobic capacity , is little investigated in transfemoral amputees . Objectives : Compare the energy expenditure of healthy participants ( control participants ) and transfemoral amputees walking with their respective preferred walking speeds on the treadmill ( TPWS ) and floor ( FPWS ) . Study design : R and omized cross-over study . Methods : Oxygen uptake ( VO2 ) was measured when walking with the FPWS and TPWS . VO2max was measured by an incremental treadmill test . Results : Mean ± st and ard deviation VO2max of the transfemoral amputees and control participants were 30.6 ± 8.7 and 49.0 ± 14.4 mL kg−1 min−1 , respectively ( p TPWS for the transfemoral amputees and control participants was 0.89 ± 0.2 and 1.33 ± 0.3 m s−1 , respectively ( p FPWS for the transfemoral amputees and control participants was 1.22 ± 0.2 and 1.52 ± 0.1 m s−1 , respectively ( p with the FPWS , the energy expenditure of the transfemoral amputees and control participants was 54 % and 31 % of VO2max , respectively ( p with the TPWS , the energy expenditure of the transfemoral amputees and control participants was 42 % and 29 % of the VO2max , respectively ( p Conclusion : Energy expenditure is higher for the transfemoral amputees than the control participants , regardless of walking surface . There are minimal differences in energy expenditure between treadmill and floor walking for the control participants but large differences for the transfemoral amputees . Clinical relevance During walking , the transfemoral amputees expend a larger percentage of their maximal aerobic capacity than healthy participants . With a low VO2max , ordinary activities , such as walking , become physically more challenging for the transfemoral amputees than the control participants , and this may , in turn , have a negative effect on the walking range of the transfemoral amputees",
" This study investigated energy expenditure and obstacle course negotiation between the C-leg ® and various non-microprocessor control ( NMC ) prosthetic knees and compared a quality of life survey ( SF-36v2 ™ ) of use of the C-leg ® to national norms . Thirteen subjects with unilateral limb loss ( 12 with trans-femoral and one with a knee disarticulation amputation ) participated in the study . The mean age was 46 years , range 30 – 75 . Energy expenditure using both the NMC and C-leg ® prostheses was measured at self-selected typical and fast walking paces on a motorized treadmill . Subjects were also asked to walk through a st and ardized walking obstacle course carrying a 4.5 kg ( 10 lb ) basket and with h and s free . Finally , the SF-36v2 ™ was completed for subjects while using the C-leg ® . Statistically significant differences were found in oxygen consumption between prostheses at both typical and fast paces with the C-leg ® showing decreased values . Use of the C-leg ® result ed in a statistically significant decrease in the number of steps and time to complete the obstacle course . Scores on a quality of life index for subjects using the C-leg ® were above the mean for norms for limitation in the use of an arm or leg , equal to the mean for the general United States population for the physical component score and were above this mean for the mental component score . Based on oxygen consumption and obstacle course findings , the C-leg ® when compared to the NMC prostheses may provide increased functional mobility and ease of performance in the home and community environment . Question naire results suggest a minimal quality of life impairment when using a C-leg ® for this cohort of individuals with amputation",
"Objective : To compare the gait of amputees wearing conventionally damped pneumatic swing-phase control knees and microchip-controlled Intelligent Prostheses . Design : Crossover trial . Setting : An amputee rehabilitation centre in a teaching hospital . Participants : Ten established unilateral transfemoral prosthetic users were asked to participate in the trial ; all agreed . Interventions : The amputees were assessed wearing pneumatic swing-phase control knees and then with the Intelligent Prosthesis . Main outcome measures : Oxygen consumption while walking at different speeds on a treadmill , video-recording of gait assessed by a panel and temporal – spatial parameters of gait whilst walking at slow , fast or normal speeds in a gait laboratory . Results : Mean oxygen cost for all subjects at 0.69 m/s was 0.33 ml/kg.m with the conventional limb and 0.30 ml/kg.m with the Intelligent Prosthesis ( p–0.01 ) . At 1.25 m/s the mean oxygen cost for the conventional limb was 0.24 ml/kg.m and for the Intelligent Prosthesis was 0.22 ml/kg.m ( not significant ) . The ANOVA analysis showed that oxygen cost was similar at normal walking speeds but increased more at lower speeds for the pneumatic swing-phase control leg compared to the Intelligent Prosthesis ( p speeds oxygen cost was lower with the Intelligent Prosthesis . Gait analysis detected no significant changes between the two legs",
"Abstract Purpose : To establish at which exercise-power level is the vascular response , as measured by oxygen uptake , closest to the response during the 6-min walk test ( 6 MWT ) in people after lower-limb amputation due to peripheral vascular disease ( PVD ) . Method : A prospect i ve exploratory cohort study was conducted . 6 MWT and exercise testing using a h and -wheel ergometer ( starting at 10 W and increasing the workload by 10 W ) were performed in 101 consecutively recruited participants after transfemoral amputation due to PVD . Agreement of oxygen uptake during 6 MWT and exercise testing was compared between the groups defined by the exercise-power level reached . Results : Linear regression through origin with Chow test for comparing slopes indicated that oxygen uptake at 30 W agreed more with 6 MWT than at 20 , 40 or 50 W. Analyses of observed differences ( one-way ANOVA with post-hoc tests , Jonckheere – Terpstra test ) confirmed 30 W to be the recommendable threshold . Conclusions : At the level of 30 W , the oxygen uptake during the exercise was the closest to the 6 MWT , so we estimated that to be the minimum required level for walking using a prosthesis after transfemoral amputation due to PVD . Implication s for Rehabilitation Exercise testing after transfemoral amputation . Walking with a prosthesis causes notable strain to the person ’s vascular system : after the 6-min walk test , the participants ' heart rate reached 75 % of the maximum predicted heart rate on average . The study shows that persons after transfemoral amputation due to peripheral vascular disease who reach the level of 30 W or more in exercise testing with an arm ergometer at admission to rehabilitation are likely to be able to walk in-doors using a prosthesis",
"Background : Studies of the maximal oxygen uptake ( VO2max ) of transfemoral amputees have mostly used protocol s that activate a relatively small muscle mass . Consequently , transfemoral amputee VO2max may be systematic ally underestimated , and the validity of these test protocol s is question able . Objectives : ( 1 ) Investigate validity and reliability of a VO2max walking protocol and ( 2 ) compare the VO2max of a transfemoral amputee group with a group of matching controls . Study design : ( 1 ) R and omized crossover study : walking versus running VO2max for the control group and ( 2 ) case-control study : transfemoral amputees versus control group VO2max . Methods : Twelve transfemoral amputees and control participants performed a walking VO2max test with increasing treadmill inclinations to voluntary exhaustion . The control group also completed a running ( “ gold-st and ard ” ) VO2max test . Results : Mean ( st and ard deviation ) control group VO2max following walking and running was similar , that is , 2.99 ( 0.6 ) L min−1 and 3.09 ( 0.7 ) L min−1 , respectively . Mean ( st and ard deviation ) transfemoral amputee walking VO2max was 2.14 ( 0.8 ) L min−1 ( compared to CON ; p of repeated VO2 measurements was 0.97 , and within-subjects st and ard deviation was 60 mL min−1 . Conclusions : The walk protocol is valid . Walking VO2max of transfemoral amputees was 40 % lower compared to control group . Reliability of the walking protocol is comparable to other walking protocol s. Clinical relevance The design , alignment , and material s of prostheses are important for effective ambulation . Cardio-respiratory fitness is , however , also important in this regard , and a low fitness may compromise health and independent living . Hence , transfemoral amputees with low physical fitness should engage in regular physical activity to improve health , gait capacity , and independency",
"In this study , the influence of different prosthetic alignments and components on oxygen consumption and the important biomechanical characteristics of the normal gait pattern of leg amputees was investigated . With 15 transtibial and 12 transfemoral amputees , the oxygen consumption during walking on a treadmill was analyzed and biomechanical parameters during walking on even ground at a self-selected speed were defined . The amputation of all patients was caused by trauma . Variations of the prosthetic alignment affect the energy consumption of transfemoral amputees more significantly than that of transtibial amputees . Comparison of different prosthetic feet worn by transtibial amputees did not show significant differences regarding metabolic parameters . Compared with conventional hydraulic knee controls , the oxygen consumption of transfemoral amputees provided with an electronically controlled hydraulic knee joint is reduced . All investigated variations can be clearly characterized by the sagittal moments acting on the joints of the prosthetic limb during gait",
"Background : The International Committee of the Red Cross supports a worldwide program of prosthetic fitting and rehabilitation . In this context , a prosthetic foot was developed and widely distributed in least developed countries . Study design : Prospect i ve , r and omized , double-blind , controlled study . Objective : To compare patient satisfaction and energy expenditure during ambulation between a low-cost prosthetic foot design ed with a polypropylene keel ( CR-Equipements ™ solid ankle cushion heel , International Committee of the Red Cross ) to a well-recognized solid ankle cushion heel foot with a wooden keel ( solid ankle cushion heel foot , Otto Bock ) . Methods : A total of 15 participants with unilateral transtibial amputation were evaluated using the two prosthetic feet in a r and omized prospect i ve double-blind crossover study . Main outcomes were patient satisfaction question naires ( Satisfaction with Prosthesis Question naire and prosthetic foot satisfaction ) and energy expenditure ( oxygen consumption — mL/kg/min , oxygen cost — mL/kg/m , and heart rate — bpm ) . Results : There were no significant differences between the two prosthetic feet for satisfaction and energy expenditure . Conclusion : The low-cost solid ankle cushion heel foot with polypropylene keel provides comparable satisfaction and similar energy expenditure as the solid ankle cushion heel foot with wooden keel . Clinical relevance The results of this study support the application and widespread use of the CR-Equipements ™ solid ankle cushion heel foot . From a cost-effectiveness st and point , patients are well satisfied and exhibit similar outcomes at a substantially lower cost"
] | 41167f7c-06ff-11f0-808a-c43d1ab1c353 |
Background This systematic review aim ed to assess the clinical effects of laser preparation compared to other types of chemical or mechanical preparation of tooth surfaces used in fissure sealant placement . Methods A systematic literature search was conducted up to January 2019 , through Pubmed , Scopus , Medline / EMBASE via OVID and the Cochrane library . Only r and omized clinical trials were included . Results Five studies were included in the systematic review and three were included in the meta- analysis . All the studies used acid-etching as a comparator to lasers . All the included studies were rated as having an overall high risk of bias introduced by performance bias . Three studies assessed the clinical effects of fissure sealants placed by acid or laser etching , one compared acid etching versus laser combined with acid etching and one investigated the influence of lasers on the objective and subjective parameters of stress during sealant application in children . The meta- analysis showed no significant difference between laser preparation and conventional acid-etching preparation at 3- ( P = 0.08 ) , 6- ( P = 0.49 ) , and 12-month ( P = 0.87 ) follow-ups . One study reported that laser preparation as an adjunct to acid-etching enhanced the retention rate . No significant difference in the incidence of caries was reported . And no significant differences were found in heart rates , oxygen saturation or degree of the patient dental anxiety between acid-etching and laser preparation . Conclusion The present limited evidence suggests that lasers could be an effective pretreatment method . The retention rate was similar to that of conventional acid etching . However , the included studies had an overall high risk of bias and more rigorously design ed research is needed | [
"The split-mouth design is a popular design in oral health research . In the most common split-mouth study , each of two treatments are r and omly assigned to either the right or left halves of the dentition . The attractiveness of the design is that it removes a lot of inter-individual variability from the estimates of the treatment effect . However , already about 20 years ago the pitfalls of the design have been reported in the oral health literature . Yet , many clinicians are not aware of the potential problems with the split-mouth design . Further , it is our experience that most statisticians are not even aware of the existence of this design . Since most of the critical remarks appeared in the oral health literature , we argue that it is necessary to introduce the split-mouth design to a statistical audience , so that both clinicians and statisticians clearly underst and the advantages , limitations , statistical considerations , and implication s of its use in clinical trials and advise them on its use in practice",
"This paper examines the evidence demonstrating the effectiveness of sealants in high-caries-risk children and discusses the Research Triangle Institute/University of North Carolina 's ( RTI/UNC ) systematic review . The strict RTI/UNC protocol limited the number of sealant studies that could be included . This analysis exp and ed their criteria to permit additional methods of determining caries risk ( for example , past caries experience , less than two pairs of sound first permanent molars available/child in half-mouth design s ) and outcome measures in addition to DMFS ( that is , percent sealant retention , survival rates , cost-effectiveness , changes in salivary S. mutans levels ) . Nine clinical studies with a r and omized , half-mouth , clinical trial design and seven studies with observational study design s were included . There is good evidence that sealants can be used efficaciously and effectively in high-risk children as long as the sealant is retained . Sealants are more effective in preventing further caries and providing cost savings in a shorter time span if placed in children who have high rather than low caries risk",
"This study aim ed to assess the in vitro efficacy of the lasers Er : YAG , Nd : YAG , and CO(2 ) operating in the low energy mode for caries prevention in pits and fissures . Forty-five caries-free enamel occlusal sections were r and omly divided into three groups : G1 - Er : YAG ( 80 mJ/2 Hz ) ; G2 - Nd : YAG Laser ( 1 W and 10 Hz ) ; and G3 - CO(2 ) Laser ( 0.4 W and 20 Hz ) . After surface treatment , the sample s were su bmi tted to challenge with acid consisting of a 10-day immersion in demineralizing ( 6 h ) and remineralizing solution ( 18 h ) . Next , enamel demineralization was quantitatively evaluated by subsurface microhardness test and polarized-light microscopy ( PLM , mm(2 ) ) and qualitatively assessed by scanning electron microscopy . The Wilcoxon test was used for comparison of each group with its own control . ANOVA ( α = 5 % ) was employed for comparison among groups , and Fisher 's LSD multiple comparison test was applied , to check the difference in means . Concerning the microhardness analyses , statistical difference between control , and experimental areas was only detected for the CO(2 ) group . Experimental values were higher than the controls . As for PLM analyses , smaller demineralized areas were measured for G2 ( Nd : YAG ) and G3 ( CO(2 ) ) compared with the control areas . In conclusion , the present findings suggest that the CO(2 ) laser should be selected in order to increase the enamel resistance to acid in pits and fissures",
"Objective : This study was performed to assess the resin tag length penetration in enamel surface after bonding of brackets to identify which system was most efficient . Methodology : Our study was based on a more robust confocal microscopy for visualizing the resin tags in enamel . Totally , 100 extracted human first and second premolars have been selected for this study and were r and omly divided into ten groups of 10 teeth each . In Group 1 , the buccal enamel surface was etched with 37 % phosphoric acid ( 3 M ESPE ) , Group 2 with 37 % phosphoric ( Ultradent ) . In Groups 5 , 6 , and 7 , erbium , chromium-doped : Yttrium sc and ium-gallium-garnet ( Er , Cr : YSGG ) laser ( Biolase ) was used for etching the using following specifications : Group 5 ( 1.5 W/20 Hz , 15 s ) , Group 6 ( 2 W/10 Hz , 15 s ) , and Group 7 ( 2 W/20 Hz , 15 s ) . In Groups 8 , 9 , and 10 , Er , Cr : YSGG laser ( Biolase ) using same specifications and additional to this step , conventional etching on the buccal enamel surface was etched with 37 % ( 3 M ESPE ) after laser etching . In Groups 1 , 5 , 6 , 7 , 8 , 9 , and 10 3 M Unitek Transbond XT primer was mixed with Rhodamine B dye ( Sigma-Aldrich , Germany ) to etched surface and then cured for 20 s. In Group 2 , Ultradents bonding agent was mixed with Rhodamine B. In Group 3 , 3 M Unitek Transbond PLUS , Monrovia , USA , which was mixed with Rhodamine B dye ( Sigma-Aldrich , Germany ) . Group 4 , with self-etching primer ( Ultradent-Peak SE , USA ) was mixed with Rhodamine B dye ( Sigma-Aldrich , Germany ) . Later ( 3 M Unitek , Transbond XT , Monrovia USA ) [ Figure 1 ] was used to bond the modified Begg brackets ( T. P. Orthodontics ) in Groups 1 , 3 , 5 , 6 , 7 , 8 , 9 , and 10 . In Groups 2 , 4 Ultradent-Peak LC Bond was used to bond the modified brackets . After curing brackets were debonded , and enamel depth penetration was assessed using confocal laser scanning microscope . Results : Group J had a mean maximum depth of penetration of 100.876 μm , and Group D was the least having a maximum value of 44.254 μm . Conclusions : Laser alone groups had comparable depths of penetration to that of self-etching groups but much lower than conventional acid etched groups",
"Objectives The purpose of this in vitro study was to evaluate the microleakage and penetration of fissure sealant in permanent molar teeth with fluorosis after pretreatment of the occlusal surface . Material s and Methods A total of 120 third molars with mild dental fluorosis were r and omly divided into 6 groups ( n = 20 ) . The tooth surfaces were sealed with an unfilled resin fissure sealant ( FS ) material . The experimental groups included : 1 ) phosphoric acid etching ( AE ) + FS ( control ) ; 2 ) AE + One-Step Plus ( OS , Bisco ) + FS ; 3 ) bur + AE + FS ; 4 ) bur + AE + OS + FS ; 5 ) Er : YAG laser + AE + FS ; and 6 ) Er : YAG laser + AE + OS + FS . After thermocycling , the teeth were immersed in 0.5 % fuchsin and sectioned . Proportions of mircoleakage ( PM ) and unfilled area ( PUA ) were measured by digital microscope . Results Overall , there were significant differences among all groups in the PM ( p = 0.00 ) . Group 3 showed the greatest PM , and was significantly different from groups 2 to 6 ( p lowest PM . Pretreatment with Er : YAG with or without adhesive led to less PM than bur pretreatment . There were no significant differences among groups in PUA . Conclusions Conventional acid etching provided a similar degree of occlusal seal in teeth with fluorosis compared to those pretreated with a bur or Er : YAG laser . Pretreatment of pits and fissures with Er : YAG in teeth with fluorosis may be an alternative method before fissure sealant application",
"A split mouth clinical trial was undertaken to compare the retention of fissure sealants placed using laser or acid conditioning . After a mean follow-up period of 14.5 months , the retention rate for laser conditioning was greater than that for acid etching ( 97.9 per cent versus 94.6 per cent , respectively ) , although this difference was not statistically significant . No adverse effects occurred during or subsequent to laser conditioning procedures . It is concluded that carbon dioxide laser conditioning is a viable alternative to acid etching for fissure sealing",
"OBJECTIVE This clinical study compared the retention rates of a nanofilled occlusal fissure sealant placed with the use of an etch- and -rinse or a self-etch adhesive over 24 months . METHODS Two-hundred and forty-four sealants were placed on the permanent premolars and molars of 16 subjects who had no restorations or sealants present on the fissures and no detectable caries . The sealants were placed with either SoloBond M two-step etch- and -rinse adhesive or FuturaBond NR one-step self-etch adhesive by four previously calibrated dentists , using a table of r and om numbers . After completion of the adhesive application , a nanofilled sealant , Gr and io Seal , was applied and light-cured . Clinical evaluations were done at baseline and at 1- , 3- , 6- , 12- , 18- and 24-month recalls . Two other calibrated examiners , who were unaware of which adhesive had been used , independently evaluated the sealants . Evaluation of the sealants on every follow-up visit involved visual examination with the aid of a dental explorer and an intra-oral mirror . Each sealant was evaluated with the following criteria : 1 = completely retained ; 2 = partial loss ; 3 = total loss . The Pearson Chi-square test was used to evaluate differences in the retention rates among the sealants used with different adhesives for each evaluation period . RESULTS For the 12-month recalls , complete retention rates of 89.3 % for the SoloBond M group and 20.5 % for the FuturaBond NR group were observed . Sixteen of the 244 restorations were unavailable after 12 months . At 24 months , a total loss of 9 sealants in the SoloBond M group and 84 in the FuturaBond NR group were observed , result ing in retention rates of 81.6 % and 15.8 % , respectively . There were statistically significant differences in retention rates between the SoloBond M and FuturaBond NR groups in all periods of evaluation ( p difference between the retention rates for premolars and molars was found at each evaluation period ( p > 0.05 ) . There was no new caries formation throughout the 24-month recall period . CONCLUSION Fissure sealants placed with etch- and -rinse adhesive showed better retention rates than those placed with self-etch adhesive",
"BACKGROUND Fissure sealants prevent occlusal caries in permanent molars . Enamel preparation methods are used before fissure sealing . AIMS To investigate effects of bioglass air-abrasion pre-treatment with and without an adhesive , on fissure enamel of permanent teeth , with respect to etchability , microleakage and microtensile bond strength . DESIGN Half of the occlusal surfaces of 50 extracted premolars underwent bioglass air-abrasion . Dye was applied to the entire occlusal surface . Photographs were taken to score etched surface by dye uptake . Adhesive was applied to 25 of the bioglass-treated areas and all teeth were fissure sealed , sectioned , and evaluated using confocal microscopy . Buccal and lingual surfaces of a further eight premolars were acid-etched and r and omly received : air-abrasion , adhesive , both , or none before sealant application for microtensile bond strength measurement in half of the sample s immediately and half following 6 months of water immersion . RESULTS Linear mixed models and multinomial logistic regression were used ( P = 0.05 ) . Bioglass air-abrasion significantly improved enamel etchability and reduced microleakage . The addition of an adhesive made no difference to either microleakage or microtensile bond strength . The combination of bioglass abrasion and adhesive led to more cohesive , rather than adhesive , failure . CONCLUSIONS Bioglass air-abrasion improved enamel etchability and reduced microleakage irrespective of the adhesive use but neither pre-treatment affected the microtensile bond strength",
"Objective : Micro-leakage , one of the major reasons for recurrent decays , may lead to uncontrollable flow of liquids , pulp inflammation and peri-apical pathology . The purpose of this in vitro study was to evaluate micro-leakage of pit and fissure sealants after using three different pit and fissure preparation techniques : 1 ) acid etching , 2 ) fissure enameloplasty and acid etching , and 3 ) air abrasion and acid etching . Material s and Methods : Sixty-nine extracted sound molars and premolars were r and omly divided into three groups ( 23 sample s in each group ) . Teeth were prepared using one of three occlusal surface treatments . Then the sealant was applied on the occlusal fissures of all teeth . The teeth were thermocycled and stored in normal saline . All teeth were sealed apically and coated with nail varnish and then were immersed in a 2 % solution of methylen blue . Two buccolingual sections were made . The surfaces were scored 0 to 3 for the extent of micro-leakage using a stereomicroscope . Data were analyzed by Kruskal- wallis and Dunn procedure . Results : Enameloplasty and acid etching were significantly different regarding micro-leakage ( P= 0.016 ) , but no significant difference in micro-leakage was observed between air abrasion and the other methods . Conclusion : Enameloplasty followed by acid etching produced significantly less micro-leakage than the acid etching technique . Air abrasion acid etching was better than the acid etching technique in reducing micro-leakage too",
"PURPOSE Alumina air abrasion is an alternative for acid-etch technique for tooth preparation before placement of a fissure sealant . The aim of this study was to compare the retention of sealants placed subsequent to air abrasion with alumina and bioactive glass ( BAG ) particles . METHODS Sixty-two 6 - 12 year old children were included in this study . Using a halfmouth design , the fissures were prepared using air abrasion with alumina particles on r and omly assigned permanent m and ibular or/ and maxillary first molars on one side of the mouth ( Group 1 ) and air abrasion with BAG on the contralateral side of the mouth ( Group 2 ) . Sealants were applied on 180 teeth , and were scored as missing , partially retained , and completely retained after three , six , nine and 12 months . Data were analyzed using Friedman and Wilcoxon tests ( α=0.05 ) . RESULTS Sealant retention rates in the alumina group were higher than those in the BAG group at all time periods ( P CONCLUSIONS Sealant retention after air abrasion with alumina particles was higher than BAG over 12 months",
"OBJECTIVE To compare the clinical performance of a pit and fissure sealant placed with the use of different enamel preparation methods , i.e. acid or Er , Cr : YSGG laser etching , over 24 months . METHODS Sixteen subjects ( 15 female , 1 male ) with no restorations or sealant present on their fissures and no detectable caries participated . Using a table of r and om numbers , a total of 112 sealants ( 56 with acid-etching , 56 with laser etching ) were placed on the permanent premolar and molar teeth . All restorative procedures except for application of the laser were performed by the same dentist . After completion of the fissure preparation either with acid or laser , the adhesive was applied ; then a pit and fissure sealant , Clinpro Sealant , was placed and polymerized . Clinical evaluations were done at baseline and at 6- , 12- , 18- , and 24-month follow-up visits by two calibrated examiners , who were unaware of which etching method had been used . The retention of sealants and caries were evaluated with the aid of a dental explorer and an intra-oral mirror . Each sealant was evaluated using the following criteria : 1=completely retained ; 2= partial loss ; 3= total loss . The Pearson chi-square test was used to evaluate differences in the retention rates among the sealants used with different etching methods . RESULTS All patients attended the 24-month follow-up visit and all sealants were evaluated ( total recall rate 100 % ) . At the end of 24 months , 83.9 % of the sealants from laser group and 85.7 % of those from acid-etch group were recorded as \" completely retained \" . There were no statistically significant differences in retention rates among the preparation methods after all evaluation periods ( p>0.05 ) . No statistically significant differences were found between the retention rates of premolar and molars at each evaluation period . No secondary caries was detected in association with any sealants . CONCLUSION The clinical performance of fissure sealants placed after acid or Er , Cr : YSGG laser etching was similar",
"OBJECTIVE This in vitro study evaluated the influence of both Er : YAG and Nd : YAG laser irradiation on deciduous enamel demineralization . BACKGROUND DATA Although there are still few studies on the use of the high-intensity laser for caries prevention in deciduous teeth , it is believed that its use on the dental structure can lead to a more acid-resistant surface . METHODS Forty enamel sample s obtained from 22 deciduous first molar teeth were ground and r and omly divided into four groups ( n = 10 ) : group 1 ( G1 ) , no treatment ( negative control ) ; G2 , fluoride ( positive control ) ; G3 , Er : YAG laser ( 2 Hz , 60 mJ , 40.3 J/cm(2 ) ) ; G4 , Nd : YAG laser ( 80 mJ , 10 Hz , 0.8 W ) . After the surface treatment , the sample s were su bmi tted to an acid challenge that consisted of a 5-day immersion in demineralizing ( 3 h ) and remineralizing solution ( 21 h ) . Next , a microhardness test was preformed . RESULTS Analysis of variance ( ANOVA ) and Student Newman Keuls tests were performed ( alpha = 5 % ) . The percentage of lesion inhibition for each group was as follows : G2 , 59.4 % ; G3 , 35.7 % ; and G4 , 40.4 % . As regards the percentage loss of mineral volume , there was no statistical difference between groups G2 ( 444.37 + /- 146.42 ) and G3 ( 441.81 + /- 207.08 ) when compared with group G1 ( 281.03 + /- 134.57 ) . All experimental groups presented a lower mineral loss compared with the non-irradiated sample s ( G4 ) . CONCLUSION The findings of the present study revealed that both Nd : YAG and Er : YAG lasers can be an alternative tool for enhancing deciduous enamel acid resistance ",
"BACKGROUND This article presents evidence -based clinical recommendations for the use of pit- and -fissure sealants on the occlusal surfaces of primary and permanent molars in children and adolescents . A guideline panel convened by the American Dental Association ( ADA ) Council on Scientific Affairs and the American Academy of Pediatric Dentistry conducted a systematic review and formulated recommendations to address clinical questions in relation to the efficacy , retention , and potential side effects of sealants to prevent dental caries ; their efficacy compared with fluoride varnishes ; and a head-to-head comparison of the different types of sealant material used to prevent caries on pits- and -fissures of occlusal surfaces . TYPES OF STUDIES REVIEW ED This is an up date of the ADA 2008 recommendations on the use of pit- and -fissure sealants on the occlusal surfaces of primary and permanent molars . The authors conducted a systematic search in MEDLINE , Embase , Cochrane Central Register of Controlled Trials , and other sources to identify r and omized controlled trials reporting on the effect of sealants ( available on the U.S. market ) when applied to the occlusal surfaces of primary and permanent molars . The authors used the Grading of Recommendations Assessment , Development , and Evaluation approach to assess the quality of the evidence and to move from the evidence to the decisions . RESULTS The guideline panel formulated 3 main recommendations . They concluded that sealants are effective in preventing and arresting pit- and -fissure occlusal carious lesions of primary and permanent molars in children and adolescents compared with the nonuse of sealants or use of fluoride varnishes . They also concluded that sealants could minimize the progression of non-cavitated occlusal carious lesions ( also referred to as initial lesions ) that receive a sealant . Finally , based on the available limited evidence , the panel was unable to provide specific recommendations on the relative merits of 1 type of sealant material over the others . Conclusions and practical implication s : These recommendations are design ed to inform practitioners during the clinical decision-making process in relation to the prevention of occlusal carious lesions in children and adolescents . Clinicians are encouraged to discuss the information in this guideline with patients or the parents of patients . The authors recommend that clinicians re-orient their efforts toward increasing the use of sealants on the occlusal surfaces of primary and permanent molars in children and adolescents",
"PURPOSE The aim of this study was to compare the microleakage of unfilled and filled sealants after conventional , bur , and air-abrasion tooth preparation . METHODS Seventy-two extracted molars were r and omly divided into three groups . In group 1 , 24 teeth were prepared by pumicing and acid etching with 37 % phosphoric acid . In group 2 , 24 teeth were prepared with a 1/4-round bur in a low-speed h and piece and then acid etched . In group 3 , 24 teeth were prepared by high-speed ( 160 PSI ) microabrasion using 50 mu alpha alumina particles in a KCP 2000 machine . In each group , 12 teeth were sealed with a filled sealant and 12 teeth with an unfilled sealant . All the teeth were stored in artificial saliva for 7 days and thermocycled for 2000 cycles . Teeth were then sealed apically and coated with nail varnish 1 mm from the margins and stained in 1 % methylene blue for 24 h. Each tooth was sectioned in three locations and ranked ( 0 - 3 ) for microleakage . RESULTS There were 216 sections and 66 % showed no leakage . CONCLUSIONS Chi-square statistical analysis of the data led to the following conclusions : 1 ) superior results were obtained when the tooth surfaces were prepared by a bur , 2 ) conventionally and KCP 2000-prepared tooth surfaces yielded similar results , and 3 ) the unfilled sealant was superior to the filled sealant",
"This l and mark study of a pit and fissure sealant found 27.6 percent complete retention and 35.4 percent partial retention on permanent first molars . In the matched pair analysis , carious or restored surfaces made up 31.3 percent of the surfaces in the sealed group and 82.8 percent in the unsealed group",
"Background : Prevention from caries is a principle in dentistry and fissure sealant therapy is being used as a preventive method success of sealants is directly depending on their retention . Aim : The Aim of the present study is to evaluate effects of enamel preparation on sealant retention . Setting s and Design : Clinical trial . Material s and Methods : About 57 children aged 6 - 8 year old took part in this study . 200 first molar teeth of these children has been r and omly separated into two groups : A case group ( Mechanically preparation of enamel ) and a control group ( conventional method , without preparation ) . After applying fissure sealants children were followed up 6 months later . Statistical Analysis Used : Mann- U- Whitney Test was used . Results : Complete retention after 6 month follow up was 86.7 % in case group and 82.8 % in control group . No significant difference was seen between the groups after 6 month follow up . ( P = 0.508 ) . Conclusion : Although statistical evaluation did n't show significant difference , but sealant retention was more after preparation technique",
" A clinical study to determine the effectiveness of an enamel adhesive in protecting pits and fissures from dental decay indicated that the technic has potential as a caries-preventive measure . The adhesive resin can be strongly bonded to enamel surfaces for comparatively long periods",
"The purpose of this study was to evaluate the effects of different surface conditioning procedures on microleakage and unfilled area proportions of three fissure sealants(Aegis , Helioseal and Helioseal F ) in primary molar teeth . One hundred and fifty teeth were r and omly divided into five main groups according to surface conditioning procedures . Main groups were ; acid-etching(Group A ) ; laser 3.75 W(Group B ) and 5 W(Group D ) ; acid-etching combined with laser 3.75 W(Group C ) and 5 W(Group E ) . Sample s were aged by thermocycling and water bath . Afterwards , they were immersed in basic fuchsin solution for 24 h and bucco-lingual sections were obtained from each tooth . Digital images were taken using a stereo-microscope and the microleakage and unfilled area proportions were assessed by using a software system . Consequently , Aegis FS containing amorphous calcium phosphate was found to exhibit the lowest microleakage in all surface conditioning procedures . Unfilled areas were not detected in Groups C and E of all FSs",
"Background : Laser etching has several advantages as compared with conventional acid etching . However , results of earlier studies on conditioning surfaces with erbium , chromium : yttrium – sc and ium – gallium – garnet ( Er , Cr : YSGG ) before application of the fissure sealant have been inconclusive . Aim : The study aim ed to evaluate the microtensile strength of resin-based fissure sealant bonded to primary enamel conditioned by Er , Cr : YSGG laser with varying power outputs . Material s and Methods : Fifty sound primary first molars were r and omized into the following five groups based on pretreatment choice : Group 1 : 3.5 W laser etching + acid etching ; Group 2 : 2.5 W laser etching + acid etching ; Group 3 : 3.5 W laser etching with no acid ; Group 4 : 2.5 W laser etching with no acid and Group 5 : acid etching with no laser . Acid etch was performed with 35 % orthophosphoric acid for 30 s. Laser etching was performed with Er , Cr : YSGG ( 2780 nm ) laser using G6 tips and 600 μm diameter , 2.5 W or 3.5 W power outputs , pulse duration of 140 μs and a repetition rate of 20 Hz . Sealant was applied on the buccal surface followed by an incremental buildup with composite resin . Microtensile bond strength was assessed and compared among the five groups using one- and two-way ANOVA . Results : There was no statistical difference in the mean bond strength between groups except in Group 4 ( 9.66 MPa ) ( Group 1 : 15.57 MPa ; Group 2 : 14.18 MPa ; Group 3 : 14.78 MPa ; Group 5 : 14.63 MPa ) . Conclusion : Pretreatment with 3.5 W Er , Cr : YSGG laser alone results in microtensile bond strengths similar to that produced by acid etching , indicating that enamel etching using 3.5 W Er , Cr : YSGG laser would result in the long-term success of pit and fissure sealants in primary teeth",
"Aim : The aim of this study was to compare the retention rates of sealant placed either with conventional acid etching or Er , Cr : YSGG laser pretreatment of enamel surface . Material s and methods : This is a prospect i ve , single blind r and omised controlled clinical trial enrolling 200 permanent first molars in 50 patients , aged 6 - 12 years for sealant placement . Study followed split mouth design where each side of the arch was r and omly allocated to the two treatment group . Group A(Acid etch group ) : 37 % phosphoric acid ( Scotchbond , 3 M ESPE , Seefeld , Germany ) was applied for 15 seconds , rinsed with water for 20 seconds and then air-dried using air spray . Group L(Laser etch group ) : Fissures were prepared with an Er , Cr : YSGG laser system ( Waterlase , BIOLASE Technology , San Clemente , CA , USA ) emitting photons at a wavelength of 2.78 µm . Laser irradiation at 1.5 W ( 60 % air and 40 % water ) , in a noncontact mode , with a repetition rate of 20 Hz for 10seconds was used . Pit and fissure sealant ( 3 M ESPE , Clinpro ) was applied and cured for 20 seconds . One blinded , calibrated examiner , who was unaware of which preparation method has been used and who was not involved in the treatment procedures , evaluated the sealant at baseline and at 3 , 6 , 9 and 12 month follow-up visits . Results : It was observed that overall retention rate in group A was slightly higher as compared to group L at all time periods , however , the difference was statistically non-significant ( p-value>0.05 ) . CONCLUSION Er , Cr : YSGG laser etching is comparable to acid etching in terms of retention and patient acceptability"
] | 41167fc2-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND The purpose of the present study was to perform a systematic review and meta- analysis of the use of alternative antibiotic regimens-including ( A ) antibiotic prophylaxis versus no prophylaxis , ( B ) longer versus shorter duration of antibiotic prophylaxis , and ( C ) alternative drugs-for patients with open fracture of the extremities . METHODS Data sources included CINAHL , EMBASE , MEDLINE , the Cochrane Central Registry of Controlled Trials ( CENTRAL ) , and the Cochrane data base of systematic review s from 1965 to December 2013 . All r and omized controlled trials comparing the effectiveness of antibiotic prophylaxis in patients with open fracture of the extremities were eligible . RESULTS We identified 329 potentially eligible articles , of which seventeen proved to be eligible . In four r and omized controlled trials involving 472 patients , we found a significantly lower infection rate in patients receiving antibiotic prophylaxis compared with those not receiving antibiotic prophylaxis ( risk ratio = 0.37 [ 95 % confidence interval , 0.21 to 0.66 ] ; absolute risk reduction = 9.6 % [ 95 % confidence interval , 5.2 % to 12.1 % ] ) . In three studies involving 1104 patients , we found no difference in the infection rate when a longer duration of antibiotics ( three to five days ) was compared with a shorter duration ( one day ) ( risk ratio = 0.97 ; 95 % confidence interval , 0.69 to 1.37 ) . Confidence in the estimates for both questions was low to moderate . Individual comparisons of alternative drugs yielded estimates warranting only low to very low confidence . CONCLUSIONS Results of r and omized controlled trials performed to date provide evidence that antibiotic prophylaxis reduces subsequent infection and that courses as short as one day are as effective as courses of three to five days , although the evidence warrants only low to moderate confidence . Given current practice , a large , multicenter , low risk of bias , r and omized controlled trial enrolling representative population s and addressing the duration of antibiotics may be the next optimum step in investigation . LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence | [
"The necessary duration of antibiotic administration after open fracture has not been established . In a double-blind prospect i ve trial we r and omized 248 patients with open fractures to receive one or five days of cefonicid sodium therapy or five days of cefam and ole nafate therapy as part of the initial treatment . Rates of fracture-associated infections in the three groups were ten ( 13 % ) of 79 , ten ( 12 % ) of 85 , and 11 ( 13 % ) of 84 , respectively . The 95 % confidence limit for the difference in infection rates between the one-day group and the combined five-day groups was 0 % to 8.3 % . The actual difference was 0.2 % . A brief course of antibiotic administration is not inferior to a prolonged course of antibiotics for prevention of postoperative fracture-site infections",
"Background The optimal antibiotic regimen is still controversial in open fractures . The purpose of this study was to evaluate the efficacy of two different antibiotic regimens in management of type III-A open fractures . Methods From January 2001 to January 2008 , patients with type IIIA open fractures admitted in Shahid Beheshti Hospital Affiliated to Babol University of Medical Sciences were enrolled . Patients r and omly received cefazolin plus gentamicin ( group I ) or cefazolin plus ciprofloxacin ( group II ) . Both regimens were administered for 3 days . All patients were followed for 3 months . The efficacy of both regimens was compared . Results One hundred-forty eight and 153 patients were treated in group I and II , respectively . The mean age of the patients treated in group I was 36.96±14.4 and in group II was 36.93±13.51 years . The rate of deep infection in group I was 5.4 % and in group II was 6.5 % . The efficacy of regimen I was 94.6 % and regimen II was 93.5 % . Conclusion Cefazolin plus gentamicin , or cefazolin plus ciprofloxacin both can be successfully used for prevention of infection in type IIIA open fractures",
"In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias",
"OBJECTIVE The purpose of this study was to compare the efficacy of a single agent , ciprofloxacin , with that of combination antibiotic therapy consisting of cefam and ole and gentamicin in all types of open fracture wounds . STUDY DESIGN A prospect i ve double-blind r and omized clinical trial . SETTING A Level 1 trauma center . PATIENTS One hundred ninety-five consecutive patients with 203 open fractures were enrolled over a twenty-month period . Twenty-nine fractures from low-velocity gunshot wounds were excluded , and three other patients were excluded because of protocol violations . Our final number of patients were 163 , with 171 open fractures . MAIN OUTCOME MEASUREMENT The infection rates for Type I and Type II open fractures for both antibiotic groups were calculated . The infection rate of Type III open fractures for both antibiotic groups was also calculated . Chi-square analysis with Yates correction was used to assess statistical significance of two treatment groups . RESULTS The infection rate for Types I and II open fractures in the ciprofloxacin group was 5.8 percent and 6 percent for the cefam and ole/gentamicin group ( p = 1.000 ) . The infection rate for Type III open fractures for the ciprofloxacin group was 31 percent ( 8 of 26 ) versus 7.7 percent ( 2 of 26 ) for the cefam and ole/gentamicin group ( p = 0.079 ) . There were no statistically significant differences in infection rate between the group treated with ciprofloxacin and that treated with cefam and ole/gentamicin for Types I and II open fracture wounds . However , there appeared to be a high failure rate for the ciprofloxacin Type III open fracture group , with patients being 5.33 times more likely to become infected than those in the combination therapy group . Although this difference was not statistically significant , possibly because of the small sample size , there was a definite trend toward statistical significance . CONCLUSION Single-agent antibiotic therapy with ciprofloxacin is effective in treatment of Type I and Type II open fracture wounds . However , on the basis of our results , we can not recommend ciprofloxacin alone for Type III wounds . Possibly one can use fluoroquinolones in combination therapy , specifically as an alternate to an aminoglycoside",
"In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if a body of evidence is associated with a high risk of publication bias . Even when individual studies included in best- evidence summaries have a low risk of bias , publication bias can result in substantial overestimates of effect . Authors should suspect publication bias when available evidence comes from a number of small studies , most of which have been commercially funded . A number of approaches based on examination of the pattern of data are available to help assess publication bias . The most popular of these is the funnel plot ; all , however , have substantial limitations . Publication bias is likely frequent , and caution in the face of early results , particularly with small sample size and number of events , is warranted",
"Systematic review s and meta-analyses published in recent years have allowed drafting of evidence -based guidelines for antibiotic prophylaxis in orthopedic and trauma surgery . It is important to recognize the limitations of the recommendations derived from the available body of evidence . Since some of the most relevant r and omized controlled clinical trials were performed more than 20 years ago , it is sometimes difficult to apply the data to today 's clinical practice . In establishing consensus guidelines , it could prove difficult to identify areas for improvement through further research and better compliance . Although recommendations for optimized treatment of orthopedic implant infections are not currently based on first-class evidence , there are very promising new concepts emerging in this field , and we are awaiting more data and decisive conclusions from larger clinical trials",
"Abstract In a r and omised double-blind trial conducted between 1990 and 1994 , 616 patients from 43 centres , pefloxacin ( group P , 316 patients ) and a cefazolin-oxacillin combination ( group C , 300 patients ) were compared in the prophylaxis of bone infection after grade 1 and 2 open leg fractures . Sample s were obtained at emergency , before and during surgery , and from drain aspirates . Antimicrobial susceptibility , slime production and adherence properties of the bacteria were tested . Cultures at emergency and before surgery showed similar distributions of gram-positive and gram-negative bacteria in both groups , while wound closure and infecting isolates showed prevailing gram-positive bacteria in group P and gram-negative bacteria in group C. Positive cultures at each stage were correlated with the occurrence of infection but were not predictive of the infecting species , which were nosocomial bacteria in most cases . Positive cultures at wound closure warn of a higher infection risk . Twenty-one of 316 ( 6.6 % ) patients in group P and 24 of 300 ( 8 % ) in group C were considered infected within 3 months . The difference is not significant ( chi-square test = 0.42;P=0.51 ) . Infecting strains were isolated from 38 patients ( group P , 18 ; group C , 20 ) . Infecting species , although not predictable , appear to be those escaping the spectrum of the prescribed antimicrobial prophylaxis",
"Objective : To develop preliminary data on Staphylococcus aureus colonization and surgical site infections ( SSIs ) in patients with open fractures who received st and ard antibiotic prophylaxis compared with a regimen including targeted methicillin-resistant Staphylococcus aureus ( MRSA ) coverage . Design : R and omized prospect i ve clinical trial . Patients : Adult patients who presented to the emergency department with an open fracture between April 2009 and July 2011 . Interventions : One hundred thirty patients were r and omized to receive prophylaxis with either cefazolin alone ( control arm ) or vancomycin and cefazolin ( experimental arm ) from presentation to the emergency department until 24 hours after the surgical intervention . Screening for S. aureus carriage was performed with nares swabs and predebridement and postdebridement open fracture wound swabs . Patients underwent prospect i ve assessment for the development of SSI for no less than 30 days and up to 12 months . Results : Nasal colonization of methicillin-sensitive S. aureus and MRSA among the sample was 20 % and 3 % , respectively . No significant difference in the rates of SSI was observed between the study arms ( 15 % vs 19 % , respectively , P = 0.62 ) . Staphylococcus aureus caused 55 % of the deep incisional/organ space SSI , with 18 % attributed to MRSA . A significantly higher rate of MRSA SSIs was observed among MRSA carriers compared with noncarriers ( 33 % vs 1 % , respectively , P = 0.003 ) . Conclusions : Staphylococcus aureus nasal colonization in trauma patients with open fractures is similar to that of the general community . In this pilot study , the addition of vancomycin to st and ard antibiotic prophylaxis was found safe , but its efficacy should be evaluated in a larger multiinstitutional trial . Level of Evidence : Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence",
"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",
"This study compared the efficacy of antibiotic impregnated beads with conventional intravenous antibiotics in the treatment of open fractures . A r and omized prospect i ve study was design ed and conducted during a 29-month period . Sixty-seven patients with 75 open fractures were treated similarly , with the exception of the method of antibiotic administration , and were followed up for at least 1 year after injury . Infection occurred in two of 24 ( 8.3 % ) fractures treated with antibiotic beads alone and in two of 38 ( 5.3 % ) fractures treated with conventional intravenous antibiotics . In an unanticipated nonr and omized third cohort group , patients received antibiotic beads and intravenous antibiotics administered for nonorthopaedic reasons or limb threatening injury , or both . Two of 13 ( 15.4 % ) fractures in this high risk group became infected . Infection ultimately resolved in all fractures treated with antibiotic beads alone or antibiotic beads in conjunction with conventional intravenous antibiotics . This study was unable to achieve statistical significance ; however , the data suggest antibiotic beads may be useful in preventing infection in open fractures . Thus , a larger multicenter r and omized prospect i ve study of isolated open fractures , eliminating other variables , is justified",
"BACKGROUND Open fractures are an important source of morbidity and are associated with delayed union , nonunion , and infection . Preventing infection through meticulous irrigation and debridement is an important goal in management , and different lavage fluids and irrigation techniques ( e.g. , high- or low-pressure lavage ) have been described for this purpose . However , there are a limited number of r and omized trials comparing irrigating solutions or irrigating technique . We compared the use of castile soap versus normal saline and high- versus low-pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds . METHODS We conducted a multicenter , blinded , r and omized 2 × 2 factorial pilot trial of 111 patients in whom an open fracture wound was treated with either castile soap solution or normal saline and either high- or low-pressure pulsatile lavage . The primary composite outcome of reoperation , measured at 12 months after initial operative procedure , included infection , wound healing problems , and nonunion . Planned reoperations were not included . Secondary outcomes included all infection , all wound healing problems , and nonunion as well as functional outcomes scores ( EuroQol-5 dimensions and short form-12 ) . RESULTS Eighty-nine patients completed the 1-year follow-up . Among all patients , 13 ( 23 % ) in the castile soap group and 13 ( 24 % ) in the saline group had a primary outcome event ( hazard ratio , 0.91 , 95 % confidence interval : 0.42 - 2.00 , p = 0.52 ) . Sixteen patients ( 28 % ) in the high-pressure group and 10 patients ( 19 % ) in the low-pressure group had a primary outcome event ( hazard ratio 0.55 , 95 % confidence interval : 0.24 - 1.27 , p = 0.17 ) . Functional outcome scores showed no significant differences at any time point between groups . CONCLUSION The fluid lavage of open wounds pilot r and omized controlled trial demonstrated the possibility that the use of low pressure may decrease the reoperation rate for infection , wound healing problems , or nonunion . We have demonstrated the desirability and feasibility of a definitive trial examining the effects of alternative irrigation approaches",
"The value of prophylactic antibiotics in fracture surgery was studied in a series of 90 patients with open fractures of various bones and 180 patients with closed malleolar fractures treated by open surgery . Dicloxacillin and benzyl penicillin were compared to saline ( placebo ) . The soft tissue lesions of the open fractures were divided into Grade I wounds and Grade II & III wounds . Of the patients with Grade I wounds , 17 received dicloxacillin , 21 benzyl penicillin and 17 saline . No major infections occurred . Twelve patients with Grade II & III wounds were treated with dicloxacillin , 10 with benzyl penicillin and 13 with saline . In the saline group , 2 patients developed a deep infection . Fifty-eight patients with closed malleolar fractures received dicloxacillin , 59 benzyl penicillin and 63 saline . Two infections developed in the placebo group . A statistically significant difference was found between the number of infections in the antibiotic groups and the number in the placebo group . Superficial thromboplebitis following the antibiotic infusion occurred in 16 per cent of the dicloxacillin treated patients and in 1 per cent of those treated with benzyl penicillin or placebo",
"BACKGROUND AND AIMS Systemic administration of antibiotics is recommended and has proved to lower infection rates in open fractures . However , no antibiotic has proved to be superior to any other . MATERIAL AND METHODS In a prospect i ve study 227 patients with 240 open fractures were r and omized to receive either clindamycin or cloxacillin for infection prevention . RESULTS The overall infection rate was 15 % . Infection occurred in 9.3 % of the clindamycin treated and in 20 % of the cloxacillin treated fractures ( p infection were gram-positive , while in the Type III open fractures 21 pathogens ( 57 % ) were gram-positive and 16 ( 43 % ) gram-negative . In the clindamycin treated fractures the infection rates in Type I and II open fractures were 3.3 and 1.8 % , respectively , while in the cloxacillin group they were 20 and 3.8 % , respectively . Both clindamycin and cloxacillin showed low effectiveness in the treatment of Type III open fractures , the highest infection rates being 75 and 67 % , respectively ( Type III B ) . CONCLUSIONS Clindamycin provides good antimicrobic coverage against the most common pathogens causing Type I and II open fracture infections . In the treatment of Type III open fractures additional administration of an antibiotic with good gram-negative coverage is recommended",
"A prospect i ve r and omized study of severe open tibial fractures ( Type II and III ) was performed . Individual fractures were r and omized to treatment groups according to initial antibiotic therapy : One consisted of a first-generation cephalosporin , and the other consisted of a third-generation cephalosporin . Initial antibiotic therapy was given in all patients for 48 h and then specific antibiotic treatment was used as indicated by culture . The purpose of this study was to determine whether or not additional gram-negative coverage had an effect on the overall infection rate or the type of infection in severe open tibial fractures . Additional factors , such as the timing of bone grafts and soft tissue coverage , were evaluated in this study as well . Although there was no statistical difference in the rate of infection with the use of a first-versus a third-generation cephalosporin , there was a trend toward a decreased infection rate as well as toward less morbid infections with the use of a third-generation cephalosporin . The study also confirms that early bone graft should not be performed prior to 6 weeks post injury or after successful soft tissue coverage has been achieved . On the other h and , soft tissue coverage procedures should be performed at the earliest possible date to decrease the overall infection rate",
"A prospect i ve , r and omized study was performed on 75 Gustilo Grade s II and III open fractures to determine the efficacy of once daily , high dose aminoglycoside therapy , compared with more conventional dosing , in reducing the infection rate when used in conjunction with an aggressive operative treatment protocol . All patients enrolled in the study were treated with immediate irrigation , debridement , operative stabilization of the fracture , and 1 g of cefazolin every 8 hours . At the time of admission patients were r and omized to two groups . Patients in Group I received gentamicin 5 mg/kg divided into twice daily doses , and patients in Group II received gentamicin 6 mg/kg given once daily . All patients were monitored for renal toxicity and observed for radiographic and clinical signs of infection until fracture union . The results of the study revealed no statistically significant difference between once daily , high dose versus divided , low dose gentamicin in infection rates . Thus , daily dosing of gentamicin was found to be safe , effective , and cost efficient in the treatment of open fractures when combined with a cephalosporin and aggressive operative debridement and stabilization",
"Two hundred forty consecutive patients admitted for operative treatment of an open fracture of the arm or leg were followed up prospect ively for the development of fracture infection . The independent risk of fracture infection was increased in patients with grade IIIB or IIIC fractures , internal or external fixation , lower-leg fracture , any blood transfusion , or injuries result ing from motorcycle accidents or motor vehicle-pedestrian accidents . By stepwise multivariate logistic regression , the most significant risk factors were the grade of the fracture , internal or external fixation , and fractures of the lower leg . These risk factors all represent local wound characteristics , and we conclude that the most important actions by the surgeon to prevent infection involve local wound care . There was no relation between the timing of antibiotic administration or duration of antibiotic therapy and infection risk",
"A comparison of prophylactic antibiotic cover of cephradine or flucloxacillin in sixty patients with open fractures is reported . There were more infections in the flucloxacillin than in the cephradine group and gastrointestinal side-effects were more common . The overall incidence of infection in the whole group , two out of 60 or 3.3 % , was acceptably low",
"A double-blind prospect i ve study was done to assess the benefit of delaying closure of the wounds associated with open fractures . An additional double-blind study compared the effectiveness of clindamycin versus cefazolin for prophylactic antibiotic coverage . Quantitative cultures of the wounds were accomplished at the time of debridement and again at the time of closure if the wound was not closed initially . Almost half of the wounds were contaminated ( 46 % ) at the time of debridement , although the incidence of wound infection was low ( 6.5 % ) . Gram-negative organisms resistant to the prophylactic antibiotic were recovered initially only eight times , but four of these ( 50 % ) became infected . The contaminating organisms in each case were present in high concentration ( greater than 10(5 ) CFU/gm of tissue ) at initial culture . The time of wound closure , cefazolin versus clindamycin , and internal fixation of the fracture were not followed by significant differences in the development of clinical infection in this series",
"In 100 patients with first- , second- , and third-degree open fractures , a r and omized , double-blind study was carried out to compare prophylactic cloxacillin and placebo . Prophylaxis was started preoperatively and continued for 10 days . The st and ard fracture treatment consisted of operative stabilization , mostly by means of plates or external fixators . In the cloxacillin group two infections were observed as compared to 12 in the control group . This difference was significant"
] | 41168008-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Many antihypertensive agents exist today for the treatment of primary hypertension ( systolic blood pressure > /=140 mmHg and /or diastolic blood pressure > /=90 mmHg ) . R and omised controlled trials have been carried out to investigate the evidence for these agents . There is , for example , strong RCT evidence that thiazides reduce mortality and morbidity . Reserpine has been used as a second-line therapy in some of those trials . However , the dose-related blood pressure reduction with this agent is not known . OBJECTIVES To investigate the dose-related effect of reserpine on blood pressure , heart rate and withdrawals due to adverse events . SEARCH STRATEGY The data bases CENTRAL , EMBASE , and MEDLINE were search ed . We also traced citations in the reference sections of the retrieved studies . SELECTION CRITERIA Included studies were truly r and omised controlled trials comparing reserpine monotherapy to placebo or no treatment in patients with primary hypertension . DATA COLLECTION AND ANALYSIS Methods of r and omization and concealment were assessed . Data on blood pressure reduction , heart rate , and withdrawal due to adverse effects were extracted and analysed . MAIN RESULTS Four RCTs ( N = 237 ) were found that met the inclusion criteria . The overall pooled effect demonstrates a statistically significant systolic blood pressure ( SBP ) reduction in patients taking reserpine compared to placebo ( WMD -7.92 , 95 % CI -14.05 , -1.78 ) . Due to significant heterogeneity across trials , a significant effect in diastolic blood pressure ( DBP ) , mean arterial pressure ( MAP ) , and heart rate ( HR ) could not be found . The SBP effects were achieved with 0.5 mg/day or greater . However , the dose-response pattern could not be determined because of the small number of trials . Data from the trial that investigated Rauwiloid against placebo was not combined with reserpine data from the remaining three trials . This is because Rauwiloid is a different alkaloid extract of the plant Rauwolfia serpentina and the dose used is not comparable to reserpine . None of the included trials reported withdrawals due to adverse effects . AUTHORS ' CONCLUSIONS Reserpine is effective in reducing SBP roughly to the same degree as other first-line antihypertensive drugs . However , we could not make definite conclusions regarding the dose-response pattern because of the small number of included trials . More RCTs are needed to assess the effects of reserpine on blood pressure and to determine the dose-related safety profile before the role of this drug in the treatment of primary hypertension can be established | [
"Fifty patients ( 25 Blacks and 25 Indians ) suffering from mild-to-moderate hypertension ( supine diastolic blood pressure 100 - 105 mmHg ) were studied in order to compare the antihypertensive effect of a combination of a beta-blocker ( sotalol hydrochloride 160 mg/d ) plus a thiazide derivative ( hydrochlorothiazide 25 mg/d ) ( Sotazide ; B-M ) with that of a combination of reserpine 0,1 mg/d ( Serpasil ; Ciba ) plus hydrochlorothiazide 25 mg/d ( Dichlotride ; Frosst MSD ) . The combination of reserpine plus hydrochlorothiazide was found to be as effective as that of sotalol plus hydrochlorothiazide in lowering the blood pressure in both the Black and the Indian patients . Two patients taking the combination containing reserpine developed side-effects , but this did not occur in any of those taking the combination containing sotalol . We feel that in developing countries , where the cost of therapy is important , reserpine in a dosage of less than 0,1 mg/d plus a thiazide derivative in low dosage is preferable to a beta-blocker plus a thiazide derivative in the treatment of hypertension",
"In a double-blind study to investigate the antihypertensive effect of a fixed triple combination with 0.05 mg reserpine , 2.5 mg clopamide and 0.4 mg dihydroergocristine in comparison to a fixed double combination with 0.05 mg reserpine and 2.5 mg clopamide , a patient subgroup of 34 patients followed a unicenter ( central unit , ' institute ' ) as well as a multicenter ( established physicians ) study design . The patients visited both investigation units on the day of admission to the study ( week 0 ) , after four weeks and after eight weeks of therapy ( after the morning intake of the drugs ) . The paper in h and looks at the results of this subgroup with respect to the conformity of blood pressure values in the two investigative units . The analyses confirm the already published results of the entire study : Both combinations proved to be highly effective antihypertensive drugs . The triple combination showed therapeutical advantages for systolic blood pressure after four weeks , for diastolic pressure after eight weeks of therapy at the ' institute ' as well as , although less distinct , in the medical offices . A comparison of the individual values did not show a convincing coherence of the measurements between institute and offices . All investigated possible systematic sources of error ( different methods of measurement , days or times of measurement ) could be excluded by correlation statistics as a reason for the divergences . The results show the necessity -- particularly in multicenter studies --of a careful documentation of all accompanying data ( e.g. method or time of measurement ) as well as a greatest possible st and ardization of investigation ( e.g. identical measuring apparatus and investigator .",
"In a double-blind , parallel , 12-week trial , antihypertensive effects of diltiazem and reserpine were compared in 107 patients with essential hypertension . Diltiazem reduced blood pressure from 176/100 mmHg to 154/86 mmHg after 12 weeks , and reserpine reduced blood pressure from 171/96 mmHg to 155/85 mmHg . The difference between diltiazem and reserpine was not statistically significant . However , among a subset of patients given 180 mg/day of diltiazem , a significantly better antihypertensive effect was achieved than among a subset given 0.3 mg of reserpine . The incidence of side effects and complications in the diltiazem group was about one half that in the reserpine group ( 12.3 % and 27.1 % , respectively ) . Side effects of diltiazem were mild , and the drug was extremely well tolerated . These results show that diltiazem is an effective antihypertensive drug for the treatment of mild to moderate essential hypertension",
"Low-dose combination therapy has been proposed as a rational first-line approach to hypertension treatment . We compared the efficacy and tolerability of the fixed combination of reserpine ( 0.1 mg ) plus the thiazide clopamid ( 5 mg ) with its single components and the calcium-antagonist nitrendipine ( 20 mg ) in a r and omized , double-blind , parallel study of 273 hypertensive patients with diastolic blood pressure ( BP ) between 100 and 114 mm Hg . The four groups did not differ regarding baseline characteristics ( mean age , 58 years ; 51 % men ; mean BP after a 2-week placebo period , 158 to 160/103 to 104 mm Hg ) . After 6 weeks of treatment with one capsule daily , mean reductions in sitting BP from baseline at 24 hours after dosing in the reserpine-clopamid combination , reserpine , clopamid , and nitrendipine groups were -23.0/-17.1 , -14.0/-11.7 , -13.6/-11.9 , and -11.6/-12.3 mm Hg , respectively ( 2P normalization rates ( diastolic BP mean BP reductions were -25.7/-18.1 , -14.6/-12.2 , -17.7/-13.4 , and -14.9/-15.3 mm Hg in the four groups , respectively ( 2P normalization rates were 69 % , 35 % , 39 % , and 45 % ( 2P reserpine and clopamid combined acted more than additively . As regards tolerability , adverse experiences were observed in 27 % , 28 % , 29 % , and 48 % of patients , respectively ( 2P rates of premature discontinuation because of adverse effects were 3 % , 3 % , 7 % , and 13 % ( 2P = .06 ) . In conclusion , a low-dose combination of reserpine and clopamid lowered BP significantly more than both the components alone and nitrendipine . Moreover , the combination was tolerated as well as its components and significantly better than nitrendipine . Thus , the use of this low-dose reserpine-thiazide combination appears to be a rational alternative to conventional monotherapy in the first-line treatment of hypertension",
" In a series of 450 patients with mild essential hypertension , propranolol alone ( P ) , propranolol plus hydrochlorothiazide ( P+T ) , propranolol plus hydralazine ( P+H ) , and propranolol plus hydrochlorothiazide plus hydralazine ( P+T+H ) were compared to reserpine plus hydrochlorothiazide ( R+T ) . Comparison was based on reduction of diastolic blood pressures ( BP ) to below 90 mm Hg and at least 5 mm Hg less than initial BP after six months of treatment . This was achieved in 92 % of patients who received P+T+H , 88 % taking R+T , 81 % receiving P+T , 72 % on P+H and 52 % taking P alone . The number of drop-outs , morbid events , and terminating side effects were insignificantly different among the various regimens . In this study , P and P+H were less effective , while P+T and P+T+H were as effective as the st and ard regimen",
"1 . The changes in plasma volume , haemodynamic variables , plasma renin activity and plasma aldosterone were studied in forty-one hypertensive patients after administration of adrenergic-blocking agents . Four drugs were used : alpha-methyldopa ( fourteen patients ) , guanethidine ( ten patients ) , clonidine ( nine patients ) and reserpine ( eight patients ) . Drugs were administered orally during 7 days ' hospitalization on a normal sodium diet ( 110 mmol/day ) . 2 . The four drugs had similar effects : a significant decrease in blood pressure , a significant increase in plasma volume and no change in stroke volume . 3 . With alpha-methyldopa and guanethidine , heart rate , plasma renin activity and plasma aldosterone were unchanged . 4 . With reserpine and clonidine , heart rate and plasma renin activity were significantly decreased , whereas plasma aldosterone did not change significantly . 5 . This study suggests that the decrease in plasma renin activity was related to the lowering of the heart rate rather than to sodium retention and that adrenergic-blocking agents can impair the normal relationship between stroke index and plasma volume , between plasma volume and plasma renin activity , and between plasma renin activity and plasma aldosterone"
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Purpose Falls are an important public health problem in older people . Medication use is considered a risk factor for falls . This study systematic ally review ed recent studies to determine the medications that might be associated with the risk of falling in older people . Methods We conducted a systematic review of prospect i ve and retrospective studies identified through the MEDLINE and CINAHL data bases that quantitatively assessed the contribution of medications to falls risk in participants ≥60 years old published in English between May 2008 and April 2013 . Results The search identified 1,895 articles ; 36 articles met the inclusion criteria . Of the 19 studies that investigated the effect of polypharmacy on the risk of falling , six studies reported that the risk of falling increased with polypharmacy . Data on the use of antihypertensive medications including calcium channel blockers , beta-blockers , and angiotensin system blocking medications were collected in 14 studies , with mixed results . Twenty-nine studies reported an association between the risk of falls and psychotropic medications including sedatives and hypnotics , antidepressants , and benzodiazepines . Conclusions The use of sedatives and hypnotics and antidepressants including tricyclic antidepressants , selective serotonin reuptake inhibitors , and serotonin norepinephrine reuptake inhibitors appears to be related with an increased risk of falls . It is not clear if the use of antihypertensive medications is associated with the risk of falls in older people | [
"A population -based sample ( N = 787 ) was followed for 8 years and assessed three times on measures of well-being ( depressive symptoms , morale , and control ) and fall history . Marginal models assessed the association between baseline well-being measures and falling . R and om effects models assessed change in well-being indicators as well as change in fall rate over 8 years . After adjustment for sociodemographics , psychotropic medication , health , and sensorimotor function , our results showed that depressive symptoms , control , and morale were risk factors for subsequent falling , and an increase in depressive symptoms or a reduction in morale was associated with an increasing fall rate . We conclude that the three well-being measures are independently associated with falling and need to be considered in fall-risk assessment s and population -based prevention and intervention strategies",
"AIM To determine the prevalence of potentially suboptimal medication use and association with adverse outcomes . METHODS A prospect i ve , observational cohort study of 4260 community-dwelling older men from Perth , Western Australia ( mean age of 77 ± 3.6 years ) was conducted . Follow-up was for 4.5 years ( or until death , if sooner ) . Cox proportional hazard models were used to explore associations between suboptimal medication use and prospect i ve clinical outcomes . Logistic regression analyses were used to explore predictors of a fall in the previous 12 months . RESULTS Use of potentially inappropriate medicines ( 48.7 % ) , polypharmacy ( ≥5 medications , 35.8 % ) and potential under-utilization ( 56.7 % ) were highly prevalent , and overall 82.3 % of participants reported some form of potentially suboptimal medication use . A self-reported history of falls in the previous 12 months was independently associated with the number of medicines taken ( odds ratio [OR]= 1.06 , 95 % confidence interval [ CI ] 1.02 , 1.09 ) and use of one or more potentially inappropriate medicines ( OR = 1.23 , 95 % CI 1.04 , 1.45 ) . After adjusting for age , co-morbidity , smoking status , body mass index , hypertension and educational attainment , the number of medicines reported was associated with admission to hospital ( hazard ratio [HR]= 1.04 , 95 % CI 1.03 , 1.06 ) , cardiovascular events ( HR = 1.09 , 95 % CI 1.06 , 1.12 ) and all cause mortality ( HR = 1.04 , 95 % CI 1.00 , 1.07 ) . Use of one or more potentially inappropriate medicines was associated with admission to hospital ( HR = 1.16 , 95 % CI 1.08 , 1.24 ) . Potential under-utilization was associated with cardiovascular events ( HR = 1.20 , 95 % CI 1.03 , 1.40 ) . CONCLUSIONS These data suggest that both medication over-use and under-use occur frequently among older men and may be harmful",
"PURPOSE To develop a simple screen based on easily collectable measures to identify older people living in residential care facilities at high risk of falls . METHODS This prospect i ve study was conducted in seven residential care facilities in the U.K. Residents aged>60 years who were not bedbound or terminally ill participated . Demographics , medical history , medication use , cognition ( mini mental state examination ( MMSE ) ) , function ( Barthel , balance and sit-to-st and ability ) and behavior ( neuro-psychiatric inventory ( NPI ) and impulsivity ) were recorded at baseline . Falls and injuries were prospect ively recorded over 6 months . Data were analyzed for differences between fallers and non-fallers and significant variables entered into logistic regression analysis . RESULTS Two hundred and forty residents completed the study . In the follow-up period , 50 % fell ≥1 times . Fallers had worse function , cognition , behavior and balance and took more medications . Falling in the past year , walking frame and hypnotic/anxiolytic and anti-depressant medication use were also associated with increased likelihood of falling . Logistic regression identified MMSE , requiring a walking frame , falling in the previous year and use of antidepressants and hypnotics/anxiolytics as independent and significant predictors of falls . The area under the receiver operating curve ( ROC ) for this model was 0.79 ( 95 % CI 0.73 - 0.84 ) . CONCLUSIONS This tool comprising multi-factorial measures provides a simple way of quantifying the probability with which a care home resident will fall over a 6-month period . The tool may also assist in guiding the development and targeting of interventions to prevent falls in this group",
"Context Underst and ing and improving the quality of medication management is particularly important in the context of the Medicare prescription drug benefit that took effect last January 2006 . Objective To determine the prevalence of physician – patient dialogue about medication cost and medication adherence among elderly adults nationwide . Design Cross-sectional survey . Participants National stratified r and om sample of community-dwelling Medicare beneficiaries aged 65 and older . Main Outcome Measures Rates of physician – patient dialogue about nonadherence and cost-related medication switching . Results Forty-one percent of seniors reported taking five or more prescription medications , and more than half has 2 or more prescribing physicians . Thirty-two percent overall and 24 % of those with 3 or more chronic conditions reported not having talked with their doctor about all their different medicines in the last 12 months . Of seniors reporting skipping doses or stopping a medication because of side effects or perceived nonefficacy , 27 % had not talked with a physician about it . Of those reporting cost-related nonadherence , 39 % had not talked with a physician about it . Thirty-eight percent of those with cost-related nonadherence reported switching to a lower priced drug , and in a multivariable model , having had a discussion about drug cost was significantly associated with this switch ( odds ratio [ OR ] 5.04 , 95 % confidence interval [ CI ] 4.28–5.93 , P seniors and their physicians around prescription medications . This communication problem is an important quality and safety issue , and takes on added salience as physicians and patients confront new challenges associated with coverage under new Medicare prescription drug plans . Meeting these challenges will require that more attention be devoted to medication management during all clinical encounters",
"The prevention of injury associated with falls in older people is a public health target in many countries around the world . Although there is good evidence that interventions such as multifactorial fall prevention and individually prescribed exercise are effective in reducing falls , the effect on serious injury rates is unclear . Historically , trials have not been adequately powered to detect injury endpoints , and variations in case definition across trials have hindered meta- analysis . It is possible that fall-prevention strategies have limited effect on falls that result in injuries or are ineffective in population s who are at a higher risk of injury . Further research is required to determine whether fall-prevention interventions can reduce serious injuries . Prevention of Falls Network Europe ( ProFaNE ) is a collaborative project to reduce the burden of fall injury in older people through excellence in research and promotion of best practice ( www.profane.eu.org ) . The European Commission funds the network , which links clinicians , members of the public , and research ers worldwide . The aims are to identify major gaps in knowledge in fall injury prevention and to facilitate the collaboration necessary for large-scale clinical research activity , including clinical trials , comparative research , and prospect i ve meta- analysis . Work is being undertaken in a 4-year program . As a first step , the development of a common set of outcome definitions and measures for future trials or meta- analysis was considered",
"INTRODUCTION drugs acting on the central nervous system ( CNS ) increase falls risk . Most data on CNS drugs and falls are in women/mixed-sex population s. This study assessed the relationship between CNS drugs and falls in men aged 60 - 75 years . METHODS a question naire was sent to r and omly selected Danish men aged 60 - 75 years . Cross-sectional data on CNS drugs and falls in the previous year were available for 4,696 men . Logistic regression investigated the relationship between falls and CNS drugs . RESULTS the median age was 66.3 ( IQR = 63.1 - 70.0 ) years ; 21.7 % were fallers . The following were associated with fallers ( OR ; 95 % CI ) : opiates ( 2.4 ; 1.5 - 3.7 ) , other analgesics ( 1.7 ; 1.4 - 2.1 ) , antiepileptics ( 2.8 ; 1.5 - 5.1 ) , antidepressants ( 2.8 ; 1.9 - 4.1 ) and anxiolytics/hypnotics ( 1.5 ; 0.9 - 2.6 ) . Effects of opiates interacted strongly and significantly with age , with a marked association with falls in the older half of the subjects only . No significant associations were found between antipsychotics and fallers . Selective serotonin reuptake inhibitors and tricyclics were significantly associated with fallers ( 3.1 ; 2.0 - 5.0 and 2.2 ; 1.0 - 4.7 , respectively ) . CONCLUSION several CNS drug classes are associated with an approximately 2 - 3-fold increase risk of falls in men aged 60 - 75 years r and omly selected from the population . Further longitudinal data are now required to confirm and further investigate the role of CNS drugs in falls causation in men",
"Objective . The aim of this prospect i ve study was to examine risk factors of falling in a very old home-dwelling population . Design . A prospect i ve study of home-dwelling elderly people . Methods . Baseline data were collected by home-nursing staff through postal question naires and clinical tests . Data on falls were recorded in telephone interviews every other month during a follow-up of 11 months constituting 494 person years ( PY ) . Negative binomial modeling was used to assess fall risk . Setting . General community . Subjects . A population sample of home-dwelling subjects aged 85 years or older ( n = 555 ) . Main outcome measures . Fall rate and risk factors of falls . Results . Altogether 512 falls occurred in 273 ( 49 % ) subjects , incidence rate 1.03/PY . According to a multivariate model , history of recurrent falling , trouble with vision when moving , use of antipsychotic drug , and feelings of anxiety , nervousness , or fear were independent risk factors for subsequent falls . Conclusion . Appropriate care of poor vision and feelings of anxiety , nervousness , or fear , and avoidance of use of antipsychotic drugs might be useful in the prevention of falls among the most elderly home-dwellers ",
"OBJECTIVES Determine the cognitive effect , safety , and tolerability of oral extended-release oxybutynin in cognitively impaired older nursing home residents with urge urinary incontinence . DESIGN R and omized , double-blinded , placebo-controlled trial . SETTING Twelve skilled nursing homes . PARTICIPANTS Fifty women aged 65 and older with urge incontinence and cognitive impairment . INTERVENTION Four-week treatment with once-daily oral extended-release oxybutynin 5 mg or placebo . MEASUREMENTS Withdrawal rates and delirium or change in cognition from baseline at 1 , 3 , 7 , 14 , 21 , and 28 days after starting treatment using the Confusion Assessment Method ( CAM ) , Mini-Mental State Examination ( MMSE ) , and Severe Impairment Battery ( SIB ) . The Brief Agitation Rating Scale , adverse events , falls incidence , and serum anticholinergic activity change with treatment were also assessed . RESULTS Participants ' mean age + /-st and ard deviation was 88.6+/-6.2 , and MMSE baseline score was 14.5+/-4.3 . Ninety-six percent of subjects receiving oxybutynin ( n=26 ) and 92 % receiving placebo ( n=24 ) completed treatment ( P=.50 ) . The differences in mean change in CAM score from baseline to all time points were equivalent between the oxybutynin and placebo groups . Delirium did not occur in either group . One participant receiving oxybutynin was withdrawn because of urinary retention , which resolved without treatment . Mild adverse events occurred in 38.5 % of participants receiving oxybutynin and 37.5 % receiving placebo ( P=.94 ) . CONCLUSION Short-term treatment using oral extended-release oxybutynin 5 mg once daily was safe and well tolerated , with no delirium , in older female nursing home participants with mild to severe dementia . Future research should investigate different dosages and long-term treatment",
"To study risk factors for falling , we conducted a one-year prospect i ve investigation , using a sample of 336 persons at least 75 years of age who were living in the community . All subjects underwent detailed clinical evaluation , including st and ardized measures of mental status , strength , reflexes , balance , and gait ; in addition , we inspected their homes for environmental hazards . Falls and their circumstances were identified during bimonthly telephone calls . During one year of follow-up , 108 subjects ( 32 percent ) fell at least once ; 24 percent of those who fell had serious injuries and 6 percent had fractures . Predisposing factors for falls were identified in linear-logistic models . The adjusted odds ratio for sedative use was 28.3 ; for cognitive impairment , 5.0 ; for disability of the lower extremities , 3.8 ; for palmomental reflex , 3.0 ; for abnormalities of balance and gait , 1.9 ; and for foot problems , 1.8 ; the lower bounds of the 95 percent confidence intervals were 1 or more for all variables . The risk of falling increased linearly with the number of risk factors , from 8 percent with none to 78 percent with four or more risk factors ( P less than 0.0001 ) . About 10 percent of the falls occurred during acute illness , 5 percent during hazardous activity , and 44 percent in the presence of environmental hazards . We conclude that falls among older persons living in the community are common and that a simple clinical assessment can identify the elderly persons who are at the greatest risk of falling",
"STUDY OBJECTIVES We sought to document the degree of polypharmacy , the frequency of adverse drug-related events ( ADREs ) leading to emergency department presentation that were recognized by emergency physicians , and the frequency of potential adverse drug interactions ( PADIs ) in medication regimens of elderly patients in the ED . METHODS We conducted a retrospective chart review on 300 r and omly selected ED visits made by patients 65 years of age and older between January 1 and December 31 , 1998 . ADREs were defined according to a st and ardized algorithm . PADIs were identified by using the drug interaction data base PharmVigilance . RESULTS After excluding 17 patient visits with inadequate documentation , 283 were left for review . Of these , 257 ( 90.8 % ) patients were taking 1 or more medications ( prescribed or over the counter ) . The number of medications consumed ranged from 0 to 17 and averaged 4.2 ( SD+/-3.1 ) drugs per patient . ADREs accounted for 10.6 % of all ED visits in our patient group . The most frequently implicated classes of medications were nonsteroidal anti-inflammatory drugs , antibiotics , anticoagulants , diuretics , hypoglycemics , beta-blockers , calcium-channel blockers , and chemotherapeutic agents . Thirty-one percent of all patients in our group had at least 1 PADI in their medication list . Among patients who presented because of an ADRE , 50 % had at least 1 PADI in their medication list that was unrelated to the ADRE with which they presented . CONCLUSION ADREs are an important cause of ED presentation in the elderly . PADIs are found in a significant proportion of medication lists . Emergency physicians must be vigilant in monitoring elderly patients for medication-related problems",
"OBJECTIVES To evaluate the association between the Drug Burden Index ( DBI ) , a measure of a person 's total exposure to anticholinergic and sedative medications that includes principles of dose-response and maximal effect and is associated with impaired physical function in community-dwelling older people , and falls in residents of residential aged care facilities ( RACFs ) . DESIGN Data were drawn from participants in a r and omized controlled trial that investigated falls and fractures . SETTING RACFs in Sydney , Australia . PARTICIPANTS Study participants ( N=602 ; 70.9 % female ) were recruited from 51 RACFs . Mean age was 85.7 ± 6.4 , and mean DBI was 0.60 ± 0.66 . MEASUREMENTS Medication history was obtained on each participant . Drugs were classified as anticholinergic or sedative and a DBI was calculated . Falls were measured over a 12-month period . Comorbidity , cognitive impairment ( Mini-Mental State Examination ) and depression ( Geriatric Depression Scale ) were determined . RESULTS There were 998 falls in 330 individuals during a follow-up period of 574.2 person-years , equating to an average rate of 1.74 falls per person-year . The univariate negative binomial regression model for falls showed incidence rate ratios of 1.69 ( 95 % confidence interval (CI)=1.22 - 2.34 ) for low DBI ( age , sex , history of falling , cognitive impairment , depression , use of a walking aid , comorbidities , polypharmacy , and incontinence , incident rate ratios of 1.61 ( 95 % CI=1.17 - 2.23 ) for low DBI and 1.90 ( 95 % CI=1.30 - 2.78 ) for high DBI were obtained . CONCLUSION DBI is significantly and independently associated with falls in older people living in RACFs . Interventional studies design ed for this population are needed to determine whether reducing DBI , through dose reduction or cessation of anticholinergic and sedative drugs , can prevent falls ",
"The aim of this study was to describe incidences of falls and fall-related injuries , and to identify predisposing factors for falls in very old people in a prospect i ve population -based follow-up study for falls . The study is part of the Umeå 85 + Study which includes half of the population aged 85 , and the total population aged 90 and > or = 95 ( -103 ) , in Umeå , Sweden . Of the 253 people interviewed , 220 ( 87 % ) were followed up for falls for 6 months , of whom 109 lived in ordinary and 111 in institutional housing . A comprehensive geriatric baseline assessment was made through interviews and testing during home visits . Forty percent of the participants did fall a total 304 times , corresponding to 2.17 falls per Person Year ( PY ) . It occurred 0.83 injuries per PY , including 0.14 fractures per PY . In a Cox regression analysis , the independent explanatory risk factors for time to first fall were dependency in activities of daily living ( ADL ) , thyroid disorders , treatment with selective serotonin reuptake inhibitors ( SSRIs ) and occurrence of falls in the preceding year . It could be predicted that every seventh participant and every third of the people who did fall would suffer a fracture within 1 year . ADL , thyroid disorders and treatment with SSRIs should be considered in fall prevention programmes",
"The objectives of this retrospective case-control study were to identify risk factors of falls in geriatric-psychiatric in patients and develop a screening tool to accurately predict falls . The study sample consisted of 225 geriatric-psychiatric in patients at a Midwestern referral facility . The sample included 136 in patients who fell and a r and om stratified sample of 89 in patients who did not fall . Data collected included age , gender , activities of daily living , and nursing parameters such as bathing assistance , bed height , use of bed rails , one-on-one observation , fall warning system , Conley Scale fall risk assessment , medical diagnosis , and medications . History of falls , impaired judgment , impaired gait , dizziness , delusions , delirium , chronic use of sedative or antipsychotic agents , and anticholinergic urinary bladder medications significantly increased fall risk . Alzheimer 's disease , acute use of sedative or anti-psychotic agents , and depression reduced fall risk . A falls risk tool , Fall Risk Assessment in Geriatric-psychiatric In patients to Lower Events ( FRAGILE ) , was developed for assessment and risk stratification with new diagnoses or medications",
"OBJECTIVES To investigate relationships between the use of cardiovascular medications , including angiotensin system-blocking medications ( ASBMs ) , orthostatic hypotension ( OH ) , fall risk , and falls in community-dwelling older people . DESIGN Prospect i ve cohort study . SETTING Sydney , Australia . PARTICIPANTS Five hundred twenty community-dwelling older adults . MEASUREMENTS Medical , medication and falls history were obtained from a st and ardized question naire in all participants . Blood pressure was measured in supine , seated , and tilted positions . Fall risk was assessed using the Physiological Profile Assessment ( PPA ) . Falls data were collected prospect ively for 12 months using monthly fall calendars . Participants were defined as nonfallers ( no falls ) and fallers ( ≥ 1 falls ) at the end of the 12-month follow-up . RESULTS Participants taking medications affecting the angiotensin system had greater quadriceps strength , but after adjusting for sex , this difference became insignificant . People taking ASBMs were less likely to fall ( odds ratio = 0.68 , 95 % confidence interval = 0.48 - 0.97 ) , and the association between ASBMs and falls remained significant after adjusting for sex , body mass index , PPA score , and psychotropic medication and 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitor ( statin ) use . OH was more frequently observed in participants taking alpha adrenergic receptor blockers ( α-blockers ) , but the presence of OH did not increase fall risk . CONCLUSION The use of cardiovascular medications in older people did not increase the risk of falls , and the use of ASBMs was associated with lower fall risk . The mechanisms for this apparent protective effect are unclear and appear not to be directly related to muscle strength . More research is required to eluci date the possible protective effects of certain cardiovascular medications in relation to falls in older people"
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OBJECTIVE To give an overview of factors related to the level of physical activity in patients with hip or knee osteoarthritis ( OA ) . METHODS An extensive systematic literature search was conducted in PubMed , CINAHL and Embase . Inclusion criteria were : studies on patients with a diagnosis of OA of hip and /or knee , studies describing factors related to physical activity ( objective or subjective ) , full length articles that were published in Dutch , German or English language . Two review ers independently assessed the method ological quality . A best- evidence synthesis was performed for factors which were investigated in two or more studies . RESULTS Eight studies were included , all with a cross-sectional design ( five high quality and three low quality studies ) , result ing in , at most , limited evidence in the best- evidence synthesis . For patients with knee OA there is limited evidence that a lower level of physical function is associated with a lower level of physical activity . There is also limited evidence that depression is not associated with the level of physical activity . For patients with hip OA there is limited evidence that higher age , higher body mass index ( BMI ) and a low level of physical function is associated with a low level of physical activity . CONCLUSION A high age ( hip OA ) , a high BMI ( hip OA ) and a low level of physical function ( both hip and knee OA ) are related to a low level of physical activity . However , the level of evidence was only limited . Before new strategies and interventions to increase physical activity in patients with OA can be developed , high quality longitudinal studies are needed to get more insight in the causality between factors and low levels of physical activity | [
"OBJECTIVE Physical activity improves function in adults with arthritis , but it is unknown if there is a grade d relationship between physical activity and functional benefit . This study was undertaken to examine the cross-sectional and longitudinal relationship between self-reported physical activity and observed functional performance in adults with knee osteoarthritis ( OA ) . METHODS The Osteoarthritis Initiative cohort included 2,589 patients with knee OA ( 2,301 with longitudinal followup data ) who were ages 45 - 79 years at baseline . Prospect i ve annual functional performance was assessed for 2 years using timed 20-meter walk tests . We used linear regression to estimate differences across physical activity quartiles in subsequent function ( baseline and 1-year activity predicts 1-year and 2-year function , respectively ) adjusted for demographic factors ( age , sex , race/ethnicity , education level , and marital status ) and health factors ( OA severity , knee symptoms , knee pain , knee injury , body mass index , comorbidity , depression , smoking , alcohol use , and other joint pain ) . RESULTS Increasing physical activity levels had a significant grade d relationship to functional performance . Adults in physical activity quartile groups from least active to most active had an average gait speed of 4.0 , 4.2 , 4.3 , and 4.5 feet/second , respectively , at baseline ( P for trend physical activity level and better performance in adults with knee OA . These findings support guidelines that encourage patients with arthritis who can not attain minimum recommended physical activity to be as active as possible",
"Background Evidence exists demonstrating the benefits of exercise for people with osteoarthritis , but little is known about whether exercise programs are effective , that is , whether the benefits of exercise can be seen in “ real life ” programs for “ normal ” people under nonlaboratory conditions . Objective To identify characteristics of and outcomes for participants who adhere to a community-based aquatic exercise program . Method Two hundred and forty-nine adults with osteoarthritis were recruited from Washington State for r and omization to a 20-week Arthritis Foundation aquatic exercise program ( n = 125 ) or a wait-list control group ( n = 124 ) . Adherers were defined as those attending at least two classes per week for 16 of 20 weeks . Measures included : Quality of Well Being Scale , Health Assessment Question naire , Center for Epidemiological Studies -Depression Scale , and a single arthritis quality of life rating-item . Results Baseline to postintervention change scores revealed that treatment-group adherers ( N = 35 ) reported improved quality of well-being , physical function , and change in arthritis quality of life compared to controls ( N = 124 ) . When comparing treatment-group adherers ( N = 35 ) to treatment-group nonadherers ( N = 67 ) , quality of well-being and depressed mood improved for adherers , but not for nonadherers . Conclusion When analyzed for level of participation , exercise benefits adults with osteoarthritis . Consistent participation in exercise programs results in better outcomes . Improved methods are needed to enhance adherence , with increased attention to the role of intrinsic factors such as self-efficacy and belief systems",
"BACKGROUND : Earlier observational studies of the relation between physical activity and obesity are inconsistent and ambiguous , showing a clear cross-sectional inverse relation , and a prospect i ve association only when physical activity at the time of follow-up is included . OBJECTIVE : To examine the long-term effect of leisure time physical activity ( LTPA ) on subsequent development of obesity and the effect of body weight on later physical inactivity in a population -based longitudinal setting taking into account the effects of historical changes on future changes as well as pertinent confounders . DESIGN : The study included 3653 women and 2626 men aged 20–78 y selected at r and om within sex – age strata from the general population of Copenhagen . At two surveys , 5 y apart , LTPA , body mass index ( BMI ) ( weight/height2 , kg/m2 ) , several possible confounders and modifying factors were assessed . Obesity ( defined as BMI ≥30 kg/m2 ) and LTPA was assessed at the 3rd survey 10 y later . Odds ratios ( with 95 % confidence limits ) for developing obesity between the last two surveys were estimated by logistic regression analysis , taking into account baseline and preceding changes in BMI and LTPA . A similar analysis of odds ratios for physical inactivity as outcome at the 3rd survey was conducted . RESULTS : Compared to physical inactivity , the odds ratios of development of obesity among women with medium and high level of activity were 0.81 ( 0.53 , 1.25 ) and 1.16 ( 0.73 , 1.84 ) , respectively , and among men , the odds ratios were 1.28 ( 0.71 , 2.33 ) and 1.65 ( 0.91 , 2.99 ) , respectively . Compared to median BMI , the odds ratio of later physical inactivity among women with high BMI was 1.91 ( 1.39 , 2.61 ) , and among men the odds ratio was 1.50 ( 1.01 , 2.22 ) . The associations were not confounded or modified by age , pre-existing diseases , smoking , alcohol intake , educational level , occupational physical activity or by familial predisposition to obesity . CONCLUSION : This study did not support that physical inactivity as reported in the freely living adult population in the long term is associated with the development of obesity , but the study indicates that obesity may lead to physical inactivity",
"OBJECTIVES To investigate the association between baseline physical activity and 1-year functional performance in adults with knee osteoarthritis ( OA ) . DESIGN Prospect i ve cohort study of knee OA development and progression with 1-year follow-up . SETTING Community . PARTICIPANTS Osteoarthritis Initiative public data on adults with knee OA ( n=2274 ; age , 45 - 79y ) who participated in functional performance assessment s ( timed 20-m walk and chair st and test ) at baseline and 1-year follow-up . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURE A good 1-year performance outcome ( separately defined for walk time and chair st and measures ) was improvement from baseline quintile or maintenance in the best quintile . RESULTS Almost 2 in 5 persons with radiographic knee OA improved or maintained high performance at 1 year . Physical activity measured by the Physical Activity Scale for the Elderly ( PASE ) was significantly associated with good walk rate and chair st and outcomes ( odds ratio per 40 units PASE [ 95 % confidence interval]=1.13 [ 1.13 , 1.17 ] and 1.10 [ 1.05 , 1.15 ] , respectively ) , as were participation in sports/recreational activities ( 1.45 [ 1.23 , 1.71 ] and 1.29 [ 1.09 , 1.51 ] , respectively ) and lifestyle activities ( 1.11 [ 1.06 , 1.16 ] and 1.09 [ 1.04 , 1.14 ] , respectively ) . An independent protective relationship for these physical activity measures approached significance after adjusting for sociodemographic and health factors . Older adults reported the least baseline physical activity and least frequent good 1-year outcomes . CONCLUSIONS These findings support public health recommendations to be physically active in order to preserve function for persons with knee OA . Physical activity messages should specifically target older adults whose low activity levels may jeopardize their ability to maintain functional performance"
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BACKGROUND Infertility is a prevalent problem and has significant consequences for individuals , families and the wider community . People 's chance of having a healthy , live birth may be impacted upon by factors such as weight , diet , smoking , other substance abuse , environmental pollutants , infections , medical conditions , medications and family medical history . However , there is no current guideline about what preconception advice should be offered to people presenting for infertility treatment . It is important to determine what preconception advice should be given about these types of factors to such people in order to help them to make positive changes and hopefully improve their chances of conception and delivering a healthy , live baby . OBJECTIVES To assess the effects of preconception advice on the chances of a live birth for people who perceive that they may be infertile and are investigating the possibility of medical treatment to address subfertility . SEARCH STRATEGY All published and unpublished r and omised controlled trials addressing preconception advice to influence lifestyle factors in people who perceived that they may be infertile and investigated the possibility of medical treatment to address subfertility were sought from the Cochrane Menstrual Disorders and Subfertility Review Group Trials Register , Cochrane Central Register of Controlled Trials ( CENTRAL ) , The Cochrane Library , MEDLINE , PubMed , EMBASE , PsycINFO , AMED , Cumulative Index to Nursing and Allied Health Literature ( CINAHL ) , LILACS , trial registers for ongoing and registered trials , citation indexes , ISI Web of Knowledge , Clinical Study Results data base , OpenSIGLE data base , China National Knowledge Infrastructure ( CNKI ) Periodical Index and Google ( inception to 5 October 2009 ) . SELECTION CRITERIA Only r and omised controlled trials ( RCTs ) , including cluster-r and omised ( group-r and omised ) trials , that considered preconception advice given to individuals who perceived that they may be infertile and were investigating the possibility of medical treatment from subfertility specialist services were eligible for inclusion . The primary outcome was live birth , defined as delivery of a live fetus after 20 completed weeks of gestation . DATA COLLECTION AND ANALYSIS Two review authors independently applied eligibility criteria to , extracted data from and assessed the risk of bias in the single included trial . MAIN RESULTS One trial assessing smoking cessation advice for 94 infertile women smokers fulfilled the criteria for this review , but the trial did not report on the review 's primary outcome of live birth or any other fertility-related outcomes . This trial of women attending a fertility clinic showed that smoking cessation advice tailored to a woman 's " stage-of-change " ( readiness to stop smoking ) did not show significant evidence of a difference in stage ( including smoking cessation rates ) compared with st and ard clinical advice . AUTHORS ' CONCLUSIONS No RCTs were located that assessed the effects of preconception advice on the chance of a live birth or other fertility outcomes in people who perceived that they may be infertile and were investigating the possibility of medical treatment to address subfertility . Given the lack of RCTs evaluating the effectiveness of preconception lifestyle advice for people in the afore-mentioned population , this review can not provide guidance for clinical practice in this area . However , it does highlight the need for further research into this important subject | [
"Abstract Objective : To study the association between coffee consumption during pregnancy and the risk of stillbirth and infant death in the first year of life . Design : Prospect i ve follow up study . Setting : Aarhus University Hospital , Denmark , 1989 - 96 . Participants : 18 478 singleton pregnancies in women with valid information about coffee consumption during pregnancy . Main outcome measures : Stillbirth ( delivery of a dead fetus at ≥28 weeks ' gestation ) and infant death ( death of a liveborn infant during the first year of life ) . Results : Pregnant women who drank eight or more cups of coffee per day during pregnancy had an increased risk of stillbirth compared with women who did not drink coffee ( odds ratio=3.0 , 95 % confidence interval 1.5 to 5.9 ) . After adjustment for smoking habits and alcohol intake during pregnancy , the relative risk of stillbirth decreased slightly . Adjustment for parity , maternal age , marital status , years of education , occupational status , and body mass index did not substantially change the estimates of association . There was no significant association between coffee consumption and death in the first year of life after adjustment for smoking habits during pregnancy . Conclusion : Drinking coffee during pregnancy is associated with an increased risk of stillbirth but not with infant death . What is already known on this topic Results from studies in monkeys suggest that high daily doses of caffeine in pregnancy increase the risk of stillbirth , but evidence from studies in humans has been lacking What this study adds Pregnant women who drank eight or more cups of coffee a day had more than twice the risk of stillbirth compared with women who did not drink coffee during",
"Several studies published within the past 10 years indicate that smoking reduces fecundity , but not all studies have found this effect , and smoking cessation is not used routinely in infertility treatment in Europe . The present study was design ed to examine male and female smoking at the start of a couple 's waiting time to a planned pregnancy . Two types of sample s were used : population -based sample s of women aged 25 - 44 years who were r and omly selected in different countries from census registers and electoral rolls , in which the unit of analysis was the couple ; and pregnancy-based sample s of pregnant women ( at least 20 weeks ' pregnant ) who were consecutively recruited during prenatal care visits , in which the unit of analysis was a pregnancy . More than 4,000 couples were included in each sample , and 10 different regions in Europe took part in data collection . The data were collected between August 1991 and February 1993 by personal interview in all population -based sample s and in all but three regions of the pregnancy sample , where self-administered question naires were used . The results based on the population sample showed a remarkably coherent association between female smoking and subfecundity in each individual country and in all countries together , both with the first pregnancy ( odds ratio ( OR ) = 1.7 , 95 % confidence interval ( CI ) 1.3 - 2.1 , at the upper level of exposure ) and during the most recent waiting time to pregnancy ( OR = 1.6 , 95 % CI 1.3 - 2.1 ) . Results based on the pregnancy sample were similar ( OR = 1.7 , 95 % CI 1.3 - 2.3 ) . No significant association was found with male smoking ( in the population sample , OR = 0.9 , 95 % CI 0.7 - 1.1 ( first pregnancy ) and OR = 1.0 , 95 % CI 0.9 - 1.3 ( most recent waiting time ) ; in the pregnancy sample , OR = 0.9 , 95 % CI 0.7 - 1.1 ) . The fecundity distribution among smokers appeared to be shifted toward longer waiting times without a change in the shape of the distribution . Women who have difficulty conceiving should try to stop smoking or to reduce their smoking to less than 10 cigarettes per day",
"AIMS To investigate the association between method of contraception and time to conception in a normal community-based population . DESIGN Prospect i ve , cross-sectional , survey . SETTING Large comprehensive ambulatory women 's health center . PATIENTS AND METHODS One thous and pregnant women at their first prenatal obstetrics visit were asked to complete a self-report question naire . The return to fertility was analyzed by type of contraceptive method , duration of use , and other sociodemographic variables . RESULTS Response rate was 80 % ( n=798 ) . Mean age of the patients was 29.9+/-5 years . Seventy-five percent had used a contraceptive before trying to conceive : 80 % oral contraceptives , 8 % intrauterine device , and 7 % barrier methods . Eighty-six percent conceived spontaneously . Contraceptive users had a significantly higher conception rate than nonusers in the first 3 months from their first attempt at pregnancy . Type of contraception was significantly correlated with time to conception . Pregnancy rates within 6 months of the first attempt was 60 % for oral contraceptive users compared to 70 and 81 % for the intrauterine device and barrier method groups , respectively . There was no correlation between time to conception and parity or duration of contraceptive use . Other factors found to be significantly related to time to conception were older age of both partners and higher body mass index . CONCLUSIONS Contraception use before a planned pregnancy does not appear to affect ease of conception . Type of method used , although not duration of use , may influence the time required to conceive",
"BACKGROUND Most analyses of age-related changes in fertility can not separate effects due to reduced frequency of sexual intercourse from effects directly related to ageing . Information on intercourse collected daily through each menstrual cycle provides the data for estimating day-specific probabilities of pregnancy for specific days relative to ovulation , and these estimates allow unconfounded analysis of ageing effects . METHODS A total of 782 healthy couples using natural family planning methods contributed prospect i ve data on 5860 menstrual cycles . Day of ovulation was based on basal body temperature measurements . Estimates of day-specific probabilities of pregnancy and the length of the fertile window were compared across age groups . RESULTS Nearly all pregnancies occurred within a 6 day fertile window . There was no evidence for a shorter fertile window in older men or women . On average , the day-specific probabilities of pregnancy declined with age for women from the late 20s onward , with probabilities of pregnancy twice as high for women aged 19 - 26 years compared with women aged 35 - 39 years . Controlling for age of the woman , fertility was significantly reduced for men aged > 35 years . CONCLUSIONS Women 's fertility begins to decline in the late 20s with substantial decreases by the late 30s . Fertility for men is less affected by age , but shows significant decline by the late 30s",
"OBJECTIVE To determine the pre-conception practice s among obstetrician-gynaecologists and family physicians in Canada . METHODS Between October 2001 and May 2002 , a survey was mailed to a national r and om sample of obstetricians and gynaecologists ( n = 539 ) and family physicians ( n = 2378 ) who were current members of the College of Family Physicians of Canada or the Society of Obstetricians and Gynaecologists of Canada . RESULTS Response rates were 41.7 % among obstetrician-gynaecologists and 31.1 % among family physicians . More than 85 % of physicians frequently discussed birth control and Pap testing with women of childbearing age , but fewer than 60 % frequently obtained a detailed history of alcohol use . Fewer than 50 % of physicians frequently discussed the following with women of childbearing age : weight management , workplace stress , mental health , addiction history , or the risks of substance use during pregnancy . Fewer than 15 % enquired about a history of sexual or emotional abuse . Family physicians were significantly more likely than obstetrician-gynaecologists to discuss mental health ( 41.1 % vs. 28.1 % ) , depression ( 44.5 % vs. 29.0 % ) , and history of alcohol use ( 59.8 % vs. 47.9 % ) with women of childbearing age ( all P folic acid ( 57.8 % vs. 47.2 % ) , sexual abuse ( 18.2 % vs. 10.8 % ) , smoking ( 56.0 % vs. 46.1 % ) , and drug use ( 45.8 % vs. 35.9 % ) ( all P women with suboptimal reproductive health status who are at risk for adverse conception , pregnancy , and birth outcomes . Physician training in identification of women at risk would allow for increased primary and secondary prevention efforts through referral to appropriate treatment and re sources",
"OBJECTIVE To determine strictly comparable rates per embryo of implantation and birth of a baby related to the woman 's age , which would be representative of natural fertility at least in relative terms . DESIGN Comparative study of IVF-ET results controlling for confounding variables including cause and duration of infertility , history of previous pregnancy , hormonal treatment , rank cycle of treatment , and numbers of embryos transferred and available . SETTING University comprehensive fertility service . PATIENTS All couples ( n = 561 ) in their first cycle of treatment reaching oocyte collection , women with normal uterus and ovulatory cycles , and men with normal sperm . INTERVENTIONS St and ardized methods of pituitary desensitization , ovarian stimulation , and IVF-ET , and maximum of three embryos transferred . MAIN OUTCOME MEASURES Oocytes , pregnancies , and live births per cycle ; fertilization and cleavage rates ; embryo implantation and live baby rates . RESULTS The numbers of oocytes and consequent embryos declined with age but fertilization and cleavage rates rose slightly . Embryo implantation rates were reduced when no more than three embryos were available ( 9.3 percent ) , especially in women aged 35 to 39 years ( 6.2 percent ) or older compared with four or more embryos ( 17.1 percent ) but were equally low in all women over 40 years even with more embryos ( 6.1 percent ) . In the age b and s 25 to 29 , 30 to 34 , 35 to 39 , and 40 to 44 years , the rates per embryo of implantation were 18.2 percent , 16.1 percent , 15.3 percent , and 6.1 percent , respectively , and of a live baby were 15.7 percent , 12.1 percent , 12.0 percent , and 3.5 percent . CONCLUSIONS Embryo implanting ability and survival decline gradually after 30 years of age , but by more than two thirds after 40 years and in younger women with reduced ovarian capacity",
"A prospect i ve study examined the reproductive outcome , live birth , miscarriage or 9 months infertility , in 585 participating couples . Examination of the data relating to environmental and occupational exposure to chemicals and radiation revealed the following associations . Infertility was significantly associated with male factors of age , occupational exposure to dusts and occupation of labourer in men aged 35 or older . Female factors associated with infertility were age and home renovating if aged 35 or older . First trimester spontaneous miscarriage was associated with male factors of age , X-rays of the abdomen or back , occupation as a tradesperson , home exposure to glues , oil paints or oven cleaners . Female factors included age , visiting factories in the course of work , X-rays of the abdomen , home use of glues and working at home if aged less than 35 . The most significant findings of the study are the poor outcomes associated with abdominal/back X-rays and home exposure to chemicals . The possible effects of having different numbers of positive factors was examined for each of miscarriage and 9 months infertility . Nine factors were examined for miscarriage and couples were found to have from zero to seven of these . The observed rate of pregnancy loss ranged from 3.7 % to 75 % with increasing numbers of factors . For infertility , four factors were examined and couples were found to have from zero to four of these . The observed rate of ' infertility ' ranged from 8.4 % to 33.3 % with increasing numbers of factors . The statistical significance of both sets of results is p = < 0.0001 . The effects of these exposures on outcome is thus cumulative",
"The effects of caffeine consumption on delayed conception were evaluated in a European multicenter study on risk factors of infertility . Information was collected retrospectively on time of unprotected intercourse for the first pregnancy and the most recent waiting time episode in a r and omly selected sample of 3,187 women aged 25 - 44 years from five European countries ( Denmark , Germany , Italy , Pol and , and Spain ) between August 1991 and February 1993 . The consumption of caffeinated beverages at the beginning of the waiting time was used to estimate daily caffeine intake , which was categorized as 0 - 100 , 101 - 300 , 301 - 500 , and > or = 501 mg . Risk of subfecundity ( > or = 9.5 months ) and the fecundability ratio , respectively , were assessed by logistic regression and Cox proportional hazard analyses , adjusting for age , parity , smoking , alcohol consumption , frequency of intercourse , educational level , working status , use of oral contraceptives , and country . A significantly increased odds ratio ( OR ) of 1.45 ( 95 % confidence interval ( CI ) 1.03 - 2.04 ) for subfecundity in the first pregnancy was observed for women drinking more than 500 mg of caffeine per day , the effect being relatively stronger in smokers ( OR = 1.56 , 95 % CI 0.92 - 2.63 ) than in nonsmokers ( OR = 1.38 , 95 % CI 0.85 - 2.23 ) . Women in the highest level of consumption had an increase in the time leading to the first pregnancy of 11 % ( hazard ratio = 0.90 , 95 % CI 0.78 - 1.03 ) . These associations were observed consistently in all countries as well as for the most recent waiting time episode . The authors conclude that high levels of caffeine intake may delay conception among fertile women",
"BACKGROUND This study evaluated the timing and amount of caffeine intake by women and men undergoing IVF and gamete intra-Fallopian transfer ( GIFT ) on oocyte retrieval , sperm parameters , fertilization , multiple gestations , miscarriage , and live births . METHODS A prospect i ve study of 221 couples was conducted in Southern California between 1993 and 1998 . \" Usual \" caffeine intake during lifetime and 1 year prior to attempt , caffeine intake during the week of the initial clinic visit , as well as intake during the week of the procedure , was evaluated from beverages ( coffee , soda , tea ) and chocolates . RESULTS Not achieving a live birth was significantly associated with \" usual \" female caffeine consumption [ adjusted odds ratios ( 95 % confidence intervals ) : 3.1 ( 1.1 , 9.7 ) and 3.9 ( 1.3 , 11.6 ) for intake of > 2 - 50 and 50 mg/day , compared with 0 - 2 mg/day ] and consumption during the week of the initial visit [ 2.9 ( 1.1 , 7.5 ) and 3.8 ( 1.4 , 10.7 ) ] female compared with 0 - 2 mg/day , although caffeine use was low . Infant gestational age decreased by 3.8 ( -6.9 , -0.7 ) or 3.5 ( -6.7 , -0.3 ) weeks for women who consumed > 50 mg/day of caffeine \" usually \" or during the week of the initial visit . The odds of having multiple gestations increased by 2.2 ( 1.1 , 4.4 ) and 3.0 ( 1.2 , 7.4 ) for men who increased their \" usual \" intake or intake during the week of the initial visit by an extra 100 mg/day . Caffeine intake was not significantly associated with other outcomes . CONCLUSIONS This is the first IVF/GIFT study to report any effect of caffeine on live births , gestational age , and multiple gestations . If these findings are replicated , caffeine use should be minimized prior to and while undergoing IVF/GIFT",
"OBJECTIVE To assess a \" stage-of-change \" oriented smoking cessation intervention for infertile and pregnant women , compared with st and ard of care . DESIGN R and omized controlled trial . SETTING Three university teaching hospitals in Hamilton , Ontario , Canada . PATIENT(S ) Infertile women at their first visit to a tertiary referral infertility clinic ( n = 94 ) and new patients seeking pre-natal care ( n = 110 ) who had smoked > /= 3 cigarettes in the past six months . INTERVENTION(S ) A three to five minute scripted intervention and booklet specific to the woman 's \" stage-of-change \" in the smoking continuum , versus st and ard of care . Exhaled carbon-monoxide ( CO ) monitoring was used to vali date exposure in both groups . MAIN OUTCOME MEASURE(S ) Delta \" stage-of-change \" and rate of maintained cessation at 12 months post follow-up . RESULT ( S ) Intervention and control were similarly effective for infertile women : the rate of maintained cessation rose significantly from 4 % to 24 % over twelve months , with a mean delta \" stage-of-change \" 0.28 . In prenatal women , neither approach was effective . Maintained cessation did not significantly change from 0 to 12 months ( 19 % to 18 % ) . Mean delta \" stage-of-change \" declined by -0.62 . CONCLUSION ( S ) For infertile women , basic information describing the impact of smoking on fertility , along with exhaled CO monitoring and a more intensive intervention were both highly effective . In pregnant women neither approach was beneficial , with some evidence of post-partum relapse",
"OBJECTIVE To examine the effects of alcohol and caffeine on conception . DESIGN Prospect i ve observational study . SETTING Healthy volunteers in two manufacturing facilities . PATIENT(S ) One hundred twenty-four women who provided daily urine sample s for measurement of steroid hormones and hCG , and prospect i ve information about alcohol and caffeine consumption . MAIN OUTCOME MEASURE(S ) Probability of conception per 100 menstrual cycles . RESULT ( S ) There was > 50 % reduction in the probability of conception during a menstrual cycle during which participants consumed alcohol . Caffeine consumption did not independently affect the probability of conception but may enhance alcohol 's negative effect . Women who abstained from alcohol and consumed less than one cup of coffee or its equivalent per day conceived 26.9 pregnancies per 100 menstrual cycles compared with 10.5 per 100 menstrual cycles among those who consumed any alcohol and more than one cup of coffee per day . CONCLUSIONS This study revealed an independent dose-related negative effect of alcohol consumption on the ability to conceive . Our results suggest that women who are attempting to conceive should abstain from consuming alcohol",
"Correction to Maternal caffeine intake during pregnancy and risk of fetal growth restriction : a large prospect i ve observational study , dx.doi.org/10.1136/bmj.a2332 available on the LRA at http://hdl.h and",
"OBJECTIVE To determine whether the amount and timing of female and male alcohol use during IVF and GIFT affect reproductive endpoints . DESIGN Multicenter prospect i ve study . SETTING Clinics in southern California . PATIENT(S ) Two hundred twenty-one couples with female infertility . INTERVENTION(S ) None . MAIN OUTCOME MEASURE(S ) Egg retrieval , transfer , fertilization , pregnancy , miscarriage , live birth , and multiple gestations . RESULT ( S ) Female alcohol consumption was associated with : ( 1 ) a 13 % decrease in the number of eggs aspirated ( adjusted 95 % confidence interval [ CI ] : -2 % to -23 % , for one additional drink per day , 1 year before the IVF or GIFT attempt ) ; ( 2 ) an increase in risk of not achieving pregnancy by 2.86 times ( 0.99 - 8.24 , 1 month prior ) ; and ( 3 ) an increase in risk of miscarriage by 2.21 times ( 1.09 - 4.49 , 1 week before the procedure ) . For men , one additional drink per day increased the risk of not achieving a live birth by 2.28 ( 1.08 - 4.80 ) to 8.32 ( 1.82 - 37.97 ) times , depending on the time period ; beer also affected live births ( ORs = 5.49 - 45.64 ) . This outcome may be due partially to increased risk of miscarriage by 2.70 to 38.04 times for men who drank IVF and GIFT . CONCLUSION ( S ) This is the first study to report an association between alcohol use and reproductive endpoints of IVF and GIFT . Because alcohol use is ubiquitous , modifying drinking habits may increase assisted reproductive technology success rates"
] | 411690ac-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Catheter ablation ( CA ) is commonly performed for persistent atrial fibrillation , but few high- quality r and omized controlled trials ( RCTs ) exist , leading to funding restrictions being proposed in several countries . We performed a r and om-effects meta- analysis of RCTs and non- RCTs to assess the efficacy of CA for persistent atrial fibrillation . METHODS AND RESULTS We systematic ally search ed PubMed , EMBASE , CENTRAL , OpenGrey , and clinical trials.gov for RCTs and non- RCTs reporting clinical outcomes after CA for persistent atrial fibrillation . Forty-six eligible studies were identified containing 3819 patients . After a single procedure , CA significantly reduced the risk of recurrent atrial fibrillation compared with medical therapy ( odds ratio [ OR ] , 0.32 ; 95 % confidence interval [ CI ] , 0.20 - 0.53 ; P AF recurrence compared with purely anatomic encirclement ( OR , 0.33 ; 95 % CI , 0.13 - 0.86 ; P=0.02 ) . Linear ablation within the left atrium ( OR , 0.22 ; 95 % CI , 0.10 - 0.49 ; P complex fractionated atrial electrogram ablation ( OR , 0.64 ; 95 % CI , 0.35 - 1.18 ; P=0.15 ) , significantly reduced AF recurrence . Results were not improved by performing more extensive linear lesion sets ( OR , 0.77 ; 95 % CI , 0.41 - 1.43 ; P=0.40 ) or from biatrial ablation ( OR , 0.62 ; 95 % CI , 0.31 - 1.24 ; P=0.17 ) . Where data were available , the relative benefits seen held true both after a single or multiple procedure(s ) . Sensitivity analyses showed that inclusion of non- RCTs increased statistical power without biasing the calculated effect sizes . CONCLUSIONS For patients with persistent atrial fibrillation , CA achieves significantly greater freedom from recurrent atrial fibrillation compared with medical therapy . The most efficacious strategy is likely to combine isolation of the pulmonary veins with limited linear ablation within the left atrium | [
"Background — Data regarding the long-term efficacy of atrial fibrillation ( AF ) ablation are still lacking . Methods and Results —Two hundred four consecutive patients symptomatic for paroxysmal or persistent/permanent AF were r and omly assigned to 2 different ablation schemes : pulmonary vein isolation ( PVI ) and PVI plus left linear lesions ( LL ) . Primary end point was to assess the maintenance of sinus rhythm ( SR ) after procedures 1 and 2 in the absence of antiarrhythmic drugs in a long-term follow-up of at least 3 years . Paroxysmal AF — With a single procedure at 12-month follow-up , 46 % of patients treated with PVI maintained SR , whereas at 3-year follow-up , 29 % were in SR ; using the “ PVI plus LL ” at the 12-month follow-up , 57 % of patients were in SR , whereas at the 3-year follow-up , 53 % remained in SR . After a second procedure , the long-term overall success rate without antiarrhythmic drugs was 62 % with PVI and 85 % with PVI plus LL . Persistent/Permanent AF — With a single procedure at the 12-month follow-up , 27 % of patients treated with PVI were in SR , whereas at the 3-year follow-up , 19 % maintained SR ; using the PVI plus LL with a single procedure at the 12-month follow-up 45 % of patients were in SR , whereas at the 3-year follow-up , 41 % remained in SR . After a second procedure , the long-term overall success rate without antiarrhythmic drugs was 39 % with PVI and 75 % with PVI plus LL . Conclusions —A long-term follow-up of AF ablation shows that short-term results can not be considered permanent because AF recurrences are still present after the first year especially in patients who have had “ PVI ” strategy . PVI isolation plus LL is superior to the PVI strategy in maintaining SR without antiarrhythmic drugs after procedures 1 and 2 both in paroxysmal and persistent AF",
"BACKGROUND Recent data have shown that the septum and anterior left atrial ( LA ) wall may contain \" rotor \" sites required for AF maintenance . However , whether adding ablation of such sites to st and ard ICE-guided PVAI improves outcome is not well known . OBJECTIVE To determine if adjuvant anterior LA ablation during PVAI improves the cure rate of paroxysmal and permanent AF . METHODS One hundred AF patients ( 60 paroxysmal , 40 persistent/permanent ) undergoing first-time PVAI were enrolled over three months to receive adjuvant anterior LA ablation ( Group I ) . These patients were compared with 100 r and omly selected , matched first-time PVAI controls from the preceding three months who did not receive adjuvant ablation ( Group II ) . All 200 patients underwent ICE-guided PVAI during which all four PV antra and SVC were isolated . In group I , a decapolar lasso catheter was used to map the septum and anterior LA wall during AF ( induced or spontaneous ) for continuous high-frequency , fractionated electrograms ( CFAE ) . Sites where CFAE were identified were ablated until the local EGM was eliminated . A complete anterior line of block was not a requisite endpoint . Patients were followed up for 12 months . Recurrence was assessed post-PVAI by symptoms , clinic visits , and Holter at 3 , 6 , and 12 months . Patients also wore rhythm transmitters for the first 3 months . Recurrence was any AF/AFL > 1 min occurring > 2 months post-PVAI . RESULTS Patients ( age 56 + /- 11 years , 37 % female , EF 53%+/- 11 % ) did not differ in baseline characteristics between group I and II by design . Group I patients had longer procedure time ( 188 + /- 45 min vs 162 + /- 37 min ) and RF duration ( 57 + /- 12 min vs 44 + /- 20 min ) than group II ( P Overall recurrence occurred in 15/100 ( 15 % ) in group I and 20/100 ( 20 % ) in group II ( P = 0.054 ) . Success rates did not differ for paroxysmal patients between group I and II ( 87 % vs 85 % , respectively ) . However , for persistent/permanent patients , group I had a higher success rate compared with group II ( 82 % vs 72 % , P = 0.047 ) . CONCLUSIONS Adjuvant anterior LA ablation does not appear to impact procedural outcome in patients with paroxysmal AF but may offer benefit to patients with persistent/permanent AF",
"AIMS To investigate the effectiveness of additional substrate modification ( SM ) by left atrial ( LA ) linear lesions as compared with pulmonary vein isolation ( PVI ) alone in patients with persistent atrial fibrillation ( AF ) in a prospect i ve r and omized study . Percutaneous PVI has evolved as an accepted treatment for paroxysmal AF but seemed to be less effective in patients with persistent AF . The benefit of PVI alone and additional linear lesions has not been vali date d in a r and omized study so far . METHODS AND RESULTS Sixty-two patients with persistent AF ( median duration 7 , range 1 - 18 months ) were r and omly assigned to either PVI alone ( n = 30 ) or additional SM ( n = 32 ) consisting of a roof line connecting both left superior and right superior PV and LA isthmus ablation between left inferior PV and mitral annulus . Procedures including SM were performed using a three-dimensional mapping system ( EnSite NavX , St Jude Medical , St Paul , MN , USA ) . Anti-arrhythmic drugs were discontinued within 8 weeks after ablation in both groups . Follow-up included daily trans-telephonic ECG transmitted irrespective of the patient 's symptoms . PVI was successful in 98 % of all targeted veins in both groups . Additional SM did not increase fluoroscopy time ( 72.1+/-18.7 vs. 72.9+/-17.3 min , P=0.92 ) because of the use of three-dimensional navigation in the PVI+SM group . AF recurrences within the first 4 weeks following ablation were more common after PVI alone ( 77 % ) than additional SM ( 44 % , P=0.002 ) . After a follow-up time of 487 ( 429 - 570 ) days , only 20 % of patients undergoing st and alone PVI remained in sinus rhythm when compared with 69 % following PVI combined with SM ( P=0.0001 ) . Two patients assigned to PVI+SM experienced procedure-related complications ( cardiac tamponade and minor stroke ) which resolved without sequelae . CONCLUSION PVI alone is insufficient in the treatment of persistent AF . However , additional left linear lesions increase the success rate significantly . Early AF-relapses are associated with a negative outcome after PVI alone but not following additional SM",
"Background —With electrogram-guided radiofrequency ablation ( RFA ) of long-lasting persistent atrial fibrillation ( AF ) , the best results have been reported when complex fractionated electrograms ( CFAEs ) in both the left ( LA ) and right ( RA ) atria were targeted . However , many studies have reported excellent outcomes from RFA of long-lasting persistent AF with the use of other ablation strategies that were limited to the LA . The incremental value of RFA of RA CFAEs is yet to be defined . Methods and Results —In 85 patients with long-lasting persistent AF ( age=59±10 years ) , RFA was directed at CFAEs in the LA and coronary sinus until AF terminated ( 19 ) or all identified LA CFAEs were eliminated . Sixty-six patients who remained in AF were r and omly assigned to cardioversion and no further RFA ( n=33 ) or to RFA of RA CFAEs ( n=33 ) . RA sites consisted of the crista terminalis ( 69 % ) , septum ( 38 % ) , superior vena cava ( 28 % ) , coronary sinus ostium ( 22 % ) , and the base of the appendage ( 31 % ) . AF terminated in 1 ( 3 % ) of 33 patients during RA RFA . At 17±6 months after a single ablation procedure , 74 % of the patients in whom AF terminated during LA RFA were in sinus rhythm . Rates of freedom from AF were similar in the patients r and omized to no RFA in the RA ( 24 % ) and those r and omized to RFA of RA CFAEs ( 30 % , P=0.8 ) . The ablation procedure was repeated in 26 patients ( 31 % ) for AF ( n=22 ) or atrial flutter ( n=4 ) . At 16±7 months after the final procedure , 89 % of the patients in whom AF terminated during LA RFA were in sinus rhythm . Among the r and omized patients , the proportion of patients who remained in sinus rhythm was similar in patients who did not undergo RFA of RA CFAEs ( 52 % ) and those who did ( 58 % , P=0.6 ) . Conclusion —After RFA of CFAEs in the LA and coronary sinus , ablation of CFAEs in the RA provides little or no increment in efficacy among patients with long-lasting persistent AF",
"Background — Pulmonary vein ( PV ) isolation is a promising new treatment for atrial fibrillation ( AF ) . We hypothesized that isolation of large areas around both ipsilateral PVs with verification of conduction block is more effective than the isolation of each individual PV . Methods and Results — A total of 110 patients , 67 with paroxysmal AF and 43 with persistent AF , were r and omly assigned to undergo either isolation of each individual PV or isolation of large areas around both ipsilateral PVs . The isolation of each individual PV was an electrophysiologically guided , ostial segmental ablation with a 64-pole basket catheter or a 20-pole circular mapping catheter ( group I ) . Isolation of large areas was performed around the 2 ipsilateral veins with a nonfluoroscopic navigation system and a circular 20-pole mapping catheter for verification of conduction block ( group II ) . In both groups , an irrigated-tip ablation catheter ( 25 to 35 W ) was used to achieve complete isolation . Procedure and ablation times were longer in group II , whereas fluoroscopic time was significantly shorter ( P≤0.001 ) . After a follow-up period of 15±4 months , 27 patients in group I ( 49 % ) and 37 patients in group II ( 67 % ) remained free of symptoms of AF and had no AF or atrial flutter during repetitive Holter monitoring without antiarrhythmic drug treatment after a single procedure ( P≤0.05 ) . Conclusions — The rate of success was significantly higher and fluoroscopy times were significantly lower in the group with large isolation areas around both ipsilateral PVs than in those who underwent individual PV isolation",
"BACKGROUND The role of pulmonary veins ( PV ) isolation in patients with persistent atrial fibrillation ( AF ) is still debated . The aim of this study was to evaluate the adjunctive role of PV isolation in patients with persistent AF who underwent circumferential PV ablation ( anatomical approach ) . METHODS We treated 97 consecutive patients presenting with drug-refractory persistent AF by an anatomical approach ( group A , n = 36 , mean age = 60 + /- 8 years , 29 males ) or an integrated approach ( group B , n = 61 , mean age 59 + /- 10 years , 48 males ) . In all patients , radiofrequency ( RF ) ablation was performed by means of a nonfluoroscopic navigation system , in order to anatomically create circumferential lines around the PV . In group B , the persistence of PV potentials was ascertained with a multipolar circular catheter . If PV potentials persisted , RF energy targeting the electrophysiological breakthroughs was delivered to disconnect the PV . Past a 2-month period of observation , success was defined as absence of any atrial tachyarrhythmia recurrence lasting > 30 seconds . RESULTS Total procedure duration ( 220 + /- 62 minutes vs 140 + /- 43 minutes , P fluoroscopy time ( 35 + /- 15 minutes vs 17 + /- 9 minutes , P RF delivery time ( 48 + /- 22 minutes vs 27 + /- 9 minutes , P cardiac perforation occurred in group A. After 15 + /- 9.1 months , 21 patients in group A ( 58 % ) and 34 patients in group B ( 56 % ) were free of atrial tachyarrhythmia recurrence ( P = 0.9 ) . CONCLUSIONS In patients with persistent AF , who underwent an anatomical approach , electrophysiological confirmation of PV disconnection significantly increased the fluoroscopy and procedural times , without effect on the long-term outcomes",
"BACKGROUND Pulmonary veins ( PVs ) have been shown to represent the most frequent sites of ectopic beats initiating paroxysmal atrial fibrillation ( AF ) . However , additional non-PV triggers , arising from different areas , have been reported as well . One of the most common non-PV sites described is the superior vena cava . AIMS The purpose of the study was to investigate the impact result ing from the systematic isolation of the superior vena cava ( SVCI ) in addition to pulmonary vein antrum isolation ( PVAI ) on the outcome of paroxysmal , persistent , and permanent AF ablation . METHODS A total of 320 consecutive patients who had been referred to our center in order to undergo a first attempt of AF ablation were r and omized into 2 groups . Group I ( 160 patients ) underwent PVAI only ; Group II ( 160 patients ) underwent PVAI and SVCI . RESULTS AF was paroxysmal in 134 ( 46 % ) , persistent in 75 ( 23 % ) , and permanent in 111 ( 31 % ) of said patients . SVCI was performed on 134 of the 160 patients ( 84 % ) in Group II . SVC isolation was not performed on the remaining 26 patients either because of phrenic nerve capture or the lack of SVC potentials . Comparison of the outcome data between the 2 groups , after a follow-up of 12 months , revealed a significant difference in total procedural success solely with patients manifesting paroxysmal atrial fibrillation ( 56/73 [ 77 % ] Group I vs. 55/61 [ 90 % ] Group II ; P = 0.04 ; OR 2.78 ) . CONCLUSIONS In our study , the strategy of the empiric SVCI in addition to PVAI has improved the outcome of AF ablation solely in patients manifesting paroxysmal AF",
"BACKGROUND Left atrial ( LA ) circumferential ablation has been reported to eliminate atrial fibrillation ( AF ) . Whether an ablation without encirclement of the pulmonary veins ( PVs ) is as effective as LA circumferential ablation is not clear . OBJECTIVES The purpose of this study was to compare the efficacy of LA circumferential ablation and nonencircling linear ablation in patients with chronic AF . METHODS Eighty patients with chronic AF were r and omized to undergo LA circumferential ablation ( n = 40 ) or nonencircling linear ablation ( n = 40 ) . In LA circumferential ablation , the PVs were encircled , with additional lines made in the mitral isthmus and posterior wall or roof . In nonencircling linear ablation , 4 + /- 1 ablation lines were created through areas of complex electrograms , with lines in the roof ( 38 ) , anterior wall ( 36 ) , septum ( 40 ) , mitral isthmus ( 32 ) , and posterior annulus ( 6 ) . The endpoint of LA circumferential ablation and nonencircling linear ablation was voltage abatement . RESULTS LA flutter occurred in 15 % after LA circumferential ablation and in 18 % after nonencircling linear ablation ( P = .8 ) . A repeat ablation procedure was performed for recurrent AF in 7 and 11 patients or for atrial flutter in 6 and 4 patients after LA circumferential ablation and nonencircling linear ablation , respectively ( P = .8 ) . At 9 + /- 4 months , the prevalence of AF was 28 % in the LA circumferential ablation and 25 % in the nonencircling linear ablation group ( P = .8 ) . Sixty-eight percent and 60 % of patients were in sinus rhythm and free of AF and atrial flutter in the absence of antiarrhythmic drug therapy after LA circumferential ablation and nonencircling linear ablation , respectively ( P = .5 ) . There were no complications . CONCLUSION Nonencircling linear ablation and LA circumferential ablation are equally efficacious in eliminating chronic AF . However , the advantage of nonencircling linear ablation is that it eliminates the need for ablation along the posterior wall of the LA . Therefore , nonencircling linear ablation may avoid the small but real risk of atrioesophageal fistula formation associated with LA circumferential ablation",
"BACKGROUND This prospect i ve multicenter r and omized study aim ed to compare the efficacy of 3 common ablation methods used for longst and ing permanent atrial fibrillation ( AF ) . METHODS A total of 144 patients with longst and ing permanent AF ( median duration 28 months ) were r and omly assigned to circumferential pulmonary vein ablation ( CPVA , group 1 , n = 47 ) , to pulmonary vein antrum isolation ( PVAI , group 2 , n = 48 ) or to a hybrid strategy combining ablation of complex fractionated or rapid atrial electrograms ( CFAE ) in both atria followed by a pulmonary vein antrum isolation ( CFAE + PVAI , group 3 , n = 49 ) . RESULTS Scarring in the left atrium and structural heart disease/hypertension were present in most patients ( 65 % ) . After a mean follow-up of 16 months , 11 % of patients in group 1 , 40 % of patients in group 2 and 61 % of patients in group 3 were in sinus rhythm after one procedure and with no antiarrhythmic drugs ( P Sinus rhythm maintenance would increase respectively to 28 % ( group 1 ) , 83 % ( group 2 ) , and 94 % ( group 3 ) after 2 procedures and with antiarrhythmic drugs ( AADs , P conversion to sinus rhythm or organization into an atrial tachyarrhythmia , in 13 % of patients ( group 1 ) , 44 % ( group 2 ) , and 74 % ( group 3 ) respectively . CFAE alone , performed as the first step of the ablation in group 3 , organized AF in only 1 patient . CONCLUSION In this study , the hybrid AF ablation strategy including antrum isolation and CFAE ablation had the highest likelihood of maintaining sinus rhythm in patients with longst and ing permanent AF . Electrical isolation of the PVs , although inadequate if performed alone , is relevant to achieve long-term sinus rhythm maintenance after ablation . Bi-atrial CFAE ablation had a minimal impact on AF termination during ablation",
"BACKGROUND Several studies have provided details of left atrial anatomy by means of the image integration techniques , particularly focusing on the atypical patterns of the pulmonary veins . OBJECTIVE To compare , in a prospect i ve , r and omized fashion , the conventional method of pulmonary vein disconnection and the image integration-guided approach . METHODS Two hundred and ninety consecutive patients ( 290 patients , mean age 55 + /- 11 years ) with drug-refractory paroxysmal or persistent atrial fibrillation were enrolled in the study and were divided into two treatment groups : group 1 ( 145 patients ) undergoing an imaging integration-guided ( CartoMerge TM ) ablation ; group 2 ( 145 patients ) treated by a conventional radiofrequency catheter ablation procedure . The arrhythmia was refractory to at least two antiarrhythmic drugs ( IC , amiodarone ) . RESULTS Electrical disconnection of all identified pulmonary veins was obtained in all patients of both groups . Bidirectional block of the cavotricuspid isthmus was achieved in 34 group 1 patients and in 40 group 2 patients . Left mitral isthmus ablation was attempted in 52 group 1 patients and in 56 group 2 patients . At a mean follow-up of 14 + /- 12 months , the atrial fibrillation-free survival rate was significantly higher in group 1 patients compared with group 2 patients ( 88 % vs 69 % , P = 0.017 ) . The analysis for the subset of patients with previously ineffective ablation ( 98 patients : 52 group 1 patients and 46 group 2 patients ) showed a significantly lower recurrence rate in group 1 versus group 2 ( 19 % vs 48 % , P image-integration guided catheter ablation of atrial fibrillation over the long term",
"Background — Steerable sheath technology is design ed to facilitate catheter access , stability , and tissue contact in target sites of atrial fibrillation ( AF ) catheter ablation . We hypothesized that rhythm control after interventional AF treatment is more successful using a steerable as compared with a nonsteerable sheath access . Methods and Results — One hundred thirty patients with paroxysmal or persistent drug-refractory AF undergoing their first ablation procedure were prospect ively included in a r and omized fashion in 2 centers . Ablation was performed by 10 operators with different levels of clinical experience . Treatment outcome was measured with serial 7-day Holter ECGs and additional symptom-based arrhythmia documentation . Single procedure success ( freedom from AF and /or atrial macroreentrant tachycardia ) was significantly higher in patients ablated with a steerable sheath ( 78 % versus 55 % after 3 months , P=0.005 ; 76 % versus 53 % after 6 months , P=0.008 ) . Rate of pulmonary vein isolation , procedure duration , and radiofrequency application time did not differ significantly , whereas fluoroscopy time was lower in the steerable sheath group ( 33±14 minutes versus 45±17 minutes , P rates showed no significant difference ( 3.2 % versus 5 % , P=0.608 ) . On multivariable analysis , steerable sheath usage remained the only powerful predictor for rhythm outcome after 6 months of follow-up ( hazard ratio , 2.837 [ 1.197 to 6.723 ] ) . Conclusions — AF catheter ablation using a manually controlled , steerable sheath for catheter navigation result ed in a significantly higher clinical success rate , with comparable complication rates and with a reduction in periprocedural fluoroscopy time . Clinical Trial Registration — URL : http:// clinical trials.gov . Unique identifier : NCT00469638",
"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 Catheter ablation of complex fractionated atrial electrograms ( CFAE ) for persistent atrial fibrillation ( AF ) is a promising treatment strategy . We tested the hypothesis that CFAE ablation is superior to linear ablation in patients with persistent or long-st and ing persistent AF . METHODS In this study , 116 patients with persistent AF were r and omly assigned to undergo circumferential PVI plus additional lines ( linear ablation group ; 59 patients ) or CFAE ablation plus ostial pulmonary vein isolation ( PVI ) ( spot ablation group ; 57 patients ) . Primary endpoint was freedom from atrial tachyarrhythmia after a single ablation procedure ( clinical and repeat 7-day Holter ) , 12 months after ablation without antiarrhythmic medication . RESULTS The primary endpoint was reached in 22 of 59 ( 37 % ) patients of the linear ablation group and in 22 of 57 ( 39 % ) patients of the spot ablation group ( P = 0.9 ) . Freedom from atrial tachyarrhythmias , including reablations , was achieved in 54 % of patients ( linear ablation group ) versus 56 % of patients ( spot ablation group ; P = 0.8 ) . The incidence of recurrent persistent AF was higher after linear ablation than after spot ablation ( 21/37 vs 11/35 patients ; P = 0.03 ) ; atrial tachycardia ( AT ) was seen more often after spot ablation ( 10/35 vs 4/37 patients ; P = 0.03 ) . CONCLUSION In patients with persistent AF , CFAE ablation plus PVI reaches the same results as circumferential PVI plus lines , in terms of freedom from symptomatic atrial tachyarrhythmias within the first year after a single ablation procedure . Arrhythmia recurrences in patients after spot ablation were caused more often by AT , whereas recurrent persistent AF was more prevalent after the linear ablation approach",
"Background Catheter ablation ( CA ) is a highly effective therapy for the treatment of paroxysmal atrial fibrillation ( AF ) when compared with antiarrhythmic drug therapy ( ADT ) . No r and omized studies have compared the two strategies in persistent AF . The present r and omized trial aim ed to compare the effectiveness of CA vs. ADT in treating persistent AF . Methods and results Patients with persistent AF were r and omly assigned to CA or ADT ( excluding patients with long-st and ing persistent AF ) . Primary endpoint at 12-month follow-up was defined as any episode of AF or atrial flutter lasting > 24 h that occurred after a 3-month blanking period . Secondary endpoints were any atrial tachyarrhythmia lasting > 30 s , hospitalization , and electrical cardioversion . In total , 146 patients were included ( aged 55 ± 9 years , 77 % male ) . The ADT group received class Ic ( 43.8 % ) or class III drugs ( 56.3 % ) . In an intention-to-treat analysis , 69 of 98 patients ( 70.4 % ) in the CA group and 21 of 48 patients ( 43.7 % ) in the ADT group were free of the primary endpoint ( P = 0.002 ) , implying an absolute risk difference of 26.6 % ( 95 % CI 10.0–43.3 ) in favour of CA . The proportion of patients free of any recurrence ( > 30 s ) was higher in the CA group than in the ADT group ( 60.2 vs. 29.2 % ; P 0.018 ) . Conclusion Catheter ablation is superior to medical therapy for the maintenance of sinus rhythm in patients with persistent AF at 12-month follow-up . Clinical Trial Registration Information NCT00863213 ( http:// clinical trials.gov/ct2/show/NCT00863213 )",
"Background — Together with pulmonary veins , many extrapulmonary vein areas may be the source of initiation and maintenance of atrial fibrillation . The left atrial appendage ( LAA ) is an underestimated site of initiation of atrial fibrillation . Here , we report the prevalence of triggers from the LAA and the best strategy for successful ablation . Methods and Results — Nine hundred eighty-seven consecutive patients ( 29 % paroxysmal , 71 % nonparoxysmal ) undergoing redo catheter ablation for atrial fibrillation were enrolled . Two hundred sixty-six patients ( 27 % ) showed firing from the LAA and became the study population . In 86 of 987 patients ( 8.7 % ; 5 paroxysmal , 81 nonparoxysmal ) , the LAA was found to be the only source of arrhythmia with no pulmonary veins or other extrapulmonary vein site reconnection . Ablation was performed either with focal lesion ( n=56 ; group 2 ) or to achieve LAA isolation by placement of the circular catheter at the ostium of the LAA guided by intracardiac echocardiography ( 167 patients ; group 3 ) . In the remaining patients , LAA firing was not ablated ( n=43 ; group 1 ) . At the 12±3-month follow-up , 32 patients ( 74 % ) in group 1 had recurrence compared with 38 ( 68 % ) in group 2 and 25 ( 15 % ) in group 3 ( P arrhythmias in 27 % of patients presenting for repeat procedures . Isolation of the LAA could achieve freedom from atrial fibrillation in patients presenting for a repeat procedure when arrhythmias initiating from this structure are demonstrated",
"BACKGROUND We conducted a r and omized , controlled trial of circumferential pulmonary-vein ablation for the treatment of chronic atrial fibrillation . METHODS A total of 146 patients with a mean ( + /-SD ) age of 57+/-9 years who had chronic atrial fibrillation were r and omly assigned to receive amiodarone and undergo two cardioversions during the first three months alone ( the control group ) or in combination with circumferential pulmonary-vein ablation . Cardiac rhythm was assessed with daily telephonic transmissions for one year . The left atrial diameter and the severity of symptoms were assessed at 12 months . RESULTS Among the 77 patients assigned to undergo circumferential pulmonary-vein ablation , ablation was repeated because of recurrent atrial fibrillation in 26 percent of patients and atypical atrial flutter in 6 percent . An intention-to-treat analysis showed that 74 percent of patients in the ablation group and 58 percent of those in the control group were free of recurrent atrial fibrillation or flutter without antiarrhythmic-drug therapy at one year ( P=0.05 ) . Among the 69 patients in the control group , 53 ( 77 percent ) crossed over to undergo circumferential pulmonary-vein ablation for recurrent atrial fibrillation by one year and only 3 ( 4 percent ) were in sinus rhythm without antiarrhythmic-drug therapy or ablation . There were significant decreases in the left atrial diameter ( 12+/-11 percent , P symptom severity score ( 59+/-21 percent , P Sinus rhythm can be maintained long term in the majority of patients with chronic atrial fibrillation by means of circumferential pulmonary-vein ablation independently of the effects of antiarrhythmic-drug therapy , cardioversion , or both . The maintenance of sinus rhythm is associated with a significant decrease in both the severity of symptoms and the left atrial diameter",
"Aims This multicentre , r and omized trial compared three strategies of AF ablation : ablation of complex fractionated electrograms ( CFE ) alone , pulmonary vein isolation ( PVI ) alone , and combined PVI + CFE ablation , using st and ardized automated mapping software . Methods and results Patients with drug-refractory , high-burden paroxysmal ( episodes > 6 h , > 4 in 6 months ) or persistent atrial fibrillation ( AF ) were enrolled at eight centres . Patients ( n = 100 ) were r and omized to one of three arms . For CFE alone ( n = 34 ) , spontaneous/induced AF was mapped using vali date d , automated CFE software and all sites . Atrial fibrillation symptoms were confirmed by loop recording . Repeat procedures were allowed within the first 6 months . The primary endpoint was freedom from AF > 30 s at 1 year . Patients ( age 57 ± 10 years , LA size 42 ± 6 mm ) were 35 % persistent AF . In CFE , ablation terminated AF in 68 % . Only 0.4 PVs per patient were isolated as a result of CFE . In PVI , 94 % had all four PVs successfully isolated . In PVI + CFE , 94 % had all four PVs isolated , 76 % had inducible AF with additional CFE ablation , with 73 % termination of AF . There were significantly more repeat procedures in the CFE arm ( 47 % ) vs. PVI ( 31 % ) or PVI + CFE ( 15 % ) ( P = 0.01 ) . After one procedure , PVI + CFE had a significantly higher freedom from AF ( 74 % ) compared with PVI ( 48 % ) and CFE ( 29 % ) ( P = 0.004 ) . After two procedures , PVI + CFE still had the highest success ( 88 % ) compared with PVI ( 68 % ) and CFE ( 38 % ) ( P = 0.001 ) . Ninety-six percent of these patients were off anti-arrhythmics . Complications were two tamponades , no PV stenosis , and no mortality . Conclusion In high-burden paroxysmal/persistent AF , PVI + CFE has the highest freedom from AF vs. PVI or CFE alone after one or two procedures . Complex fractionated electrogram alone has the lowest one and two procedure success rates with a higher incidence of repeat procedures . Clinical Trials.gov identifier number NCT00367757",
"OBJECTIVES We hypothesized that human atrial fibrillation ( AF ) may be sustained by localized sources ( electrical rotors and focal impulses ) , whose elimination ( focal impulse and rotor modulation [ FIRM ] ) may improve outcome from AF ablation . BACKGROUND Catheter ablation for AF is a promising therapy , whose success is limited in part by uncertainty in the mechanisms that sustain AF . We developed a computational approach to map whether AF is sustained by several me and ering waves ( the prevailing hypothesis ) or localized sources , then prospect ively tested whether targeting patient-specific mechanisms revealed by mapping would improve AF ablation outcome . METHODS We recruited 92 subjects during 107 consecutive ablation procedures for paroxysmal or persistent ( 72 % ) AF . Cases were prospect ively treated , in a 2-arm 1:2 design , by ablation at sources ( FIRM-guided ) followed by conventional ablation ( n = 36 ) , or conventional ablation alone ( n = 71 ; FIRM-blinded ) . RESULTS Localized rotors or focal impulses were detected in 98 ( 97 % ) of 101 cases with sustained AF , each exhibiting 2.1 ± 1.0 sources . The acute endpoint ( AF termination or consistent slowing ) was achieved in 86 % of FIRM-guided cases versus 20 % of FIRM-blinded cases ( p FIRM ablation alone at the primary source terminated AF in a median 2.5 min ( interquartile range : 1.0 to 3.1 min ) . Total ablation time did not differ between groups ( 57.8 ± 22.8 min vs. 52.1 ± 17.8 min , p = 0.16 ) . During a median 273 days ( interquartile range : 132 to 681 days ) after a single procedure , FIRM-guided cases had higher freedom from AF ( 82.4 % vs. 44.9 % ; p electrocardiography monitoring . Adverse events did not differ between groups . CONCLUSIONS Localized electrical rotors and focal impulse sources are prevalent sustaining mechanisms for human AF . FIRM ablation at patient-specific sources acutely terminated or slowed AF , and improved outcome . These results offer a novel mechanistic framework and treatment paradigm for AF . ( Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation [ CONFIRM ] ; NCT01008722 )",
"OBJECTIVES This study sought to determine whether ablation of complex fractionated atrial electrograms ( CFAEs ) after antral pulmonary vein isolation ( APVI ) further improves the clinical outcome of APVI in patients with long-lasting persistent atrial fibrillation ( AF ) . BACKGROUND Ablation of CFAEs has been reported to eliminate persistent AF . However , residual pulmonary vein arrhythmogenicity is a common mechanism of recurrence . METHODS In this r and omized study , 119 consecutive patients ( mean age 60 + /- 9 years ) with long-lasting persistent AF underwent APVI with an irrigated-tip radiofrequency ablation catheter . Antral pulmonary vein isolation result ed in termination of AF in 19 of 119 patients ( Group A , 16 % ) . The remaining 100 patients who still were in AF were r and omized to no further ablation and underwent cardioversion ( Group B , n = 50 ) or to ablation of CFAEs in the left atrium or coronary sinus for up to 2 additional hours of procedure duration ( Group C , n = 50 ) . RESULTS Atrial fibrillation terminated during ablation of CFAEs in 9 of 50 patients ( 18 % ) in Group C. At 10 + /- 3 months after a single ablation procedure , 18 of 50 ( 36 % ) in Group B and 17 of 50 ( 34 % ) in Group C were in sinus rhythm without antiarrhythmic drugs ( p = 0.84 ) . In Group A , 15 of 19 patients ( 79 % ) were in sinus rhythm . A repeat ablation procedure was performed in 34 of 100 r and omized patients ( for AF in 30 and atrial flutter in 4 ) . At 9 + /- 4 months after the final procedure , 34 of 50 ( 68 % ) in Group B and 30 of 50 ( 60 % ) in Group C were in sinus rhythm without antiarrhythmic drugs ( p = 0.40 ) . CONCLUSIONS Up to 2 h of additional ablation of CFAEs after APVI does not appear to improve clinical outcomes in patients with long-lasting persistent AF ",
"BACKGROUND The deployment of an ablation line connecting the left inferior PV to the mitral annulus ( mitral isthmus line [ MIL ] ) enhances the efficacy of pulmonary vein disconnection ( PVD ) in preventing atrial fibrillation ( AF ) recurrences . OBJECTIVES To investigate the long-term effect of the additional linear lesion in a prospect i ve r and omized study . METHODS One hundred and eighty-seven patients ( 37 females , mean age : 55 + /- 11 years ) with paroxysmal ( 126 ) or persistent ( 61 patients ) AF , were prospect ively r and omized into two groups : PVD ( group A , 92 patients ) or PVD combined with MIL ( group B , 95 patients ) , performed by means of an irrigated-tip ablation catheter . RESULTS Successful disconnection of all PVs was achieved in all patients . A bidirectional block ( BB ) along the left atrial isthmus was obtained in 72 of 95 ( 76 % ) patients in group B , most of whom required additional RF pulses from within the distal CS . A transient ischemic attack occurred in 1 patient of group A , and a cardiac tamponade occurred in 1 patient of group B. At 1 year , 53 + /- 5 % ( group A ) and 71 + /- 5 % ( group B ) remained arrhythmia free ( P = 0.01 ) ; subgroup analysis highlights a higher improvement among patients with persistent AF ( 74 + /- 9 % vs 36 + /- 9 % ; P sinus rhythm maintenance rate , particularly in patients with persistent AF , without the risk for major complications",
"BACKGROUND The limited efficacy and complications of segmental ostial pulmonary vein isolation ( PVI ) for treating atrial fibrillation ( AF ) have been discussed so , in the present study the feasibility and efficiency of performing segmental pulmonary vein ( PV ) antrum isolation to treat AF were assessed . METHODS AND RESULTS A total of 187 patients with drug-refractory AF ( paroxysmal 120 , persistent 67 ) underwent segmental PVI guided by circumferential 20-electrode catheters ( Lasso ) . Radiofrequency ( RF ) current was delivered either at the ostium using a regular Lasso ( 15 - 20 mm in diameter , 70 patients : Group 1 ) or at the antrum using a larger Lasso ( 25 - 30 mm in diameter , 117 patients : Group 2 ) . A significantly wider region had to be ablated , with a longer RF application time , to isolate all 4 PVs in Group 2 patients than in Group 1 patients . Although the rate of recurrence of AF after the initial session was equal in both groups , a significantly greater number of patients were free from AF after a mean of 1.4 procedures in Group 2 than in Group 1 ( 93 % vs 76 % for paroxysmal AF , 78 % vs 48 % for persistent AF ) . CONCLUSIONS Segmental antral PVI using large-sized Lasso catheters was found to be more effective and safer than ostial PVI for the treatment of AF",
"AIMS We conducted a multi-centre , prospect i ve , controlled , r and omized trial to investigate the adjunctive role of ablation therapy to antiarrhythmic drug therapy in preventing atrial fibrillation ( AF ) relapses in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy had already failed . METHODS AND RESULTS One hundred and thirty seven patients were r and omized to ablation and antiarrhythmic drug therapy ( ablation group ) or antiarrhythmic drug therapy alone ( control group ) . In the ablation group , patients underwent cavo-tricuspid and left inferior pulmonary vein (PV)-mitral isthmus ablation plus circumferential PV ablation . The primary end-point of the study was the absence of any recurrence of atrial arrhythmia lasting > 30 s in the 1-year follow-up period , after 1-month blanking period . Three ( 4.4 % ) major complications were related to ablation : one patient had a stroke during left atrium ablation , another suffered transient phrenic paralysis , and the third had a pericardial effusion which required pericardiocentesis . After 12 months of follow-up , 63/69 ( 91.3 % ) control group patients had at least one AF recurrence , whereas 30/68 ( 44.1 % ) ( P atrial arrhythmia recurrence ( four patients had atrial flutter , 26 patients AF ) . CONCLUSION Ablation therapy combined with antiarrhythmic drug therapy is superior to antiarrhythmic drug therapy alone in preventing atrial arrhythmia recurrences in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy has already failed",
"Background — The single-procedure efficacy of pulmonary vein isolation ( PVI ) is less than optimal in patients with persistent atrial fibrillation ( AF ) . Adjunctive techniques have been developed to enhance single-procedure efficacy in these patients . We conducted a study to compare 3 ablation strategies in patients with persistent AF . Methods and Results — Subjects were r and omized as follows : arm 1 , PVI + ablation of non-PV triggers identified using a stimulation protocol ( st and ard approach ) ; arm 2 , st and ard approach + empirical ablation at common non-PV AF trigger sites ( mitral annulus , fossa ovalis , eustachian ridge , crista terminalis , and superior vena cava ) ; or arm 3 , st and ard approach + ablation of left atrial complex fractionated electrogram sites . Patients were seen at 6 weeks , 6 months , and 1 year ; transtelephonic monitoring was performed at each visit . Antiarrhythmic drugs were discontinued at 3 to 6 months . The primary study end point was freedom from atrial arrhythmias off antiarrhythmic drugs at 1 year after a single-ablation procedure . A total of 156 patients ( aged 59±9 years ; 136 males ; AF duration , 47±50 months ) participated ( arm 1 , 55 patients ; arm 2 , 50 patients ; arm 3 , 51 patients ) . Procedural outcomes ( procedure , fluoroscopy , and PVI times ) were comparable between the 3 arms . More lesions were required to target non-PV trigger sites than a complex fractionated electrogram ( 33±9 versus 22±9 ; P single-procedure efficacy in patients with persistent AF . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00379301",
"Objective Whether early rhythm suppression with extensive antiarrhythmic drugs ( AADs ) in persistent atrial fi brillation ( AF ) after catheter ablation decreases arrhythmia recurrence is unknown . We now report the 12-month follow-up data in this prospect i ve and r and omized study . Methods and results 123 consecutive patients with persistent AF undergoing catheter ablation were r and omly divided into an extensive AADs therapy group ( group 1 : 62 patients using both class Ic and III AADs ) or one AAD therapy group ( group 2 : 61 patients using class Ic or III AADs alone ) for the initial 2 months after ablation . Recurrence of atrial tachyarrhythmias ( ATa ) was valuated at both 2 months and 12 months following ablation . During the fi rst 2 months after ablation , less ATa were found in group 1 compared with group 2 ( 17/62 versus 29/61 , P= 0.021 ) . However , there was no diff erence with regard to ATa at 12 months between the groups ( 21/62 versus 22/61 , P= 0.799 ) . ATa at 2 months and left atrial diameter ( LAD ) were the statistically signifi ca nt predictors of ATa during 12-month follow-up . Conclusions While use of extensive AADs within the initial 2 months after persistent AF ablation decreases early ATa , it does not prevent late ATa . Moreover , LAD as well as early ATa is a strong predictor of ATa at 12 months",
"BACKGROUND High-frequency stimulation ( HFS ) of the atria induces atrial fibrillation ( AF ) when applied during sinus rhythm and elicits a parasympathetic response when delivered at sites where ganglionated plexi ( GPs ) are located . However , little is known about its impact after an electrophysiological study . OBJECTIVE To evaluate the impact of HFS on the short-term and long-term outcomes after the ablation of persistent AF . METHODS Thirty consecutive patients with persistent or long-st and ing persistent AF were r and omly assigned to either receive HFS of the left atrium ( n = 15 ) or not ( n = 15 ) during their electrophysiological studies . Patients receiving HFS were examined to determine whether or not a vagal response was elicited by the HFS at sites where GPs were located before and after conventional pulmonary vein isolation without any ablation targeting the GPs . Patients not receiving the HFS underwent the ablation procedure alone . The rate of recurrence of AF within 3 months of the procedure ( early recurrence [ ER ] ) and the frequency of that occurring after that period ( late recurrence ) were compared between the patient groups . RESULTS The incidence of ER occurred more frequently in patients with HFS than in those without ( 80 % vs 40 % ; P = .015 ) , whereas the occurrence of late recurrence was similar between the 2 groups ( 27 % vs 33 % ; P = .73 ) . In the HFS group , the number of GPs decreased from 3.4 ± 1.1 to 1.5 ± 0.8 after the pulmonary vein isolation ( P CONCLUSION HFS increases the incidence of ER in patients with persistent AF despite a partial GP modification result ing from the pulmonary vein isolation",
"BACKGROUND The best method for performing atrial fibrillation ( AF ) ablation is still under debate . The importance of using a circular mapping ( CM ) catheter for assessing isolation of the pulmonary vein ( PV ) antrum on the outcome of the procedure has not been clearly established . OBJECTIVE The purpose of this study was to evaluate whether use of a CM catheter improves the arrhythmia-free proportion after circumferential pulmonary vein ablation ( CPVA ) . METHODS A series of 146 consecutive patients ( 83 % males , age 53 + /- 10 years , 53 % paroxysmal AF ) were r and omized to two ablation strategies . In both groups , ipsilateral PV encirclement was performed until disappearance or dissociation of the local electrogram within the surrounded area . In the first group , only the radiofrequency catheter was used to both map and ablate ( CPVA group , n = 73 ) . In the other group , a CM catheter was added to assess the electrical activity of the PV antrum ( CPVA-CM group , n = 73 ) . An ablation line along the left atrial roof was also created in all patients . RESULTS Procedural and fluoroscopic times were longer in the CPVA-CM group ( P Severe procedure-related complications occurred in 1 ( 1.4 % ) patient in the CPVA group and in 3 ( 4.1 % ) patients in the CPVA-CM group ( P = .317 ) . After mean follow-up of 9 + /- 3 months , 31 ( 42.5 % ) patients in the CPVA group and 47 ( 64.4 % ) patients in the CPVA-CM group were arrhythmia-free without antiarrhythmic medication ( P = .008 ) . CONCLUSION Use of a CM catheter to ensure isolation of the PV antrum improved the success of CPVA but increased some procedural requirements",
"AIMS Catheter positioning and stability are recognized challenges in catheter ablation of atrial fibrillation ( AF ) . This prospect i ve r and omized study assessed whether routinely using a steerable sheath affects procedure outcomes . METHODS AND RESULTS Fifty-six AF patients were r and omized to ablation using either an Agilis NXT ( St Jude Medical , St Paul , MN , USA ) steerable sheath or a fixed-curve Mullins sheath ( Cook Medical Inc. , Bloomington , IN , USA ) for the ablation catheter . A mapping system with CT integration was used to isolate the pulmonary veins ( PVs ) in pairs and further ablation performed if AF persisted . There was no significant difference in time to gain trans-septal access , CT registration time , time to isolate PVs , fluoroscopy time for PV isolation , total procedure time , or total fluoroscopy time . A learning curve was seen for the steerable sheath , and after correcting for this , CT registration time and right PV isolation were quicker in this group . One patient crossed over from fixed-curve to steerable . Acute , 3- , and 6-month single procedure success were similar in both groups . CONCLUSION Allowing for the usage learning curve , a steerable sheath reduced time for some elements of AF ablation . Although this did not result in improved success , it may be useful for inexperienced operators , but at increased procedure cost",
"Background —Ablation of the pulmonary veins ( PVs ) for atrial fibrillation treatment is often combined with linear radiofrequency lesions along the left atrium ( LA ) to improve the success rate . The study was design ed to assess the contribution of LA posterior wall isolation to the outcome of circumferential pulmonary vein ablation ( CPVA ) . Methods and Results —CPVA consisted of continuous radiofrequency lesions encircling both ipsilateral PVs plus an ablation line along the mitral isthmus . Patients were then r and omized into 2 groups . In the first group , superior PVs were connected by linear lesions along the LA roof ( CPVA-1 group ) . In the second group , the LA posterior wall was isolated by adding a second line connecting the inferior aspect of the 2 inferior PVs ( CPVA-2 group ) . The study included 120 patients ( 53±11 years , 77 % male , 60 % paroxysmal atrial fibrillation , LA of 41.3±5.4 mm , 46 % with hypertension , and 22 % with structural heart disease ) . After a single ablation procedure and a mean follow-up of 10±4 months , 24 ( 40 % ) patients of the CPVA-1 group had atrial fibrillation recurrences and 3 ( 5 % ) had new-onset LA flutter . In the CPVA-2 group , recurrences were due to atrial fibrillation episodes in 23 patients ( 38 % ) and LA flutter in 4 ( 7 % ) . Freedom from arrhythmia recurrences was not statistically different in the CPVA-1 group as compared with the CPVA-2 group ( log rank P=0.943 ) . Conclusion —Isolation of the LA posterior wall did not increase the success rate of CPVA ",
"OBJECTIVES The aim of this study was to compare -- in patients with persistent and permanent atrial fibrillation (AF)--the efficacy and safety of left atrial ablation with that of a biatrial approach . BACKGROUND Left atrium-based catheter ablation of AF , although very effective in the paroxysmal form of the arrhythmia , has an insufficient efficacy in patients with persistent and permanent AF . METHODS Eighty highly symptomatic patients ( age , 58.6 + /- 8.9 years ) with persistent ( n = 43 ) and permanent AF ( n = 37 ) , refractory to antiarrhythmic drugs , were r and omized to two different ablation approaches guided by electroanatomical mapping . A procedure including circumferential pulmonary vein , mitral isthmus , and cavotricuspid isthmus ablation was performed in 41 cases ( left atrial ablation group ) . In the remaining 39 patients ( biatrial ablation group ) , the aforementioned approach was integrated by the following lesions in the right atrium : intercaval posterior line , intercaval septal line , and electrical disconnection of the superior vena cava . RESULTS During follow-up ( mean duration 14 + /- 5 months ) , AF recurred in 39 % of patients in the left atrial ablation group and in 15 % of patients in the biatrial ablation group ( p = 0.022 ) . Multivariable Cox regression analysis showed that ablation technique was an independent predictor of AF recurrence during follow-up . CONCLUSIONS In patients with persistent and permanent AF , circumferential pulmonary vein ablation , combined with linear lesions in the right atrium , is feasible , safe , and has a significantly higher success rate than left atrial and cavotricuspid ablation alone",
"BACKGROUND Although mitral isthmus ( MI ) ablation in atrial fibrillation ( AF ) patients has been shown to be an effective ablative strategy , the establishment of the bidirectional conduction block of the MI is technically challenging . We investigated the usefulness of a steerable sheath for MI ablation in patients with persistent AF and its impact on the clinical outcome of persistent AF ablation . METHODS A total of 80 consecutive patients undergoing MI ablation were r and omized to 1 of the following 2 groups : group S ( using a steerable long sheath ) or group NS ( using a nonsteerable long sheath ) . MI ablation was performed by using an open-irrigated ablation catheter with the guidance of a 3-dimensional mapping system . The endpoint of the MI ablation was the achievement of a bidirectional block . RESULTS Bidirectional block through the MI was achieved in 87.5 % ( 70/80 ) of patients with 14.0 ± 6.7 minutes of radiofrequency application . The bidirectional block was more frequently achieved in patients in group S compared to group NS ( 97.5 % ( 39/40 ) vs 77.5 % ( 31/40 ) , P = 0.02 ) . Additionally , epicardial ablation within the coronary sinus was less frequently required in group S compared to group NS ( 12.5 % ( 5/40 ) vs 72.5 % ( 29/40 ) , P after the procedure more frequently occurred in the patients in whom MI block had not been achieved during the initial procedure ( 40.0 % ( 4/10 ) vs 10.0 % ( 7/70 ) , P = 0.04 ) . CONCLUSIONS The MI block could be achieved in the majority of patients by using a steerable sheath . An incomplete MI block increased the risk of AT following persistent AF ablation",
"BACKGROUND A detailed appreciation of left atrial/pulmonary vein ( LA/PV ) anatomy may be important in improving the safety and success of catheter ablation ( CA ) for atrial fibrillation ( AF ) . OBJECTIVES The aim of this nonr and omized study was to determine the impact of computerized tomography ( CT ) image integration into a 3-dimensional ( 3D ) mapping system on the clinical outcome of patients undergoing CA for AF . METHODS Ninety-four patients ( age : 56 + /- 10 years ) with AF ( paroxysmal 46 , persistent 48 ) underwent wide encirclement of ipsilateral PV pairs using irrigated radiofrequency ablation with the endpoint of electrical isolation . Ablation was guided by 3D mapping alone ( electroanatomic 24 , noncontact 23 ) in 47 ( 3DM group ) patients and by CT image integration ( Cartomerge ) in 47 ( CT group ) . In persistent AF , a combination of linear ablation and targeted ablation of complex fractionated electrograms was also performed . RESULTS Successful PV electrical isolation did not differ between the two groups . A significant reduction in fluoroscopy times was demonstrated in the CT group ( 49 + /- 27 minutes vs 3DM group 62 + /- 26 minutes , P = 0.03 ) . Arrhythmia recurrence was reduced in the CT group ( 32 % vs 51 % in the 3DM group , P success on 7-day monitor off antiarrhythmic drugs was achieved in 60 % in the 3DM group when compared with 83 % in the CT group ( P fluoroscopy times , arrhythmia recurrence , and increased restoration of sinus rhythm . Improved visualization of complex LA geometries might improve the safety and success of CA for AF",
"BACKGROUND The efficacy of ablation of complex fractionated atrial electrograms ( CFEs ) in the single ablation procedure for nonparoxysmal atrial fibrillation ( AF ) patients is not well demonstrated . The aim of this study was to compare the ablation strategies of pulmonary vein isolation ( PVI ) plus linear ablation with and without additional ablation ofCFEs in these patients . METHODS Consecutive 60 patients ( 49 + /- 11 years old , 50 male , 10 female ) with nonparoxysmal AF underwent catheter ablation guided by a NavX mapping system . A stepwise approach included a circumferential PVI and left atrial ( LA ) linear ablation followed by either the additional ablation of continuous CFEs in the LA/coronary sinus ( the first 30 patients ) or not ( the second 30 patients ) , detected by an automatic algorithm . RESULTS There was no difference in the baseline characteristics between the two groups . Complete PVI eliminated some continuous CFEs and altered the distribution of CFEs . Following PVI and linear ablation , the remaining continuous CFEs were identified in 7.9 + /-10 % mapping sites of the LA and CS , and were ablated successfully with a procedural AF termination rate of 53 % . With a follow-up of 19 + /-11 months , a Kaplan-Meier analysis showed that the patients with additional ablation of the CFEs had a higher rate of sinus rhythm maintenance . Multivariate analysis showed the single procedure success could be predicted by the procedural AF termination and the additional ablation of continuous CFEs in the LA/CS . CONCLUSIONS Ablation of continuous CFEs after PVI and LA linear ablation had a better long-term efficacy based on the results of single-ablation procedure",
"Objective — Additional septal linear ablation in patients undergoing ablation of long-st and ing persistent atrial fibrillation ( AF ) could be beneficial due to additional extensive atrial tissue ablation and incidental ablation of sites with complex fractionated electrograms . We assessed the long-term outcome of patients after ablation of long-st and ing persistent AF with an additional left atrial ( LA ) septal line . Methods — Thirty-four patients were included . The patients were r and omized into two groups and underwent pulmonary vein ( PV ) isolation with roof line , mitral isthmus line and coronary sinus ablation . In group 1 an additional LA septal line was created . Results — AF converted into atrial tachycardia in 2 patients during septal ablation in group 1 . In group 2 AF terminated via atrial tachycardia in 3 patients ( P = ns ) . During a mean follow-up of 620 ± 119 days , 7 ( 41 % ) and 8 ( 47 % ) patients from group 1 and group 2 were free from recurrences ( P = ns ) . Redo procedures were performed in 5 patients of group 1 and in 5 patients of group 2 . For a follow-up of 349 ± 273 days after the last ablation , Cox ’s F-test showed a trend of more recurrences in group 1 ( P = 0.07 ) . Conclusions — In patients with long-st and ing AF , an additional LA septal linear ablation is not associated with a significantly higher AF termination rate . A septal linear lesion might increase the risk of septal reentrant tachycardias , and is associated with a trend towards a worse outcome ",
"BACKGROUND Left lateral mitral isthmus ( LLMI ) ablation achieves a low percentage of bidirectional conduction block in atrial fibrillation ( AF ) ablation . OBJECTIVE The purpose of this study was to investigate whether linear ablation through the lowest voltage area on the left atrial anterior wall ( LAAW ) can lead to better clinical outcomes compared to LLMI ablation . METHODS We obtained high-density three-dimensional ( 3D ) voltage mapping ( CARTO ) of the LA in 29 patients with persistent AF and determined the area of low voltage . In the multicenter prospect i ve study , clinical outcomes of LAAW ( n = 100 ) and LLMI ablations ( n = 100 ) were compared in patients with persistent AF ( 79.4 % male , 59.4 ± 10.6 years ) . RESULTS ( 1 ) The low-voltage area consistently existed on LAAW and had a correlation with the LA-aorta contact area ( R = 0.921 , P Mean voltage of LAAW was significantly lower than that of LLMI ( P The length of LAAW ablation ( 37.9 ± 3.4 mm vs 26.6 ± 3.2 mm , P achievement of bidirectional block was higher ( 68.0 % vs 32.0 % , P = .0001 ) than in LLMI ablation . Mean duration of LAAW and LLMI ablations was 19.3 ± 2.9 minutes and 18.2 ± 3.7 minutes , respectively ( P = .086 ) . ( 3 ) During follow-up of 23.3 ± 7.4 months , the recurrence rate of AF after LAAW ablation ( 26.0 % ) was significantly lower than that of LLMI ablation ( 41.0 % , P = .021 ) after a single procedure . CONCLUSION The voltage map is useful for guiding linear ablation in persistent AF patients . LAAW is the most frequent low-voltage area around the mitral annulus , and linear ablation along LAAW results in a better clinical outcome with a higher rate of bidirectional conduction block compared to LLMI ablation",
"Background —Electric isolation of the pulmonary veins and posterior left atrium with a single ring of radiofrequency lesions ( single-ring isolation [ SRI ] ) may result in fewer atrial fibrillation ( AF ) recurrences than wide antral pulmonary vein isolation ( wide antral isolation [ WAI ] ) by abolishing extravenous AF triggers . The effect of mitral isthmus line ( MIL ) ablation on outcomes after SRI has not previously been assessed . Methods and Results —We r and omly assigned 220 consecutive patients ( 58±10 years old ; 82 % men ) with highly symptomatic AF ( 61 % paroxysmal , 39 % persistent/longst and ing persistent ) to undergo either SRI or WAI . Half of each cohort was also r and omly allocated to have left lateral MIL ablation ( 2 × 2 factorial study design ) . Patients were followed clinical ly and with 7-day Holter studies for arrhythmia recurrences . The primary end points were recurrence of AF and organized atrial tachyarrhythmias . AF-free survival at 2 years was better after SRI ( 74 % [ 95 % CI , 65%–82 % ] ) than WAI ( 61 % [ 51%–70 % ] ; P=0.031 ) . Organized atrial tachyarrhythmia – free survival was similar after SRI and WAI ( 67 % [ 57%–75 % ] ersus 64 % [ 54%–72 % ] , respectively , at 2 years ; P=0.988 ) . MIL ablation result ed in better 2-year organized atrial tachyarrhythmia – free survival ( 71 % [ 62%–79 % ] versus 60 % [ 50%–69 % ] ; P=0.07 ) , which approached statistical significance . Survival free of any atrial arrhythmia after one procedure was not significantly affected by isolation technique or MIL ablation . Conclusions —SRI result ed in fewer AF recurrences compared with WAI on long-term follow-up but did not reduce the recurrence of all atrial arrhythmias . MIL ablation may reduce organized atrial tachyarrhythmia recurrences . Clinical Trial Registration —http://www.anzctr.org.au ; ACTRN12606000467538",
"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 )",
"AIMS In many laboratories , cooled-tip catheters have replaced 8 mm-tip catheters due to their theoretical advantage of achieving larger lesions and avoiding charring . However , direct comparisons between the catheters in the subset of atrial fibrillation ( AF ) ablation are scarce . The aim of this study was to compare the efficacy , safety , and lesion extension created by 8 mm-tip vs. cooled-tip catheter with different energy setting s for circumferential pulmonary vein ablation ( CPVA ) . METHODS AND RESULTS A series of 221 consecutive patients with symptomatic AF were included in the study . Circumferential pulmonary vein ablation was performed using an 8 mm-tip catheter ( 55 W , 50 degrees C ) in 90 patients ( Group 1 ) , a cooled-tip ( 30 W , 45 degrees C ) in 42 ( Group 2 ) , and a cooled-tip ( 40 W , 45 degrees C ) in 89 ( Group 3 ) . In a subgroup of 60 patients , troponin I ( TpnI ) , creatinine kinase , and myoglobin values were obtained before and at 12 and 24 h after ablation . At 1 year follow-up , the probability of being arrhythmia-free after a single procedure was 53 , 35 , and 55 % in patients from Groups 1 , 2 , and 3 , respectively . Ablation with a cooled-tip catheter at 30 W led to a higher recurrence rate ( P = 0.030 ) and was identified in Cox regression analysis as an independent predictor of AF recurrence ( HR , 1.713 ; 95 % CI , 1.02 - 2.90 ; P = 0.045 ) . There were no differences in intra-procedure complications ( 2.2 vs. 5.6 vs. 4.9 % , P = 0.542 ) . The myocardial lesion according to TpnI was smaller in Group 2 ( P = 0.02 ) . CONCLUSION The cooled-tip catheter at 30 W was less efficacious than both the 8 mm catheter and the cooled-tip with a 40 W power setting",
"BACKGROUND Additional ablation of complex fractionated atrial electrograms ( CFAE ) after pulmonary vein isolation ( PVI ) has been shown to improve the success of ablation of persistent atrial fibrillation ( AF ) . However , extensive ablation is often necessary to eliminate all CFAE or to terminate AF . We assessed the usefulness of the administration of an antiarrhythmic drug ( AAD ) before CFAE ablation . METHODS AND RESULTS One-hundred and ten patients with persistent AF first underwent PVI , roof and floor linear ablation ( box isolation ) . One hundred patients who remained in AF after box isolation were then r and omized to either receive ( AAD group , n=50 ) or not receive ( no-AAD group , n=50 ) intravenous nifekalant ( 0.3mg/kg ) followed by a CFAE ablation . In the AAD group , nifekalant terminated AF in 19 ( 38 % ) patients and ablation of localized CFAE was performed in 31 patients who remained in AF after nifekalant , and terminated AF in 11 ( 35 % ) patients . In the no-AAD group , ablation of CFAE terminated AF in 13 ( 26 % ) patients . The AAD group had a significantly lesser number of radio frequency applications at CFAE sites ( 18 ± 12 versus 36 ± 10 , p shorter procedure time ( 162 ± 34 versus 197 ± 29 min , p no-AAD group . However , there was no significant difference in success rate at 12 months after a single ablation procedure between the two groups ( AAD group , 74 % versus no-AAD group , 76 % ) . CONCLUSIONS An approach to ablation using nifekalant may be useful in localizing areas of CFAE , reducing the number of applications at CFAE sites and procedure time . Ablation of only CFAE localized with nifekalant may be sufficient for clinical outcome",
"BACKGROUND The relationship between the applied techniques and clinical outcomes after radiofrequency ( RF ) ablation of atrial fibrillation ( AF ) remains unclear . We compared the results of ablation by RF delivered via a point-by-point versus catheter dragging technique for the treatment of AF . METHODS This study included 66 patients with drug-refractory AF who underwent circumferential pulmonary vein ( PV ) ablation . A point-by-point technique was used in 35 ( 53 % ) patients ( Group I ) , and catheter dragging technique in the remaining 31 ( 47 % ) patients ( Group II ) . If AF persisted or remained inducible after the PV isolation , additional ablation of complex fractionated atrial electrograms and linear ablation were performed . RESULTS Significantly , fewer RF applications were delivered in Group II than in Group I. The total RF energy duration delivered was comparable between the two groups ( P = 0.55 ) . However , the total energy of RF deliveries was significantly greater in Group II than in Group I ( P = 0.02 ) . Despite a longer fluoroscopic exposure time ( P = 0.01 ) , the total procedural duration was significantly shorter in Group II than in Group I ( P = 0.005 ) . Within 3 months after a single ablation procedure , 24 patients ( 69 % ) in Group I versus 13 patients ( 42 % ) in Group II had ≥1 recurrence(s ) of atrial tachyarrhythmias ( P = 0.03 ) . A multivariate analysis showed that a point-by-point ablation was the only independent predictor of early atrial tachyarrhythmia recurrences . CONCLUSIONS The catheter dragging technique for ablation of AF was associated with a lower early recurrence rate of atrial tachyarrhythmias than the point-by-point technique",
"BACKGROUND Persistent and long-st and ing persistent atrial fibrillation ( AF ) often requires extensive and /or repeat radiofrequency ( RF ) ablation procedures . OBJECTIVE The Tailored Treatment of Persistent Atrial Fibrillation ( TTOP-AF ) study assessed the effectiveness and safety of the phased RF system in a r and omized controlled comparison of medical therapy against phased RF ablation for the management of persistent and long-st and ing persistent AF . METHODS Patients who had failed at least 1 antiarrhythmic drug ( AAD ) were r and omized ( 2:1 ) to ablation management ( AM ) or medical management ( MM ) . AM patients were allowed up to 2 ablations . Index and retreatment procedures consisted of pulmonary vein isolation and ablation of complex fractionated atrial electrograms . MM patients received AAD changes and /or cardioversion . The primary end points of the TTOP-AF study included chronic effectiveness and safety at 6 months and acute safety within 7 days of ablation . RESULTS At 6 months , a greater proportion of AM patients achieved effectiveness off AAD ( 77 of 138 [ 55.8 % ] ) compared to MM patients ( 19 of 72 [ 26.4 % ] ) ( P successful while 12.3 % ( 17/138 ) experienced a serious procedure and /or device-related adverse event . The predefined acute safety end point was not met . The proportion of patients with chronic safety events did not differ significantly between groups . CONCLUSIONS Catheter ablation of persistent/long-st and ing persistent AF with the phased RF ablation system is effective with greater reduction of AF compared with MM . More intense anticoagulation strategies , careful attention to catheter placement relative to the pulmonary vein ostia , and elimination of electrode interaction are expected to reduce the risk of stroke , pulmonary vein stenosis , and asymptomatic cerebral emboli",
"BACKGROUND Both segmental ostial and circumferential extraostial pulmonary vein ( PV ) isolation have been proven effective in the treatment of atrial fibrillation ( AF ) . However , the recurrence of AF and PV conduction after the 2 ablation strategies has never been compared in a r and omized study . METHODS A total of 100 consecutive patients ( age 56 + /- 10 ; 71 men ) with symptomatic AF ( paroxysmal , 51 ; persistent , 49 ) were r and omized to segmental ostial ( n = 54 ) or circumferential extraostial ( n = 46 ) PV isolation . A circular catheter positioned at the ostium of each target PV guided the ostial PV isolation . Extraostial PV isolation was performed by encircling the paired left and right PVs , respectively , guided by an electroanatomic mapping system . RESULTS A total of 84 % of the patients had recurrent AF after the first PV isolation procedure , showing 72 % with AF and 12 % with organized left atrial tachycardia . In patients undergoing reablation , all but 2 patients had recurrence of left atrium PV conduction ( > 95 % ) . During a mean follow-up of 12 months without antiarrhythmic medication , 57 % of patients who underwent extraostial PV isolation were free of arrhythmia symptoms compared with 31 % of patients who underwent ostial PV isolation ( P success rate between the 2 ablation strategies was mainly seen in patients known with persistent AF ( 52 % and 15 % , respectively ; P = .02 ) as opposed to patients with paroxysmal AF ( 65 % and 46 % , respectively ; P = .26 ) . CONCLUSIONS Overall , the more proximal , extraostial PV isolation was found to be superior to ostial PV isolation , especially in patients known with persistent AF . A high recurrence rate of 84 % after a single complete PV isolation procedure was seen . At reablation , more than 95 % had recurrence of left atrium PV conduction regardless of the procedure used , supporting the idea that complete PV isolation seems essential to prevent arrhythmia recurrences",
"INTRODUCTION Pulmonary vein ( PV ) isolation for atrial fibrillation ( AF ) can be performed using a segmental ostial or a circumferential extra-ostial approach . The relative merits and potential limitations of each approach are currently debated . Here we report our early experience with each of these approaches , including their relative efficacy and safety . METHODS AND RESULTS Forty patients with drug-refractory AF underwent segmental ostial PV isolation and were compared to 40 consecutive patients who underwent PV isolation using a circumferential extra-ostial approach . The latter approach described here is novel in two aspects : ( 1 ) the endpoint for ablation was PV isolation and not only delay in left atrial to PV conduction time , and ( 2 ) isolation of the right and left PVs was achieved by a single encirclement of ipsilateral veins . At follow-up , 60 % of the patients in the segmental group were free of AF compared to 75 % of the patients in the circumferential group . There was one thromboembolic cerebrovascular complication during the ablation procedure in each group . CONCLUSION PV isolation using a circumferential extra-ostial approach , where the ipsilateral PVs are isolated together by one encircling line of block using electroanatomic mapping , is a technically feasible procedure . This approach is at least as effective and safe as the more established segmental ostial approach for AF ablation",
"AIMS Ablation of complex fractionated atrial electrograms ( CFAEs ) is a new approach for the treatment of atrial fibrillation ( AF ) . The purpose of the study was to assess the efficacy of CFAE ablation as a st and -alone strategy in patients with persistent AF and to compare it with a combined approach of CFAE ablation and pulmonary vein isolation ( PVI ) . METHODS AND RESULTS The study included 77 consecutive patients with persistent AF who underwent radiofrequency ( RF ) ablation of CFAE as a sole ablation procedure ( CFAE group , n = 23 patients ) or a combined approach of CFAE ablation and PVI ( CFAE plus PVI group , n = 54 patients ) . Procedures were guided by three-dimensional mapping systems . After the procedure , AF recurrences were evaluated with 7-day Holter recordings at 1 , 3 , and 6 months and every 6 months thereafter . Treatment failure was defined as > or=1 AF episode lasting > 30 s on Holter recordings during follow-up . After a mean follow-up time of 13 + /- 10 months , 2 of 23 patients ( 9 % ) with CFAE ablation and 22 of 54 patients ( 41 % ) with CFAE plus PVI were in sinus rhythm after a single ablation procedure without anti-arrhythmic medication ( P = 0.008 ) . CONCLUSION Ablation of CFAE as a st and -alone ablation strategy seems insufficient for the treatment of patients with persistent AF . Pulmonary vein isolation plus CFAE ablation significantly increases the mid-term success rate"
] | 41169110-06ff-11f0-808a-c43d1ab1c353 |
Background The expectation that training enhances performance is well explored in professional sport . However , the additional challenges of physical and cognitive maturation may require careful consideration when determining workloads to enhance performance in adolescents . Objective The objective of this study was to determine the state of knowledge on the relationship between workloads , physical performance , injury and /or illness in adolescent male football players . Methods A systematic review of workloads , physical performance , injury and illness in male adolescent football players was conducted . Studies for this review were identified through a systematic search of six electronic data bases ( Academic Search Complete , CINAHL , PsycINFO , PubMed , SPORTD iscus , and Web of Science ) . For the purpose of this review , load was defined as the cumulative amount of stress placed on an individual from multiple training sessions and games over a period of time , expressed in terms of either the external workloads performed ( e.g. , resistance lifted , kilometres run ) or the internal response ( e.g. , heart rate , rating of perceived exertion ) to that workload . Results A total of 2,081 studies were initially retrieved from the six data bases , of which 892 were duplicates . After screening the titles , abstract s and full texts , we identified 23 articles meeting our criteria around adolescent football players , workloads , physical performance , injury and /or illness . Seventeen articles addressed the relationship between load and physical performance , four articles addressed the relationship between load and injury and two articles addressed both . A wide range of training modalities were employed to improve the physical performance of adolescent football players , with strength training , high-intensity interval training , dribbling and small-sided games training , and a combination of these modalities in addition to normal football training , result ing in improved performances on a wide range of physiological and skill assessment s. Furthermore , there was some ( limited ) evidence that higher workloads may be associated with the development of better physical qualities , with one study demonstrating enhanced submaximal interval shuttle run performance with each additional hour of training or game play . Of the few studies examining negative consequences associated with workloads , increases in training load led to increases in injury rates , while longer training duration was associated with a greater incidence of illness . Conclusion The combined capacity for adolescent males to grow , train and improve physical performance highlights and underscores an exciting responsiveness to training in the football environment . However , the capacity to train has some established barriers for adolescents experiencing high workloads , which could also result in negative consequences . Additional research on stage-appropriate training for adolescent male footballers is required in order to address the knowledge gaps and enhance safe and efficient training practice | [
"Brink , MS , Nederhof , E , Visscher , C , Schmikli , SL , and Lemmink , KAPM . Monitoring load , recovery , and performance in young elite soccer players . J Strength Cond Res 24(3 ) : 597 - 603 , 2010-The purpose of this study was to investigate the relation between training load , recovery , and monthly field test performance in young elite soccer players to develop training guidelines to enhance performance . In a prospect i ve , nonexperimental cohort design , 18 young elite soccer players registered training and match duration for a full competitive season by means of daily training logs . Furthermore , session rating of perceived exertion ( RPE ) and total quality of recovery ( TQR ) scores were recorded . Weekly duration ( TLd ) , load ( duration × session RPE = TLrpe ) , and TQR scores were calculated for 1 and 2 weeks before a monthly submaximal interval shuttle run tests to determine interval endurance capacity . Participants spent on average 394.4 ± 134.9 minutes per week on training and game play with an average session RPE of 14.4 ± 1.2 ( somewhat hard ) and TQR of 14.7 ± 1.3 ( good recovery ) . R and om intercept models showed that every extra hour training or game play result ed in enhanced field test performance ( p scores did not contribute to the prediction of performance . The duration of training and game play in the week before field test performance is most strongly related to interval endurance capacity . Therefore , coaches should focus on training duration to improve interval endurance capacity in elite soccer players . To evaluate the group and individual training response , field tests should be frequently executed and be incorporated in the training program",
"The purpose of the present study was to examine the influence of direct supervision on muscular strength , power , and running speed during 12 weeks of resistance training in young rugby league players . Two matched groups of young ( 16.7 ± 1.1 years [ mean ± SD ] ) , talented rugby league players completed the same periodized resistance-training program in either a supervised ( SUP ) ( N = 21 ) or an unsupervised ( UNSUP ) ( N = 21 ) environment . Measures of 3 repetition maximum ( 3RM ) bench press , 3RM squat , maximal chin-ups , vertical jump , 10– and 20-m sprints , and body mass were completed pretest ( week 0 ) , midtest ( week 6 ) , and posttest ( week 12 ) training program . Results show that 12 weeks of periodized resistance training result ed in an increased body mass , 3RM bench press , 3RM squat , maximum number of chin-ups , vertical jump height , and 10– and 20-m sprint performance in both groups ( p strength increases for 3RM bench press and squat ( p significantly increased 3RM squat strength ( at 6 and 12 weeks ) and 3RM bench press strength ( 12 weeks ) when compared to the UNSUP group ( p increase in the 3RM bench press , 3RM squat , and chin-upmax was also significantly greater in the SUP group than in the UNSUP group ( p show that the direct supervision of resistance training in young athletes results in greater training adherence and increased strength gains than does unsupervised training",
"To examine the effects of aerobic interval training on the decline in short-passing ability caused by a short bout of high-intensity intermittent activities . For this r and omized controlled trial , 26 junior soccer players ( mean age , 17.8 + /- 0.6 years ; mean height , 178 + /- 5 cm ; mean body mass , 74.5 + /- 6.9 kg ) were recruited . After baseline measurements , subjects were r and omly allocated to 1 of 2 groups : the control group ( CG ) or the aerobic interval training group ( ITG ) . The ITG completed 4 weeks of high-intensity aerobic training , consisting of 4 bouts of running for 4 min at 90%-95 % of maximal heart rate , with 3 min of active recovery between sets , in addition to normal training . Maximum oxygen uptake , Yo-Yo Intermittent Recovery Test level 1 ( YYIRT ) , and short-passing ability ( measured using the Loughborough Soccer Passing Test ( LSPT ) ) were measured before and after a 5 min high-intensity simulation ( HIS ) , reproducing the most intense phase of a match . The ITG ( n = 11 ) , but not the CG ( n = 10 ) , showed a significant 12 % and 4 % increase in YYIRT and maximal oxygen consumption after training , respectively , and reduced the worsening in LSPT penalty time after the HIS ( p relative exercise intensity during HIS decreased in the ITG only ( p junior soccer players may benefit from aerobic training to attenuate the decline in short-passing ability caused by a short bout of intermittent activities completed at the same pretraining workload",
"Objective In this study , the injury incidence and association with type and volume of training in international rowers were described . Design A prospect i ve cohort design was used over a 12-month period . Patients 20 international rowers who were competing as part of the Irish Amateur Rowing Union squad system . Methods The rowers were interviewed monthly , and data were collected regarding their training and competition exposure as well as their injury experience . Results A mean injury rate of 3.67 per 1000 exposure hours was reported with a total of 44 injuries reported in a 12-month period . The mean number of injuries sustained per athlete was 2.2 ( 1.24 ) over the 12-month period . The area where the greatest number of injuries were reported was the lumbar spine ( 31.82 % of total injuries , 95 % CI 20 to 50 ) ( fig 2 ) followed by the knee ( 15.91 % of total injuries , 95 % CI 10 to 30 ) and the cervical spine ( 11.36 % of total injuries , 95 % CI 5 to 24 ) . Half of the injuries ( 22 injuries , 50 % of total reported injuries ) were to the spine ( χ2 = 30.8 , df = 9 , p = 0.0003 ) . Ergometer training load was the most significantly associated with injury risk ( r = 0.68 , p = 0.01 ) . Conclusion International rowers are at higher risk of injury than most non-contact sports and some contact sports . The high risk of lumbar spine injury and the significant association of high volume of ergometer training merit further research to reduce time and competition lost to injury",
"PURPOSE The purpose of this study was to determine the magnitude of changes in cardiac output ( Qc ) , stroke volume ( SV ) , and arterial-mixed venous oxygen difference ( a-vO2 diff ) during submaximal exercise following a 20-wk endurance training program , with the primary focus on identifying differences in response by race , sex , and age . METHODS The participants in this study ( N = 631 ) were healthy and previously sedentary men ( N = 277 ) and women ( N = 354 ) of varying age ( 17 - 65 yr ) and race ( blacks , N = 217 ; whites , N = 414 ) who had completed the HERITAGE Family Study protocol . After baseline measurements , participants trained on cycle ergometers 3 d x wk(-1 ) for a total of 60 exercise sessions starting at the HR associated with 55 % of maximal oxygen uptake ( VO2max ) for 30 min/session and building to the HR associated with 75 % of VO2max for 50 min/session , which was maintained during the last 6 wk . HR , Qc ( CO2 rebreathing ) , and SV ( Qc/HR ) were determined in duplicate at 50 W and at 60 % of VO2max on two different days both before and after training . RESULTS After training , there were significant decreases in HR and Qc , and significant increases in SV and a-vO2 diff at 50 W ( except for no change in a-vO2 diff in black men ) . The changes in HR differed by sex and age , and the changes in SV , Qc , and a-vO2 diff differed by race . Qc decreased by 0.6 L x min(-1 ) at 50 W for the total sample , consistent with the decrease in VO2 at this power output . At 60 % of VO2max HR decreased , and SV , Q , and a-VO2 diff increased . There were small differences in response by sex ( HR and SV ) , race ( HR ) , and age ( HR and Qc ) . CONCLUSION It is concluded that the cardiovascular systems of men and women , blacks and whites , and younger and older subjects are not limited in their ability to adapt to endurance training",
"The aim of this study was to compare the effects of specific ( small-sided games ) vs. generic ( running ) aerobic interval training on physical fitness and objective measures of match performance in soccer . Forty junior players were r and omly assigned to either generic ( n=20 ) or specific ( n=20 ) interval training consisting of 4 bouts of 4 min at 90 - 95 % of maximum heart rate with 3 min active rest periods , completed twice a week . The following outcomes were measured at baseline ( Pre ) , after 4 weeks of pre-season training ( Mid ) , and after a further 8 weeks of training during the regular season ( Post ) : maximum oxygen uptake , lactate threshold ( Tlac ) , running economy at Tlac , a soccer-specific endurance test ( Ekblom 's circuit ) , and indices of physical performance during soccer matches ( total distance and time spent st and ing , walking , and at low- and high-intensity running speed ) . Training load , as quantified by heart rate and rating of perceived exertion , was recorded during all training sessions and was similar between groups . There were significant improvements in aerobic fitness and match performance in both groups of soccer players , especially in response to the first 4 weeks of pre-season training . However , no significant differences between specific and generic aerobic interval training were found in any of the measured variables including soccer specific tests . The results of this study showed that both small-sided games and running are equally effective modes of aerobic interval training in junior soccer players",
"Background : In professional soccer , a significant amount of training time is used to improve players ' aerobic capacity . However , it is not known whether soccer specific training fulfils the criterion of effective endurance training to improve maximal oxygen uptake , namely an exercise intensity of 90–95 % of maximal heart rate in periods of three to eight minutes . Objective : To determine whether ball dribbling and small group play are appropriate activities for interval training , and whether heart rate in soccer specific training is a valid measure of actual work intensity . Methods : Six well trained first division soccer players took part in the study . To test whether soccer specific training was effective interval training , players ran in a specially design ed dribbling track , as well as participating in small group play ( five a side ) . Laboratory tests were carried out to establish the relation between heart rate and oxygen uptake while running on a treadmill . Corresponding measurements were made on the soccer field using a portable system for measuring oxygen uptake . Results : Exercise intensity during small group play was 91.3 % of maximal heart rate or 84.5 % of maximal oxygen uptake . Corresponding values using a dribbling track were 93.5 % and 91.7 % . No higher heart rate was observed during soccer training . Conclusions : Soccer specific exercise using ball dribbling or small group play may be performed as aerobic interval training . Heart rate monitoring during soccer specific exercise is a valid indicator of actual exercise intensity",
"Objectives —Although the nature of rugby injury has been well documented , little is known about key risk factors . A prospect i ve cohort study was undertaken to examine the association between potential risk factors and injury risk , measured both as an injury incidence rate and as a proportion of the playing season missed . The latter measure incorporates a measure of injury severity . Methods —A cohort of 258 male players ( mean ( SD ) age 20.6 ( 3.7 ) years ) were followed through a full competitive season . At a preseason assessment , basic characteristics , health and lifestyle patterns , playing experience , injury experience , training patterns , and anthropometric characteristics were recorded , and then a battery of fitness tests were carried out . Results —A multiple regression model identified grade and previous injury experience as risk factors for in season injury , measured as an injury incidence rate . A second model identified previous injury experience , hours of strenuous physical activity a week , playing position , cigarette smoking status , body mass index , years of rugby participation , stress , aerobic and anaerobic performance , and number of push ups as risk factors for in season injury , measured as proportion of season missed . Conclusions —The findings emphasise the importance of previous injury as a predictor of injury incidence and of missing play . They also show the importance of considering both the incidence rate and severity of injury when identifying risk factors for injury in sport",
"OBJECTIVES The aim of this study was to assess the physiological responses to an intensified rugby league competition and explore the relationships between fatigue and match performance . DESIGN Prospect i ve cohort study . METHODS Fifteen junior rugby league players ( n=8 forwards , 7 backs ; mean±SE , age 16.6±0.2 years ; body mass 81.6±3.0 kg ; and height 178.9±1.8 cm ) competed in five 40min games over 5 days ( two games each on days 1 and 2 , one game on day 4 , and no games on days 3 and 5 ) . Over the competition , players performed a countermovement jump to assess neuromuscular fatigue , provided a fingertip blood sample to measure blood creatine kinase , and completed a question naire to monitor perceived wellbeing ; ratings of perceived effort were recorded following each game . Global positioning system and video analysis of each game were used to assess match performance . RESULTS Over the first 3 days , there were progressive and large increases in neuromuscular fatigue which peaked 12h after game 4 ( forwards ES=4.45 , p=0.014 ; backs ES=3.62 , p=0.029 ) , and muscle damage which peaked 1h post game 4 ( forwards ES=4.45 , p=0.004 ; backs ES=3.94 p=0.012 ) , as well as reductions in perceived wellbeing . These measures gradually recovered over the final 2 days of the competition . Compared to the backs , the forwards experienced greater increases in creatine kinase following game 2 ( ES=1.30 ) and game 4 ( ES=1.24 ) and reductions in perceived wellbeing ( ES=0.25 - 0.46 ) . Match intensity , high-speed running , and repeated-high intensity effort bouts decreased in games 4 and 5 of the competition . Small to large associations were observed between the changes in fatigue , muscle damage and match performance , with significant correlations between creatine kinase and repeated high-intensity effort bout number ( r=-0.70 , p=0.031 ) and frequency ( r=0.74 , p=0.002 ) and low-speed activity ( r=-0.56 , p=0.029 ) . CONCLUSIONS Fatigue and muscle damage accumulate over an intensified competition , which is likely to contribute to reductions in high-intensity activities and work rates during competition",
"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 study whether field performance tests can make a valid distinction between non-functionally overreaching ( NFO ) athletes and control athletes . Design Monthly field performance tests were used to determine a performance decrement ( PD ) throughout a season . Athletes with a minimum of 1 month PD were compared with control athletes without a PD on mood characteristics and resting levels of stress hormones . Setting Sporting field and sports medical laboratory . Participants 129 young elite athletes , 77 soccer players and 52 middle-long distance runners were followed prospect ively during the 2006–2007 season . Fifteen of them were invited to the laboratory . Eight athletes showed a performance decrease lasting longer than 1 month , and seven athletes without a performance decrease acted as their controls . Main outcome measures Performance changes over time were measured using field tests . Profile of Mood States and resting levels of adrenocorticotrophic hormone ( ACTH ) and cortisol in blood were measured in the laboratory . Results PD athletes showed several symptoms typical of the non-functional state of overreaching ( OR ) . The PD group scored higher on depression and anger than controls . They also showed a specific pattern of correlations between negative mood subscales ( tension , fatigue and depression ) , which was absent in controls . ACTH levels at rest were similar , but lower cortisol levels in PD athletes pointed at a blunted cortisol response . Cortisol levels were decoupled from ACTH levels only in PD athletes . Conclusions Implementing performance-related criteria in field tests can help coaches and sports physicians to distinguish NFO athletes from athletes with balanced workload and recovery",
"The aim of this study was to examine the influence of perceived intensity , duration and load of matches and training on the incidence of injury in rugby league players . The incidence of injury was prospect ively studied in 79 semi-professional rugby league players during the 2001 season . All injuries sustained during matches and training sessions were recorded . Training sessions were conducted from December to September , with matches played from February to September . The intensity of individual training sessions and matches was estimated using a modified rating of perceived exertion scale . Training load was calculated by multiplying the training intensity by the duration of the training session . The match load was calculated by multiplying the match intensity by the time each player participated in the match . Training load increased from December ( 278.3 [ 95 % confidence interval , CI 262.2 to 294.5 ] units ) to February ( 385.5 [ 95 % CI 362.4 to 408.5 ] units ) , followed by a decline until September ( 98.4 [ 95 % CI 76.5 to 120.4 ] units ) . Match load increased from February ( 204.0 [ 95 % CI 186.2 to 221.8 ] units ) to September ( 356.8 [ 95 % CI 302.5 to 411.1 ] units ) . More training injuries were sustained in the first half of the season ( first vs second : 69.2 % vs 30.8 % , P match injuries occurred more frequently in the latter stages of the season ( 53.6 % vs 46.4 % , P changes in training injury incidence and changes in training intensity ( r = 0.83 ) , training duration ( r = 0.79 ) and training load ( r = 0.86 ) . In addition , changes in the incidence of match injuries were significantly correlated ( P changes in match intensity ( r = 0.74 ) , match duration ( r = 0.86 ) and match load ( r = 0.86 ) . These findings suggest that as the intensity , duration and load of rugby league training sessions and matches is increased , the incidence of injury is also increased",
"OBJECTIVES To investigate the relationship between training load and injury in professional rugby league players ; DESIGN Prospect i ve cohort study ; METHODS Seventy-nine professional rugby league players ( mean±SD age , 23.3±3.8 years ) participated in this four-year study . A periodized field , strength , and power training program was implemented , with training loads progressively increased in the general preparatory phase of the season and reduced during the competitive phase of the season . Training loads and injuries were recorded for each training session . RESULTS Training load was significantly related ( P overall injury ( r=0.82 ) , non-contact field injury ( r=0.82 ) , and contact field injury ( r=0.80 ) rates . Significant relationships were also observed between the field training load and overall field injury ( r=0.68 ) , non-contact field injury ( r=0.65 ) , and contact field injury ( r=0.63 ) rates . Strength and power training loads were significantly related to the incidence of strength and power injuries ( r=0.63 ) . There was no significant relationship between field training loads and the incidence of strength and power injuries . However , strength and power training loads were significantly ( P with the incidence of contact ( r=0.75 ) and non-contact ( r=0.82 ) field training injuries . CONCLUSIONS These findings suggest that the harder rugby league players train , the more injuries they will sustain , and that high strength and power training loads may contribute indirectly to field injuries . Monitoring of training loads and careful scheduling of field and gymnasium sessions to avoid residual fatigue is warranted to minimize the effect of training-related injuries on professional rugby league players",
"The aim of this study was to prospect ively monitor sport-specific performance and assess the stress-recovery balance in overreached ( OR ) soccer players and controls . During two competitive seasons , 94 players participated in the study . The stress-recovery balance ( RESTQ-Sport ) and sport-specific performance ( Interval Shuttle Run Test ) were assessed monthly . Seven players with performance decrement of at least a month were classified as OR . Stress and recovery measures were assessed between groups ( OR vs healthy players ) and at different times within the OR group . An unfavorable total recovery score appeared 2 months before diagnosis when compared with the reference values of the healthy group established at the start of the season ( P=0.009 ) and also over the two seasons ( P=0.028 ) . The scales Emotional Stress ( P=0.044 ) , Physical Recovery ( P=0.009 ) , General Well-being ( P=0.001 ) and Sleep Quality ( P=0.045 ) were sensitive to OR compared with the average of the healthy group over the two seasons . Finally , Fatigue and Being in Shape demonstrated the largest changes in stress and recovery within the OR players ( effect size=1.14 and 1.50 ) . The longitudinal monitoring of performance and changes in stress and recovery may be useful for the detection of OR in its earliest stage . The information obtained from these tests can be used to optimize individual training and recovery programs",
"Background Although player fatigue and playing intensity have been suggested to contribute to injuries in rugby league players , no study has confirmed if the level of physical fitness is a risk factor for injury in rugby league players . The aim of this study was to identify risk factors for injury in subelite rugby league players . Hypothesis Low physical fitness levels are risk factors for injury in subelite rugby league players . Study Design Cohort study ; Level of evidence , 2 . Methods One hundred fifty-three players from a subelite rugby league club underwent preseason measurements of muscular power ( vertical jump ) , speed ( 10- and 40-m sprint ) , and maximal aerobic power ( multistage fitness test ) over 4 competitive seasons . All injuries sustained by players were prospect ively recorded over the 4 competitive seasons . Results The risk of injury was greater in players with low 10- and 40-m speed . Players with a low maximal aerobic power had a greater risk of sustaining a contact injury . In addition , players who completed less than 18 weeks of training before sustaining their initial injuries were at greater risk of sustaining a subsequent injury . Conclusions Subelite rugby league players with low speed and maximal aerobic power are at an increased risk of injury . In addition , players who complete less than 18 weeks of training before sustaining an initial injury are at greater risk of sustaining a subsequent injury . These findings highlight the importance of speed and endurance training to reduce the incidence of injury in subelite rugby league players",
"This study assessed whether the Recovery-Stress Question naire for Athletes ( RESTQ-Sport ) could be used to monitor changes in perceived stress and recovery during intensified training of rugby league players . 20 semiprofessional rugby league players were divided into two equal groups r and omly assigned to complete 6 wk . of Normal Training or Intensified Training , each followed with a 7-day taper . Multistage Fitness Test performance and RESTQ – Sport measures were taken at the beginning , at 2-wk . intervals , and at the end of the training period . Endurance significantly decreased with Intensified Training and returned to baseline levels following the taper , while remaining unchanged in the Normal Training group . The RESTQ – Sport scores with training were positively related to stress subscale scores ( Fatigue , Disturbed Breaks , and General Stress ) and recovery subscale measures ( Success , Physical Recovery , Being in Shape , Self-efficacy , Social Relaxation , General Well-being , and Sleep Quality ) decreasing in the Intensified Training group and then normalising following the taper ( Stress subscales : Fatigue and General Stress , and Recovery subscales : Physical Recovery and General Well-being ) . The RESTQ – Sport is a practical psychometric tool for monitoring responses to training in team-sport athletes",
"The aim of this study was to compare 7 weeks of soccer-specific small-sided game ( SSG ) and mixed generic fitness training , on selected physiological , perceptual and performance variables . Twenty-five elite youth players were r and omly allocated to either a SSG ( coach selected ) or generic training group ( GTG ) , in a r and omised , parallel matched-group design . In addition to normal training , each group completed two fitness training sessions per week of equal duration . Players completed a V O ( 2 max ) treadmill test , Multistage Fitness Test ( MSFT ) , Yo-Yo Intermittent Recovery Test Level 1 ( YYIRTL1 ) , 12x20 m test of repeated-sprint ability ( RSA ) and 20-m sprint test pre and post training . Training heart rate , perceived training intensity and perceptual fatigue measures were recorded throughout the training period . There were no differences in training heart rate or perceptual well-being measures . However , the GTG did perceive their training to be more intense than SSG . There were no changes in either group for V O ( 2 max ) , MSFT , RSA or sprint performance . However , there were improvements in YYIRTL1 performance for both groups over time , but not between groups . The results show that both types of training are equally effective at improving pre-season YYIRTL1 performance , despite GTG being perceived to be more intense",
"Buchheit , M , Mendez-Villanueva , A , Delhomel , G , Brughelli , M , and Ahmaidi , S. Improving repeated sprint ability in young elite soccer players : repeated shuttle sprints vs. explosive strength training . J Strength Cond Res 24(10 ) : 2715 - 2722 , 2010-To compare the effects of explosive strength ( ExpS ) vs. repeated shuttle sprint ( RS ) training on repeated sprint ability ( RSA ) in young elite soccer players , 15 elite male adolescents ( 14.5 ± 0.5 years ) performed , in addition to their soccer training program , RS ( n = 7 ) or ExpS ( n = 8) training once a week for a total of 10 weeks . RS training consisted of 2 - 3 sets of 5 - 6 × 15- to 20-m repeated shuttle sprints interspersed with 14 seconds of passive or 23 seconds of active recovery ( ≈2 m·s−1 ) ; ExpS training consisted of 4 - 6 series of 4 - 6 exercises ( e.g. , maximal unilateral countermovement jumps ( CMJs ) , calf and squat plyometric jumps , and short sprints ) . Before and after training , performance was assessed by 10 and 30 m ( 10 and 30 m ) sprint times , best ( RSAbest ) and mean ( RSAmean ) times on a repeated shuttle sprint ability test , a CMJ , and a hopping ( Hop ) test . After training , except for 10 m ( p = 0.22 ) , all performances were significantly improved in both groups ( all p 's 0.45 ) . RS training induced greater improvement in RSAbest ( −2.90 ± 2.1 vs. −0.08 ± 3.3 % , p = 0.04 ) and tended to enhance RSAmean more ( −2.61 ± 2.8 vs. −0.75 ± 2.5 % , p = 0.10 , effect size [ ES ] = 0.70 ) than ExpS. In contrast , ExpS tended to induce greater improvements in CMJ ( 14.8 ± 7.7 vs. 6.8 ± 3.7 % , p = 0.02 ) and Hop height ( 27.5 ± 19.2 vs. 13.5 ± 13.2 % , p = 0.08 , ES = 0.9 ) compared with RS . Improvements in the repeated shuttle sprint test were only observed after RS training , whereas CMJ height was only increased after ExpS. Because RS and ExpS were equally efficient at enhancing maximal sprinting speed , RS training-induced improvements in RSA were likely more related to progresses in the ability to change direction"
] | 41169156-06ff-11f0-808a-c43d1ab1c353 |
Purpose To identify measures used to evaluate the broad constructs of functional impairment and limitations in the critically ill across the continuum of recovery , and to evaluate , synthesis e and compare the clinimetric properties of the measures identified . Methods A systematic review of articles was carried out using the data bases Medline ( 1950–2014 ) , CINAHL ( 1982–2014 ) , EMBASE ( 1980–2014 ) , Cochrane Library ( 2014 ) and Scopus ( 1960–2014 ) . Additional studies were identified by search ing personal files . Eligibility criteria for selection : Search 1 : studies which assessed muscle mass , strength or function using objective non-laboratory measures ; Search 2 : studies which evaluated a clinimetric property ( reliability , measurement error , validity or responsiveness ) for one of the measures identified in search one . Two independent review ers assessed articles for inclusion and assessed risk of bias using the consensus-based st and ards for selection of health status measurement instruments checklist . Results Thirty-three measures were identified ; however , only 20 had established clinimetric properties . Ultrasonography , dynamometry , physical function in intensive care test scored and the Chelsea critical care physical assessment tool performed the strongest for the measurement of impairment of body systems ( muscle mass and strength ) and activity limitations ( physical function ) , respectively . Conclusions There is considerable variability in the type of measures utilized to measure physical impairments and limitations in survivors of critical illness . Future work should identify a core set of st and ardized measures , which can be utilized across the continuum of critical illness recovery embedded within the International Classification of Functioning framework . This will enable improved comparisons between future studies , which in turn will assist in identifying the most effective treatment strategies to ameliorate the devastating longer-term outcomes of a critical illness | [
"Purpose : The purpose of this review is to evaluate the literature related to mobilization of the critically ill patient with an emphasis on functional outcomes and patient safety . Methods : We search ed the electronic data bases of PubMed , CINAHL , Medline ( Ovid ) , and The Cochrane Library for a period spanning 2000‐2011 . Articles used in this review included r and omized and nonr and omized clinical trials , prospect i ve and retrospective analyses , and case series in peer review ed journals . Sackett 's Levels of Evidence were used to classify the current literature to evaluate the strength of the outcomes reported . Results : Fifteen studies met inclusion criteria and were review ed . According to Sackett 's Levels of Evidence , 9 studies were level 4 evidence , one study was level 3 , 4 studies were level 2 , and one study was level one evidence . Ten studies pertained to patient safety/feasibility and 10 studies pertained to functional outcomes with 5 fitting into both categories . Conclusion : A search of the scientific literature revealed a limited number of studies that examined the mobilization of critically ill patients in the intensive care unit . However , literature that does exist supports early mobilization and physical therapy as a safe and effective intervention that can have a significant impact on functional outcomes",
"Introduction The purpose of this trial was to investigate the effectiveness of an exercise rehabilitation program commencing during ICU admission and continuing into the outpatient setting compared with usual care on physical function and health-related quality of life in ICU survivors . Methods We conducted a single-center , assessor-blinded , r and omized controlled trial . One hundred and fifty participants were stratified and r and omized to receive usual care or intervention if they were in the ICU for 5 days or more and had no permanent neurological insult . The intervention group received intensive exercises in the ICU and the ward and as out patients . Participants were assessed at recruitment , ICU admission , hospital discharge and at 3- , 6- and 12-month follow-up . Physical function was evaluated using the Six-Minute Walk Test ( 6MWT ) ( primary outcome ) , the Timed Up and Go Test and the Physical Function in ICU Test . Patient-reported outcomes were measured using the Short Form 36 Health Survey , version 2 ( SF-36v2 ) and Assessment of Quality of Life ( AQoL ) Instrument . Data were analyzed using mixed models . Results The a priori enrollment goal was not reached . There were no between-group differences in demographic and hospital data , including acuity and length of acute hospital stay ( LOS ) ( Acute Physiology and Chronic Health Evaluation II score : 21 vs 19 ; hospital LOS : 20 vs 24 days ) . No significant differences were found for the primary outcome of 6MWT or any other outcomes at 12 months after ICU discharge . However , exploratory analyses showed the rate of change over time and mean between-group differences in 6MWT from first assessment were greater in the intervention group . Conclusions Further research examining the trajectory of improvement with rehabilitation is warranted in this population .Trial registration The trial was registered with the Australian New Zeal and Clinical Trials Registry ACTRN12605000776606",
"Background The purpose of this study was to identify predictors of 3-month mortality in critically ill older persons under medical care and to assess the clinical impact of an ICU stay on physical and cognitive dependence and subjective health status in survivors . Methods We conducted a prospect i ve observational cohort study including all older persons 75 years and older consecutively admitted into ICU during a one-year period , except those admitted after cardiac arrest , All patients were followed for 3 months or until death . Comorbidities were assessed using the Charlson index and physical dependence was evaluated using the Katz index of Activity of Daily Living ( ADL ) . Cognitive dependence was determined by a score based on the individual components of the Lawton index of Daily Living and subjective health status was evaluated using the Nottingham Health Profile ( NHP ) score . Results One hundred patients were included in the analysis . The mean age was 79.3 ± 3.4 years . The median Charlson index was 6 [ IQR , 4 to 7 ] and the mean ADL and cognitive scores were 5.4 ± 1.1 and 1.2 ± 1.4 , respectively , corresponding to a population with a high level of comorbidities but low physical and cognitive dependence . Mortality was 61/100 ( 61 % ) at 3 months . In multivariate analysis only comorbidities assessed by the Charlson index [ Adjusted Odds Ratio , 1.6 ; 95 % CI , 1.2 - 2.2 ; p the number of organ failures assessed by the SOFA score [ Adjusted Odds Ratio , 2.5 ; 95 % CI , 1.1 - 5.2 ; p 22 patients needing renal support after Day 3 died . Compared with pre-admission , physical ( p = 0.04 ) , and cognitive ( p = 0.62 ) dependence in survivors had changed very little at 3 months . In addition , the mean NHP score was 213.1 ± 132.8 at 3 months , suggesting an acceptable perception of their quality of life . Conclusions In a selected population of non surgical patients 75 years and older , admission into the ICU is associated with a 3-month survival rate of 38 % with little impact on physical and cognitive dependence and subjective health status . Nevertheless , a high comorbidity level ( ie , Charlson index ) , multi-organ failure , and the need for extra-renal support at the early phase of intensive care could be considered as predictors of death",
"Multiple organ failure ( MOF ) is accompanied by muscle wasting , but changes in body composition are frequently obscured by fluid retention ( edema ) , mainly in superficial and visceral tissue . There is a need to assess body composition and changes in body composition in these circumstances independently of edema . A relation was sought between fat-free ( lean tissue ) mass [ calculated from body weight and skinfold thicknesses and measured by using dual-energy X-ray absorptiometry ( DXA ) ] and muscle thickness ( measured using ultrasound at a variety of sites accessible in an unconscious supine subject ) to determine which sites correlated best with lean body mass . The three best sites were midbiceps , midforearm anteriorly , and midthigh anteriorly : R2 for the simple sum of the three sites correlated with fat-free mass from skinfold thicknesses was 71.1 % , and with lean tissue mass from DXA was 76.1 % . Serial measurements of both muscle thickness and midupper-arm circumference in nine patients with MOF showed a complete dissociation ; in all nine there was a significant negative correlation of muscle thickness with time ( P in arm circumference were r and om . Only one patient showed a significant negative correlation with time , seven showed no change , and one other showed a significant increase . The muscle thicknesses that correlate best with lean body mass are measured over the biceps , anterior forearm , and anterior thigh . Monitoring muscle thicknesses at these three sites identifies wasting in edematous patients as it is happening",
"The objective of this study was to assess the utility of bioelectrical impedance analysis ( BIA ) in determining nutritional status in critically ill patients in the intensive care unit ( ICU ) . Data were collected prospect ively in 33 mechanically ventilated medical and surgical ICU patients requiring nutrition as part of their care . BIA , with subsequent calculation of body-composition indexes , was performed every other day for the duration of ICU stay . Body cell mass ( BCM ) changes correlated with energy and protein intakes ( r2 = 0.87 , P Maintenance of BCM was achieved by a daily provision of 125.5 kJ.kg-1.d-1 ( 30 kcal.kg-1.d-1 ) and 1.5 g protein/kg whereas greater intakes allowed restoration of BCM . The mean ratios of exchangeable sodium to potassium ( Nae : Ke ) improved only in patients achieving positive nitrogen balance ( P = 0.013 ) . Body-composition changes determined by BIA represent a feasible adjunctive method for evaluating and monitoring nutritional status in ICU patients",
"OBJECTIVES To determine whether routine nutrition assessment parameters and body composition change after nutritional support in intensive care unit ( ICU ) patients and whether the changes , if any , are related to cumulative energy and fluid balances . DESIGN A prospect i ve study . SETTING A university teaching hospital . PATIENTS Forty-five mechanically ventilated medical and surgical patients admitted to the ICU who received nutritional support for 7 days ( group 1 ) and 9 patients of this group who received nutritional support for 3 weeks or longer ( group 2 ) . INTERVENTIONS Enteral and parenteral nutritional support prescribed on the basis of metabolic cart measurements of energy expenditure . OUTCOME MEASURES Routine nutrition assessment , including determinations of weight , serum albumin and prealbumin , and lymphocyte count and body composition , including measurements of body cell mass , extracellular fluid and body fat , determined from bioelectric impedance analysis . RESULTS In group 1 patients , weight , albumin and prealbumin levels , and extracellular mass changed , but there was no change in lymphocyte count , body cell mass or body fat . Changes in weight and extracellular mass were slightly related to cumulative fluid balance ; changes in albumin and prealbumin levels were not related to cumulative energy or fluid balance . The findings were similar for group 2 patients . CONCLUSIONS Changes in routine nutrition assessment parameters and body composition are slightly affected by fluid balance but not by energy balance ; thus , they are not specific indicators of the adequacy of nutritional support in ICU patients . Improved nutrition assessment parameters are required to better monitor the response to nutritional support in critically ill patients",
"PURPOSE To study the mortality and outcome of critically ill elderly patients in a developing country with focus on nutritional and socioeconomic status . METHODS A prospect i ve study of 109 patients ( 215 screened ) admitted consecutively to the intensive care unit from 2011 to 2012 . Demographics , Acute Physiology and Chronic Health Evaluation ( APACHE ) II score , mechanical ventilation , Malnutrition Universal Screening Tool score , socioeconomic category , functional status , delirium , and length of stay were recorded . Telephonic assessment of outcome was done at 1 year . Appropriate statistical tests compared differences between subgroups . Multivariate analysis was performed on significant variables ( P APACHE II score ( P severe malnutrition ( P=.006 ; OR , 0.08 ; 95 % CI , 0.01 - 0.48 ) , and delirium ( P=.03 ; OR , 0.32 ; 95 % CI , 0.11 - 0.9 ) . Risk factors for short-term mortality ( at 28 days ) were APACHE II score ( P=.02 ; OR , 1.1 [ 1.0 - 1.2 ] ) and premorbid functional status ( P=.03 ; OR , 0.2 [ 0.1 - 0.8 ] ) . Kaplan-Meier survival analysis showed a significant association with malnutrition ( log-rank test , P=.012 ) but not with socioeconomic category . Most ( 72 % ) of the survivors had a favorable functional status . CONCLUSIONS Malnutrition , delirium , and APACHEII were risk factors for long-term mortality . Survivors had a good functional outcome . Appropriate quality of life tools for this population need to be developed",
"Objective The goal of the paper is to determine inter-rater reliability of trained examiners performing st and ardized strength assessment s using manual muscle testing ( MMT ) . Design , subjects , and setting The authors report on 19 trainees undergoing quality assurance within a multi-site prospect i ve cohort study .InterventionInter-rater reliability for specially trained evaluators ( “ trainees ” ) and a reference rater , performing MMT using both simulated and actual patients recovering from critical illness was evaluated . Measurements and results Across 26 muscle groups tested by 19 trainee-reference rater pairs , the median ( interquartile range ) percent agreement and intraclass correlation coefficient ( ICC ; 95 % CI ) were : 96 % ( 91 , 98 % ) and 0.98 ( 0.95 , 1.00 ) , respectively . Across all 19 pairs , the ICC ( 95 % CI ) for the overall composite MMT score was 0.99 ( 0.98–1.00 ) . When limited to actual patients , the ICC was 1.00 ( 95 % CI 0.99–1.00 ) . The agreement ( kappa ; 95 % CI ) in detecting clinical ly significant weakness was 0.88 ( 0.44–1.00 ) . Conclusions MMT has excellent inter-rater reliability in trained examiners and is a reliable method of comprehensively assessing muscle strength",
"OBJECTIVE Patients in intensive care exhibit a high degree of loss of muscle mass . Appropriate instruments are needed to document muscle wasting in these patients . The aim of this pilot study was to describe muscle wasting in patients in the intensive care unit . DESIGN Two-fold study setting : prospect i ve longitudinal and cross-sectional single-blind . PATIENTS A total of 118 patients in the intensive care unit ( length of stay 1 - 98 days ; male : female ratio 88:30 ; age 55 + /- 17 years ) were included in a two-fold study setting . METHODS Muscle layer thickness of the M. quadriceps femoris was documented using ultrasound measurement at well-defined points . Seventeen pilot- patients were measured twice ; at baseline and after 28 days . In another group of 101 patients , muscle layer thickness was determined once after a r and om length of stay . The results of both groups were compared and correlated . RESULTS In both groups , M. quadriceps femoris thickness showed a significant negative correlation with length of stay in the intensive care unit ( p muscle wasting in intensive care patients could be described using a logarithmic function . CONCLUSION Loss of muscle mass shows a negative correlation with length of stay , and seems to be higher during the first 2 - 3 weeks of immobilization/intensive care unit stay . Ultrasound is a valid and practical measurement tool for documenting muscle mass ( e.g. muscle layer thickness ) as part of the daily routine at an intensive care unit",
"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",
"Background Accurate measurement of quality of life in older ICU survivors is difficult but critical for underst and ing the long-term impact of our treatments . Activities of daily living ( ADLs ) are important components of functional status and more easily measured than quality of life ( QOL ) . We sought to determine the cross-sectional associations between disability in ADLs and QOL as measured by version one of the Short Form 12-item Health Survey ( SF-12 ) at both one month and one year post-ICU discharge . Methods Data was prospect ively collected on 309 patients over age 60 admitted to the Yale-New Haven Hospital Medical ICU between 2002 and 2004 . Among survivors an assessment of ADL 's and QOL was performed at one month and one-year post-ICU discharge . The SF-12 was scored using the version one norm based scoring with 1990 population norms . Multivariable regression was used to adjust the association between ADLs and QOL for important covariates . Results Our analysis of SF-12 data from 110 patients at one month post-ICU discharge showed that depression and ADL disability were associated with decreased QOL . Our model accounted for 17 % of variability in SF12 physical scores ( PCS ) and 20 % of variability in SF12 mental scores ( MCS ) . The mean PCS of 37 was significantly lower than the population mean whereas the mean MCS score of 51 was similar to the population mean . At one year mean PCS scores improved and ADL disability was no longer significantly associated with QOL . Mortality was 17 % ( 53 patients ) at ICU discharge , 26 % ( 79 patients ) at hospital discharge , 33 % ( 105 patients ) at one month post ICU admission , and was 45 % ( 138 patients ) at one year post ICU discharge . Conclusions In our population of older ICU survivors , disability in ADLs was associated with reduced QOL as measured by the SF-12 at one month but not at one year . Although better markers of QOL in ICU survivors are needed , ADLs are a readily observable outcome . In the meantime , clinicians must try to offer realistic estimates of prognosis based on available data and re sources are needed to assist ICU survivors with impaired ADLs who wish to maintain their independence . More aggressive diagnosis and treatment of depression in this population should also be explored as an intervention to improve quality of life",
"Background and Purpose . Patients requiring prolonged mechanical ventilation ( PMV ) are frequently deconditioned because of respiratory failure precipitated by the underlying disease , the adverse effects of medications , and a period of prolonged immobilization . The effects of 6 weeks of physical training on the strength of respiratory and limb muscles , on ventilator-free time , and on functional status in patients requiring PMV were examined . Subjects . Thirty-nine patients with PMV were initially enrolled in the study and were assigned to either a treatment group ( n=20 ) or a control group ( n=19 ) . Three subjects in the treatment group and 4 subjects in the control group died during the 6-week intervention period and thus their data were excluded from the final analysis . Methods . Subjects in the treatment group received physical training 5 days a week for 6 weeks . Strength of respiratory and limb muscles , ventilator-free time , and functional status , which was measured by the Barthel Index of Activities of Daily Living ( BI ) and Functional Independence Measure ( FIM ) , were examined at baseline and at the third and sixth weeks of the study period . Results . Respiratory and limb muscle strength improved significantly at the third and sixth weeks in the treatment group compared with baseline measurements . Total BI and FIM scores increased significantly in the treatment group and remained unchanged in the control group . Effect sizes of the BI and FIM scores were 2.02 and 1.93 , respectively , at the sixth week . Discussion and Conclusion . The results show that a 6-week physical training program may improve limb muscle strength and ventilator-free time and thus improve functional outcomes in patients requiring PMV",
"BACKGROUND The importance of evaluating disability outcome measures is well recognised . The Functional Independence Measure ( FIM ) was developed to be a more comprehensive and “ sensitive ” measure of disability than the Barthel Index ( BI ) . Although the FIM is widely used and has been shown to be reliable and valid , there is limited information about its responsiveness , particularly in comparison with the BI . This study compares the appropriateness and responsiveness of these two disability measures in patients with multiple sclerosis and stroke . METHODS Patients with multiple sclerosis ( n=201 ) and poststroke ( n=82 ) patients undergoing inpatient neurorehabilitation were studied . Admission and discharge scores were generated for the BI and the three scales of the FIM ( total , motor , and cognitive ) . Appropriateness of the measures to the study sample s was determined by examining score distributions , floor and ceiling effects . Responsiveness was determined using an effect size calculation . RESULTS The BI , FIM total , and FIM motor scales show good variability and have small floor and ceiling effects in the study sample s. The FIM cognitive scale showed a notable ceiling effect in patients with multiple sclerosis . Comparable effect sizes were found for the BI , and two FIM scales ( total and motor ) in both patients with multiple sclerosis and stroke patients . CONCLUSION All measures were appropriate to the study sample . The FIM cognitive scale , however , has limited usefulness as an outcome measure in progressive multiple sclerosis . The BI , FIM total , and FIM motor scales show similar responsiveness , suggesting that both the FIM total and FIM motor scales have no advantage over the BI in evaluating change",
"PURPOSE The purpose of this study was to determine the interrater reliability of the Perme Intensive Care Unit Mobility Score . MATERIAL S AND METHODS This was a prospect i ve observational study . Data were collected from 20 patients admitted in a cardiovascular intensive care unit . The interrater reliability was tested using the intraclass correlation coefficient with 95 % confidence interval and the Cohen κ coefficient of 0.9 , using a 2-tailed α of .05 to provide a 90 % power . RESULTS The 15 items of the Perme ICU Mobility Score were individually analyzed . Interrater reliability ( Cohen κ coefficient ) for items 2 , 3 , 5 , 6 , 7 , 8 , 13 , and 15 was 1.0000 ; for item 1 , 0.8276 ; item 4 , 0.8000 ; item 9 , 0.6000 ; item 10 , 0.7297 ; item 11 , 0.7260 ; item 12 , 0.7872 ; and item 14 , 0.9048 ; the intraclass correlation coefficient ( 95 % confidence interval ) was 0.9880 ( 0.97743 - 0.99859 ) . CONCLUSIONS The Perme ICU Mobility Score is a reliable tool to assess mobility status of patients admitted to the cardiovascular intensive care unit in a specific moment in time , which can be an important tool for research and clinical practice",
"OBJECTIVES To determine predictors of mortality in the intensive care unit ( ICU ) and at 6 months after discharge ; to assess the lifestyles of survivors 6 months after discharge . DESIGN Prospect i ve cohort study of patients screened upon admission and 6 months after discharge from the ICU . SETTING The ICU of a university hospital . PARTICIPANTS One hundred sixteen consecutive patients age 70 and older admitted to the ICU and treated by mechanical ventilation for at least 24 hours . MEASUREMENTS A comprehensive medical , functional , nutritional , and social assessment was undertaken for each patient upon admission to the ICU . Functional status and residence were recorded for patients still living 6 months after discharge from the ICU . RESULTS Mortality in the ICU and 6 months after discharge was 31 % and 52 % , respectively . The predictors of in-ICU mortality on multivariate analysis were a high omega score per day in the ICU and a high simplified acute physiologic score corrected for points related to age ( SAPS IIc ) . The predictors of mortality at 6 months were a high omega score per day in the ICU , a high SAPS IIc , and a mid-arm circumference ( MAC ) under the 10th percentile for the older French population in good health . Six months after discharge from the ICU , 91 % of the surviving patients had the same residential status and 89 % had a similar or improved functional status compared with pre-admission status . CONCLUSIONS Although severity of illness remains an important predictor of in-ICU mortality and mortality at 6 months after release from ICU , we found that impaired nutritional status upon admission was related to 6-month mortality . These results emphasize the need for a systematic nutritional assessment in older patients admitted to the ICU and treated by mechanical ventilation",
"Objectives : To assess whether the presence and severity of intensive care unit-acquired paresis are associated with intensive care unit and in-hospital mortality . Design : Prospect i ve , observational study . Setting : Two medical , one surgical , and one medico-surgical intensive care units in two university hospitals and one university-affiliated hospital . Patients : A total of 115 consecutive patients were enrolled after > 7 days of mechanical ventilation . Interventions : None . Measurements and Main Results : The Medical Research Council score ( from 0–60 ) was used to evaluate upper and lower limb strength at time of awakening , identified as the ability to follow five comm and s. Intensive care unit-acquired paresis was defined as a Medical Research Council score hospital mortality . At awakening , median Medical Research Council score was 41 ( interquartile range , 21–52 ) , and 75 ( 65 % ) patients had intensive care unit-acquired paresis . Hospital non-survivors had a significantly lower Medical Research Council score at awakening ( 21 [ 11–43 ] ) vs. 41 [ 28–53 ] ; p = .008 ) and a significantly higher rate of intensive care unit-acquired paresis ( 85.1 % vs. 58.4 % ; p = .02 ) compared to survivors . After multivariate risk adjustment , intensive care unit-acquired paresis was independently associated with higher hospital and intensive care unit mortality ( odds ratio for hospital mortality , 2.02 ; 95 % confidence interval , 1.03–8.03 ; p = .048 ) . Each Medical Research Council point decrease was associated with a significantly higher hospital mortality ( odds ratio , 1.03 ; 95 % confidence interval , 1.01–1.05 ; p = .033 ) . Conclusions : Both the presence and severity of intensive care unit-acquired paresis at the time of awakening are associated with increased intensive care unit and hospital mortality ; the mechanisms underlying this association need further study",
"Objective : Muscle weakness often complicates critical illness and is associated with increased risk of morbidity , mortality , and limiting functional outcome even years later . To assess the presence of muscle weakness and to examine the effects of interventions , objective and reliable muscle strength measurements are required . The first objective of this study is to determine interobserver reliability of h and held dynamometry . Secondary objectives are to quantify muscle weakness , to evaluate distribution of muscle weakness , and to evaluate gender-related differences in muscle strength . Design : Cross-sectional observational study . Setting : The surgical and medical intensive care units of a large , tertiary referral , university hospital . Patients : A cross-sectional , r and omly selected sample of awake and cooperative critically ill patients . Interventions : None . Measurements and Main Results : H and held dynamometry was performed in critically ill patients who had at least a score of 3 ( movement against gravity ) on the Medical Research Council scale . Three upper limb and three lower limb muscle groups were tested at the right-h and side . Patients were tested twice daily by two independent raters . Fifty-one test – retests were performed in 39 critically ill patients . H and held dynamometry demonstrated good interobserver agreement with intraclass correlation coefficients > 0.90 in four of the muscle groups tested ( range , 0.91–0.96 ) and somewhat less for hip flexion ( intraclass correlation coefficient , 0.80 ) and ankle dorsiflexion ( intraclass correlation coefficient , 0.76 ) . Limb muscle strength was considerably reduced in all muscle groups as shown by the median z-score ( range , −1.08 to −3.48 sd units ) . Elbow flexors , knee extensors , and ankle dorsiflexors were the most affected muscle groups . Loss of muscle strength was comparable between men and women . Conclusions : H and held dynamometry is a tool with a very good interobserver reliability to assess limb muscle strength in awake and cooperative critically ill patients . Future studies should focus on the sensitivity of h and held dynamometry in longitudinal studies to evaluate predictive values toward patients ' functional outcome",
"Purpose The aim of this study was to assess mortality in healthy elderly patients after non-elective medical ICU admission and to identify predictive factors of mortality in these patients . Methods Patients ≥65 years living at home and with full-autonomy ( Barthel index , BI > 60 ) , without cognitive impairment , and non-electively admitted to a medical ICU were prospect ively recruited . A full comprehensive geriatric assessment was made with vali date d scales . Results A total of 230 patients were included , 110 ( 48 % ) between 65 and 74 years and 120 ( 52 % ) ≥75 years . No significant differences were observed between the two groups in premorbid functional and cognitive status , main diagnosis at ICU admission , APACHE II and SOFA scores , use of mechanical ventilation or haemodialysis or length of ICU stay . Over a mean follow-up of 522 days ( range 20–1,170 days ) the cumulative mortality of the whole group was 55 % , being significantly higher in older subjects ( 62 vs. 47 % ; P = 0.024 ) . On multivariate analysis , only parameters related to quality of life ( QOL ) and functional status were independent predictors of cumulated mortality ( P mortality was 2.45 ( 95 % CI : 1.15–5.25 ; P = 0.03 ) and 4.10 ( 95 % CI : 1.53–10.99 ; P = 0.006 ) , respectively , compared to those with better scores . Conclusions Healthy elderly non-elective medical patients admitted to the ICU have a high mortality rate related to premorbid QOL . The LI and /or EQ-5Dvas may be useful tools to identify patients with the best chance of survival",
"Background Skeletal muscle wasting and weakness are common in patients with sepsis in the intensive care unit , although less is known about deficits in diaphragm and limb muscles when mechanical ventilation also is required . Objective The objective of this study was to concurrently investigate relative differences in both thickness and strength of respiratory and peripheral muscles during routine care . Design A prospect i ve , cross-sectional study of 16 alert patients with sepsis and 16 people who were healthy ( control group ) was used . Methods Assessment was made of the diaphragm , upper arm , forearm , and thigh muscle thicknesses with the use of ultrasound ; respiratory muscle strength by means of maximal inspiratory pressure ; and isometric h and grip , elbow flexion , and knee extension forces with the use of portable dynamometry . To describe relative changes , data also were normalized to fat-free body mass ( FFM ) measured by bioelectrical impedance spectroscopy . Results Patients ( 9 men , 7 women ; mean age=62 years , SD=17 ) were assessed after a median of 16 days ( interquartile range=11–29 ) of intensive care unit admission . Patients ' diaphragm thickness did not differ from that of the control group , even for a given FFM . When normalized to FFM , only the difference in patients ' mid-thigh muscle size significantly deviated from that of the control group . Within the patient sample , all peripheral muscle groups were thinner compared with the diaphragm . Patients were significantly weaker than were the control group participants in all muscle groups , including for a given FFM . Within the critically ill group , limb weakness was greater than the already-significant respiratory muscle weakness . Limitations Volitional strength tests were applied such that successive measurements from earlier in the course of illness could not be reliably obtained . Conclusions When measured at bedside , survivors of sepsis and a period of mechanical ventilation may have respiratory muscle weakness without remarkable diaphragm wasting . Furthermore , deficits in peripheral muscle strength and size may exceed those in the diaphragm",
"Objective : Survivors of severe critical illness frequently develop substantial and persistent physical complications , including muscle weakness , impaired physical function , and decreased health-related quality of life . Our objective was to determine the longitudinal epidemiology of muscle weakness , physical function , and health-related quality of life and their associations with critical illness and ICU exposures . Design : A multisite prospect i ve study with longitudinal follow-up at 3 , 6 , 12 , and 24 months after acute lung injury . Setting : Thirteen ICUs from four academic teaching hospitals . Patients : Two hundred twenty-two survivors of acute lung injury . Interventions : None . Measurements and Main Results : At each time point , patients underwent st and ardized clinical evaluations of extremity , h and grip , and respiratory muscle strength ; anthropometrics ( height , weight , mid-arm circumference , and triceps skin fold thickness ) ; 6-minute walk distance , and the Medical Outcomes Short-Form 36 health-related quality of life survey . During their hospitalization , survivors also had detailed daily evaluation of critical illness and related treatment variables . Over one third of survivors had objective evidence of muscle weakness at hospital discharge , with most improving within 12 months . This weakness was associated with substantial impairments in physical function and health-related quality of life that persisted at 24 months . The duration of bed rest during critical illness was consistently associated with weakness throughout 24-month follow-up . The cumulative dose of systematic corticosteroids and use of neuromuscular blockers in the ICU were not associated with weakness . Conclusions : Muscle weakness is common after acute lung injury , usually recovering within 12 months . This weakness is associated with substantial impairments in physical function and health-related quality of life that continue beyond 24 months . These results provide valuable prognostic information regarding physical recovery after acute lung injury . Evidence -based methods to reduce the duration of bed rest during critical illness may be important for improving these long-term impairments",
"Background and Purpose Long-term acute care hospitals ( LTACHs ) have emerged for patients requiring medical care beyond a short stay . Minimal data have been reported on functional outcomes in this setting . The purpose s of this study were : ( 1 ) to measure the clinical utility of the Functional Status Score for the Intensive Care Unit ( FSS-ICU ) in an LTACH setting and ( 2 ) to explore the association between FSS-ICU score and discharge setting . Participants Data were obtained from 101 patients ( median age=70 years , interquartile range [IQR]=61–78 ; 39 % female , 61 % male ) who were admitted to an LTACH . Participants were categorized into 1 of 5 groups by discharge setting : ( 1 ) home ( n=14 ) , ( 2 ) inpatient rehabilitation facility ( n=26 ) , ( 3 ) skilled nursing facility ( n=23 ) , ( 4 ) long-term care/hospice/expired ( n=13 ) , or ( 5 ) transferred to a short-stay hospital ( n=25 ) . Methods Data were prospect ively collected from a 38-bed LTACH in the United States over 8 months beginning in September 2010 . Functional status was scored using the FSS-ICU within 4 days of admission and every 2 weeks until discharge . The FSS-ICU consists of 5 categories : rolling , supine-to-sit transfers , unsupported sitting , sit-to-st and transfers , and ambulation . Each category was rated from 0 to 7 , with a maximum cumulative FSS-ICU score of 35 . Results Cumulative FSS-ICU scores significantly improved from a median ( IQR ) of 9 ( 3–17 ) to 14 ( 5–24 ) at discharge . Median ( IQR ) cumulative discharge FSS-ICU scores were significantly different among the discharge categories : home=28 ( 22–32 ) , inpatient rehabilitation facility=21 ( 15–24 ) , skilled nursing facility=14 ( 8–21 ) , long-term care/hospice/expired=5 ( 0–11 ) , and transfer to a short-stay hospital=4 ( 0–7 ) . Discussion and Conclusions Patients receiving therapy at an LTACH demonstrate significant improvements from admission to discharge using the FSS-ICU . This outcome tool discriminates among discharge setting s and successfully documents functional improvements of patients in an LTACH setting ",
"Purpose Neuromuscular abnormalities are common in ICU patients . We aim ed to assess the incidence of clinical ly diagnosed ICU-acquired paresis ( ICUAP ) and its impact on outcome . Methods Forty-two patients with systemic inflammatory response syndrome on mechanical ventilation for ≥48 h were prospect ively studied . Diagnosis of ICUAP was defined as symmetric limb muscle weakness in at least two muscle groups at ICU discharge without other explanation . The threshold Medical Research Council ( MRC ) Score was set at 35 ( of 50 ) points . Activities in daily living were scored using the Barthel Index 28 and 180 days after ICU discharge . Results Three patients died before sedation was stopped . ICUAP was diagnosed in 13 of the 39 patients ( 33 % ) . Multivariate regression analysis yielded five ICUAP-predicting variables ( P : SAPS II at ICU admission , treatment with steroids , muscle relaxants or norepinephrine , and days with sepsis . Patients with ICUAP had lower admission SAPS II scores [ 37 ± 13 vs. 49 ± 15 ( P = 0.018 ) ] , lower Barthel Index at 28 days and lower survival at 180 days after ICU discharge ( 38 vs. 77 % , P = 0.033 ) than patients without ICUAP . Daily TISS-28 scores were similar but cumulative TISS-28 scores were higher in patients with ICUAP ( 664 ± 275 ) than in patients without ICUAP ( 417 ± 236 ; P = 0.008 ) . The only independent risk factor for death before day 180 was the presence of ICUAP . Conclusions A clinical diagnosis of ICUAP was frequently established in this patient group . Despite lower SAPS II scores , these patients needed more re sources and had high mortality and prolonged recovery periods after ICU discharge",
"Critical illness affects body composition profoundly , especially body cell mass ( BCM ) . BCM loss reflects lean tissue wasting and could be a nutritional marker in critically ill patients . However , BCM assessment with usual isotopic or tracer methods is impractical in intensive care units ( ICUs ) . We aim ed to modelize the BCM of critically ill patients using variables available at bedside . Fat-free mass ( FFM ) , bone mineral ( Mo ) , and extracellular water ( ECW ) of 49 critically ill patients were measured prospect ively by dual-energy X-ray absorptiometry and multifrequency bioimpedance . BCM was estimated according to the four-compartment cellular level : BCM = FFM - ( ECW/0.98 ) - ( 0.73 × Mo ) . Variables that might influence the BCM were assessed , and multivariable analysis using fractional polynomials was conducted to determine the relations between BCM and these data . Bootstrap resampling was then used to estimate the most stable model predicting BCM . BCM was 22.7 ± 5.4 kg . The most frequent model included height ( cm ) , leg circumference ( cm ) , weight shift ( Δ ) between ICU admission and body composition assessment ( kg ) , and trunk length ( cm ) as a linear function : BCM ( kg ) = 0.266 × height + 0.287 × leg circumference + 0.305 × Δweight - 0.406 × trunk length - 13.52 . The fraction of variance explained by this model ( adjusted r(2 ) ) was 46 % . Including bioelectrical impedance analysis variables in the model did not improve BCM prediction . In summary , our results suggest that BCM can be estimated at bedside , with an error lower than ±20 % in 90 % subjects , on the basis of static ( height , trunk length ) , less stable ( leg circumference ) , and dynamic biometric variables ( Δweight ) for critically ill patients",
"BACKGROUND : Rehabilitation is a non-pharmacologic therapy that can restore health and reverse the patient 's disability , but the efficacy of rehabilitation in critically ill patients is not well documented . METHODS : In a prospect i ve cohort study , we assessed whether the degree of change in functional status after comprehensive rehabilitation influenced clinical outcomes in 77 tracheotomized patients ( mean ± SD age 75 ± 7 y ) admitted for difficult weaning to our regional weaning center . The care plan , including peripheral muscle training , was delivered daily . We recorded admission demographic , anthropometric , and functional characteristics . We measured the change in basic activities of daily living score ( ΔBADL ) , survival , and weaning success rate as clinical outcomes . We performed the Pearson correlation analysis and linear regression , with ΔBADL as the dependent variable , to test the predictive power of the baseline measurements . RESULTS : Sixty-seven patients ( 87 % ) survived , and 55 of them ( 74 % ) succeeded in weaning during their stay in the weaning center . The mean ± SD ΔBADL improvement was 2.5 ± 2.0 points ( median 2 points ) . Baseline performance of the latissimus dorsi predicted ΔBADL ( β = 0.388 , 95 % CI 0.111–1,664 , P = .03 ) . The probability of remaining ventilator-free ( P = .043 ) and survival ( P = .001 ) differed across the 4 ΔBADL categories ( 0 = no change , 1–2 = least improvement , and > 2 = improvement above median change ) . CONCLUSIONS : Mortality rate and weaning success differ according to ΔBADL following active rehabilitation/training in tracheotomized , ventilated , difficult-to-wean patients . The performance of the latissimus dorsi was the only significant predictor of change",
"OBJECTIVES To identify prognostic factors that are independently predictive of in-hospital mortality in older patients hospitalized in a medical intensive care unit ( MICU ) . DESIGN Prospect i ve cohort study . SETTING A MICU in an Italian university hospital . PARTICIPANTS Patients aged 65 and older consecutively admitted to the MICU directly from the first-aid unit . MEASUREMENTS Upon admission , the following variables were examined : demographics , clinical history ( diabetes mellitus , active neoplasm , cognitive impairment , immobilization , pressure ulcers , use of nutritional support , home oxygen therapy ) , physiopathology ( Acute Physiology and Chronic Health Evaluation ( APACHE ) II ) , and cognition/function ( activity of daily living ( ADL ) , instrumental activity of daily living ( IADL ) , Short Portable Mental Status Question naire ( SPMSQ ) ) . The vital status of the patient at the end of hospitalization was recorded . RESULTS Over a period of 10 months , 659 patients were recruited ( mean age + /- st and ard deviation = 76.6 + /- 7.5 ; 352 men and 307 women ) . There were 97 deaths ( 14.71 % ) . The following factors proved to be significantly associated with in-hospital mortality : old age , low body mass index ( BMI ) values , low values of albumin , high scores on APACHE II , functional impairment ( ADL , IADL ) , cognitive impairment ( SPMSQ ) , history of cognitive deterioration , history of confinement to bed , and presence of pressure ulcers . Using multivariate analysis , the following variables were independently predictive of in-hospital mortality : lack of independence in ADLs ( P moderate-to-severe cognitive impairment on SPMSQ ( P score on APACHE II ( P = .002 ) , and low BMI values ( P = .031 ) . CONCLUSION The prognosis of older patients hospitalized in medical intensive care units depends not only on the acute physiological impairments , but also on a series of preexisting conditions , such as loss of functional independence , severe and moderate cognitive impairment , and low BMI",
"BACKGROUND Body composition is commonly altered in response to critical illness and can be estimated at the bedside with bioelectrical impedance spectroscopy ( BIS ) . Different electrode configurations may be used to mitigate assumptions of the technique , but the reliability of tetra-polar and octo-polar arrangements has yet to be established . This study aim ed to compare both configurations , in a prospect i ve observational study of 17 critically ill survivors and 12 healthy controls . METHODS Weight , supine body length , and BIS on both tetra-polar and octo-polar configured devices were recorded , then repeated 2 days later . Bioelectrical impedance vector analysis was subsequently performed using data from the tetra-polar device at a frequency of 50 kHz . RESULTS Test-retest agreement was acceptable for the tetra-polar device ( intraclass correlation coefficient range , patients : 0.876 - 0.988 vs controls : 0.983 - 0.998 , P ≤ 0.001 ) . However , lower and wider ranging test-retest intraclass correlation coefficients were obtained with the octo-polar instrument in both groups . Furthermore , there was a difference in the mass/volume of body compartments measured on each device in both patients ( P ≤ .017 ) and controls ( P ≤ .045 ) . A change in the composition profile of critically ill males was evident between measurement occasions , which was reflected by a reduction in body weight of 1.6 ( 1.5 ) kg ( P ≤ 0.001 ) across the sample over the same period . CONCLUSIONS BIS devices should not be used interchangeably in the clinical setting . The reliability of the tetra-polar instrument was good , but daily fluctuations in body weight may have affected the results",
"Risk assessment is nowadays an essential part of the management of seriously ill subjects , and multiple scoring methods are available , based on single or preferably multiple determinations . Some of these protocol s have been successfully used around the world , and they permit the prediction of outcomes in different clinical population s. However , many indices are labor-intensive or dem and an exp and ed set of biochemical determinations , thus representing an economical burden . Aim ing to evaluate the prognostic value of ordinary variables that are already present in the clinical observation , 50 consecutive patients admitted at the intensive care unit were prospect ively documented . Methods included clinical ( age , sex , stay in ICU , FIO2 ) , biochemical ( serum albumin , hemoglobin , glucose , creatinine , WBC count ) , and bioimpedance variables ( resistance , reactance , body impedance coefficient ) . All these values were registered at admission and before discharge or death , and compared with survival rate . Initially only WBC count was significantly different in survivors , but ongoing documentation revealed that later on , four indices were endowed with prognostic impact : serum album , glucose levels , WBC count and FIO2 requirements . Organ or function-sustaining procedures were also associated with outcome , nominally mechanical ventilation , vasoactive drugs , and enteral/parenteral nutrition . Furthermore , patients su bmi tted to two or three of these methods exhibited higher mortality than those receiving just one , with even better result for those not requiring any . It is concluded that observation of ongoing changes in conventional clinical variables available in the clinical chart are a valid means of estimating the mortality risk in critical cases",
"Objectives : To test if the surgical intensive care unit optimal mobility score predicts mortality and intensive care unit and hospital length of stay . Design : Prospect i ve single-center cohort study . Setting : Surgical intensive care unit of the Massachusetts General Hospital . Patients : One hundred thirteen consecutive patients admitted to the surgical intensive care unit . Investigations : We tested the hypotheses that the surgical intensive care unit optimal mobility score independent of comorbidity index , Acute Physiology and Chronic Health Evaluation II , creatinine , hypotension , hypernatremia , acidosis , hypoxia , and hypercarbia predicts hospital mortality , surgical intensive care unit and total hospital length of stay . Measurements and Main Results : Two nurses independently predicted the patients ’ mobilization capacity by using the surgical intensive care unit optimal mobility score the morning after admission , whereas a third nurse recorded the achieved mobilization levels of patients at the end of the day . A multidisciplinary expert team measured patients ’ grip strength and assessed their predicted mobilization capacity independently . Multivariate analysis revealed that the surgical intensive care unit optimal mobility score was the only independent predictor of mortality . Surgical intensive care unit optimal mobility score , hypotension , and hypernatremia ( > 144 mmol/L ) independently predicted intensive care unit length of stay , whereas the surgical intensive care unit optimal mobility score and hypernatremia predicted total hospital length of stay . The Acute Physiology and Chronic Health Evaluation II score was not identified in the multivariate analysis . The surgical intensive care unit optimal mobility score was also a reliable and valid instrument in predicting achieved mobilization levels of patients . Conclusions : In surgical critically ill patients presenting without preexisting impairment of functional mobility , the surgical intensive care unit optimal mobility score is a reliable and valid tool to predict mortality and intensive care unit and hospital length of stay . ( Crit Care Med 2012 ; 40:–1128",
"PURPOSE The aim of this study was to describe the frequency , physiologic effects , safety , and patient outcomes associated with traditional rehabilitation therapy in patients who require mechanical ventilation . MATERIAL S AND METHODS Prospect i ve observational report of consecutive patients ventilated 4 or more days and eligible for rehabilitation in a single medical intensive care unit ( ICU ) during a 13-week period was conducted . RESULTS Of the 32 patients who met the inclusion criteria , only 21 ( 66 % ) received physician orders for evaluation by rehabilitation services ( physical and /or occupational therapy ) . Fifty rehabilitation treatments were provided to 19 patients on a median of 12 % of medical ICU days per patient , with deep sedation and unavailability of rehabilitation staff representing major barriers to treatment . Physiologic changes during rehabilitation therapy were minimal . Joint contractures were frequent in the lower extremities and did not improve during hospitalization . In 53 % and 79 % of initial ICU assessment s , muscle weakness was present in upper and lower extremities , respectively , with a decreased prevalence of 19 % and 43 % at hospital discharge , respectively . New impairments in physical function were common at hospital discharge . CONCLUSIONS This pilot project illustrated important barriers to providing rehabilitation to mechanically ventilated patients in an ICU and impairments in strength , range of motion , and functional outcomes at hospital discharge",
"IMPORTANCE Survivors of critical illness demonstrate skeletal muscle wasting with associated functional impairment . OBJECTIVE To perform a comprehensive prospect i ve characterization of skeletal muscle wasting , defining the pathogenic roles of altered protein synthesis and breakdown . DESIGN , SETTING , AND PARTICIPANTS Sixty-three critically ill patients ( 59 % male ; mean age : 54.7 years [ 95 % CI , 50.0 - 59.6 years ] ) with an Acute Physiology and Chronic Health Evaluation II score of 23.5 ( 95 % CI , 21.9 - 25.2 ) were prospect ively recruited within 24 hours following intensive care unit ( ICU ) admission from August 2009 to April 2011 at a university teaching and a community hospital in Engl and . Patients were recruited if older than 18 years and were anticipated to be intubated for longer than 48 hours , to spend more than 7 days in critical care , and to survive ICU stay . MAIN OUTCOMES AND MEASURES Muscle loss was determined through serial ultrasound measurement of the rectus femoris cross-sectional area ( CSA ) on days 1 , 3 , 7 , and 10 . In a subset of patients , the fiber CSA area was quantified along with the ratio of protein to DNA on days 1 and 7 . Histopathological analysis was performed . In addition , muscle protein synthesis , breakdown rates , and respective signaling pathways were characterized . RESULTS There were significant reductions in the rectus femoris CSA observed at day 10 ( −17.7 % [ 95 % CI , −25.9 % to 8.1 % ] ; P the rectus femoris CSA decreased by 10.3 % ( 95 % CI , 6.1 % to 14.5 % ) , the fiber CSA by 17.5 % ( 95 % CI , 5.8 % to 29.3 % ) , and the ratio of protein to DNA by 29.5 % ( 95 % CI , 13.4 % to 45.6 % ) . Decrease in the rectus femoris CSA was greater in patients who experienced multiorgan failure by day 7 ( −15.7 % ; 95 % CI , −27.7 % to 11.4 % ) compared with single organ failure ( −3.0 % ; 95 % CI , −5.3 % to 2.1 % ) ( P ; P = .03 ) . Myofiber necrosis occurred in 20 of 37 patients ( 54.1 % ) . Protein synthesis measured by the muscle protein fractional synthetic rate was depressed in patients on day 1 ( 0.035%/hour ; 95 % CI , 0.023 % to 0.047%/hour ) compared with rates observed in fasted healthy controls ( 0.039%/hour ; 95 % CI , 0.029 % to 0.048%/hour ) ( P = .57 ) and increased by day 7 ( 0.076 % [ 95 % CI , 0.032%-0.120%/hour ] ; P = .03 ) to rates associated with fed controls ( 0.065%/hour [ 95 % CI , 0.049 % to 0.080%/hour ] ; P = .30 ) , independent of nutritional load . Leg protein breakdown remained elevated throughout the study ( 8.5 [ 95 % CI , 4.7 to 12.3 ] to 10.6 [ 95 % CI , 6.8 to 14.4 ] μmol of phenylalanine/min/ideal body weight × 100 ; P = .40 ) . The pattern of intracellular signaling supported increased breakdown ( n = 9 , r = −0.83 , P = .005 ) and decreased synthesis ( n = 9 , r = −0.69 , P = .04 ) . CONCLUSIONS AND RELEVANCE Among these critically ill patients , muscle wasting occurred early and rapidly during the first week of critical illness and was more severe among those with multiorgan failure compared with single organ failure . These findings may provide insights into skeletal muscle wasting in critical illness",
"Purpose . To evaluate the functional status of patients within the first week of discharge from an intensive care unit ( ICU ) , and to identify predictors and explanatory factors of functional status . Methods . A prospect i ve , observational , cohort study was conducted with consecutive ICU patients who had stayed in a mixed , closed-format , university-level ICU for longer than 48 h. Results . Between 3 and 7 days of discharge from the ICU , functional status ( as primary outcome ) , walking ability , muscle strength , and sensory and cognitive functioning were assessed in 69 survivors . The overall functional status was poor ( median Barthel Index 6 ) . In their ability to perform basic activities of daily living , 67 % percent were severely dependent , 15 % were moderately dependent , and 9 % were slightly dependent on other people . Independent walking was impossible for 73 % of participants , grip strength was reduced for 50 % , and 30 % had cognitive impairments . Duration of ventilation was associated with functional status after ICU discharge . Reduced grip strength and walking ability were identified as explanatory factors for poorer functional status shortly after discharge from the ICU . Conclusion . In the first week after discharge from the ICU , the majority of the patients had substantial functional disabilities in activities of daily living . These disabilities were more severe in patients who experienced ventilation for a longer period of time . There is a need for prospect i ve studies focusing on functional recovery to support informed decision-making concerning the care of critically ill patients after ICU discharge",
"PURPOSE To determine whether frailty can be measured within 4 days prior to hospital discharge in older intensive care unit ( ICU ) survivors of respiratory failure and whether it is associated with post-discharge disability and mortality . MATERIAL S AND METHODS We performed a single-center prospect i ve cohort study of 22 medical ICU survivors age 65 years or older who had received noninvasive or invasive mechanical ventilation for at least 24 hours . Frailty was defined as a score of ≥3 using Fried 's 5-point scale . We measured disability with the Katz Activities of Daily Living . We estimated unadjusted associations between Fried 's frailty score and incident disability at 1-month and 6-month mortality using Cox proportional hazard models . RESULTS The mean ( SD ) age was 77 ( 9 ) years , mean Acute Physiology and Chronic Health Evaluation II score was 27 ( 9.7 ) , mean frailty score was 3.4 ( 1.3 ) , and 18 ( 82 % ) were frail . Nine subjects ( 41 % ) died within 6 months , and all were frail . Each 1-point increase in frailty score was associated with a 90 % increased rate of incident disability at 1-month ( rate ratio : 1.9 , 95 % CI 0.7 - 4.9 ) and a threefold increase in 6-month mortality ( rate ratio : 3.0 , 95 % CI 1.4 - 6.3 ) . CONCLUSIONS Frailty can be measured in older ICU survivors near hospital discharge and is associated with 6-month mortality in unadjusted analysis . Larger studies to determine if frailty independently predicts outcomes are warranted",
"The increase of elderly in our society requires simple tools for quantification of sarcopenia in inpatient and outpatient setting s. The aim of this study was to compare parameters determined with musculoskeletal ultrasound ( M-US ) with muscle strength in young and elderly patients . In this prospect i ve , r and omised and observer blind study , 26 young ( 24.2 ± 3.7 years ) and 26 old ( age 67.8 ± 4.8 years ) patients were included . Muscle thickness , pennation angle and echogenicity of all muscles of musculus quadriceps were measured by M-US and correlated with isometric maximum voluntary contraction force ( MVC ) of musculus quadriceps . Reproducibility of M-US measurements as well as simple and multiple regression models were calculated . Of all measured M-US variables the highest reproducibility was found for measurements of thickness ( intraclass correlation coefficients , 85–97 % ) . Simple regression analysis showed a highly significant correlation of thickness measurements of all muscles of musculus quadriceps with MVC in the elderly and in the young . Multiple regression analysis revealed that thickness of musculus vastus medialis had the best correlation with MVC in the elderly . This study showed that measurement of muscle thickness , especially of musculus vastus medialis , by M-US is a reliable , bedside method for monitoring the extent of sarcopenia",
"Background Paresis acquired in the intensive care unit ( ICU ) is common in patients who are critically ill and independently predicts mortality and morbidity . Manual muscle testing ( MMT ) and h and grip dynamometry assessment s have been used to evaluate muscle weakness in patients in a medical ICU , but similar data for patients in a surgical ICU ( SICU ) are limited . Objective The purpose of this study was to evaluate the predictive value of strength measured by MMT and h and grip dynamometry at ICU admission for in-hospital mortality , SICU length of stay ( LOS ) , hospital LOS , and duration of mechanical ventilation . Design This investigation was a prospect i ve , observational study . Methods One hundred ten patients were screened for eligibility for testing in the SICU of a large , academic medical center . The Acute Physiology and Chronic Health Evaluation ( APACHE ) II score , diagnoses , and laboratory data were collected . Measurements were obtained by MMT quantified with the sum ( total ) score on the Medical Research Council Scale and by h and grip dynamometry . Outcome data , including in-hospital mortality , SICU LOS , hospital LOS , and duration of mechanical ventilation , were collected for all participants . Results One hundred seven participants were eligible for testing ; 89 % were tested successfully at a median of 3 days ( 25th–75th percentiles=3–6 days ) after admission . Sedation was the most frequent barrier to testing ( 70.6 % ) . Manual muscle testing was identified as an independent predictor of mortality , SICU LOS , hospital LOS , and duration of mechanical ventilation . Grip strength was not independently associated with these outcomes . Limitations This study did not address whether muscle weakness translates to functional outcome impairment . Conclusions In contrast to h and grip strength , MMT reliably predicted in-hospital mortality , duration of mechanical ventilation , SICU LOS , and hospital LOS",
"Background Recent studies have demonstrated safety , feasibility , and decreased hospital length of stay for patients with weakness acquired in the intensive care unit ( ICU ) who receive early physical rehabilitation . The scored Physical Function in Intensive Care Test ( PFIT-s ) was specifically design ed for this population and demonstrated excellent psychometrics in an Australian ICU population . Objective The purpose of this study was to determine the responsiveness and predictive capabilities of the PFIT-s in patients in the United States admitted to the ICU who required mechanical ventilation ( MV ) for 4 days or longer . Methods This nested study within a r and omized trial administered the PFIT-s , Medical Research Council ( MRC ) sum score , and grip strength test at ICU recruitment and then weekly until hospital discharge , including at ICU discharge . Spearman rho was used to determine validity . The effect size index was used to calculate measurement responsiveness for the PFIT-s . The receiver operating characteristic curve was used in predicting participants ' ability to perform functional components of the PFIT-s . Results From August 2009 to July 2012 , 51 patients were recruited from 4 ICUs in the Denver , Colorado , metro area . At ICU discharge , PFIT-s scores were highly correlated to MRC sum scores ( rho=.923 ) and grip strength ( rho=.763 ) ( P test responsiveness was large ( 1.14 ) . At ICU discharge , an MRC sum score cut-point of 41.5 predicted participants ' ability to perform the st and ing components of the PFIT-s . Limitations The small sample size was a limitation . However , the findings are consistent with those in a larger sample from Australia . Conclusions The PFIT-s is a feasible and valid measure of function for individuals who require MV for 4 days or longer and who are alert , able to follow comm and s , and have sufficient strength to participate",
"RATIONALE ICU-acquired paresis ( ICUAP ) is common in survivors of critical illness . There is significant associated morbidity , including prolonged time on the ventilator and longer hospital stay . However , it is unclear whether ICUAP is independently associated with mortality , as sicker patients are more prone and existing studies have not adjusted for this . OBJECTIVES To test the hypothesis that ICUAP is independently associated with increased mortality . Secondarily , to determine if h and grip dynamometry is a concise measure of global strength and is independently associated with mortality . METHODS A prospect i ve multicenter cohort study was conducted in intensive care units ( ICU ) of five academic medical centers . Adults requiring at least 5 days of mechanical ventilation without evidence of preexisting neuromuscular disease were followed until awakening and were then examined for strength . MEASUREMENTS AND MAIN RESULTS We measured global strength and h and grip dynamometry . The primary outcome was in-hospital mortality and secondary outcomes were hospital and ICU-free days , ICU readmission , and recurrent respiratory failure . Subjects with ICUAP ( average MRC score of hospital stays and required mechanical ventilation longer . H and grip strength was lower in subjects with ICUAP and had good test performance for diagnosing ICUAP . After adjustment for severity of illness , ICUAP was independently associated with hospital mortality ( odds ratio [ OR ] , 7.8 ; 95 % confidence interval [ CI ] , 2.4 - 25.3 ; P = 0.001 ) . Separately , h and grip strength was independently associated with hospital mortality ( OR , 4.5 ; 95 % CI , 1.5 - 13.6 ; P = 0.007 ) . CONCLUSIONS ICUAP is independently associated with increased hospital mortality . H and grip strength is also independently associated with poor hospital outcome and may serve as a simple test to identify ICUAP . Clinical trial registered with www . clinical trials.gov ( NCT00106665 )"
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Background According to the World Health Organization , the elderly are at the highest risk of injury or death from a fall . Age-related changes in strength , balance and flexibility are degenerative factors that may increase the risk of falling , and an aquatic training may offer a favourable environment to improve these modifiable risk factors . Methods A systematic review was conducted to assess the potential preventative role of aquatic exercise for reducing the risk of falls in the elderly by improving predisposing risk factors . Electronic data bases and reference lists of pertinent articles published between 2005 and 2018 were search ed . R and omized controlled trials ( RCTs ) that directly or indirectly addressed the effect of aquatic exercise for the prevention of falls in healthy participants were included within the synthesis . Studies were included if they were reported between January 2005 and May 2018 within a population aged between 60 and 90 years old that were without exercise-effecting comorbidities . Data related to participant demographics , study design , methodology , interventions and outcomes was extracted by one review er . Method ological quality assessment was independently performed by two review ers using the PEDro ( Physiotherapy Evidence Data base ) scale . Results Fourteen trials met the inclusion criteria . Exercise intervention duration and frequency varied from 2 to 24 weeks , from 2 to 3 times per week , from 40 to 90 min per session . Fall rate was not reported in any of the studies analysed . However , aquatic exercise improved key predisposing physical fitness components that are modifiable and internal risk factors for falling . Conclusions There is limited , low- quality evidence to support the use of aquatic exercise for improving physiological components that are risk factors for falling . Although the evidence is limited , and many interventions are not well described , these results should be considered by health and exercise professionals when making evidence -based , clinical decisions regarding training programmes to reduce the risk of falling | [
"Multimodal exercise programs incorporating traditional progressive resistance training ( PRT ) , weight-bearing impact training and /or balance training are recommended to reduce risk factors for falls and fracture . However , muscle power , or the ability to produce force rapidly , has emerged as a more crucial variable to functional decline than muscle strength or mass . The aim of this 12-month community-based r and omized controlled trial , termed Osteo-cise : Strong Bones for Life , was to evaluate the effectiveness and feasibility of a multimodal exercise program incorporating high-velocity (HV)-PRT , combined with an osteoporosis education and behavioral change program , on bone mineral density ( BMD ) , body composition , muscle strength and functional muscle performance in older adults . Falls incidence was evaluated as a secondary outcome . A total of 162 older adults ( mean ± SD ; 67 ± 6 years ) with risk factors for falls and /or low BMD were r and omized to the Osteo-cise program ( n = 81 ) or a control group ( n = 81 ) . Exercise consisted of fitness center-based HV-PRT , weight-bearing impact and challenging balance/mobility activities performed three times weekly . After 12 months , the Osteo-cise program led to modest but significant net gains in femoral neck and lumbar spine BMD ( 1.0 % to 1.1 % , p 0.05 ) , muscle strength ( 10 % to 13 % , p ( Timed Stair Climb , 5 % , p ) and dynamic balance ( Four Square Step Test 6 % , p on total body lean mass or mobility ( timed-up- and -go ) , and no difference in falls rate ( incidence rate ratio [ IRR ] , 1.22 ; 95 % confidence interval [ CI ] , 0.72 - 2.04 ) . In conclusion , this study demonstrates that the Osteo-cise : Strong Bones for Life community-based , multimodal exercise program represents an effective approach to improve multiple musculoskeletal and functional performance measures in older adults with risk factors for falls and /or low BMD . Although this did not translate into a reduction in the rate of falls , further large-scale trials are needed to evaluate the efficacy of this multimodal approach on reducing falls and fracture",
"Background Gait and balance impairments may increase the risk of falls , the leading cause of accidental death in the elderly population . Fall-related injuries constitute a serious public health problem associated with high costs for society as well as human suffering . A rapid step is the most important protective postural strategy , acting to recover equilibrium and prevent a fall from initiating . It can arise from large perturbations , but also frequently as a consequence of volitional movements . We propose to use a novel water-based training program which includes specific perturbation exercises that will target the stepping responses that could potentially have a profound effect in reducing risk of falling . We describe the water-based balance training program and a study protocol to evaluate its efficacy ( Trial registration number # NCT00708136 ) . Methods / Design The proposed water-based training program involves use of unpredictable , multi-directional perturbations in a group setting to evoke compensatory and volitional stepping responses . Perturbations are made by pushing slightly the subjects and by water turbulence , in 24 training sessions conducted over 12 weeks . Concurrent cognitive tasks during movement tasks are included . Principles of physical training and exercise including awareness , continuity , motivation , overload , periodicity , progression and specificity were used in the development of this novel program . Specific goals are to increase the speed of stepping responses and improve the postural control mechanism and physical functioning . A prospect i ve , r and omized , cross-over trial with concealed allocation , assessor blinding and intention-to-treat analysis will be performed to evaluate the efficacy of the water-based training program . A total of 36 community-dwelling adults ( age 65–88 ) with no recent history of instability or falling will be assigned to either the perturbation-based training or a control group ( no training ) . Voluntary step reaction times and postural stability using stabiliogram diffusion analysis will be tested before and after the 12 weeks of training . Discussion This study will determine whether a water-based balance training program that includes perturbation exercises , in a group setting , can improve speed of voluntary stepping responses and improve balance control . Results will help guide the development of more cost-effective interventions that can prevent the occurrence of falls in the elderly",
"BACKGROUND Water-based resistance training ( WRT ) has been indicated to promote strength gains in elderly population . However , no study has compared different training strategies to identify the most efficient one . The aim of this study was to compare the effects of 3 WRT strategies on the strength and functional capacity of older women . METHODS In total , 36 women were r and omly allocated to training groups : simple set of 30 seconds [ 1 × 30s ; 66.41 ( 1.36 ) y ; n = 12 ] , multiple sets of 10 seconds [ 3 × 10s ; 66.50 ( 1.43 ) y ; n = 11 ] , and simple set of 10 seconds [ 1 × 10s ; 65.23 ( 1.09 ) y ; n = 13 ] . Training lasted for 12 weeks . The maximal dynamic strength ( in kilograms ) and muscular endurance ( number of repetitions ) of knee extension , knee flexion , elbow flexion , and bench press , as well as functional capacity ( number of repetitions ) , were evaluated . RESULTS All types of training promoted similar gains in maximal dynamic strength of knee extension and flexion as well as elbow flexion . Only the 1 × 30s and 1 × 10s groups presented increments in bench press maximal strength . All 3 groups showed increases in muscular endurance in all exercises and functional capacity . CONCLUSIONS WRT using long- or short- duration simple sets promotes the same gains in strength and functional capacity in older women as does WRT using multiple sets",
"To examine effects of 21-week twice/week strength training ( ST ) period followed by an additional 21-week twice or once/week ST period on force production , walking and balance in aging people . Seventy-two women ( 58 ± 7 years ; W ) and 63 ( 58 ± 6 years ) men ( M ) were r and omized for the first 21-week ST period : STW and STM , control ( C ) CW and CM . Training participants were r and omized for the second 21-week ST period : once/week STWx1 and STMx1 , twice/week STWx2 and STMx2 . LegPress , isometric leg extension rate of force development ( RFD ) , walking time , and balance . First 21-week ST period : leg press , RFD , balance , and walking improved significantly in STW and STM . Second 21-week ST period : leg press first increased in STMx1 and STMx2 , and then decreased to the level of 21 weeks in STMx2 and remained unchanged in STWx2 and decreased in STWx1 and STMx1 . Walking and balance improved significantly in STWx1 and STWx2 . A progressive 21-week ST period twice/week in aging people can lead to large improvements in maximal strength , walking time , and balance in both genders . A further strength training period with the same amount of training may maintain the strength gains , whereas balance and walking may be maintained with less training",
"The aim of the present study was to evaluate the effects of an AAG on BMD , osteocalcin and functional autonomy in older women . The sample consisted of eighty-two post-menopausal women with low BMD , r and omly divided into two groups : the Aquatic Aerobics Group [ AAG ; n=42 ; age : 66.8±4.2years ] , su bmi tted to two weekly sessions over eight months , and the Control Group ( GC ; n=42 ; age : 66.9±3.2years ) , which did not participate in regular exercise . BMD was measured by Dual Energy X-ray Absorptiometry [ DXA ] of the lumbar and femur , and serum osteocalcin was measured using electrochemiluminescence . A functional autonomy assessment protocol ( GDLAM , 2004 ) was also applied . Statistical analyses used were repeated measures ANOVA and Tukey 's post hoc tests . The results showed a significant improvement in tests following the GDLAM protocol : 10 meters walk ( 10mw ) -p=0.003 ; rising from a ventral decubitus position ( RVDP ) - Δ%=0.78 , p rising from a chair and moving around the house ( RCMH ) -p autonomy index ( AI ) -p=0.007 , with more favorable results observed in the AAG when compared to the CG . The AAG achieved the best results for BMD ; however , no inter or intragroup statistical differences were recorded for total femur -p=0.975 and lumbar L(2)-L(4)p=0.597 . For serum osteocalcin , intra and intergroup statistical differences of p=0.042 and p=0.027 were observed in the AAG , respectively . This demonstrates that an eight-month aquatic aerobic exercise program can improve functional autonomy and osteocalcin levels , although training did not improve lumbar and total femur BMD in the older women",
"[ Purpose ] The purpose of the present study was to examine the effects of an aqua aerobic therapy exercise for older adults on biomechanical and physiological factors affecting gait . [ Subjects ] A total of 15 subjects participated in this study and they were r and omly divided into the experimental and the control group . [ Methods ] Physiological variables , leg strength , power and flexibility , and biomechanical variables , both kinematic and kinetic , were measured before and after the aqua aerobic therapy exercise . Each subject was instructed to walk along an elevated walkway and during the trials a trapdoor opened at r and om to create a 10 cm falling perturbation . Full body motion and kinetics was gathered during the gait . [ Results ] There were significant reductions in body weight , and body fat mass , and stride time after the perturbation . Significant increases in leg strength corresponded to the maximum joint moment of the l and ing leg showing that the subjects ' ability for recovery of balance after the perturbation improved . [ Conclusion ] As the results showed significant improvements in gait pattern and recovery time after perturbed gait , we conclude that aqua aerobic therapy is an effective exercise method for training older adults to reduce their risk of falling",
"This study evaluated the effects of a water exercise training program that includes perturbation exercises ( WEP ) to improve the speed of voluntary stepping reaction in older adults . Speed of voluntary stepping considered as an important skill to prevent a fall when balance is lost . In a single-blinded r and omized controlled trial with a crossover design thirty-six independent old adults ( 64 - 88 years old ) were divided into two groups . Group A received WEP for the first 12 weeks , followed by no intervention for the second 12 weeks . Group B did not receive intervention for the first 12 weeks and received WEP for the second 12 weeks . Voluntary Step Execution Test and postural stability in upright st and ing ( eyes open and closed conditions ) were measured at baseline , 12 weeks , and 24 weeks . A significant interaction effect between group and time was found for the step execution , due to improvement in initiation phase and swing phase duration s in the WEP group . Also significant improvement in postural stability parameters in eyes open and closed conditions is noted . The present results indicate that the primary benefit of WEP that include perturbations to induce stepping , was a reduction in voluntary stepping times . The WEP generalized to a better control of balance in up-right st and ing",
"OBJECTIVE To analyze the effects of a water-based exercise program on peak torque ( PT ) and rate of torque development ( RTD ) during maximal voluntary ballistic isometric contractions of the lower limb muscles and the performance of a number of functional tests in the elderly . METHOD Thirty-seven elderly were r and omly assigned to water-based training ( 3 d/wk for 12 wk ) or a control group . Extensor and flexor PT and RTD of the ankle , knee , and hip joints and functional tests were evaluated before and after training . RESULTS PT increased after training for the hip flexors ( 18 % ) and extensors ( 40 % ) and the plantar-flexor ( 42 % ) muscles in the water-based group . RTD increased after training for the hip-extensor ( 10 % ) , knee-extensor ( 11 % ) , and ankle plantar-flexor ( 27 % ) muscles in the water-based group . Functional tests also improved after training in the water-based group ( p water-based program improved PT and RTD and functional performance in the elderly",
"Background Hip muscle weakness in older people seems to be an influencing factor of falls . Currently , it is unclear which muscles out of the hip muscle group play an important role in older people . A validating process in the measurement regarding muscle strength related to falls is necessary before answering that question . Objective Firstly , we aim ed to investigate which hip muscle group strength shows an acceptable level of distinction between older adult fallers and non-fallers compared to a predefined external criterion regarding falling . Secondly , we aim ed to compare the same outcomes and questions for h and -grip strength in relation to the same external criterion . Design This study was a cross-sectional validity study . Methods The maximum voluntary isometric strength ( MVIS ) and the rate of force generation of hip abductors ( ABD ) , adductors , internal and external rotators , extensors , and flexors were measured with a dynamometer fixed to a custom-made frame as well as h and -grip strength with a Martin Vigorimeter in 60 older people aged over 65 years ( 38 females and 22 males ) . Results The area under the curve ( AUC ) and the results of the mean decrease in Gini index assessed by r and om forest approach show that of all the assessed parameters , hip ABD MVIS showed the highest discriminative value regarding the chosen external criterion in older people ( AUC ABD MVIS 0.825 , 95 % confidence interval : 0.712–0.938 ) . Conclusion Results indicate that ABD MVIS is a useful measure to distinguish between older adult fallers and non-fallers regarding the chosen external criterion",
"Background With increasing age neuromuscular deficits ( e.g. , sarcopenia ) may result in impaired physical performance and an increased risk for falls . Prominent intrinsic fall-risk factors are age-related decreases in balance and strength / power performance as well as cognitive decline . Additional studies are needed to develop specifically tailored exercise programs for older adults that can easily be implemented into clinical practice . Thus , the objective of the present trial is to assess the effects of a fall prevention program that was developed by an interdisciplinary expert panel on measures of balance , strength / power , body composition , cognition , psychosocial well-being , and falls self-efficacy in healthy older adults . Additionally , the time-related effects of detraining are tested . Methods / Design Healthy old people ( n = 54 ) between the age of 65 to 80 years will participate in this trial . The testing protocol comprises tests for the assessment of static / dynamic steady-state balance ( i.e. , Sharpened Romberg Test , instrumented gait analysis ) , proactive balance ( i.e. , Functional Reach Test ; Timed Up and Go Test ) , reactive balance ( i.e. , perturbation test during bipedal stance ; Push and Release Test ) , strength ( i.e. , h and grip strength test ; Chair St and Test ) , and power ( i.e. , Stair Climb Power Test ; countermovement jump ) . Further , body composition will be analysed using a bioelectrical impedance analysis system . In addition , question naires for the assessment of psychosocial ( i.e. , World Health Organisation Quality of Life Assessment -Bref ) , cognitive ( i.e. , Mini Mental State Examination ) , and fall risk determinants ( i.e. , Fall Efficacy Scale – International ) will be included in the study protocol . Participants will be r and omized into two intervention groups or the control / waiting group . After baseline measures , participants in the intervention groups will conduct a 12-week balance and strength / power exercise intervention 3 times per week , with each training session lasting 30 min . ( actual training time ) . One intervention group will complete an extensive supervised training program , while the other intervention group will complete a short version ( ' 3 times 3 ’ ) that is home-based and controlled by weekly phone calls . Post-tests will be conducted right after the intervention period . Additionally , detraining effects will be measured 12 weeks after program cessation . The control group / waiting group will not participate in any specific intervention during the experimental period , but will receive the extensive supervised program after the experimental period . Discussion It is expected that particularly the supervised combination of balance and strength / power training will improve performance in variables of balance , strength / power , body composition , cognitive function , psychosocial well-being , and falls self-efficacy of older adults . In addition , information regarding fall risk assessment , dose – response-relations , detraining effects , and supervision of training will be provided . Further , training-induced health-relevant changes , such as improved performance in activities of daily living , cognitive function , and quality of life , as well as a reduced risk for falls may help to lower costs in the health care system . Finally , practitioners , therapists , and instructors will be provided with a scientifically evaluated feasible , safe , and easy-to-administer exercise program for fall prevention . Trial registration Clinical Trials.gov Identifier :",
"OBJECTIVES To compare the effectiveness of group resistance and agility-training programs in reducing fall risk in community-dwelling older women with low bone mass . DESIGN A r and omized , controlled , single-blind 25-week prospect i ve study with assessment s at baseline , midpoint , and trial completion . SETTING Community center . PARTICIPANTS Community-dwelling women aged 75 to 85 with low bone mass . INTERVENTION Participants were r and omly assigned to one of three groups : resistance training ( n=32 ) , agility training ( n=34 ) , and stretching ( sham ) exercises ( n=32 ) . The exercise classes for each study arm were held twice weekly . MEASUREMENTS The primary outcome measure was fall risk ( derived from weighted scores from tests of postural sway , reaction time , strength , proprioception , and vision ) , as measured using a Physiological Profile Assessment ( PPA ) . Secondary outcome measures were ankle dorsiflexion strength , foot reaction time , and Community Balance and Mobility Scale score . RESULTS Attendance at the exercise sessions for all three groups was excellent : resistance training ( 85.4 % ) , agility training ( 87.3 % ) , and stretching program ( 78.8 % ) . At the end of the trial , PPA fall-risk scores were reduced by 57.3 % and 47.5 % in the resistance and agility-training groups , respectively , but by only 20.2 % in the stretching group . In the resistance and agility groups , the reduction in fall risk was mediated primarily by improved postural stability , where sway was reduced by 30.6 % and 29.2 % , respectively . There were no significant differences between the groups for the secondary outcomes measures . Within the resistance-training group , reductions in sway were significantly associated with improved strength , as assessed using increased squat load used in the exercise sessions . CONCLUSION These findings support the implementation of community-based resistance and agility-training programs to reduce fall risk in older women with low bone mass . Such programs may have particular public health benefits because it has been shown that this group is at increased risk of falling and sustaining fall-related fractures",
"BACKGROUND AND PURPOSE Exercises in water have been shown to be effective for improving strength and passive range of motion ( PROM ) . Traditional rehabilitation following intra-articular anterior cruciate ligament ( ACL ) reconstruction has taken place on l and . This study was design ed to compare the effects of exercises in water on strength and girth of the thigh musculature , knee PROM , joint laxity , effusion , and functional outcome with the effects of similar exercises on l and in subjects following intra-articular reconstruction of the ACL . SUBJECTS Twenty subjects were r and omly assigned to either a group that exercised on l and or a group that exercised in water . METHODS Thigh girth , joint effusion , and knee PROM measurements were recorded at 2-week intervals for the first 8 weeks postoperatively . Isokinetic and isometric peak torque measurements for the thigh musculature , knee joint laxity assessment s , and Lysholm scores were obtained at the end of 8 weeks . RESULTS Higher outcome scores were recorded in the water group than in the l and group , as measured by Lysholm scales . No differences were noted between groups for knee PROM , thigh girth , or quadriceps femoris muscle performance . In the water group , less joint effusion was noted after the 8 weeks . In the l and group , greater peak torque for isokinetic knee flexion was recorded . CONCLUSION AND DISCUSSION Although exercise in water may not be as effective as exercise on l and for regaining maximum muscle performance , rehabilitation in water may minimize the amount of joint effusion and lead to greater self-reports of functional improvement in subjects with intra-articular ACL reconstructions",
"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 .",
"PURPOSE The purpose of this study was to determine the physiological responses of elderly women to a well-rounded exercise program performed in water ( WEX ) . METHODS The participants ( 60 - 75 yr of age ) were r and omly divided into a training ( TR ) group ( N = 15 ) and a control group ( N = 15 ) . The TR group participated in a 12-wk supervised WEX program , 70 min x day(-1 ) , 3 d x wk(-1 ) . The WEX consisted of 20 min of warm-up and stretching exercise , 10 min of resistance exercise , 30 min of endurance-type exercise ( walking and dancing ) , and 10 min of cool-down exercise . RESULTS The WEX led to an increase ( P peak VO2 ( 12 % ) and VO2 at lactate threshold ( 20 % ) . Muscular strength evaluated by a hydraulic resistance machine increased significantly at resistance dial setting 8 ( slow ) for knee extension ( 8 % ) , knee flexion ( 13 % ) , chest press ( 7 % ) and pull ( 11 % ) , shoulder press ( 4 % ) and pull ( 6 % ) , and back extension ( 6 % ) . Vertical jump ( 9 % ) , side-stepping agility ( 22 % ) , trunk extension ( 11 % ) , and FEV1.0 ( 7 % ) also increased significantly . There was a significant decrease in skin-fold thickness ( -8 % ) , low-density lipoprotein ( LDL ) cholesterol ( -17 % ) , and total cholesterol ( -11 % ) . There were no significant changes in these variables in the control group . CONCLUSION These results indicate that WEX elicits significant improvements in cardiorespiratory fitness , muscular strength , body fat , and total cholesterol in older adult women . Water-based exercise appears to be a very safe and beneficial mode of exercise that can be performed as part of a well-rounded exercise program",
"The purpose of the present study was to determine the effectiveness of a 24-week aquatic training ( AT ) program , which included both aerobic and resistance components , on muscle strength ( isometric and dynamic ) , flexibility , and functional mobility in healthy women over 60 years of age . Twenty-two subjects were assigned r and omly to either an AT ( n = 12 ) or a control ( C , n = 10 ) group . Volunteers participated in a supervised shallow-water exercise program for 60 minutes a day , 3 days a week ; the exercise program consisted of a 10-minute warm-up and stretching , 25 minutes of endurance-type exercise ( dancing ) at 80 % of heart rate (HR)max , 20 minutes of upper- and lower-body resistance exercises with specialized water-resistance equipment , and a 5-minute cool down . Maximal isometric torque of knee extensors ( KEXT ) and knee flexors ( KFLEX ) were evaluated by a Cybex Norm dynamometer , grip strength ( HGR ) was evaluated using a Jamar hydraulic dynamometer , and dynamic strength was evaluated via the 3 repetition maximum ( 3RM ) test for chest press , knee extension , lat pull down , and leg press . Jumping performance was evaluated using the squat jump ( SJ ) , functional mobility with the timed up- and -go ( TUG ) test , and trunk flexion with the sit- and -reach test . Body composition was measured using the bioelectrical impedance method . The AT induced significant improvements in KEXT ( 10.5 % ) and KFLEX ( 13.4 % ) peak torque , HGR strength ( 13 % ) , 3RM ( 25.7–29.4 % ) , SJ ( 24.6 % ) , sit- and -reach ( 11.6 % ) , and TUG ( 19.8 % ) performance . The AT group demonstrated a significant increase in lean body mass ( 3.4 % ) . No significant changes in these variables were observed in the C group . The results indicate that AT , with both aerobic and resistance components , is an alternative training method for improving neuromuscular and functional fitness performance in healthy elderly women",
"OBJECTIVE The aim of this study was to evaluate the effects of a water-based exercise program on static and dynamic balance . METHOD Thirty-six older women were r and omly assigned to a water-based training ( 3 days/week for 12 weeks ) or control group . Water level was kept at the level of the xiphoid process and temperature at ∼28 - 30 ° C . Each session included aerobic activities and lower limb strength exercises . The medial-lateral , the anterior-posterior amplitude , and displacement of the center of pressure ( CP-D ) were measured in a quiet st and ing position ( 60 sec eyes opened and closed ) . The dynamic balance and 8-Foot Up- and -Go tests were also applied . Group comparisons were made using two-way analysis of variance ( ANOVA ) with repeated measures . RESULTS No differences were found in the center of pressure variables ; however , the WBT group showed better performance in the 8 Foot Up- and -Go Test after training ( 5.61±0.76 vs. 5.18±0.42 ; p The water-based training was effective in improving dynamic balance , but not static balance",
"The Timed Up and Go ( TUG ) test is recommended by the U.S. Centers for Disease Control and Prevention as an easy to administer clinical test to evaluate a senior citizen 's fall risk . Limited evidence has been presented in the literature validating the TUG test . In this study , the authors sought to assess correlations between the TUG test and various balance markers utilizing the OptoGait system . A total of 51 healthy seniors completed r and omized trials of the TUG test and a gait test utilizing OptoGait photoelectric technology . Correlations among mean and SD values for these variables and TUG performance were calculated . Utilizing a Bonferroni adjustment and an alpha level of .05 , eight significant correlations of a moderately strong degree ( absolute r scores between .51 and .78 ) emerged . Correlation results indicate that the TUG test is a valid tool for screening balance deficits that lead to increased fall risk in senior citizens",
"Purpose : The purpose of this study was to determine the effect of a unique exercise programme ( Fall Arrest Strategy Training , or FAST ) on upper body strength , range of motion ( ROM ) , and fall risk in older women . FAST was design ed to improve upper body capacity to prevent injury when a fall can not be avoided . Method : A quasi-r and omized site design included 71 older women ( aged 67 - 95 y , mean age 83 years ) , who participated either in a st and ard fall prevention programme ( Staying on Your Feet , or SOYF ; n=29 ) or in SOYF combined with FAST ( n=42 ) . The women were measured three times-at baseline , after the 12-week intervention , and again 12 weeks later-for upper body strength , ROM , and fall risk factors ( fall risk question naire , balance , mobility , and leg strength ) . Results : No significant differences were found in age , physical activity , or cognitive or functional status between the SOYF-st and ard and the SOYF-FAST groups . Both groups improved their fall risk status after the intervention , with no significant differences between them ; however , the SOYF-FAST group showed greater improvements in upper extremity strength and ROM ( p=0.007 ) . Conclusion : FAST can feasibly be integrated into fall prevention programming , with additional gains in upper body strength and ROM in older women"
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The rising epidemic of non-communicable diseases ( NCDs ) poses substantial health and economic challenges to both individuals and society . Application of incentive-based strategies based on traditional and behavioural economic theory has emerged as a potential strategy to address rising rates of NCDs . Yet , whether or not incentives truly represent a promising strategy for addressing NCDs has not been systematic ally addressed nor is it clear whether certain behavioural economic strategies outperform others or simply offering a cash-based incentive for meeting a goal . In this systematic review we aim to determine whether there is an evidence base for any of these strategies . Forty-eight published r and omized controlled trials ( 70 contrasts ) evaluating the effectiveness of incentive-based strategies for improvements in NCD risk-factors were review ed . Our primary conclusion is that there is a lack of compelling evidence that incentives of any form represent a compelling NCD reduction strategy . More evidence for long-term effectiveness and cost-effectiveness is needed to justify third party funding of any incentive based strategy | [
"Employers commonly use adjustments to health insurance premiums as incentives to encourage healthy behavior , but the effectiveness of those adjustments is controversial . We gave 197 obese participants in a workplace wellness program a weight loss goal equivalent to 5 percent of their baseline weight . They were r and omly assigned to a control arm , with no financial incentive for achieving the goal , or to one of three intervention arms offering an incentive valued at $ 550 . Two intervention arms used health insurance premium adjustments , beginning the following year ( delayed ) or in the first pay period after achieving the goal ( immediate ) . A third arm used a daily lottery incentive separate from premiums . At twelve months there were no statistically significant differences in mean weight change either between the control group ( whose members had a mean gain of 0.1 pound ) and any of the incentive groups ( delayed premium adjustment , -1.2 pound ; immediate premium adjustment , -1.4 pound ; daily lottery incentive , -1.0 pound ) or among the intervention groups . The apparent failure of the incentives to promote weight loss suggests that employers that encourage weight reduction through workplace wellness programs should test alternatives to the conventional premium adjustment approach by using alternative incentive design s , larger incentives , or both",
"OBJECTIVE To examine the viability of monetary incentives to increase fitness-center use and maintain/improve the Body Mass Indexes ( BMI s ) of first-year students over the fall semester . METHOD R and omized-controlled trial with no-treatment and incentive conditions involving 117 first-year students . For 12 weeks , students in the incentive condition received monetary payments ranging from $ 10 to $ 38.75 for meeting research er-set fitness-center use goals that were identical across conditions . Fitness-center use was monitored through electronic ID-card check-in and check-out records at the campus fitness center . RESULTS 63 % of incentive-condition participants met the weekly fitness-center use goals on average compared to only 13 % of control-condition participants , a significant difference , p Goal achievement significantly decreased over time , p incentive conditions , p=0.23 . Average BMI increases over the fall semester in the control ( 24.2 ( 0.6 ) to 24.6 (0.6)kg/m(2 ) ) versus incentive condition ( 23.1 ( 0.4 ) to 23.5 (0.4)kg/m(2 ) ) were not significantly different ( p=0.70 ) . CONCLUSION Weekly monetary incentives result ed in significantly more first-year students meeting weekly fitness-center use goals . However , the increased fitness-center use by the incentive condition did not prevent an increase in BMI during fall semester",
"Exercise is the best predictor of long-term weight loss . This study evaluated two strategies for improving exercise adherence and long-term weight loss in obese out patients . Obese men and women ( N = 193 ) were r and omized to 1 of 5 treatment groups for 18 months : st and ard behavior therapy ( SBT ) ; SBT with supervised walks ( SW ) 3 times per week ; SBT + SW with personal trainers ( PT ) , who walked with participants , made phone reminders , and did make-up SW ; SBT + SW with monetary incentives ( I ) for completing SW ; and SBT + SW + PT + I. Both PT and I enhanced attendance at SWs , the combination producing the best adherence . Increased walk attendance did not result in higher overall energy expenditure , however , and long-term weight loss was also not improved . Post hoc analyses suggest that the level of exercise needed for successful long-term weight loss is much higher than that usually recommended in behavioral treatment programs",
"Objective To examine whether adding either small , variable financial incentives or optional group sessions improves weight losses in a community-based , Internet behavioral program . Design and methods Participants ( N=268 ) from Shape Up Rhode Isl and 2012 , a 3 month Web-based community wellness initiative , were r and omized to : Shape Up+Internet behavioral program ( SI ) , Shape Up+Internet program+Incentives ( SII ) , or Shape Up+Internet program+Group sessions ( SIG ) . Results At the end of the 3 month program , SII achieved significantly greater weight losses than SI ( SII:6.4 % [ 5.1 - 7.7 ] ; SI:4.2 % [ 3.0 - 5.6 ] ; P=.03 ) ; weight losses in SIG were not significantly different from the other two conditions ( SIG : 5.8 % [ 4.5 - 7.1 ] , P’s≥.10 ) . However , at the 12 month no treatment follow-up visit , both SII and SIG had greater weight losses than SI ( SII : 3.1 % [ 1.8 - 4.4 ] ; SIG : 4.5 % [ 3.2 - 5.8 ] ; SI : 1.2 % [ -0.1 - 2.6 ] ; P’s≤.05 ) . SII was the most cost-effective approach at both 3 ( SII : $ 34/kg ; SI : $ 34/kg ; SIG : $ 87/kg ) and 12 months ( SII : $ 64/kg ; SI : $ 140/kg ; SIG : $ 113/kg ) . Conclusions Modest financial incentives enhance weight losses during a community campaign and both incentives and optional group meetings improved overall weight loss outcomes during the follow-up period . However , the use of the financial incentives is the most cost-effective approach",
"Background This research evaluated the effects of financial incentives and purchase restrictions on food purchasing in a food benefit program for low income people . Methods Participants ( n=279 ) were r and omized to groups : 1 ) Incentive- 30 % financial incentive for fruits and vegetables purchased with food benefits ; 2 ) Restriction- no purchase of sugar-sweetened beverages , sweet baked goods , or c and ies with food benefits ; 3 ) Incentive plus Restriction ; or 4 ) Control- no incentive or restrictions . Participants received a study -specific debit card where funds were added monthly for 12-weeks . Food purchase receipts were collected over 16 weeks . Total dollars spent on grocery purchases and by targeted food categories were computed from receipts . Group differences were examined using general linear models . Results Weekly purchases of fruit significantly increased in the Incentive plus Restriction ( $ 4.8 ) compared to the Restriction ( $ 1.7 ) and Control ( $ 2.1 ) groups ( p significantly decreased in the Incentive plus Restriction(−$0.8 per week ) and Restriction ( $ -1.4 per week ) groups compared to the Control group ( + $ 1.5 ; p purchases significantly decreased in the Restriction ( −$0.70 per week ) compared to the Control group ( + $ 0.82 per week ; p Paired financial incentives and restrictions on foods and beverages purchased with food program funds may support more healthful food purchases compared to no incentives or restrictions . Clinical trial registration Clinical trials.gov Identifier : NCT02643576",
"RCTs would be more useful if there were more realistic expectations of them and if their pitfalls were better recognized . For example , and contrary to many cl aims in the applied literature , r and omization does not equalize everything but the treatment across treatments and controls , it does not automatically deliver a precise estimate of the average treatment effect ( ATE ) , and it does not relieve us of the need to think about ( observed or unobserved ) confounders . Estimates apply to the trial sample only , sometimes a convenience sample , and usually selected ; justification is required to extend them to other groups , including any population to which the trial sample belongs . Dem and ing “ external validity � ? is unhelpful because it expects too much of an RCT while undervaluing its contribution . Statistical inference on ATEs involves hazards that are not always recognized . RCTs do indeed require minimal assumptions and can operate with little prior knowledge . This is an advantage when persuading distrustful audiences , but it is a disadvantage for cumulative scientific progress , where prior knowledge should be built upon and not discarded . RCTs can play a role in building scientific knowledge and useful predictions but they can only do so as part of a cumulative program , combining with other methods , including conceptual and theoretical development , to discover not “ what works , � ? but “ why things work � ?",
"BACKGROUND Despite the increasing popularity of activity trackers , little evidence exists that they can improve health outcomes . We aim ed to investigate whether use of activity trackers , alone or in combination with cash incentives or charitable donations , lead to increases in physical activity and improvements in health outcomes . METHODS In this r and omised controlled trial , employees from 13 organisations in Singapore were r and omly assigned ( 1:1:1:1 ) with a computer generated assignment schedule to control ( no tracker or incentives ) , Fitbit Zip activity tracker , tracker plus charity incentives , or tracker plus cash incentives . Participants had to be English speaking , full-time employees , aged 21 - 65 years , able to walk at least ten steps continuously , and non-pregnant . Incentives were tied to weekly steps , and the primary outcome , moderate-to-vigorous physical activity ( MVPA ) bout min per week , was measured via a sealed accelerometer and assessed on an intention-to-treat basis at 6 months ( end of intervention ) and 12 months ( after a 6 month post-intervention follow-up period ) . Other outcome measures included steps , participants meeting 70 000 steps per week target , and health-related outcomes including weight , blood pressure , and quality -of-life measures . This trial is registered at Clinical Trials.gov , number NCT01855776 . FINDINGS Between June 13 , 2013 , and Aug 15 , 2014 , 800 participants were recruited and r and omly assigned to the control ( n=201 ) , Fitbit ( n=203 ) , charity ( n=199 ) , and cash ( n=197 ) groups . At 6 months , compared with control , the cash group logged an additional 29 MVPA bout min per week ( 95 % CI 10 - 47 ; p=0·0024 ) and the charity group an additional 21 MVPA bout min per week ( 2 - 39 ; p=0·0310 ) ; the difference between Fitbit only and control was not significant ( 16 MVPA bout min per week [ -2 to 35 ; p=0·0854 ] ) . Increases in MVPA bout min per week in the cash and charity groups were not significantly greater than that of the Fitbit group . At 12 months , the Fitbit group logged an additional 37 MVPA bout min per week ( 19 - 56 ; p=0·0001 ) and the charity group an additional 32 MVPA bout min per week ( 12 - 51 ; p=0·0013 ) compared with control ; the difference between cash and control was not significant ( 15 MVPA bout min per week [ -5 to 34 ; p=0·1363 ] ) . A decrease in physical activity of -23 MVPA bout min per week ( 95 % CI -42 to -4 ; p=0·0184 ) was seen when comparing the cash group with the Fitbit group . There were no improvements in any health outcomes ( weight , blood pressure , etc ) at either assessment . INTERPRETATION The cash incentive was most effective at increasing MVPA bout min per week at 6 months , but this effect was not sustained 6 months after the incentives were discontinued . At 12 months , the activity tracker with or without charity incentives were effective at stemming the reduction in MVPA bout min per week seen in the control group , but we identified no evidence of improvements in health outcomes , either with or without incentives , calling into question the value of these devices for health promotion . Although other incentive strategies might generate greater increases in step activity and improvements in health outcomes , incentives would probably need to be in place long term to avoid any potential decrease in physical activity result ing from discontinuation . FUNDING Ministry of Health , Singapore",
"Many older adults do not meet physical activity recommendations and suffer from health-related complications . Reinforcement interventions can have pronounced effects on promoting behavior change ; this study evaluated the efficacy of a reinforcement intervention to enhance walking in older adults . Forty-five sedentary adults with mild to moderate hypertension were r and omized to 12-week interventions consisting of pedometers and guidelines to walk 10,000 steps/day or that same intervention with chances to win $ 1-$100 prizes for meeting recommendations . Patients walked an average of about 4,000 steps/day at baseline . Throughout the intervention , participants in the reinforcement intervention met walking goals on 82.5 % ± 25.8 % of days versus 55.3 % ± 37.1 % of days in the control condition , p though steps walked increased significantly in both groups relative to baseline , participants in the reinforcement condition walked an average of about 2,000 more steps/day than participants in the control condition , p the reinforcement intervention also evidence d greater reductions in blood pressure and weight over time and improvements in fitness indices , ps This reinforcement-based intervention substantially increased walking and improved clinical parameters , suggesting that larger-scale evaluations of reinforcement-based interventions for enhancing active lifestyles in older adults are warranted . Ultimately , economic analyses may reveal reinforcement interventions to be cost-effective , especially in high-risk population s of older adults ",
"The majority of smokers have no plans to quit in the near future . These complacent smokers are less likely to quit than other smokers , and few interventions are known to reduce smoking in this population . Although monetary incentives can reduce complacent smokers ' breath carbon monoxide ( BCO ) levels , it is not clear whether these effects can be sustained beyond the several weeks that past studies have examined . The authors compared complacent smokers r and omly assigned to receive incentives for BCO reductions ( n=18 ) or noncontingent incentives ( n=19 ) for 3 months . Contingent incentives were associated with ( a ) reduced BCO ; ( b ) more BCO sample s indicative of abstinence ; ( c ) fewer cigarettes smoked and more days abstinent at study end ; and ( d ) lower salivary cotinine . These behaviors can predict future cessation , and 2 of the 18 smokers ( 11 % ) receiving BCO-contingent incentives reported quitting as compared with none in the control group . Contingency management procedures , such as those used here , may effectively promote cessation among complacent smokers and provide a model for underst and ing the possible effects of some environmental interventions ( like workplace smoking bans ) on the behavior of complacent smokers",
"ABSTRACT BACKGROUND Previous efforts to use incentives for weight loss have result ed in substantial weight regain after 16 weeks . OBJECTIVE To evaluate a longer term weight loss intervention using financial incentives . DESIGN A 32-week , three-arm r and omized controlled trial of financial incentives for weight loss consisting of a 24-week weight loss phase during which all participants were given a weight loss goal of 1 pound per week , followed by an 8-week maintenance phase . PARTICIPANTS Veterans who were patients at the Philadelphia Veterans Affairs Medical Center with BMI s of 30–40.INTERVENTION Participants were r and omly assigned to participate in either a weight-monitoring program involving a consultation with a dietician and monthly weigh-ins ( control condition ) , or the same program with one of two financial incentive plans . Both incentive arms used deposit contracts ( DC ) in which participants put their own money at risk ( matched 1:1 ) , which they lost if they failed to lose weight . In one incentive arm participants were told that the period after 24 weeks was for weight-loss maintenance ; in the other , no such distinction was made . MAIN MEASUREWeight loss after 32 weeks . KEY RESULTS Results were analyzed using intention-to-treat . There was no difference in weight loss between the incentive arms ( P = 0.80 ) . Incentive participants lost more weight than control participants [ mean DC = 8.70 pounds , mean control = 1.17 , P = 0.04 , 95 % CI of the difference in means ( 0.56 , 14.50 ) ] . Follow-up data 36 weeks after the 32-week intervention had ended indicated weight regain ; the net weight loss between the incentive and control groups was no longer significant ( mean DC = 1.2 pounds , 95 % CI , -2.58–5.00 ; mean control = 0.27 , 95 % CI , -3.77–4.30 , P = 0.76 ) . CONCLUSIONS Financial incentives produced significant weight loss over an 8-month intervention ; however , participants regained weight post-intervention",
"Objective : To evaluate the efficacy of a simple weight loss intervention , based on principles of habit formation . Design : An exploratory trial in which overweight and obese adults were r and omized either to a habit-based intervention condition ( with two subgroups given weekly vs monthly weighing ; n=33 , n=36 ) or to a waiting-list control condition ( n=35 ) over 8 weeks . Intervention participants were followed up for 8 months . Participants : A total of 104 adults ( 35 men , 69 women ) with an average BMI of 30.9 kg m−2.Intervention : Intervention participants were given a leaflet containing advice on habit formation and simple recommendations for eating and activity behaviours promoting negative energy balance , together with a self-monitoring checklist . Main outcome measures : Weight change over 8 weeks in the intervention condition compared with the control condition and weight loss maintenance over 32 weeks in the intervention condition . Results : At 8 weeks , people in the intervention condition had lost significantly more weight ( mean=2.0 kg ) than those in the control condition ( 0.4 kg ) , with no difference between weekly and monthly weighing subgroups . At 32 weeks , those who remained in the study had lost an average of 3.8 kg , with 54 % losing 5 % or more of their body weight . An intention-to-treat analysis ( based on last-observation-carried-forward ) reduced this to 2.6 kg , with 26 % achieving a 5 % weight loss . Conclusions : This easily disseminable , low-cost , simple intervention produced clinical ly significant weight loss . In limited re source setting s it has potential as a tool for obesity management",
"INTRODUCTION Implementation of evidence -based interventions for smoking during pregnancy is challenging . We developed 2 highly replicable interventions for smoking during pregnancy : ( a ) a computer-delivered 5As-based brief intervention ( CD-5As ) and ( b ) a computer-assisted , simplified , and low-intensity contingency management ( CM-Lite ) . METHODS A sample of 110 primarily Black pregnant women reporting smoking in the past week were recruited from prenatal care clinics and r and omly assigned to CD-5As ( n = 26 ) , CM-Lite ( n = 28 ) , CD-5As plus CM-Lite ( n = 30 ) , or treatment as usual ( n = 26 ) . Self-report of smoking , urine cotinine , and breath CO were measured 10 weeks following r and omization . RESULTS Participants rated both interventions highly ( e.g. , 87.5 % of CD-5As participants reported increases in likelihood of quitting ) , but most CM-Lite participants did not initiate reinforcement sessions and did not show increased abstinence . CD-5As led to increased abstinence as measured by cotinine ( 43.5 % cotinine negative vs. 17.4 % ; odds ratio [ OR ] = 10.1 , p = .02 ) but not for CO-confirmed 7-day point prevalence ( 30.4 % abstinent vs. 8.7 % ; OR = 5.7 , p = .06 ) . Collapsing across CM-Lite status , participants receiving the CD-5As intervention were more likely to talk to a doctor or nurse about their smoking ( 60.5 % vs. 30.8 % ; OR = 3.0 , p = .02 ) . CONCLUSIONS Low-intensity participant-initiated CM did not affect smoking in this sample , but the CD-5As intervention was successful in increasing abstinence during pregnancy . Further research should seek to replicate these results in larger and more diverse sample s. Should CD-5As continue to prove efficacious , it could greatly increase the proportion of pregnant smokers who receive an evidence -based brief intervention",
"We conducted a r and omized controlled trial testing the effect of modest incentives to attend the gym among new members of a fitness facility , a population that is already engaged in trying to change a health behavior . Our experiment r and omized 836 new members of a private gym into a control group , receiving a $ 30 payment unconditionally , or one of 3 incentive groups , receiving a payment if they attended the gym at least 9 times over their first 6 weeks as members . The incentives were a $ 30 payment , a $ 60 payment , and an item costing $ 30 that leveraged the endowment effect . These incentives had only moderate impacts on attendance during members ’ first 6 weeks and no effect on their subsequent visit trajectories . We document substantial overconfidence among new members about their likely visit rates and discuss how overconfidence may undermine the effectiveness of a modest incentive program",
"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 .",
"BACKGROUND Data on the effectiveness of employer-sponsored financial incentives for employee weight loss are limited . OBJECTIVE To test the effectiveness of 2 financial incentive design s for promoting weight loss among obese employees . DESIGN R and omized , controlled trial . ( Clinical Trials.gov : NCT01208350 ) SETTING Children 's Hospital of Philadelphia . PARTICIPANTS 105 employees with a body mass index between 30 and 40 kg/m2 . INTERVENTION 24 weeks of monthly weigh-ins ( control group ; n = 35 ) ; individual incentive , design ed as $ 100 per person per month for meeting or exceeding weight-loss goals ( n = 35 ) ; and group incentive , design ed as $ 500 per month split among participants within groups of 5 who met or exceeded weight-loss goals ( n = 35 ) . MEASUREMENTS Weight loss after 24 weeks ( primary outcome ) and 36 weeks and changes in behavioral mediators of weight loss ( secondary outcomes ) . RESULTS Group-incentive participants lost more weight than control participants ( mean between-group difference , 4.4 kg [ 95 % CI , 2.0 to 6.7 kg ] ; P individual-incentive participants ( mean between-group difference , 3.2 kg [ CI , 0.9 to 5.5 kg ] ; P = 0.008 ) . Twelve weeks after incentives ended and after adjustment for 3-group comparisons , group-incentive participants maintained greater weight loss than control group participants ( mean between-group difference , 2.9 kg [ CI , 0.5 to 5.3 kg ] ; P = 0.016 ) but not greater than individual-incentive participants ( mean between-group difference , 2.7 kg [ CI , 0.4 to 5.0 kg ] ; P = 0.024 ) . LIMITATION Single employer and short follow-up . CONCLUSION A group-based financial incentive was more effective than an individual incentive and monthly weigh-ins at promoting weight loss among obese employees at 24 weeks . PRIMARY FUNDING SOURCE National Institute on Aging",
"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",
"Purpose To evaluate the effect of financial incentive in a diabetes prevention weight loss program at worksites . Design Group-level r and omized intervention study . Setting Four long-term care facilities , r and omly assigned to “ incentive-IG ” or “ non incentive-NIG ” groups . Participants Ninety-nine employees , all overweight or obese ( BMI = mean 34.8±7.4 kg/m2 ) and at risk for type 2 diabetes . Intervention A 16 week weight loss program ( diabetes prevention program ) with a 3 month follow up . IG could either choose a \" st and ard incentive \" to receive cash award when achieving the projected weight loss or to participate in a \" st and ard plus deposit incentive \" to get additional money matched with their deposit for projected weight loss . All of the participants received a one-hour consultation for a healthy weight loss at the beginning . Measures Weight-loss , diabetes risk score ( DRS ) , and cardiovascular risk outcomes . Analyses Linear and logistic regressions for completed cases with adjustments for clustering effect at group level . Results IG lost on average more pounds ( p=0.027 ) , reduced BMI ( p=0.04 ) , and reduced in DRS ( p=0.011 ) compared to NIG at week 16 . At the 12-week follow-up period , those in IG plus deposit subgroup had twice the odds ( OR=2.2 , p=0.042 ) and those in the st and ard IG had three times the odds of achieving weight loss goals than NIG ; those in the IG plus deposit group reduced DRS by 0.4 ( p=0.045 ) . Conclusion Monetary incentives appear to be effective in reducing weight and diabetes risk ",
"Smoking causes chronic obstructive pulmonary disease ( COPD ) , but few controlled studies have tested anti-smoking treatments in COPD . With procedures likely to attract unmotivated persons we recruited 49 quite-ill , smoking COPD patients . During one or two daily home visits for 85 days , breath carbon monoxide ( CO ) and self-reports of daily smoking were obtained . Patients , given quit date s and nicotine gum ( 2-mg pieces , up to 30 per day ) , were assigned r and omly to three groups : Experimentals were reinforced with lottery tickets for CO were reinforced for reporting no smoking that day . Controls received non-contingent payments . Each group 's mean CO level fell at the quit date . Thereafter , reinforced patients maintained significantly lower CO levels than Controls . Although many more 24-h abstentions occurred in the intervention period than in baseline , few patients sustained abstinence ; the groups did not differ in that regard . Outcome was predicted by decisions to throw away cigarettes when intervention began , but not by motivation scales nor Fagerstrom dependence scores . Pay schedules apparently exaggerated self-reports of reduced smoking . Although results are statistically significant , there is still no proven , practical treatment for smoking in advanced COPD",
"Objective : Evaluate the effectiveness of monetary incentives for increasing engagement in smoking cessation treatment and improving 6-month abstinence in low-income pregnant smokers . Method : Two-group r and omized clinical trial recruiting low-income ( Medicaid-registered ) pregnant smokers receiving assistance through a perinatal support program . Participants were r and omized to either an incentive ( n = 505 ) or control condition ( n = 509 ) . All participants were offered identical smoking cessation counseling at contacts . Incentive condition participants received incentives for attending pre- and postbirth treatment contacts : $ 25 for each of 6 prebirth provider visits , $ 25–40 for each of 4 postbirth home visits at Weeks 1 , 2 , 4 , and 6 ( total = $ 130 ) , $ 20 for each of 5 postbirth counseling calls and $ 40 for biochemically verified abstinence at the Week 1 and 6-month visits . Control condition participants received only $ 40 for attendance at the Week 1 and 6-month postbirth visits ( $ 40 each ) . Main outcomes : Primary outcome was biochemically confirmed 7-day point-prevalence abstinence at 6-month postbirth follow-up . Secondary outcomes included number of home visits and phone calls taken over the first 6 months postbirth ; biochemically confirmed abstinence at postbirth Week 1 visit ; and self-reported smoking status at 2- and 4-month visits . Results : Incentive condition participants had a higher biochemically confirmed abstinence rate at 6-month postbirth than controls ( 14.7 % vs. 9.2 % , respectively : p low-income pregnant smokers ’ engagement and success in smoking cessation treatment",
"ABSTRACT BACKGROUND More than half of adults in the United States do not attain the minimum recommended level of physical activity to achieve health benefits . The optimal design of financial incentives to promote physical activity is unknown . OBJECTIVE To compare the effectiveness of individual versus team-based financial incentives to increase physical activity . DESIGN R and omized , controlled trial comparing three interventions to control . PARTICIPANTS Three hundred and four adult employees from an organization in Philadelphia formed 76 four-member teams . INTERVENTIONS All participants received daily feedback on performance towards achieving a daily 7000 step goal during the intervention ( weeks 1– 13 ) and follow-up ( weeks 14– 26 ) periods . The control arm received no other intervention . In the three financial incentive arms , drawings were held in which one team was selected as the winner every other day during the 13-week intervention . A participant on a winning team was eligible as follows : $ 50 if he or she met the goal ( individual incentive ) , $ 50 only if all four team members met the goal ( team incentive ) , or $ 20 if he or she met the goal individually and $ 10 more for each of three teammates that also met the goal ( combined incentive).MAIN MEASURES Mean proportion of participant-days achieving the 7000 step goal during the intervention . KEY RESULTS Compared to the control group during the intervention period , the mean proportion achieving the 7000 step goal was significantly greater for the combined incentive ( 0.35 vs. 0.18 , difference : 0.17 , 95 % confidence interval [ CI ] : 0.07–0.28 , p individual incentive ( 0.25 vs 0.18 , difference : 0.08 , 95 % CI : -0.02–0.18 , p = 0.13 ) or the team incentive ( 0.17 vs 0.18 , difference : -0.003 , 95 % CI : -0.11–0.10 , p = 0.96 ) . The combined incentive arm participants also achieved the goal at significantly greater rates than the team incentive ( 0.35 vs. 0.17 , difference : 0.18 , 95 % CI : 0.08–0.28 , p individual incentive ( 0.35 vs. 0.25 , difference : 0.10 , 95 % CI : -0.001–0.19 , p = 0.05 ) . Only the combined incentive had greater mean daily steps than control ( difference : 1446 , 95 % CI : 448–2444 , p ≤ 0.005 ) . There were no significant differences between arms during the follow-up period ( weeks 14– 26 ) . CONCLUSIONS Financial incentives rewarded for a combination of individual and team performance were most effective for increasing physical activity . Trial Registration Clinical trials.gov identifier : NCT02001194",
"BACKGROUND Adjunctive behavioral smoking cessation treatments have the potential to improve outcomes beyond st and ard care . The present study had two aims : ( 1 ) compare st and ard care ( SC ) for smoking ( four weeks of brief counseling and monitoring ) to SC plus prize-based contingency management ( CM ) , involving the chance to earn prizes on days with demonstrated smoking abstinence ( carbon monoxide ( CO ) ≤6 ppm ) ; and ( 2 ) compare the relative efficacy of two prize reinforcement schedules-one a traditional CM schedule , and the second an early enhanced CM schedule providing greater reinforcement magnitude in the initial week of treatment but equal overall reinforcement . METHODS Participants ( N=81 nicotine-dependent cigarette smokers ) were r and omly assigned to one of the three conditions . RESULTS Prize CM result ed in significant reductions in cigarette smoking relative to SC . These reductions were not apparent at follow-up . We found no meaningful differences between the traditional and enhanced CM conditions . CONCLUSIONS Our findings reveal that prize CM leads to significant reductions in smoking during treatment relative to a control intervention , but the benefits did not extend long-term",
"INTRODUCTION Low-income population s are especially likely to smoke and have difficulty quitting . This study evaluated a monetary incentive intended to increase smoking treatment engagement and abstinence among Medicaid recipients who smoke . STUDY DESIGN Two-group r and omized clinical trial of Incentive ( n=948 ) and Control interventions ( n=952 ) for smoking . SETTING / PARTICIPANTS Medicaid recipients recruited from primary care patients ( n=920 ) and callers to the Wisconsin Tobacco Quit Line ( n=980 ) . INTERVENTION Participants were offered five quitline cessation calls and were encouraged to obtain cessation medication ( covered by Medicaid ) . All participants received payment for completing a baseline assessment and a 6-month smoking test . Only Incentive condition participants received compensation for taking counseling calls ( $ 30 per call ) and for biochemically verified abstinence at the 6-month visit ( $ 40 ) . MAIN OUTCOME MEASURES Seven-day point-prevalence smoking abstinence 6-months post study entry and cost/quit . RESULTS Incentive condition participants had significantly higher biochemically determined 7-day point-prevalence smoking abstinence rates 6 months after study induction than did Controls ( 21.6 % vs 13.8 % , respectively , p incentives was present across other abstinence indices , but the size of effects and levels of abstinence varied considerably across indices . Incentive condition participants were also significantly more likely than non-incentivized Control participants to accept Wisconsin Tobacco Quit Line treatment calls and their acceptance of calls mediated their attainment of higher abstinence rates at 6-month follow-up . The cost/quit/participant averaged $ 4,268.26 for the Control participants and $ 3,601.37 for the Incentive participants . CONCLUSIONS This study shows that fairly moderate levels of incentive payments for treatment engagement and abstinence ( a total possible payment of $ 190 ) increased very low-income smokers ' engagement and success in smoking cessation treatment . CLINICAL REGISTRATION This study is registered at www . clinical trials.gov : NCT02713594",
"OBJECTIVE Population -level strategies to improve healthy food choices are needed for obesity prevention . We conducted a r and omized controlled trial of 2672 employees at the Massachusetts General Hospital who were regular customers of the hospital cafeteria with all items labeled green ( healthy ) , yellow ( less healthy ) , or red ( unhealthy ) to determine if social norm ( peer-comparison ) feedback with or without financial incentives increased employees ' healthy food choices . METHODS Participants were r and omized in 2012 to three arms : 1 ) monthly letter with social norm feedback about healthy food purchases , comparing employee to \" all \" and to \" healthiest \" customers ( feedback-only ) ; 2 ) monthly letter with social norm feedback plus small financial incentive for increasing green purchases ( feedback-incentive ) ; or 3 ) no contact ( control ) . The main outcome was change in proportion of green-labeled purchases at the end of 3-month intervention . Post-hoc analyses examined linear trends . RESULTS At baseline , the proportion of green-labeled purchases ( 50 % ) did not differ between arms . At the end of the 3-month intervention , the percentage increase in green-labeled purchases was larger in the feedback-incentive arm compared to control ( 2.2 % vs. 0.1 % , P=0.03 ) , but the two intervention arms were not different . The rate of increase in green-labeled purchases was higher in both feedback-only ( P=0.04 ) and feedback-incentive arms ( P=0.004 ) compared to control . At the end of a 3-month wash-out , there were no differences between control and intervention arms . CONCLUSIONS Social norms plus small financial incentives increased employees ' healthy food choices over the short-term . Future research will be needed to assess the impact of this relatively low-cost intervention on employees ' food choices and weight over the long-term . TRIAL REGISTRATION Clinical Trials.gov : NCT01604499",
"BACKGROUND Contingency management ( CM ) is an efficacious intervention for reducing cigarette smoking . However , CM is rarely adopted as a smoking cessation treatment in the community . This study analyzed the effectiveness of a CM procedure in combination with a cognitive-behavioral treatment ( CBT ) for smoking cessation among treatment-seeking patients from the general population . METHODS A total of 92 patients were r and omly assigned to one of two treatment conditions : CBT ( N=49 ) or CBT+CM ( N=43 ) . The CM procedure included a voucher program through which nicotine abstinence was reinforced on a schedule of escalating magnitude of reinforcement with a reset contingency . Self-reported smoking status was confirmed with both carbon monoxide ( CO ) level in expired air and cotinine levels in urine . RESULTS Of the patients who received CBT+CM 97.7 % , completed 6 weeks of treatment , versus 81.6 % of those who received CBT ( p=.03 ) . At the post-treatment assessment , 95.3 % of the patients assigned to the CBT+CM condition achieved abstinence in comparison to the 59.2 % in the CBT group ( p=.000 ) . At the one-month follow-up , 72.1 % of the patients who received CBT+CM maintained smoking abstinence , versus 34.7 % in the CBT group ( p=.001 ) . At the six-month follow-up , 51.2 % of the patients who received CBT+CM maintained smoking abstinence in comparison to the 28.6 % in the CBT group ( p=.04 ) . CONCLUSIONS Results from this r and omized clinical trial showed that adding CM to a CBT is effective , and is feasible as an intervention approach with treatment-seeking patients in a community setting",
"Purpose : To test whether employer matching of employees ’ monetary contributions increases employees ’ ( 1 ) participation in deposit contracts to promote weight loss and ( 2 ) weight loss . Design : A 36-week r and omized trial . Setting : Large employer in the northeast United States . Participants : One hundred thirty-two obese employees . Interventions : Over 24 weeks , participants were asked to lose 24 pounds and r and omized to monthly weigh-ins or daily weigh-ins with monthly opportunities to deposit $ 1 to $ 3 per day that was not matched , matched 1:1 , or matched 2:1 . Deposits and matched funds were returned to participants for each day they were below their goal weight . Measures : Rates of making ≥1 deposit , weight loss at 24 weeks ( primary outcome ) , and 36 weeks . Analysis : Deposit rates were compared using χ2 tests . Weight loss was compared using t tests . Results : Among participants eligible to make deposits , 29 % made ≥1 deposit and matching did not increase participation . At 24 weeks , control participants gained an average of 1.0 pound , whereas 1:1 match participants lost an average of 5.3 pounds ( P = .005 ) . After 36 weeks , control participants gained an average of 2.1 pounds , whereas no match participants lost an average of 5.1 pounds ( P = .008 ) . Conclusion : Participation in deposit contracts to promote weight loss was low , and matching deposits did not increase participation . For deposit contracts to impact population health , ongoing participation will need to be higher",
"The prevalence of overweight and obesity has more than doubled in the past three decades , leading to rising rates of non-communicable diseases . This study tests whether adding a payment/rewards ( term reward ) program to an existing evidence -based weight loss program can increase weight loss and weight loss maintenance . We conducted a parallel-group r and omized controlled trial from October 2012 to October 2015 with 161 overweight or obese individuals r and omized to either control or reward arm in a 1:2 ratio . Control and reward arm participants received a four month weight loss program at the LIFE ( Lifestyle Improvement and Fitness Enhancement ) Centre at Singapore General Hospital . Those in the reward arm paid a fee of S$165.00 ( 1 US$ = 1.35S$ ) to access a program that provided rewards of up to S$660 for meeting weight loss and physical activity goals . Participants could choose to receive rewards as guaranteed cash payments or a lottery ticket with a 1 in 10 chance of winning but with the same expected value . The primary outcome was weight loss at months 4 , 8 , and 12 . 161 participants were r and omized to control ( n = 54 ) or reward ( n = 107 ) arms . Average weight loss was more than twice as great in the reward arm compared to the control arm at month 4 when the program concluded ( 3.4 kg vs 1.4 kg , p a payment/rewards program can be used to improve weight loss and weight loss maintenance when combined with an evidence -based weight loss program . Future efforts should attempt to replicate this approach and identify how to cost effectively exp and these programs to maximize their reach . This study is registered at www . clinical trials.gov ( Identifier : NCT01533454 )",
"OBJECTIVES We evaluated the effectiveness of offering adjunctive financial incentives for abstinence ( contingency management [ CM ] ) within a safety net hospital smoking cessation program . METHODS We r and omized participants ( n = 146 ) from a Dallas County , Texas , Tobacco Cessation Clinic from 2011 to 2013 to usual care ( UC ; cessation program ; n = 71 ) or CM ( UC + 4 weeks of financial incentives ; n = 75 ) , and followed from 1 week before the quit date through 4 weeks after the quit date . A subset ( n = 128 ) was asked to attend a visit 12 weeks after the scheduled quit date . RESULTS Participants were primarily Black ( 62.3 % ) or White ( 28.1 % ) and female ( 57.5 % ) . Most participants were uninsured ( 52.1 % ) and had an annual household income of less than $ 12 000 ( 55.5 % ) . Abstinence rates were significantly higher for those assigned to CM than UC at all visits following the quit date ( all Ps Point prevalence abstinence rates in the CM and UC groups were 49.3 % versus 25.4 % at 4 weeks after the quit date and 32.8 % versus 14.1 % at 12 weeks after the quit date . CM participants earned an average of $ 63.40 ( $ 150 possible ) for abstinence during the first 4 weeks after the scheduled quit date . CONCLUSIONS Offering small financial incentives for abstinence might be an effective means to improve abstinence rates among socioeconomically disadvantaged individuals participating in smoking cessation treatment",
"Exercise is important for long-term weight loss , but few studies have examined ways to improve exercise adherence in overweight subjects participating in a behavioral weight loss program . This paper presents two studies , one conducted at the University of Pittsburgh and one at the University of Minnesota , that sought to improve exercise adherence by exerting more direct control over the environmental antecedents and consequences controlling exercise . Study 1 investigated the use of a personal trainer who called participants regularly and met them at their home or office at scheduled times for a walk . Study 2 investigated the effect of a lottery incentive for exercise adherence . In both studies , the effect of these manipulations was examined in the context of a 24-week st and ard behavioral weight control program with three supervised exercise sessions per week . Neither intervention achieved statistically significant improvements in exercise adherence compared to control conditions , perhaps due in part to the limited statistical power of the studies . Future studies should focus on better underst and ing the barriers to exercise and design ing behavioral interventions that address these barriers",
"There is a paucity of evidence on the heterogeneous impacts of financial incentives on weight loss . Between March 2010 and January 2012 , in a r and omized controlled trial , we assigned 700 obese persons to three experimental arms . We test whether particular subgroups react differently to financial incentives for weight loss . Two treatment groups obtained a cash reward ( € 150 and € 300 with 237 and 229 participants , respectively ) for achieving an individually-assigned target weight within four months ; the control group ( 234 participants ) was not incentivized . Participants and administrators were not blinded to the intervention . We find that monetary rewards effectively induced obese individuals to reduce weight across all subgroups . However , there is no evidence for treatment-effect heterogeneity for those groups that were incentivized . Among those who were in the € 300 group , statistically significant and large weight losses were observed for women , singles , and those who are not working ( all above 4 kg in four months ) . In addition , the magnitude of the reward matters only for women and migrants . The effectiveness of financial incentives to reduce weight nevertheless raises sensitive ethical issues that should be taken into consideration by policymakers",
"The purpose of the present study was to examine the effect of a previously untested reinforcement strategy ( i.e. , 1 month 's free membership ) on attendance at a fitness facility . Participants were paying members of a fitness facility r and omly assigned to control ( n = 100 ) , placebo ( n = 100 ) , and reinforcement ( n = 100 ) conditions . The control condition received no intervention ; the placebo condition received a letter by mail ; and the reinforcement condition received the same letter by mail , except that it included an additional paragraph instructing them that they could earn 1 month 's free membership if they attended the fitness facility at least 12 times in the next month . Attendance was monitored for I month baseline and postintervention by using the facility 's computer system . Analysis of variance , t tests , and chi-square analysis all revealed that the reinforcement condition had the best attendance record during the intervention period . These preliminary results shed some light on increasing attendance at a fitness facility . Discussion highlighted the practical implication s of the findings and offered directions for future research",
"BACKGROUND It is not known whether large financial incentives enhance long-term smoking cessation rates outside clinical or workplace setting s. OBJECTIVES The goal of this study was to test whether large financial incentives improved long-term smoking cessation rates in low-income smokers , in a general population setting , without face-to-face or telephone counseling . METHODS This was a 2-arm , parallel group , individually r and omized controlled trial , with follow-up after 3 , 6 , and 18 months . Participants were 805 low-income smokers enrolled between 2011 and 2013 from the general population in Geneva , Switzerl and . We r and omly assigned participants to receive either booklets plus access to a smoking cessation website ( control group , n = 404 ) , or the same intervention plus financial incentives ( intervention group , n = 401 ) . Incremental financial rewards , to a maximum of U.S. $ 1,650 , were offered for biochemically verified abstinence at 1 , 2 , and 3 weeks , and 1 , 3 , and 6 months . No in-person counseling , telephone counseling , or medications were provided . The primary outcome was continuous abstinence between 6 months ( end of incentives ) and 18 months ( 12 months after the incentives ended ) , verified by expired carbon monoxide and salivary cotinine . We also assessed biochemically verified 7-day abstinence at 3 , 6 , and 18 months . RESULTS Rates of continuous abstinence between months 6 and 18 were 9.5 % in the incentive group and 3.7 % in the control group ( p = 0.001 ) . Rates of 7-day abstinence were higher in the incentive group than in the control group at 3 ( 54.9 % vs. 11.9 % ; p low-income smokers who did not receive face-to-face or telephone smoking cessation counseling , large financial incentives increased long-term rates of smoking cessation . ( Financial incentives for smoking cessation in low-income smokers ; IS RCT N04019434 )",
"OBJECTIVE To examine whether an efficacious voucher-based incentives intervention for decreasing smoking during pregnancy and increasing fetal growth could be improved without increasing costs . The strategy was to redistribute the usual incentives so that higher values were available early in the quit attempt . METHOD 118 pregnant smokers in greater Burlington , Vermont ( studied December , 2006-June , 2012 ) were r and omly assigned to the revised contingent voucher ( RCV ) or usual contingent voucher ( CV ) schedule of abstinence-contingent vouchers , or to a non-contingent voucher ( NCV ) control condition wherein vouchers were provided independent of smoking status . Smoking status was biochemically verified ; serial sonographic estimates of fetal growth were obtained at gestational weeks 30 - 34 . RESULTS RCV and CV conditions increased point-prevalence abstinence above NCV levels at early ( RCV : 40 % , CV : 46 % , NCV : 13 % , p=.007 ) and late-pregnancy ( RCV : 45 % ; CV : 36 % ; NCV , 18 % ; p=.04 ) assessment s , but abstinence levels did not differ between the RCV and CV conditions . The RCV intervention did not increase fetal growth above control levels while the CV condition did so ( p increasing antepartum abstinence and fetal growth , but other strategies ( e.g. , increasing overall incentive values ) will be necessary to improve outcomes further",
"Smoking cessation interventions have posed significant challenges for health professionals , particularly when directed at high risk , low income , pregnant smokers . Typical quit rates for pregnant women who receive publicly financed obstetrical care have rarely exceeded 12–16%.1 As many as 70 % of women who quit smoking during pregnancy relapse within one year of delivery.2 Two areas that have received particular attention as possible adjuncts to behaviour change are the use of reinforcements and social supports . Reinforcement in the form of incentives/rewards for positive behaviours has been controversial as an intervention strategy . Some argue that the “ overjustification effect ” of external rewards may cause subjects to lose internal motivation to modify behaviour over the long term.3 However , results of several studies , including two meta-analyses on reinforcement , provide compelling evidence that positive reinforcement provides positive behavioural changes.4 - 8 A second area of study that has been explored in the behaviour change research is the role of social support in motivating and sustaining selected behaviour change . Recent studies have empirically linked tobacco quit rates with daily interaction with a supportive “ other , ” preferably one who did not smoke.9 10 The primary objective of our intervention was to determine whether the combination of bolstered social support and financial incentives had an effect in significantly reducing smoking behaviour among low income , high risk , pregnant and postpartum women who participate in Oregon 's Women , Infants , and Children ( WIC ) program . The Significant Other Supporter ( SOS ) program was a r and omised , experimentally design ed smoking cessation study implemented in four Oregon WIC program sites . Criteria for entry into the study included the following : age 15 years or older ; self reported smoker ( “ even a puff in the last seven days ” ) ; English speaker/reader ; WIC eligible ; and 28 weeks gestation or less . Eligible subjects were r and omised into one of two groups , and were",
"OBJECTIVES This study examined the effect of program format and incentives on participation and cessation in worksite smoking cessation programs . METHODS Twenty-four worksites were r and omized to 6 conditions that differed in cessation program format and the use of incentives . Programs were offered for 18 months in each worksite . A total of 2402 cigarette smokers identified at baseline were surveyed 12 and 24 months later to assess participation in programs and cessation . RESULTS A total of 407 ( 16.9 % ) of the smoker cohort registered for programs ; on the 12- and 24-month surveys , 15.4 % and 19.4 % of the cohort , respectively , reported that they had not smoked in the previous 7 days . Registration for programs in incentive sites was almost double that of no-incentive sites ( 22.4 % vs 11.9 % ) , but increased registration did not translate into significantly greater cessation rates . Program type did not affect registration or cessation rates . CONCLUSIONS Although incentives increase rates of registration in worksite smoking cessation programs , they do not appear to increase cessation rates . Phone counseling seems to be at least as effective as group programs for promoting smoking cessation in worksites",
"Sixty-three companies in the Chicago area were recruited to participate in a worksite smoking cessation program . Participants in each worksite received a television program and newspaper supplement ( part of a community-wide media campaign ) , and one of three conditions : ( 1 ) self-help manuals alone ( M ) , ( 2 ) self-help manuals and incentives for 6 months ( IM ) or ( 3 ) maintenance manuals , incentives and cognitive-behavioral support groups for 6 months ( GIM ) . Results at the 2 year assessment are examined using a r and om-effects regression model . In addition , various definitions of quit-rate commonly used in smoking cessation research are explored and the advantages of using a public health approach in the worksite are examined",
"OBJECTIVE A pilot r and omized trial assessed the feasibility and effectiveness of an intervention combining Smartcare ( activity tracker with a smartphone application ) and financial incentives . METHODS A three-arm , open-label r and omized controlled trial design involving traditional education , Smartcare , and Smartcare with financial incentives was involved in this study . The latter group received financial incentives depending on the achievement of daily physical activity goals ( process incentive ) and weight loss targets ( outcome incentive ) . Male university students ( N = 105 ) with body mass index of ≥27 were enrolled . RESULTS The average weight loss in the traditional education , Smartcare , and Smartcare with financial incentives groups was -0.4 , -1.1 , and -3.1 kg , respectively , with significantly greater weight loss in the third group ( both Ps The final weight loss goal was achieved by 0 , 2 , and 10 participants in the traditional education , Smartcare , and Smartcare with financial incentives groups ( odds ratio for the Smartcare with financial incentive vs. Smartcare = 7.27 , 95 % confidence interval : 1.45 - 36.47 ) . Levels of physical activity were significantly higher in this group . CONCLUSIONS The addition of financial incentives to Smartcare was effective in increasing physical activity and reducing obesity",
"Objective : To test the ability of two levels of modest financial incentives to encourage weight loss among overweight employees . Methods : This study used a r and omized design with measurements at baseline , 3 , and 6 months and two levels of financial incentives ( $ 7 and $ 14 per percentage point of weight lost ) . Payments were structured so that all participants had equal ability to obtain the incentives during the study period . Results : At 3 months , participants with no financial incentive lost 2 pounds , those in the $ 7 group lost approximately 3 pounds , and those in the $ 14 group lost 4.7 pounds . Between baseline and 6 months , when the financial gains were equalized , weight losses were similar across groups . Conclusion : This study revealed that modest financial incentives can be effective in motivating overweight employees to lose weight",
"OBJECTIVE Less than half of all U.S. adults meet public health recommendations for physical activity , and even fewer older adults ( aged 50 years and over ) are sufficiently active . Because inactivity increases the risk of costly medical complications , successful efforts to increase physical activity among older adults may potentially be cost-effective . We sought to test if financial incentives for walking could increase physical activity among sedentary older adults . METHODS We conducted a 4-week r and omized controlled study using pedometers . A total of 51 adults age 50 + from the Raleigh-Durham area of North Carolina participated in the study in April-May 2007 . Individuals were r and omized into one of two arms . The control group received a fixed payment of $ 75 ; the intervention group received a fixed payment of $ 50 plus up to $ 25 more per week depending on the number of weekly aerobic minutes , defined as 10 + minutes of continuous walking or jogging . RESULTS The control group logged 2.3 h per week , on average . The intervention group logged 4.1 h per week and received an additional weekly payment of $ 17.50 , on average . CONCLUSION Modest financial incentives tied to aerobic minutes are an effective , and potentially cost-effective , approach for increasing physical activity among sedentary older adults ",
"OBJECTIVE Reinforcement-based treatments , based on behavioral economics models , can improve outcomes of medical conditions with behavioral components . This study evaluated the efficacy of a low-cost reinforcement intervention to produce initial weight loss . METHODS Overweight individuals ( n=56 ) were r and omized to one of two 12-week treatments : Lifestyle , Exercise , Attitudes , Relationships , Nutrition manual with supportive counseling or that same treatment with opportunities to win $ 1 to $ 100 prizes for losing weight and completing weight-loss activities . RESULTS Patients receiving reinforcement lost significantly more weight ( 6.0 % ± 4.9 % baseline bodyweight ) than patients in the non-reinforcement condition ( 3.5 % ± 4.1 % ; P=.04 ) . Moreover , 64.3 % of patients receiving reinforcement achieved weight loss of ≥ 5 % baseline bodyweight versus 25.0 % of those in the non-reinforcement condition ( P=.003 ) . Proportional weight loss was significantly related to reductions in total cholesterol and 24-hour ambulatory heart rate . CONCLUSION This reinforcement-based intervention substantially enhances short-term weight loss , and reductions in weight are associated with important changes in clinical biomarkers . Larger-scale evaluation of reinforcement-based treatments for weight loss is warranted",
"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",
"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",
"BACKGROUND Financial incentives promote many health behaviors , but effective ways to deliver health incentives remain uncertain . METHODS We r and omly assigned CVS Caremark employees and their relatives and friends to one of four incentive programs or to usual care for smoking cessation . Two of the incentive programs targeted individuals , and two targeted groups of six participants . One of the individual-oriented programs and one of the group-oriented programs entailed rewards of approximately $ 800 for smoking cessation ; the others entailed refundable deposits of $ 150 plus $ 650 in reward payments for successful participants . Usual care included informational re sources and free smoking-cessation aids . RESULTS Overall , 2538 participants were enrolled . Of those assigned to reward-based programs , 90.0 % accepted the assignment , as compared with 13.7 % of those assigned to deposit-based programs ( P rates of sustained abstinence from smoking through 6 months were higher with each of the four incentive programs ( range , 9.4 to 16.0 % ) than with usual care ( 6.0 % ) ( P reward-based programs was sustained through 12 months . Group-oriented and individual-oriented programs were associated with similar 6-month abstinence rates ( 13.7 % and 12.1 % , respectively ; P=0.29 ) . Reward-based programs were associated with higher abstinence rates than deposit-based programs ( 15.7 % vs. 10.2 % , P acceptance , the rate of abstinence at 6 months was 13.2 percentage points ( 95 % confidence interval , 3.1 to 22.8 ) higher in the deposit-based programs than in the reward-based programs among the estimated 13.7 % of the participants who would accept participation in either type of program . CONCLUSIONS Reward-based programs were much more commonly accepted than deposit-based programs , leading to higher rates of sustained abstinence from smoking . Group-oriented incentive programs were no more effective than individual-oriented programs . ( Funded by the National Institutes of Health and CVS Caremark ; Clinical Trials.gov number , NCT01526265 . )",
"INTRODUCTION Despite evidence that regular physical activity confers health benefits , physical activity rates among older adults remain low . Both personal and social goals may enhance older adults ' motivation to become active . This study tested the effects of financial incentives , donations to charity , and the combined effects of both interventions on older adults ' uptake and retention of increased levels of walking . STUDY DESIGN RCT comparing three interventions to control . Data collection occurred from 2012 to 2013 . Analyses were conducted in 2013 - 2016 . PARTICIPANTS Ninety-four adults aged ≥65 years from Philadelphia-area retirement communities . INTERVENTION All participants received digital pedometers , walking goals of a 50 % increase in daily steps , and weekly feedback on goal attainment . Participants were r and omized to one of four groups : ( 1 ) Control : received weekly feedback only ; ( 2 ) Financial Incentives : received payment of $ 20 each week walking goals were met ; ( 3 ) Social Goals : received donation of $ 20 to a charity of choice each week walking goals were met ; and ( 4 ) Combined : received $ 20 each week walking goals were met that could be received by participant , donated to a charity of choice , or divided between the participant and charity . MAIN OUTCOME MEASURES Mean proportion of days walking goals were met during the 16-week intervention and 4-week follow-up period . RESULTS After adjusting for baseline walking , the proportion of days step goals were met during the 16-week intervention period was higher in all intervention groups versus controls ( relative risk , 3.71 ; 95 % CI=1.37 , 10.01 ) . During the 4-week follow up period , the proportion of days step goals were met did not differ in intervention groups compared to control ( relative risk , 2.91 ; 95 % CI=0.62 , 13.64 ) . CONCLUSIONS Incentive schemes that use donations to a charity of choice , personal financial incentives , or a combination of the two can each increase older adults ' initial uptake of increased levels of walking . TRIAL REGISTRATION This study is registered at www . clinical trials.gov NCT01643538",
"Background . Financial incentives and peer networks could be delivered through eHealth technologies to encourage older adults to walk more . Methods . We conducted a 24-week r and omized trial in which 92 older adults with a computer and Internet access received a pedometer , daily walking goals , and weekly feedback on goal achievement . Participants were r and omized to weekly feedback only ( Comparison ) , entry into a lottery with potential to earn up to $ 200 each week walking goals were met ( Financial Incentive ) , linkage to four other participants through an online message board ( Peer Network ) , or both interventions ( Combined ) . Main outcomes were the proportion of days walking goals were met during the 16-week intervention and 8-week follow-up . We conducted a content analysis of messages posted by Peer Network and Combined arm participants . Results . During the 16-week intervention , there were no differences in the proportion of days walking goals were met in the Financial Incentive ( 39.7 % ; p = .78 ) , Peer Network ( 24.9 % ; p = .08 ) , and Combined ( 36.0 % ; p = .77 ) arms compared with the Comparison arm ( 36.0 % ) . During 8 weeks of follow-up , the proportion of days walking goals were met was lower in the Peer Network arm ( 18.7 % ; p = .025 ) but not in the Financial Incentive ( 29.3 % ; p = .50 ) or Combined ( 24.8 % ; p = .37 ) arms , relative to the Comparison arm ( 34.5 % ) . Messages posted by participants focused on barriers to walking and provision of social support . Conclusions . Financial incentives and peer networks delivered through eHealth technologies did not result in older adults walking more"
] | 41169228-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Beta-blockers are one of the more commonly prescribed classes of anti-hypertensive drugs , both as first-line and second-line . OBJECTIVES To quantify the effect on systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , heart rate and withdrawals due to adverse effects of beta-blocker therapy when given as a second-line drug in adult patients with primary hypertension . SEARCH STRATEGY CENTRAL ( The Cochrane Library 2009 , Issue 2 ) , MEDLINE ( 1966-Aug 2009 ) , EMBASE ( 1988-Aug 2009 ) and bibliographic citations of articles and review s were search ed . SELECTION CRITERIA Double-blind , r and omized controlled trials comparing a beta-blocker in combination with a drug from another class of anti-hypertensive drugs compared with that drug alone for a duration of 3 to 12 weeks in patients with primary hypertension were included . DATA COLLECTION AND ANALYSIS Two review ers independently extracted the data and assessed trial quality of each included study . MAIN RESULTS 20 double-blind RCTs evaluated the BP lowering efficacy of beta-blockers as second-line drug in 3744 hypertensive patients ( baseline BP of 158/102 mmHg ; mean duration of 7 weeks ) . The BP reduction from adding a beta-blocker as the second drug was estimated by comparing the difference in BP reduction between the combination and monotherapy groups . A reduction in BP was seen with adding a beta-blocker to thiazide diuretics or calcium channel blockers at doses as low as 0.25 times the manufacturer 's recommended starting dose . The BP lowering efficacy of beta-blockers as a second drug was 6/4 mmHg at 1 times the starting dose and 8/6 mmHg at 2 times the starting dose . Beta-blockers reduced heart rate by 10 beats/min at 1 to 2 times the starting dose . Beta-blockers did not statistically significantly increase withdrawals due to adverse effects but this was likely due to the lack of reporting of this outcome in 35 % of the included RCTs . AUTHORS ' CONCLUSIONS Addition of a beta-blocker to diuretics or calcium-channel blockers reduces BP by 6/4mmHg at 1 times the starting dose and by 8/6 mmHg at 2 times the starting dose . When the blood pressure lowering effect of beta-blockers from this review was compared to that of thiazide diuretics from our previous review ( Chen 2009 ) , second-line beta-blockers reduce systolic BP to the same extent as second-line thiazide diuretics , but reduce diastolic BP to a greater degree . The different effect on diastolic BP means that beta-blockers have little or no effect on pulse pressure whereas thiazides cause a significant dose-related decrease in pulse pressure . This difference in the pattern of BP lowering with beta-blockers as compared to thiazides might be the explanation for the fact that beta-blockers appear to be less effective at reducing adverse cardiovascular outcomes than thiazide diuretics , particularly in older individuals | [
"In a prospect i ve cohort study , associations of resting heart rate with risk of coronary , cardiovascular disease , cancer , and all-cause mortality in age-specific cohorts of black and white men and women were examined over 22 years of follow-up . Participants were employees from 84 companies and organizations in the Chicago , Illinois , area who volunteered for a screening examination . Participants included 9,706 men aged 18 - 39 years , 7,760 men aged 40 - 59 years , 1,321 men aged 60 - 74 years , 6,928 women aged 18 - 39 years , 6,915 women aged 40 - 59 years , and 1,151 women aged 60 - 74 years at the baseline examination in 1967 - 1973 . Vital status was ascertained through 1992 . For fatal coronary disease , multivariate-adjusted relative risks associated with a 12 beats per minute higher heart rate ( one st and ard deviation ) were as follows : for men aged 18 - 39 years , relative risk ( RR ) = 1.27 ( 95 % confidence interval ( CI ) 1.08 - 1.48 ) ; for men aged 40 - 59 years , RR = 1.13 ( 95 % CI 1.05 - 1.21 ) ; for men aged 60 - 74 years , RR = 1.00 ( 95 % CI 0.89 - 1.12 ) ; for women aged 40 - 59 years , RR = 1.21 ( 95 % CI 1.07 - 1.36 ) ; and for women aged 60 - 74 years , RR = 1.16 ( 95 % CI 0.99 - 1.37 ) . Corresponding risks for all fatal cardiovascular diseases were similar to those for coronary death alone . Deaths from cancer were significantly associated with heart rate in men and women aged 40 - 59 years . All-cause mortality was associated with higher heart rate in men aged 18 - 39 years ( RR = 1.11 , 95 % CI 1.01 - 1.20 ) , men aged 40 - 59 years ( RR = 1.16 , 95 % CI 1.11 - 1.21 ) , and women aged 40 - 59 years ( RR = 1.20 , 95 % CI 1.13 - 1.27 ) . Heart rate was not associated with mortality in women aged 18 - 39 years . In summary , heart rate was a risk factor for mortality from coronary disease , all cardiovascular diseases , and all causes in younger men and in middle-aged men and women , and for cancer mortality in middle-aged men and women",
"Summary In a multicentre , double-blind , between-patient study the hypotensive effect of oxprenolol was investigated in 329 patients with mild to moderate hypertension . A factorial experimental design with three factors was chosen : oxprenolol — none or daily doses of 20 , 40 , 60 and 80 mg ; dihydralazine and hydrochlorothiazide , respectively , none or 30 mg daily . Each treatment was given for 4 weeks after an adequate period of withdrawal from any other possible hypotensive therapy and one week of placebo wash-out . Irrespective of the association with dihydralazine and /or hydrochlorothiazide , oxprenolol had a hypotensive effect linearly related to dose for st and ing systolic ( P diastolic ( P pressure , and for lying diastolic ( P pressure . The addition of dihydralazine enhanced the time-course of the hypotensive effect of oxprenolol , particularly the 80 mg dose level . In general , the combination of oxprenolol with dihydralazine and hydrochlorothiazide caused larger reductions in blood pressure , particularly with oxprenolol 80 mg . In the latter group , the eventual falls in blood pressure were 30.5 and 14.4 mmHg for lying systolic and diastolic , respectively ; and 32.1 and 20.0 mmHg for the st and ing systolic and diastolic pressures . The drug was well tolerated ; major side effects ( heart failure and bronchospasm ) occurred in three patients",
"The effect of atenolol , a new beta-1-adrenergic receptor blocking agent , was studied in a double-blind cross-over trial in 24 carefully selected hypertensive out patients . After a four-week run-in period on matching placebo each patient received atenolol 200 mg/day , atenolol 400 mg/day , a combination of atenolol 200/mg day with bendrofluazide 5 mg/day , and bendrofluazide 5 mg/day alone , according to a r and om sequence . Atenolol at either dose produced a significantly greater reduction in all blood pressure levels except st and ing systolic pressure than bendrofluazide alone . There was no statistically significant difference between the effects of the two atenolol doses on either blood pressure or pulse rate . The addition of bendrofluazide to atenolol result ed in a further significant lowering of the blood pressure . A significant effect of thiazide on weight was noted . The study shows that atenolol , a cardioselective beta-blocker of similar potency to propranolol in animals but without membrane-stabilizing or partial agonist acitivity , is an effective and well-tolerated hypotensive agent",
"This r and omised , double-blind study was design ed to investigate the efficacy of a once-daily ( OD ) combination of the AT1 receptor blocker , eprosartan 600 mg , and the thiazide diuretic , hydrochlorothiazide ( HCTZ ) 12.5 mg , in patients with mild to moderate hypertension ( sitting diastolic blood pressure ( sitDBP ) ⩾98 mm Hg and ⩽114 mm Hg ) not adequately controlled with eprosartan 600 mg OD . A total of 494 patients entered the open-label monotherapy run-in phase , which consisted of eprosartan 600 mg OD for 3 weeks . Patients who responded to monotherapy were not eligible to enter the r and omised phase of the study and were withdrawn . The remaining 309 patients were then r and omised to either eprosartan 600 mg plus HCTZ 12.5 mg OD or to continue on eprosartan 600 mg OD . In the eprosartan plus HCTZ combination group , both sitDBP and sitting systolic blood pressure ( sitSBP ) were significantly reduced compared with the eprosartan monotherapy group . In addition , the response rate was higher in the combination group compared with the monotherapy group . There were no significant effects on reduction of sitDBP due to gender , prior use of antihypertensives or baseline severity of hypertension . The tolerability profile for the combination group was similar to that for the monotherapy group . Headache was the most frequent adverse event in both treatment groups . The majority of adverse events were mild to moderate in intensity . In this study of patients who were unresponsive to eprosartan monotherapy for 3 weeks , a combination product of eprosartan 600 mg and HCTZ 12.5 mg was shown to be an effective and well tolerated treatment",
"Fixed-dose combination therapy has received increased interest since publication of JNC-VI report and WHO/ISH guidelines 1999 . We compared in a r and omized , double-blind study the efficacy and tolerability of valsartan 80 mg combined with hydrochlorothiazide ( HCTZ ) 12.5 mg to monotherapy with either HCTZ 12.5 mg or 25 mg in patients with essential hypertension inadequately controlled by previous HCTZ 12.5 mg monotherapy . Two hundred and seventeen patients whose blood pressure ( BP ) control remained poor ( 95 mmHg h sitting diastolic BP HCTZ 12.5 mg were r and omized to receive either combination therapy with valsartan 80 mg plus HCTZ 12.5 mg ( V/HCTZ ) or monotherapy with HCTZ 12.5 mg or HCTZ 25 mg for 8 weeks . Reduction of sitting trough diastolic BP between baseline and week 8 as well as tolerability was evaluated . Reduction in trough diastolic BP was most pronounced in the V/HCTZ group ( –11.3 mmHg ) and significantly greater than in the HCTZ 12.5 mg group ( –2.9 mmHg , p HCTZ 25 mg group ( –5.7 mmHg , p . Tolerability of study medication was comparable between all three groups . In conclusion , switching to V/HCTZ combination therapy provides an additional lowering of BP compared to dosage increase of the thiazide in patients with BP insufficiently controlled by HCTZ 12.5 mg monotherapy",
"In this double-blind , r and omised , three-way crossover ( latin square design ) , multicentre study , the aim was to compare the efficacy and tolerability of the fixed combination of felodipine and metoprolol with the individual components as monotherapy . A total of 58 patients with supine diastolic blood pressure of 100 - 115 mmHg were treated with ( 1 ) a fixed combination of felodipine plus metoprolol 5/50 - 10/100 mg ( FM ) , ( 2 ) felodipine 5 - 10 mg ( F ) or ( 3 ) metoprolol 50 - 100 mg ( M ) , for 12 weeks each . All treatments were extended-release formulations administered once daily and blood pressure was measured 24 h after dosing . Dose titration was performed after 6 weeks if diastolic blood pressure was > 90 mmHg . After 12 weeks of active treatment , the mean supine blood pressures were 153/89 , 159/93 and 163/94 mmHg with FM , F and M , respectively . The mean differences in systolic/diastolic blood pressure were -5.6/-3.1 mmHg ( p = 0.007/p = 0.002 ) , -10.2/-4.4 mmHg ( p Blood pressure control ( supine diastolic blood pressure < or = 90 mmHg ) after 12 weeks was achieved in a significantly greater proportion of patients during treatment with FM than with F or M ; 71 % , 45 % and 40 % were controlled with the respective treatments . With FM , 45 % of the patients were taking the higher dose after 12 weeks of treatment . The corresponding figures for F and M were 60 % and 67 % , respectively . Thirteen of the 58 patients ( 22 % ) were controlled only with FM . ( ABSTRACT TRUNCATED AT 250 WORDS",
"In 15 patients with mild to moderate essential hypertension , the effects of diltiazem ( 120 mg twice daily ) were compared with those of atenolol ( 50 mg once daily ) , the two drugs in combination , and placebo in a r and omized double-blind cross-over study with treatment phases of 4 weeks duration . Blood pressure was reduced in the active treatment phases ( supine blood pressure : diltiazem , 172/92 mmHg ; atenolol , 172/92 mmHg ; diltiazem plus atenolol , 164/88 mmHg ; pooled estimate of s.e.m . by analysis of variance = 3/1 ) compared with placebo ( 180/101 mmHg ) . Factorial analysis confirmed fully additive antihypertensive effects of the drugs in combination . The time interval from the beginning of the P wave to the beginning of the QRS complex ( P-R interval ) was longer during combination therapy ( 0.184s ) compared with either diltiazem ( 0.175s ) or atenolol ( 0.174s ) alone , or placebo ( 0.164s ) ; s.e.m . by analysis of variance = 0.003 . No clinical ly significant conduction disturbances occurred . Plasma atrial natriuretic peptide was elevated by atenolol but not diltiazem . Thus , in subjects with uncomplicated essential hypertension , diltiazem and atenolol had equal antihypertensive efficacy when used alone , and fully additive effects in combination , on both blood pressure and cardiac conduction",
"Summary Sixteen patients with essential hypertension completed a double blind factorial trial comparing the effects of indapamide ( 2.5 mg daily ) and pindolol ( 10 mg daily ) on blood pressure , heart rate , plasma renin activity and plasma aldosterone concentration . There were four r and omised test phases of eight weeks each during which patients received indapamide alone , pindolol alone , indapamide plus pindolol and no active treatment ( placebo ) . Blood pressure and heart rate were measured every two weeks . Supine mean arterial pressure fell from 117 mm Hg in the placebo phase to 111 mm Hg in the indapamide phase , 106 mm Hg in the pindolol phase and 103 mm Hg in the combined indapamide plus pindolol phase . Factorial analysis confirmed that the hypotensive effects of the two drugs were additive , without evidence of potentiation or antagonism . Indapamide caused significant reductions in plasma potassium and chloride , and increases in plasma bicarbonate and urate concentrations ; it also caused increases in plasma renin activity and aldosterone concentration . These changes are similar to those observed with thiazide diuretics",
"Context Hypertension is a recognized risk factor for the development of congestive heart failure ( CHF ) . By measuring blood pressure , however , we have not yet been able to underst and the significance of pulse pressure as a contributor to CHF in middle-aged men and women . Contribution Using data from the Framingham Heart Study , the authors found that although elevations of systolic , diastolic , and pulse pressure were all related to the risk for CHF , the relation was strongest for systolic and pulse pressure . Caution s Underst and ing the relationships between systolic , diastolic , and pulse pressure and risk for CHF is helpful ; however , they do not help determine the increased risk faced by a person with systolic hypertension who also has increased pulse pressure . The Editors Hypertension is the most common risk factor for congestive heart failure ( CHF ) . It confers a twofold risk for the occurrence of CHF and also carries the highest population attributable risk among all risk factors for CHF ( 1 , 2 ) . Placebo-controlled clinical trials in patients with hypertension have demonstrated a consistent reduction in risk for CHF attributable to the lowering of elevated blood pressure ( 3 - 6 ) . The causal role of hypertension in the pathogenesis of CHF underscores the need to identify high-risk patients because early treatment may prevent or delay the occurrence of CHF ( 2 , 7 ) . The prognostic significance of systolic and diastolic blood pressure in CHF has been reported . However , blood pressure may also be divided into two other components : steady ( mean arterial pressure ) and pulsatile ( pulse arterial pressure ) ( 8 - 10 ) . Pulse pressure , a simple correlate of conduit vessel stiffness , is associated with left ventricular hypertrophy ( 11 ) . Increased pulse pressure has also been implicated in the development and progression of large-vessel atherosclerosis and small-vessel disease ( 12 - 14 ) . Accumulating evidence indicates that pulse pressure ( defined as the difference between systolic and diastolic blood pressure ) may be an important predictor of cardiovascular events ( 15 - 18 ) . Pulse pressure predicts the risk for CHF in elderly persons ( 19 , 20 ) ; however , the association of pulse pressure with CHF in middle-aged men and women has not been examined . The Framingham Heart Study provides an opportunity to examine the long-term associations of systolic , diastolic , and pulse pressure with the new onset of CHF in middle-aged and elderly men and women . Blood pressure and traditional risk factors have been measured repeatedly at serial examinations in this community-based cohort with long-term follow-up . We examined systolic blood pressure , diastolic blood pressure , and pulse pressure as predictors of risk for CHF in the Framingham Heart Study . Methods The Framingham Heart Study , which began in 1948 , has followed 5209 participants ( 28 to 62 years of age at entry to the study ) as part of a prospect i ve epidemiologic study of cardiovascular disease . Enrollment criteria and study design have been published previously ( 21 ) . Biennial follow-up visits included a medical history , physical examination , blood pressure measurements , 12-lead electrocardiography , and laboratory tests . Eligibility requirements for inclusion in our study were as follows : Participants had to be free of coronary heart disease and CHF and not be receiving antihypertensive therapy at Framingham Heart Study clinic baseline examinations 10 , 11 , or 12 ( 1968 to 1973 ) . Participants were followed for onset of CHF through mid-1994 . We obtained data for selected risk factors from the baseline examination . Methods for assessing risk factors have been published previously ( 21 , 22 ) . Risk factors , including age , sex , cigarette smoking , heart rate , antihypertensive medication use , and total and high-density lipoprotein cholesterol levels , were assessed . Sitting systolic and diastolic blood pressure were measured twice by the examining physician ( using a mercury column sphygmomanometer ) and averaged . We used body mass index ( kg/m2 ) as a measure of obesity . Participants were categorized as smokers if they smoked cigarettes regularly within the 1-year period before the baseline examination . Electrocardiography revealed left ventricular hypertrophy when increased voltage was associated with major ST-T repolarization changes ( strain pattern ) ( 22 ) . Diabetes mellitus was defined on the basis of a fasting blood glucose level greater than 7.77 mmol/L ( > 140 mg/dL ) , two r and om nonfasting blood glucose levels greater than 11.10 mmol/L ( > 200 mg/dL ) , or the use of insulin or an oral hypoglycemic agent . Diagnostic criteria for CHF have been described previously ( 21 , 22 ) . At each clinic examination , a history of interim hospitalizations and symptoms of CHF were obtained . Outside medical records of participants who did not attend an examination were evaluated for incident CHF . All suspected interim events were review ed by a panel of three physicians who evaluated relevant Framingham Heart Study clinic notes , outside physician reports , and hospitalization records . Congestive heart failure was diagnosed when at least two major or one major and two minor criteria were present . Minor criteria were considered only if their presence could not be attributed to another disease process . Major criteria were paroxysmal nocturnal dyspnea , pulmonary rales , distended jugular veins , enlarging heart size on chest radiography , acute pulmonary edema , hepatojugular reflux , third heart sound , jugular venous pressure of 16 cm or greater , and weight loss of 4.5 kg or greater in response to diuresis . Major criteria also included pulmonary edema , visceral congestion , or cardiomegaly on autopsy . Minor criteria were bilateral ankle edema , nocturnal cough , shortness of breath on ordinary exertion , hepatomegaly , pleural effusion , decrease in vital capacity by one third from the previous maximum recorded value , and heart rate of 120 beats/min or more . Statistical Analysis We used multivariable Cox proportional-hazards regression models to examine the relations of systolic , diastolic , and pulse pressure with CHF . After accounting for age and sex and using a P value less than 0.15 as the selection criterion , we determined covariates by stepwise selection from the following list : body mass index , diabetes , smoking status , total cholesterol level , high-density lipoprotein ( HDL ) cholesterol level , totalHDL cholesterol ratio , left ventricular hypertrophy , and heart rate . Only total cholesterol level and totalHDL cholesterol ratio did not enter the model . After accounting for relevant covariates , we used Cox proportional-hazards models to obtain hazard ratio estimates with 95 % CIs for st and ardized values of systolic , diastolic , and pulse pressure . These estimates were obtained individually and pairwise by using SAS software ( SAS Institute , Inc. , Cary , North Carolina ) ( 23 ) . We repeated analyses for participants stratified according to hypertension status and sex . Because blood pressure and age are correlated , we conducted separate analyses for participants younger than 60 years of age and 60 years of age and older . To examine constancy of effects over time , follow-up was divided into early and late periods ( blood pressure as a time-varying covariate and assessed the effect of antihypertensive treatment after the baseline blood pressure measurements . We used the KaplanMeier method to plot age- and sex-st and ardized cumulative incidence rates for CHF as a function of pulse pressure tertile at baseline . Descriptive data are presented as percentages or means ( SD ) . A P value less than 0.05 was considered statistically significant . Role of the Funding Sources The funding sources had no role in the design , conduct , analyses , and reporting of the study or in the decision to su bmi t the manuscript for publication . Results A total of 894 men and 1146 women , age 50 to 79 years , fulfilled criteria for inclusion in our study . Table 1 presents baseline clinical characteristics for these persons . During 35 497 person-years of follow-up ( mean , 17.4 years [ range , 0.06 to 24 years ] ) , CHF developed in 234 ( 11.8 % ) persons . Myocardial infa rct ion preceded CHF in 59 ( 25 % ) persons . Table 1 . Baseline Clinical Characteristics of the Study Participants Increments of 1 SD in systolic pressure , pulse pressure , and diastolic pressure were associated with hazard ratios for congestive failure of 1.56 , 1.55 , and 1.24 , respectively , after adjustment for age , sex , smoking , left ventricular hypertrophy , body mass index , diabetes mellitus , HDL cholesterol level , and heart rate ( Table 2 ) . When blood pressure tertiles were used , similar associations were observed among various components of blood pressure and CHF . No threshold effect or J-shaped association was documented ( Table 2 ) . The cumulative incidence of CHF according to tertiles of baseline pulse pressure is plotted in the Figure . Table 2 . Risk FactorAdjusted Association of Blood Pressure with Congestive Heart Failure Figure . Cumulative incidence of congestive heart failure according to pulse pressure tertiles at the baseline examination . The joint influences of different blood pressure components were also examined , with adjustment for the covariates mentioned previously . Of note , correlations among the blood pressure variables ranged from modest to very high ( r = 0.20 for diastolic and pulse pressure , r = 0.65 for diastolic and systolic pressure , and r = 0.88 for systolic and pulse pressure ) . Diastolic pressure was not significant ( hazard ratio , 1.12 [ CI , 0.98 to 1.29 ] ) in conjunction with pulse pressure ( hazard ratio , 1.51 [ CI , 1.33 to 1.72 ] ) . Likewise , diastolic pressure was not significant ( hazard ratio , 0.86 [ CI , 0.72 to 1.03 ] ) in conjunction with systolic pressure ( hazard ratio , 1.71 [ CI , 1.45 to 2.01 ] ) , but joint estimates were less stable than those obtained for individual pressure variables . Finally",
"Abstract Objective : To determine whether tight control of blood pressure prevents macrovascular and microvascular complications in patients with type 2 diabetes . Design : R and omised controlled trial comparing tight control of blood pressure aim ing at a blood pressure of angiotensin converting enzyme inhibitor captopril or a β blocker atenolol as main treatment ) with less tight control aim ing at a blood pressure of 20 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Subjects : 1148 hypertensive patients with type 2 diabetes ( mean age 56 , mean blood pressure at entry 160/94 mm Hg ) ; 758 patients were allocated to tight control of blood pressure and 390 patients to less tight control with a median follow up of 8.4 years . Main outcome measures : Predefined clinical end points , fatal and non-fatal , related to diabetes , deaths related to diabetes , and all cause mortality . Surrogate measures of microvascular disease included urinary albumin excretion and retinal photography . Results : Mean blood pressure during follow up was significantly reduced in the group assigned tight blood pressure control ( 144/82 mm Hg ) compared with the group assigned to less tight control ( 154/87 mm Hg ) ( P Reductions in risk in the group assigned to tight control compared with that assigned to less tight control were 24 % in diabetes related end points ( 95 % confidence interval 8 % to 38 % ) ( P=0.0046 ) , 32 % in deaths related to diabetes ( 6 % to 51 % ) ( P=0.019 ) , 44 % in strokes ( 11 % to 65 % ) ( P=0.013 ) , and 37 % in microvascular end points ( 11 % to 56 % ) ( P=0.0092 ) , predominantly owing to a reduced risk of retinal photocoagulation . There was a non-significant reduction in all cause mortality . After nine years of follow up the group assigned to tight blood pressure control also had a 34 % reduction in risk in the proportion of patients with deterioration of retinopathy by two steps ( 99 % confidence interval 11 % to 50 % ) ( P=0.0004 ) and a 47 % reduced risk ( 7 % to 70 % ) ( P=0.004 ) of deterioration in visual acuity by three lines of the early treatment of diabetic retinopathy study ( ETDRS ) chart . After nine years of follow up 29 % of patients in the group assigned to tight control required three or more treatments to lower blood pressure to achieve target blood pressures . Conclusion : Tight blood pressure control in patients with hypertension and type 2 diabetes achieves a clinical ly important reduction in the risk of deaths related to diabetes , complications related to diabetes , progression of diabetic retinopathy , and deterioration in visual acuity",
"BACKGROUND The safety and effectiveness of different dosages and combinations of antihypertensive agents can be efficiently studied using a multifactorial trial design . In consultation with the Cardio-Renal Division of the Food and Drug Administration , we conducted a r and omized , double-blind , placebo-controlled , 3 x 4 factorial trial of bisoprolol , a beta 1-selective adrenergic blocking agent , and hydrochlorothiazide . METHODS A total of 512 patients with mild to moderate essential hypertension were r and omized to once-daily treatment with bisoprolol ( 0 , 2.5 , 10 , or 40 mg ) , hydrochlorothiazide ( 0 , 6.25 , or 25 mg ) , and all possible combinations . Diastolic and systolic blood pressures were monitored during this 12-week trial . RESULTS The effects of bisoprolol and hydrochlorothiazide were additive with respect to reductions in diastolic and systolic blood pressures over the dosage ranges studied . The addition of hydrochlorothiazide ( or bisoprolol ) to therapy with bisoprolol ( or hydrochlorothiazide ) produced an incremental reduction in blood pressure . Dosages of hydrochlorothiazide as low as 6.25 mg/d contributed a significant antihypertensive effect . A hydrochlorothiazide dosage of 6.25 mg/d produced significantly less hypokalemia and less of an increase in uric acid levels than a dosage of 25 mg/d . The low-dose combination of bisoprolol , 2.5 mg/d , and hydrochlorothiazide , 6.25 mg/d , reduced diastolic blood pressure to lower than 90 mm Hg in 61 % of patients and demonstrated a safety profile that compared favorably with that of placebo . CONCLUSIONS The utility of factorial design trials to characterize dose-response relationships and to test the potential interactions between various antihypertensive agents has been demonstrated . The combination of low dosages of bisoprolol and hydrochlorothiazide may be a rational alternative to conventional stepped-care therapy for the initial treatment of patients with mild to moderate hypertension",
"In a r and omised , crossover study of patients with moderate to severe essential hypertension , the effects of the calcium entry antagonist nifedipine and the beta-receptor blocking drug acebutolol were studied on their own , and in combination . After 4 weeks of nifedipine tablets 20 mg twice daily ( Adalat , Bayer ) , mean supine blood pressure ( BP ) fell by 20 mmHg and after 4 weeks of acebutolol 200 mg twice a day ( Sectral , May & Baker ) by 11 mmHg . When nifedipine and acebutolol were given in combination in the above doses for 4 weeks , there was a significantly greater fall in BP than with either agent alone , supine mean arterial pressure falling by 27 mmHg . The above BPs were measured 2 h after the last dose of tablets . Measurements 12 h after the last dose showed smaller falls in BP , with a significantly greater fall with combination treatment than with acebutolol alone . The fall in BP 12 h after the last dose of the combination was greater than with nifedipine alone but this difference was not statistically significant . This r and omised , controlled study showed that nifedipine and acebutolol have a marked additive effect on BP which is sustained for at least 12 h after treatment",
"Summary In this r and omised , double-blind , crossover trial , the efficacy in hypertension of atenolol and nifedipine as single agents or in combination was compared . 81 patients with mild to moderate essential hypertension ( sitting diastolic blood pressure 100–120 mm Hg , aged 20–70 years ) from 6 outpatient clinics entered the study . By use of a Latin-square design , patients received , in r and omised fashion , sustained release nifedipine 20 mg twice daily , atenolol 50 mg in the morning and then placebo in the evening , or sustained release nifedipine 20 mg plus atenolol 50 mg in the morning and then placebo in the evening . Each schedule was followed for 4 weeks . All treatments lowered systolic and diastolic blood pressure in the supine and st and ing positions compared with pretreatment values . The combination regimen significantly reduced supine and st and ing systolic ( p and diastolic ( p ) blood pressure compared with nifedipine alone , and it also significantly reduced supine and st and ing systolic ( p respectively ) and diastolic ( p compared with atenolol alone . Heart rate was significantly decreased by atenolol and the combination compared with nifedipine alone.15 patients withdrew because of side effects : 9 during nifedipine treatment , 2 during atenolol treatment and 4 during combination treatment . Side effects were typical of those associated with nifedipine or atenolol . Flushes and hot sweats , which were frequent with nifedipine , were significantly less ( p atenolol or the combination . For selected patients who do not respond to monotherapy with nifedipine or atenolol , the combination regimen seems an appropriate and useful alternative to β-blocker/diuretic combinations , especially where ischaemic heart disease may co-exist",
"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",
"Summary In a multicentre , double-blind , crossover , placebo-controlled study , the antihypertensive effect of labetalol 100 mg and chlorthalidone 10 mg , given alone or in combination , has been assessed in 32 hypertensive patients . The combination had a greater effect in reducing blood pressure than did its separate components . This was particularly evident after exercise . Heart rate increased during chlorthalidone therapy , decreased during labetalol therapy , and a summation effect was observed during treatment with the combination . In most cases additivity was observed , as no interaction between the single components was observed , except for heart rate after exercise , and for diastolic blood pressure in the upright position . No interaction was observed either in the biochemical indices or in the clinical side-effects",
"Summary : In this double-blind , r and omized , parallel-group study , the aim was to compare the efficacy and tolerability of a new fixed combination of felodipine and metoprolol with the individual components in monotherapy . After a placebo period of 4 weeks , 159 patients with mild to moderate essential hypertension were r and omized to extended-release formulations of either felodipine plus metoprolol 10 + 100 mg ( FM ) , felodipine 10 mg ( F ) , or metoprolol 100 mg ( M ) once daily if supine diastolic blood pressure > 95 mm Hg . After 12 weeks of active treatment , the reductions in supine blood pressure ( 24 h after dosing ) were 20/14 , 13/10 , and 11/8 mm Hg for FM , F , and M , respectively . The difference in change was 7/4 mm Hg ( p = 0.004/p = 0.006 ) and 8/5 mm Hg ( p = 0.0002/p Blood pressure control ( diastolic blood pressure Adverse experiences were those to be expected from previous studies with felodipine and metoprolol and did not differ in frequency between groups . It can be concluded that a fixed combination of metoprolol and felodipine has a clinical ly relevant and significantly better blood pressure reduction 24 h postdose than the individual substances in monotherapy , without decreased tolerability",
"In 16 patients with essential hypertension the effects of enalapril 20 mg once daily were compared with those of atenolol 50 mg once daily , with the two drugs in combination and with placebo using a double-blind cross-over design with allocation of treatment order by r and omised Latin squares . For each patient there were four treatment phases , each of four weeks duration , which together comprised a 2 x 2 factorial experiment . All blood pressure parameters were reduced in the three active treatment phases compared to placebo ( p less than 0.001 ) . Supine blood pressures ( group means ) were 171/97 ( placebo ) , 147/85 ( enalapril ) , 154/84 ( atenolol ) and 144/78 ( enalapril plus atenolol ) ( S.E.M. + /- 2/+/- 1-ANOVA ) , and st and ing blood pressures were 170/105 ( placebo ) , 146/92 ( enalapril ) , 154/92 ( atenolol ) and 147/86 ( enalapril plus atenolol ) ( S.E.M. + /- 3/+/- 1 ) . In the combination phase there was an additional hypotensive response but the potential fully additive effects of the two agents were attenuated by 30 - 50 % . The mechanism of the attenuated hypotensive effect of the combined agents has not been determined . Plasma atrial natriuretic peptide ( ANP ) concentration was doubled in the presence of atenolol ( P less than 0.01 ) suggesting that ANP may contribute to the hypotensive effect of the beta-blocker",
"Fifteen out- patients with moderate hypertension were r and omly and sequentially treated with atenolol , indapamide and a combination of the two drugs after a wash-out period of at least 1 week and a 2-week placebo run-in period . The duration of treatment was 4 weeks in each case . The dosage was 2.5 mg indapamide and 100 mg atenolol , in single tablets which were taken at 11.00 hours . All the treatment regimens produced a highly significant ( p less than 0.001 ) reduction in systolic and diastolic , supine and st and ing blood pressure ; these reductions were not significantly different for the single drugs but were significantly greater for the combined therapy . The number of patients reaching the end-point of a diastolic blood pressure of 95 mmHg or less was the same with either atenolol or indapamide , i.e. 7 ( 46.6 % ) , but was greater with the combined therapy , i.e. 10 ( 66.6 % ) . A significant ( p less than 0.001 ) reduction in pulse rate was observed with the treatments involving atenolol . Acceptability of the treatments was very good ; the number of volunteered and elicited complaints during the different treatments being less compared to the placebo period , particularly for the combined treatment . No significant difference was observed in the blood biochemistry tests . The results are discussed in light of the mechanisms of action of the two drugs , which seem well integrated with each other , and the duration of the antihypertensive effect , which allows a single administration with consequent good treatment compliance",
"Two hundred thirty-four patients with supine diastolic blood pressure of between 95 and 114 mm Hg were enrolled into a double-blind , r and omized , parallel , multicenter trial . The patients were r and omized to either nicardipine 30 mg tid , propranolol 40 mg tid , or nicardipine 30 mg tid and propranolol 40 mg tid for six weeks . Two hundred six patients yielded data for analyses . Of the 28 not included , seven had missing data , whereas the remaining 21 were excluded because they either failed to meet inclusion criteria or were noncompliant at endpoint . Both nicardipine and propranolol as monotherapies and in combination achieved statistically significant , ( P less than .01 ) , supine diastolic blood pressure reduction relative to baseline . The combination of nicardipine and propranolol showed a greater reduction in supine diastolic and systolic measurements than either of the monotherapies . Nicardipine produced greater blood pressure reductions one hour after dosing , whereas the propranolol treatment tended to produce slightly greater blood pressure decreases eight hours after dose . The combination always result ed in the greatest blood pressure reduction , independent of time after dose . Adverse experiences were reported by 26 % of patients in the nicardipine-treated group , most often transient vasodilatory effects , by 17 % of the propranolol-treated patients , and by 18 % of the combination-treated group . This study demonstrated at the doses studied that nicardipine alone produced equivalent blood pressure reductions to those obtained by propranolol alone , but that the combination of these two drugs produced greater reductions in blood pressures than either of the monotherapies",
"BACKGROUND To attain goal blood pressure ( BP ) , many hypertensive patients require combination antihypertensive therapy . Thiazide diuretic/beta-blocker regimens lower BP , and clinical studies indicate that they reduce the risk for cardiovascular consequences of hypertension . Fixed-dose combination tablets can simplify multidrug treatment regimens . METHODS This multicenter , r and omized , double-blind , placebo-controlled , unbalanced factorial study ( N = 1571 ) was design ed to determine whether hydrochlorothiazide ( HCT ) and extended release ( ER ) metoprolol both contribute to an antihypertensive effect . Hypertensive adults with sitting diastolic BP ( SiDBP ) 95 to 114 mm Hg and systolic BP ( SiSBP ) received one of three hydrochlorothiazide doses ( 6.25 mg , 12.5 mg , or 25 mg ) , one of four ER-metoprolol doses ( 25 mg , 50 mg , 100 mg , 200 mg ) , or one of nine of the combinations or placebo for 8 weeks . RESULTS Blood pressure decreased with all combinations ( P Reductions with placebo were 5.3 ( SiDBP ) and 4.2 mm Hg ( SiSBP ) . Both active agents contributed to the combination effect ( P = .0015 for SiDBP ; P = .0006 for SiSBP ) . Several low-dose combinations were approximately as effective as high doses of the individual agents ( differences within 1 to 2.5 mm Hg ) . The adverse event discontinuation rate was 2.9 % . Serum potassium decreased and uric acid increased with increasing doses of HCT . CONCLUSIONS Extended-release metoprolol/hydrochlorothiazide is an effective antihypertensive combination that offers additive antihypertensive contributions from both components",
"In a double-blind trial , 545 out- patients with essential hypertension received 25 mg/day chlorthalidone alone ( 274 patients ) or in fixed combination with 200 mg/day slow-release metoprolol ( 271 patients ) for 8 weeks . Both treatments significantly ( P ) decreased systolic and diastolic blood pressure ; 45.6 % of patients receiving chlorthalidone and 82.5 % receiving combined therapy had a diastolic blood pressure of less than 95 mmHg . Patients not controlled by chlorthalidone or chlorthalidone plus metoprolol subsequently received chlorthalidone plus metoprolol ( 137 patients ) or chlorthalidone plus metoprolol plus a third drug ( 34 patients ) , respectively , for 8 weeks . A total of 79.5 % of patients receiving chlorthalidone plus metoprolol and 61.8 % receiving chlorthalidone plus metoprolol plus a third drug had a diastolic blood pressure of less than 95 mmHg . Only 5.9 % of patients experienced mild to modérate side-effects . Plasma potassium leveis significantly ( P<0.01 ) decreased during the first 8 weeks only . It is concluded that a diuretic alone or in fixed combination with a β-blocker is effective in the long-term treatment of arterial hypertension",
"The tolerance and antihypertensive action of acebutolol , as a sole drug and in combination with a diuretic , were studied in a population of 34 female subjects aged over 65 years , with a mean of 81 years , suffering from well tolerated essential hypertension . The study was carried out in the form of double blind permutations , each subject receiving successively in an order determined by r and om selection each of three therapeutic phases : acebutolol , acebutolol in combination with a diuretic and a placebo . The results showed that in the elderly acebutolol had a moderate diuretic action which was remarkably potentialised by diuretics . The tolerance of this beta-blocker was excellent : no cases of cardiac failure , and no disturbances in atrioventricular conduction developed during the phases with active treatment",
"In a double-blind , crossover study , five white men with mild-to-moderate hypertension received placebo and fixed doses of atenolol , metoprolol , chlorthalidone , verapamil , and the combination of atenolol and chlorthalidone in a quasi-r and om order . Daily dosages were : atenolol , 100 mg ; metoprolol , 200 mg ; chlorthalidone , 50 mg ; verapamil , 240 mg ; and the same doses of atenolol and chlorthalidone in combination . St and ard office and daytime ambulatory blood pressures were assessed at the end of each month-long trial . Atenolol , metoprolol , chlorthalidone , and verapamil controlled office blood pressure with similar reductions . Verapamil did not lower ambulatory blood pressure at this dose ( which is lower than is now commonly used ) , but reductions in ambulatory blood pressure were similar for atenolol , metoprolol , and chlorthalidone . The combination of atenolol and chlorthalidone maintained blood pressure control more effectively than the single drug treatments in both office and ambulatory setting s , and the combined hypotensive effects were additive . However , reductions in the office due to the combination appeared to overestimate hypotensive effectiveness in the ambulatory setting . This study suggests that the effectiveness of commonly prescribed antihypertensive regimens varies according to setting as well as drug , and that assessment of treatment effectiveness can be improved by automated ambulatory blood pressure monitoring",
"BACKGROUND Characteristics such as age and race are often cited as determinants of the response of blood pressure to specific antihypertensive agents , but this clinical ly important issue has not been examined in sufficiently large trials , involving all st and ard treatments , to determine the effect of such factors . METHODS In a r and omized , double-blind study at 15 clinics , we assigned 1292 men with diastolic blood pressures of 95 to 109 mm Hg , after a placebo washout period , to receive placebo or one of six drugs : hydrochlorothiazide ( 12.5 to 50 mg per day ) , atenolol ( 25 to 100 mg per day ) , captopril ( 25 to 100 mg per day ) , clonidine ( 0.2 to 0.6 mg per day ) , a sustained-release preparation of diltiazem ( 120 to 360 mg per day ) , or prazosin ( 4 to 20 mg per day ) . The drug doses were titrated to a goal of less than 90 mm Hg for maximal diastolic pressure , and the patients continued to receive therapy for at least one year . RESULTS The mean ( + /- SD ) age of the r and omized patients was 59 + /- 10 years , and 48 percent were black . The average blood pressure at base line was 152 + /- 14/99 + /- 3 mm Hg . Diltiazem therapy had the highest rate of success : 59 percent of the treated patients had reached the blood-pressure goal at the end of the titration phase and had a diastolic blood pressure of less than 95 mm Hg at one year . Atenolol was successful by this definition in 51 percent of the patients , clonidine in 50 percent , hydrochlorothiazide in 46 percent , captopril in 42 percent , and prazosin in 42 percent ; all these agents were superior to placebo ( success rate , 25 percent ) . Diltiazem ranked first for younger blacks ( ) and older blacks ( > or = 60 years ) , among whom the success rate was 64 percent , captopril for younger whites ( success rate , 55 percent ) , and atenolol for older whites ( 68 percent ) . Drug intolerance was more frequent with clonidine ( 14 percent ) and prazosin ( 12 percent ) than with the other drugs . CONCLUSIONS Among men , race and age have an important effect on the response to single-drug therapy for hypertension . In addition to cost and quality of life , these factors should be considered in the initial choice of a drug",
"1 . The aim of the study was to compare the efficacy and the tolerability of treatment with atenolol ( 50 - 100 mg once daily ) , nitrendipine ( 20 - 40 mg once daily ) and their combination ( atenolol 50 mg + nitrendipine 20 mg ) once daily in patients with mild to moderate essential hypertension . 2 . The study was a r and omised , double-blind , placebo controlled parallel groups design : blood pressures were measured at ' trough ' effect ( i.e. 24 h after dosing ) to assess the adequacy of once-daily treatment . 3 . Mean blood pressures ( mm Hg ) recorded on four occasions over 12 weeks of treatment were significantly lower both with atenolol ( 155/97 sitting : 155/104 st and ing ) and with the combination of atenolol plus nitrendipine ( 153/96 sitting : 152/104 st and ing ) than with placebo ( 169/108 sitting : 169/114 st and ing ) . Nitrendipine alone had no significant effect on blood pressure 24 h after dosing ( 165/104 sitting : 165/110 st and ing ) . 4 . Withdrawals due to adverse effects were more common during treatment with nitrendipine : 7/32 of the patients experienced adverse effects attributable to intense systemic vasodilatation ( e.g. , flushing , erythema , headache ) . 2/37 patients taking atenolol were withdrawn : one because he developed a psoriatic rash and the other because of impaired peripheral circulation . Of the 35 patients taking combination treatment , two were withdrawn : one developed headaches and dyspnoea , and the other asthma . 5 . The results suggest that once daily dosing with nitrendipine does not control blood pressure throughout the 24 h period in the majority of patients , and is associated with a considerable burden of adverse effects . Combination treatment was better tolerated but appeared to offer no advantages over atenolol alone in terms either of blood pressure control or adverse effects",
"In 101 hypertensive patients , the effects of a combination of propranolol and bendrofluazide were compared with those of each drug alone . After an introductory period with a placebo , the patients received , in a double-blind r and omized trial , propranolol 80 mg twice a day , bendrofluazide 2.5 mg twice a day , or both drugs together twice daily . The combination produced significantly greater reductions in lying , st and ing , and post-exercise systolic and diastolic blood pressure than either drug separately . Side-effects were minimal and the combination was well accepted by patients",
"1 The hypotensive effect of single daily dosing with atenolol 100 mg and chlorthalidone 25 mg given alone or in combination has been assessed in a double-blind , crossover , placebo controlled trial in fifteen hypertensive patients . 2 Average lying blood pressures were : Placebo 155.4/103.9 mm Hg , atenolol 134.6/85.8 mm Hg , chlorthalidone 139.5/90.1 mm Hg , combination 127.7/82.5 mm Hg . 3 The effect of the combination therapy in reducing lying diastolic pressure compared with placebo ( a fall of 21.4 mm Hg ) was significantly less than the 31.9 mm Hg fall predicted from the sum of the individual effects ( P = 0.01 ) . 4 Observations on blood pressure at rest and under mental , isometric and bicycle ergometer stress were made pre-dose and post-dose for a 12 h period at the end of the last treatment period . 5 Lying blood pressure declined from the zero hour ( pre-dose ) reading on all treatments to a low at 15.00 - -18.00 h and then rose again . 6 The rise in systolic blood pressure after isometric exercise and mental stress was of a similar magnitude with all four treatment regimes . 7 Atenolol , alone and in combination with chlorthalidone , reduced the blood pressure and the pulse rate increase on exercise 2 h post-dose when compared with readings 24 h post-dose . 8 Once daily dosing with a combination of atenolol and chlorthalidone produced a fall in supine blood pressure over a 24 h period but the effect on exercise induced changes was not uniform over this period",
"1 . The effects of timolol alone and in combination with a fixed dose of hydrochlorothiazide and amiloride have been studied in a double-blind , controlled study in fifty-four patients with mild to moderate essential hypertension . 2 . After a 4 weeks placebo period patients were r and omly assigned to enter groups receiving timolol alone ( group A ) , hydrochlorothiazide + amiloride ( group B ) or timolol + hydrochlorothiazide + amiloride ( group C ) . Each treatment was carried out for 6 weeks . 3 . The use of timolol ( 10 mg ) , hydrochlorothiazide ( 25 mg ) and amiloride ( 2 - 5 mg ) in a combination tablet given twice daily gave better control of blood pressure in patients with mild to moderate essential hypertension than did equivalent dosages of timolol alone or of hydrochlorothiazide and amiloride . 4 . Clinical and laboratory side effects were minimal",
"In a r and omized , double-blind , within-patient study , 28 out- patients with mild to moderate hypertension were given , at the end of a 3-week placebo wash-out period , four different antihypertensive treatments for 3 weeks each . the treatments were 50 mg atenolol , 100 mg atenolol , 12.5 mg chlorthalidone and a fixed combination of 50 mg atenolol and 12.5 mg chlorthalidone . All treatments were given once daily . Visits were scheduled for the last day of each treatment period , 24 - 26 hours after the last dose , and there was an intermediary wash-out period between each pair of active treatments . Supine systolic/diastolic blood pressure was 165/102 on placebo , 153/93 mmHg on 50 mg atenolol , 155/91 mmHg on 100 mg atenolol , 148/93 mmHg on 12.5 mg chlorthalidone and 144/89 mmHg on the combination . All the changes in pressure were significant ( p less than 0.01 ) versus placebo . Supine systolic blood pressure was lower on the combination than on 100 mg atenolol alone ( p less than 0.05 ) and upright systolic pressure was lower on the combination than on 100 mg atenolol ( p less than 0.05 ) or 50 mg atenolol ( p less than 0.05 ) alone . The heart rate was lowered by atenolol alone or combined with chlorthalidone but did not fall below 56 bpm in any patient . Serum potassium levels were lower on 12.5 mg chlorthalidone than on placebo ( 3.88 mEq/l vs 4.09 mEq/l -- p less than 0.05 ) but the difference was trivial ; on the combination of atenolol-chlorthalidone there was no significant difference versus placebo ( 3.97 mEq/l vs 4.09 mEq/l -- NS ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Ninety four patients with mild hypertension ( average supine diastolic blood pressure ( phase V ) 95 - 110 mm Hg ) were allocated at r and om to receive restriction of dietary sodium ( maximum allowed 70 mmol(mEq)/24 h ) or a normal diet . In addition , they received in r and om order 25 mg chlorthalidone , 200 mg metoprolol ( slow release ) , and a fixed combination of these two drugs . Each drug treatment was given for four weeks and alternated with four weeks of placebo . Forty four patients were allocated to sodium restriction ( group 1 ) and 50 to normal diet ( group 2 ) . The mean 24 hour urinary sodium excretion in group 1 was 74 ( SD 31 ) mmol(mEq)/24 h , and in group 2 132 ( 51 ) mmol/24 h. Compared with the screening blood pressure the average decrement of the supine blood pressure in group 1 was 16.0/8.6 mm Hg with placebo , 21.7/11.5 mm Hg with the diuretic , 28.5/17.8 mm Hg with the beta blocker , and 28.9/18.4 mm Hg with the combined agent ; in group 2 these values were 13.3/6.1 , 20.3/9.7 , 21.3/12.9 , and 29.4/16.8 mm Hg , respectively . There was a sharp decrease of the average potassium concentration during chlorthalidone and combination treatment periods ( average value 3.3 mmol(mEq)/1 ) . These results suggest that moderate salt restriction used as sole treatment has a limited though demonstrable blood pressure lowering effect but that when it is used as an adjuvant to beta blocker treatment its value is greatly enhanced",
"The antihypertensive effect of a fixed dosage combination of the cardioselective beta-adrenoceptor blocker , atenolol , and the oral thiazide-like diuretic , chlorthalidone ( Tenoretic ) was studied in 24 hypertensive Nigerians in a double-blind , cross-over comparison with three other treatments . These were atenolol alone , 100 mg daily , chlorthalidone alone , 25 mg daily , and atenolol ( 100 mg ) plus chlorthalidone ( 25 mg ) daily taken as separate formulations . Tenoretic was taken as a once-daily tablet containing 100 mg atenolol plus 25 mg chlorthalidone . The order of administration of the drugs was r and omized . Each drug was taken for 4 weeks . The results showed that atenolol and chlorthalidone lowered blood pressure to the same extent . Combination of the two drugs whether taken separately or in fixed-dosage combination was better than either product singly . The drugs were well tolerated",
"The efficacy and safety of verapamil and propranolol were examined in 14 hypertensive patients ( mean age 51.2 , range 30 to 65 ) in a double-blind , r and omized , crossover study of verapamil , 360 mg , propranolol , 240 mg , these 2 formulations in combination and placebo , each given for 4 weeks . Supine blood pressure , heart rate , atrioventricular conduction ( PR interval ) and left ventricular function were measured . All treatments reduced diastolic blood pressure ( mean + /- st and ard deviation ) ( p less than 0.001 ) : placebo to 106.6 + /- 8.1 mm Hg ; propranolol to 93.8 + /- 7.7 ; verapamil to 89.8 + /- 7.8 ; the combination to 84.1 + /- 6.1 , but the effect of the combination was significantly greater than that of either drug alone ( p less than 0.05 ) . Heart rate at rest ( placebo , 80.2 + /- 12.2 beats/min ) was reduced by propranolol ( 63.3 + /- 9.4 , p less than 0.001 ) , but not by verapamil ( 79.0 + /- 8.9 ) . However , the addition of verapamil to propranolol led to a further reduction in heart rate ( 56.9 + /- 8.4 , p less than 0.005 ) . PR interval was prolonged significantly by the combination ( 185.5 + /- 35.3 ms ) when compared with placebo ( 154.0 + /- 22.7 ) ; propranolol ( 159.1 + /- 21.2 ) and verapamil ( 165.5 + /- 32.4 ) ( p less than 0.005 for each ) . The active drugs increased end-diastolic dimension and end-systolic dimension . For each variable , the effect of the combination was statistically significant ( p less than 0.01 ) . Fractional shortening was not altered significantly by any of the treatments . Thus verapamil plus propranolol is a very effective antihypertensive combination but heart rate , atrioventricular conduction and left ventricular function may be affected adversely , necessitating careful monitoring of therapy",
"This study compared with placebo the efficacy and tolerability of optimised doses of felodipine 5 - 20 mg daily , metoprolol 50 - 200 mg daily and their combination in subjects 60 years or over with isolated systolic hypertension . The study employed a r and omised double-blind crossover design with allocation of treatment order within subjects by Latin squares . For each subject , after a single-blind run-in placebo phase , there were four r and omised treatment phases each of six weeks duration , with a dose titration step at three weeks if necessary . Twenty-eight subjects entered the r and omised phases of the study and twenty-one completed all four phases--13 male , 8 female ( ages : median 71 , range 59 - 85 years ) . At the end of both the felodipine and metoprolol phases systolic and diastolic pressure were reduced at 2 hours postdose compared with the placebo phase ( p blood pressure reduction with felodipine ( -40/-20 mmHg ) being greater than that with metoprolol ( -15/-9 mmHg ) ( p supine systolic blood pressure ( -17 mmHg ) with felodipine ( p metoprolol . At both measurement times the two drugs when in combination had an additive effect on blood pressure . There was a 20 % increase in reported symptoms during each of the active treatment phases . Four subjects withdrew during the r and omised phases because of probable drug-related adverse events and six subjects required dosage reductions during the felodipine or combination phases . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The effects of nebivolol , a new beta-blocker with vasodilating properties , and hydrochlorothiazide ( HCTZ ) as monotherapies and in combination on BP and plasma lipids , lipoproteins and apolipoproteins were compared with placebo in a parallel 3 x 4 factorial design study . After an eight week wash-out period , 240 patients with primary hypertension were r and omised to receive either placebo , nebivolol 1 , 5 or 10 mg , HCTZ 12.5 or 25 mg or one of the six possible combinations of nebivolol and HCTZ . Twenty patients were assigned to each of the 12 parallel groups . After 12 weeks of treatment , there was a significant dose-related reduction in BP among all active treatment groups . Apart from a slight and isolated increase in triglycerides with HCTZ 12.5 mg , lipid , lipoprotein and apolipoprotein levels as well as lipoprotein and apolipoprotein ratios were not significantly modified by 12 week active treatments when compared with placebo treatment . The results of this multifactorial study with 12 small sample size groups , suggest that nebivolol as monotherapy and in combination with HCTZ does not cause deleterious effects on the lipid profile",
"The antihypertensive effect of Inderectic , a new combination capsule of propranolol 80 mg and bendrofluazide 2.5 mg , given twice daily was investigated in 21 hypertensive patients using a double-blind r and omized crossover method . Inderectic was compared with either agent used alone and with the same combination given as separate tablets . It gave a greater fall in mean lying and st and ing systolic and diastolic blood pressure than either agent alone . There was no statistically significant difference for the effect on these variables between the free combination and combined formulation . Only minor side-effects were recorded , no patient having to be withdrawn from the study and no biochemical changes were observed"
] | 4116926e-06ff-11f0-808a-c43d1ab1c353 |
Purpose of Review In the past years , the relationship between lower urinary tract symptoms and erectile dysfunction has been widely explored . The aim of our systematic review is to summarize the published evidence over the past year on lower urinary tract symptoms ( LUTS ) and erectile dysfunction (ED).Recent Findings Recent data support the relationship between LUTS and ED in Eastern Europe and in Asia . The role of phosphodiesterase inhibitors alone or in combination with alpha blockers to treat LUTS and ED , especially in younger patients , is strongly supported by high level of evidence . Summary LUTS and ED are prevalent conditions in men over 50 ; epidemiologically , the relationship between both conditions has been confirmed all over the world . PDE5i alone or in combination with alpha blockers can be considered the gold st and ard for the treatment of young patients with storage symptoms and concomitant ED . In clinical research , a better underst and ing of the molecular pathways behind this association may also help to identify new possible targets and develop novel therapeutic approaches to manage both disorders ; the identification of new biomarkers of both disorders is also compulsory in this area | [
"Introduction : Epidemiological studies suggest a link between the symptoms of lower urinary tract ( LUTS ) caused by benign prostatic hyperplasia ( BPH ) and erectile dysfunction ( ED ) . Increasing expected period of life , justify the interest of establishing correlations LUTS / BPH and ED in order to find more efficient ways of treating these pathologies . Goal : The objective was to evaluate the correlation of symptoms in LUTS/BPH with the degree of ED . Patients and Methods : The study was conducted as a prospect i ve study which involved males aged 40 - 60 yr with present symptoms of LUTS/BPH . All study subjects underwent quantification of subjective symptoms through the International Prostate Symptom Score-IPSS and International Index of Erectile Dysfunction- IIEF-5 . The first group of respondents had IPSS 0 - 8 , second group IPSS 9 - 19 and the third group IPSS 20 to 35 . Results : The results of ANOVA ( F = 112.492 , p = 0.000 ) showed that there was a statistically significant difference ( p degree of erectile function ( IIEF ) . Tahmane test showed that there was a statistically significant difference between the first and second group ( p = 0.000 Mean degree of ED correlates with IPSS . The results of Fisher ’s exact test ( p = 0.000 ) confirmed that there was a statistically significant relationship ( p IPSS score and degree of erectile dysfunction ( IIEF ) . Conclusion : Elderly patients have a significantly higher value of IPSS score compared to younger patients . The degree of erectile dysfunction is correlated with symptoms of IPSS score . Severity of symptoms of LUTS/BPH and higher IPSS score , worsens the ED . Results of IIEF-5 score are inversely proportional with symptoms of IPSS score , and increase in IPSS score comes to a decline in IIEF score",
"OBJECTIVE To investigate the effects of tadalafil on storage and voiding function in treatment-naïve patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia , based on a urodynamic study . METHODS This was an open-labeled , single-center , prospect i ve study . A total of 80 untreated out patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia received tadalafil 5 mg/day for 12 weeks . Subjective symptoms and objective findings on voiding and storage function obtained through urodynamic studies , including cystometry and pressure flow study , were evaluated before and after treatment . RESULTS A total of 71 patients with a mean age of 70.2 years and a mean prostate volume of 45.6 mL were included in the analysis . In the International Prostate Symptom Score and Overactive Bladder Symptom Score , mean total scores significantly improved from 18.2 to 13.4 ( P Mean maximum bladder capacity significantly increased by approximately 35 mL ( P Detrusor overactivity disappeared in 15 ( 39.5 % ) of 38 patients with detrusor overactivity at baseline ( P Mean maximum flow rate on pressure flow study significantly increased from 7.1 to 9.1 mL/s ( P mean bladder outlet obstruction index significantly decreased from 61.3 to 47.1 ( P tadalafil 5 mg once daily effectively relieves lower urinary tract symptoms based on objective improvement of storage and voiding function , such as detrusor overactivity and bladder outlet obstruction , in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia",
"OBJECTIVES To examine whether the severity of lower urinary tract symptoms ( LUTS ) , when controlled for other factors , is related to erectile dysfunction ( ED ) in the male veteran population . Early evidence suggests that LUTS may be associated with ED in men . METHODS A total of 181 male veterans were prospect ively entered into the study . They completed the Sexual Health Inventory for Men ( SHIM ) and International Prostate Symptom Score ( IPSS ) question naires . Of the 181 men , 144 also underwent uroflowmetry , including determination of the postvoid residual urine volume . Demographic and medical history data were recorded . Pearson correlation coefficients and multiple linear regression analysis were used to examine the relationship between LUTS and ED , as well as the effects of age and comorbidities . RESULTS The correlation coefficient ( r ) for the SHIM score with the total IPSS was -0.17 ( P = 0.023 ) ; with the obstructive IPSS , it was -0.20 ( P = 0.006 ) ; and with the irritative IPSS , -0.05 ( P = 0.492 ) . Age was the only other factor with a statistically significant correlation with the SHIM score ( r = -0.23 , P = 0.002 ) . Multiple linear regression modeling showed obstructive IPSS ( P = 0.001 ) and depression ( P = 0.017 ) to be the only statistically significant predictors of the SHIM score . A consistent negative correlation was found between obstructive IPSS and the SHIM score across age groups , with the strongest effect for men aged 60 to 70 years ( r = -0.412 , P = 0.003 ) . CONCLUSIONS Obstructive LUTS correlated with , and were predictive of , ED , even after controlling for age and comorbidities . Although age correlated with ED , it did not add to the power of the multiple linear regression model composed of obstructive IPSS and depression",
"BACKGROUND Phosphodiesterase type 5 inhibitors and α-adrenergic blocking agents ( α-blockers ) are widely used for the treatment of erectile dysfunction ( ED ) and lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) . AIMS To assess the efficacy and safety of fixed-dose combinations ( FDCs ) of tamsulosin and tadalafil compared with tadalafil monotherapy in patients with comorbid BPH-associated LUTS and ED . METHODS A r and omized , double-blinded , active-controlled trial was conducted of 510 men with BPH-associated LUTS and ED . Patients were treated with FDCs of tamsulosin 0.4 mg plus tadalafil 5 mg ( FDC 0.4/5 mg ) , tamsulosin 0.2 mg plus tadalafil 5 mg ( FDC 0.2/5 mg ) , or tadalafil 5 mg for a 12-week treatment period . For a subsequent 12-week extension period , the patients were administered FDC 0.4/5 mg . OUTCOMES The primary outcomes were changes from baseline in total International Prostate Symptom Score ( IPSS ) and International Index of Erectile Function erectile function domain ( IIEF-EF ) score at week 12 to prove superiority and non-inferiority of FDCs compared with tadalafil 5 mg . The safety assessment s were adverse reactions , laboratory test results , and vital signs at week 24 . RESULTS The mean changes in total IPSS and IIEF-EF scores were -9.46 and 9.17 for FDC 0.4/5 mg and -8.14 and 9.49 for tadalafil 5 mg , respectively , which indicated superiority in LUTS improvement ( P = .0320 ) and non-inferiority in ED treatment with FDC 0.4/5 mg compared with tadalafil 5 mg . However , the results from FDC 0.2/5 mg failed to demonstrate superiority in LUTS improvement . No clinical ly significant adverse events regarding the investigational products were observed during the 24-week period . CLINICAL IMPLICATION S The FDC 0.4/5 mg is the first combined formulation of an α-blocker and a phosphodiesterase type 5 inhibitor that offers benefits in patient compliance and as add-on therapy in patients with comorbid BPH-associated LUTS and ED . STRENGTHS AND LIMITATIONS The study clearly demonstrated the advantage of FDC 0.4/5 mg . The main advantage of FDC 0.4/5 mg was the enhanced efficacy on BPH-associated LUTS comorbidity with ED , the lower incidence of side effects , and the simplification and convenience of therapy , which led to better overall patient compliance . However , the lack of a tamsulosin monotherapy control group was a limitation of this study . CONCLUSION The FDC 0.4/5 mg therapy was safe , well tolerated , and efficacious , indicating that combination therapy could provide clinical benefits for patients with BPH-associated LUTS complaints and ameliorate the comorbidity of ED . Kim SW , Park NC , Lee SW , et al. Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil for Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction : Results of a R and omized , Double-Blinded , Active-Controlled Trial . J Sex Med 2017;14:1018 - 1027",
"Abstract Purpose : To compare the efficacy and safety of sildenafil 25 mg qd , 25 mg bid or 50 mg qd – on treating lower urinary tract symptoms with benign prostatic hyperplasia ( LUTS/BPH ) . Material s and methods : Men aged > 45 years with LUTS/BPH were r and omly assigned to receive sildenafil 25 mg qd ( n = 42 ) , bid ( n = 41 ) , 50 mg qd ( n = 38 ) or placebo ( n = 41 ) for 8 weeks . Changes from baseline in International Prostate Symptom Score ( I-PSS ) , maximum urinary flow rate ( Qmax ) and postvoid residual urine volume ( PVR ) were assessed at week 4 and week 8 . Results : Sildenafil 25 mg qd ( -7.3 ± 5.8 ) and 25 mg bid ( -7.0 ± 5.7 ) exhibited significant improvements of I-PSS compared to placebo ( -5.2 ± 6.4 ) ( p = 0.020 , 0.025 , respectively ) . In particular , voiding domain was more affected than storage domain . Only sildenafil 50 mg qd improved nocturia significantly ( versus placebo , p = 0.027 ) . Quality of life score was improved in all treatment groups . Qmax and PVR did not change significantly in all groups . All regimens were well tolerated . Conclusions : Sildenafil 25 mg qd , 25 mg bid and 50 mg qd are safe and effective to improve LUTS/BPH in long term , along with coexisting ED . In particular , nocturia is most well-controlled by 50 mg qd",
"OBJECTIVE To evaluate sexual dysfunction and enlargement of seminal vesicles in sexually active men who were treated by α1-blockers for benign prostatic hyperplasia and its possible clinical application . MATERIAL S AND METHODS This is a prospect i ve cohort study from January 2015 to December 2016 . We enrolled sexually active men above the age of 40 years having moderate to severe lower urinary tract symptoms ( LUTS ) . We excluded patients with a history of prostate surgery , suspicious digital rectal examination findings , a serum prostate-specific antigen of > 4 ng/dL , and a history of medication with anticholinergic , cholinergic , and diuretic agents . Patients were divided into groups A , B , and C based on the prescription of silodosin 8 mg , tamsulosin 0.4 mg , or alfuzosin 10 mg orally once for LUTS and at 4 and 12 weeks . RESULTS The mean age was 54.8 years ( 41 - 68 years ) . Twelve weeks of treatment with silodosin , tamsulosin , and alfuzosin result ed in a significant improvement in the total International Prostate Symptom Score and the quality of life score ( P The baseline erectile function scores were 26.4 , 27.6 , and 28.1 , and the baseline overall satisfaction ( OS ) ( International Index of Erectile Function [IIEF]-OS ) scores were 7.1 , 8.3 , and 8.6 among groups A , B , and C , respectively . After 12 weeks of α1-blockers , the IIEF-erectile function scores were 24.0 , 24.7 , and 26.2 , and the IIEF-OS scores were 6.4 , 7.8 , and 7.9 . All 3 groups demonstrated a statistically significant enlargement of seminal vesicles after 12 weeks ' treatment , most significant in group A patients ( 7.65 - 14.11 cc , P CONCLUSION Alpha-blockers as silodosin , tamsulosin , and alfuzosin are a safe and effective tool in benign prostatic hyperplasia for improving LUTS and the quality of life . Loss of seminal emission with alpha-blockers appears as the cause of seminal vesicle enlargement . The exact mechanism of these findings needs further clinical and experimental research",
"Purpose We investigated the effects of long‐term testosterone therapy on urinary and sexual function , and quality of life in hypogonadal men . Material s and Methods We performed an observational , prospect i ve , cumulative registry study in 656 men with a mean ± SD age of 60.7 ± 7.2 years who had total testosterone 12.1 nmol/l or less and symptoms of hypogonadism . In the testosterone treated group 360 men received parenteral testosterone undecanoate 1,000 mg/12 weeks for up to 10 years . The 296 men who elected against testosterone therapy served as controls . From each group 82 patients were propensity matched by age , waist circumference and body mass index , result ing in 82 matched pairs of 164 men . Data were analyzed and estimated differences between the groups were adjusted for components of metabolic syndrome and quality of life . Results We found significant decreases in I‐PSS ( International Prostate Symptom Score ) and post‐void bladder volume ( each p receiving testosterone therapy but not in the untreated group . We recorded a decrease in AMS ( Aging Males ’ Symptoms Scale ) in the testosterone treated group but not in the untreated group ( p the IIEF‐EF ( International Index of Erectile Function‐Erectile Function ) domain in the testosterone treated group but not in the untreated group ( p Conclusions Long‐term testosterone therapy in hypogonadal men result ed in significant improvements in urinary and sexual function , and in quality of life . In untreated hypogonadal men voiding and erectile function deteriorated with continued followup",
"To prospect ively assess the impact of the fixed‐dose combination ( FDC ) of the 5α‐reductase inhibitor ( 5ARI ) , dutasteride 0.5 mg and the α1‐adrenoceptor antagonist , tamsulosin 0.4 mg ( DUT‐TAM FDC ) therapy on sexual function domain scores in sexually active men with lower urinary tract symptoms ( LUTS ) secondary to benign prostatic hyperplasia ( BPH ) , using the Men 's Sexual Health Question naire ( MSHQ )",
"Purpose Men affected by multiple sclerosis often experience neurogenic overactive bladder ( OAB ) , lower urinary tract symptoms and erectile dysfunction ( ED ) . The aim of the study was to investigate modifications of urinary and sexual functions after administration of daily tadalafil ( TAD ) 5 mg . Methods Twenty men were enrolled in a single-blind , 4-week prospect i ve study while 10 men without treatment served as controls . Primary outcomes were changes from baseline of International Prostate Symptom ( IPSS ) , OAB question naire ( OAB-q-short form ) and International Index of Erectile Function ( IIEF-5 ) scores . To evaluate the influence of bladder filling on somatic reflexes , we studied variations of the H-reflex evoked by electrical stimuli applied to the tibial nerve at the popliteal fossa and recorded from the soleus muscle . Also testosterone/estradiol ( T/E ) ratio was measured before and after treatment . Results In TAD group , an improvement in IPSS ( p OAB-q ( p IIEF-5 ( p Qmax ( p T/E ratio ( p post-void residual volume ( p TAD in patients with multiple sclerosis improves storage symptoms , post-void residual volume , steroid hormone pattern and ED without urodynamic changes"
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BACKGROUND AND PURPOSE Central poststroke pain is a chronic neuropathic disorder that follows a stroke . Current research on its management is limited , and no review has evaluated all therapies for central poststroke pain . METHODS We conducted a systematic review of r and omized controlled trials to evaluate therapies for central poststroke pain . We identified eligible trials , in any language , by systematic search es of AMED , CENTRAL , CINAHL , DARE , EMBASE , HealthSTAR , MEDLINE , and PsychINFO . Eligible trials ( 1 ) enrolled ≥10 patients with central poststroke pain ; ( 2 ) r and omly assigned them to an active therapy or a control arm ; and ( 3 ) collected outcome data ≥14 days after treatment . Pairs of review ers , independently and in duplicate , screened titles and abstract s of identified citations , review ed full texts of potentially eligible trials , and extracted information from eligible studies . We used a modified Cochrane tool to evaluate risk of bias of eligible studies , and collected patient-important outcomes according to recommendations by the Initiative on Methods , Measurement , and Pain Assessment in Clinical Trials . We conducted , when possible , r and om effects meta-analyses , and evaluated our certainty in treatment effects using the Grading of Recommendations Assessment , Development , and Evaluation System . RESULTS Eight eligible English language r and omized controlled trials ( 459 patients ) tested anticonvulsants , an antidepressant , an opioid antagonist , repetitive transcranial magnetic stimulation , and acupuncture . Results suggested that all therapies had little to no effect on pain and other patient-important outcomes . Our certainty in the treatment estimates ranged from very low to low . CONCLUSIONS Our findings are inconsistent with major clinical practice guidelines ; the available evidence suggests no beneficial effects of any therapies that research ers have evaluated in r and omized controlled trials | [
"In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias",
"& NA ; The double‐blinded r and omized controlled trial showed that daily repetitive transcranial magnetic stimulation of primary motor cortex provided short‐term positive effect on neuropathic pain without serious adverse events . & NA ; There is little evidence for multisession repetitive transcranial magnetic stimulation ( rTMS ) on pain relief in patients with neuropathic pain ( NP ) , although single‐session rTMS was suggested to provide transient pain relief in NP patients . We aim ed to assess the efficacy and safety of 10 daily rTMS in NP patients . We conducted a r and omized , double‐blind , sham‐controlled , crossover study at 7 centers . Seventy NP patients were r and omly assigned to 2 groups . A series of 10 daily 5‐Hz rTMS ( 500 pulses/session ) of primary motor cortex ( M1 ) or sham stimulation was applied to each patient with a follow‐up of 17 days . The primary outcome was short‐term pain relief assessed using a visual analogue scale ( VAS ) . The secondary outcomes were short‐term change in the short form of the McGill pain question naire ( SF‐MPQ ) , cumulative changes in the following scores ( VAS , SF‐MPQ , the Patient Global Impression of Change scale [ PGIC ] , and the Beck Depression Inventory [ BDI ] ) , and the incidence of adverse events . Analysis was by intention to treat . This trial is registered with the University hospital Medical Information Network Clinical Trials Registry . Sixty‐four NP patients were included in the intention‐to‐treat analysis . The real rTMS , compared with the sham , showed significant short‐term improvements in VAS and SF‐MPQ scores without a carry‐over effect . PGIC scores were significantly better in real rTMS compared with sham during the period with daily rTMS . There were no significant cumulative improvements in VAS , SF‐MPQ , and BDI . No serious adverse events were observed . Our findings demonstrate that daily high‐frequency rTMS of M1 is tolerable and transiently provides modest pain relief in NP patients",
"Introduction Systematic review er authors intending to include all r and omized participants in their meta-analyses need to make assumptions about the outcomes of participants with missing data . Objective The objective of this paper is to provide systematic review er authors with a relatively simple guidance for addressing dichotomous data for participants excluded from analyses of r and omized trials . Methods This guide is based on a review of the Cochrane h and book and published method ological research . The guide deals with participants excluded from the analysis who were considered ‘ non-adherent to the protocol ’ but for whom data are available , and participants with missing data . Results Systematic review er authors should include data from ‘ non-adherent ’ participants excluded from the primary study authors ' analysis but for whom data are available . For missing , unavailable participant data , authors may conduct a complete case analysis ( excluding those with missing data ) as the primary analysis . Alternatively , they may conduct a primary analysis that makes plausible assumptions about the outcomes of participants with missing data . When the primary analysis suggests important benefit , sensitivity meta-analyses using relatively extreme assumptions that may vary in plausibility can inform the extent to which risk of bias impacts the confidence in the results of the primary analysis . The more plausible assumptions draw on the outcome event rates within the trial or in all trials included in the meta- analysis . The proposed guide does not take into account the uncertainty associated with assumed events . Conclusions This guide proposes methods for h and ling participants excluded from analyses of r and omized trials . These methods can help in establishing the extent to which risk of bias impacts meta- analysis results",
"Objective . Pain is a patient-important outcome , but current reporting in r and omized controlled trials and systematic review s is often suboptimal , impeding clinical interpretation and decision making . Methods . A working group at the 2014 Outcome Measures in Rheumatology ( OMERACT 12 ) was convened to provide guidance for reporting treatment effects regarding pain for individual studies and systematic review s. Results For individual trials , authors should report , in addition to mean change , the proportion of patients achieving 1 or more thresholds of improvement from baseline pain ( e.g. , ≥ 20 % , ≥ 30 % , ≥ 50 % ) , achievement of a desirable pain state ( e.g. , no worse than mild pain ) , and /or a combination of change and state . Effects on pain should be accompanied by other patient-important outcomes to facilitate interpretation . When pooling data for meta analysis , authors should consider converting all continuous measures for pain to a 100 mm visual analog scale ( VAS ) for pain and use the established , minimally important difference ( MID ) of 10 mm , and the conventionally used , appreciably important differences of 20 mm , 30 mm , and 50 mm , to facilitate interpretation . Effects ≤ 0.5 units suggest a small or very small effect . To further increase interpretability , the pooled estimate on the VAS should also be transformed to a binary outcome and expressed as a relative risk and risk difference . This transformation can be achieved by calculating the probability of experiencing a treatment effect greater than the MID and the thresholds for appreciably important differences in pain reduction in the control and intervention groups . Conclusion . Presentation of relative effects regarding pain will facilitate interpretation of treatment effects",
"Objective : Central poststroke pain ( CPSP ) is usually difficult to treat . Amitriptyline , the only oral preparation shown to be effective in a r and omized controlled trial , is often associated with a range of side effects related to the many mechanisms of actions of tricyclic antidepressants . We investigated the effect of lamotrigine , a drug that reduces neuronal hyperexcitability , on poststroke pain . Methods : Thirty consecutive patients with CPSP ( median age 59 years , range 37 to 77 ; median pain duration 2.0 years , range 0.3 to 12 ) from two centers participated in a r and omized , double-blind , placebo-controlled cross-over study . The study consisted of two 8-week treatment periods separated by 2 weeks of wash-out . The primary endpoint was the median value of the mean daily pain score during the last week of treatment while treated with 200 mg/d lamotrigine . Secondary endpoints were median pain scores while on lamotrigine 25 mg/d , 50 mg/d , and 100 mg/d ; a global pain score ; assessment of evoked pain ; areas of spontaneous pain ; and allodynia/dysesthesia . Results : Lamotrigine 200 mg/d reduced the median pain score to 5 , compared to 7 during placebo ( p = 0.01 ) in the intent-to-treat population of 27 patients . No significant effect was obtained at lower doses . Twelve patients ( 44 % ) responded to the treatment . There was a uniform tendency to reduction of all secondary outcome measures , but lamotrigine only had significant effects on some of the secondary outcome measures . Lamotrigine was well tolerated with few and transient side effects . Two mild rashes occurred during lamotrigine treatment , one causing withdrawal from study . Conclusions : Oral lamotrigine 200 mg daily is a well tolerated and moderately effective treatment for central poststroke pain . Lamotrigine may be an alternative to tricyclic antidepressants in the treatment of CPSP",
"& NA ; A double‐blind , 3‐phase , cross‐over , placebo‐controlled trial of the pain‐relieving effect of amitriptyline and carbamazepine was carried out in 15 patients with central post‐stroke pain ( CPSP ) but without signs of depression . Treatment was given , in r and omized order , for periods of 4 weeks , separated by 1 week wash‐out . The final doses were 75 and 800 mg/day , respectively , for amitriptyline and carbamazepine . The treatment effects were assessed by daily ratings of pain intensity on a 10‐step verbal scale and at the end of each treatment period by a global rating of the analgesic effect on a 5‐step verbal scale . For the assessment of depression the Comprehensive Psychopathological Rating Scale ( CPRS ) was used . Amitriptyline produced a statistically significant reduction of pain when compared to placebo . According to the global rating , 10 of the 15 patients were responders to this drug . The effect could already be noticed during the second treatment week and it appeared to be correlated to the plasma concentration , since the median total ami‐ and nortriptyline concentrations were 497 and 247 nmol/1 , respectively , for responders and non‐responders . The early onset , together with the fact that the patients were not depressed , nor did they obtain reduced scores on ratings of depressive symptoms and signs , provides strong support for the conclusion that the pain relief was not caused by an antidepressive effect . Five of the 14 patients treated with carbamazepine reported some pain relief , but the effect did not reach statistical significance when compared to placebo . No correlation was found between effect and plasma concentration . In general , the patients tolerated the planned final dose of amitriptyline well . No final dose reduction was necessary . Carbamazepine caused more side effects and the final dose had to be reduced in 4 patients . However , only 1 patient had to be taken off medication , on day 25 , due to drug interaction",
"Objective : We describe the frequency , duration , clinical characteristics , and radiologic correlates of central poststroke pain ( CPSP ) in young ischemic stroke survivors in a prospect i ve study setting . Methods : A question naire of pain and sensory abnormalities and EQ-5D quality -of-life question naire were sent to all 824 surviving and eligible patients of the Helsinki Young Stroke Registry . Patients ( n = 58 ) with suspected CPSP were invited to a clinical visit and filled in the PainDETECT , Brief Pain Inventory , and Beck Depression Inventory question naires . Results : Of the included 824 patients , 49 had CPSP ( 5.9 % ) , 246 patients ( 29.9 % ) had sensory abnormality without CPSP , and 529 patients ( 64.2 % ) had neither sensory abnormality nor CPSP . The median follow-up time from stroke was 8.5 years ( interquartile range 5.0–12.1 ) . Patients with CPSP had low quality of life compared to those with sensory abnormality without CPSP ( p = 0.007 ) as well as to those with no sensory abnormality and no CPSP ( p other pain . CPSP was associated with moderate ( p severe ( p stroke symptoms , but there was no difference in age at stroke onset or subtype of stroke according to the TOAST classification between the groups . Stroke localization was not correlated with CPSP . Conclusions : Late persistent CPSP was found in 5.9 % of young stroke survivors and was associated with concomitant other pain , impaired quality of life , and moderate or severe stroke symptoms",
"& NA ; Central post‐stroke pain ( CPSP ) is a neuropathic pain syndrome characterized by constant or intermittent pain in a body part occurring after stroke and associated with sensory abnormalities in the painful body part . This study describes CPSP prospect ively during the first year after stroke and characterizes the cerebrovascular lesions and neurological signs associated with the CPSP syndrome . Two hundred and sixty‐seven consecutively admitted patients younger than 81 years were examined in the first week , at 1 , 6 and 12 months after stroke . Sensibility to touch ( cotton wool ) , temperature ( 20 ° C and 40 ° C ) , and pinprick was studied using the contralateral face and extremity as control . A CT scan was done 8 ( median ) days ( range : 1–34 days ) after stroke . Two hundred and seven ( 78 % ) patients surviving at least 6 months who were able to communicate reliably formed the basis of the study . Abnormal sensory signs were found at least once in 87 ( 42 % ) patients . CPSP was found in 16 ( 8 % ) patients of whom all but 1 patient also had evoked dysesthesia or allodynia . Further 1 patient had persistent evoked dysesthesia but denied pain . CPSP was not related to sex or age . In patients with single acute cerebral lesions there were no relation between size or location of the lesions and the presence of CPSP . The pain was light in 6 ( 3 % ) patients and moderate to severe in 10 ( 5 % ) patients . The pain quality was usually lacerating or aching . Fifteen ( 94 % ) patients had decreased temperature , touch and pain sensibility and 9 ( 56 % ) reported allodynia to cold stimulation and another 9 ( 56 % ) patients reported this to touch . Pain onset was within 1 month after stroke in 10 ( 63 % ) patients , between 1 and 6 months in 3 ( 19 % ) patients and more than 6 months after stroke in 3 ( 19 % ) patients",
"& NA ; Intravenous naloxone has been cl aim ed to produce pain relief in opioid‐resistant central post‐stroke pain ( CPSP , ‘ thalamic syndrome ’ ) . In a double‐blind trial , carried out in 20 patients with established CPSP , naloxone ( up to 8 mg in 20 ml vehicle ) was tested against normal saline ; each patient was r and omly given naloxone or saline and the other substance 2 or 3 weeks later . VAS and verbal pain scores were obtained immediately before and after naloxone or saline injection , and subjective ratings followed for 2 weeks . Three patients obtained transient pain relief with naloxone , 4 with saline , and another 4 with both . Statistical tests failed to show any influence of giving naloxone first or second . In all cases except one , pain relief had disappeared by the evening of the day on which the test was performed ; one case , following naloxone , continued to experience pain relief until the following morning . We therefore conclude that intravenous naloxone is of no value in alleviating the pain of CPSP ",
"In the GRADE approach , r and omized trials are classified as high quality evidence and observational studies as low quality evidence but both can be rated down if a body of evidence is associated with a high risk of publication bias . Even when individual studies included in best- evidence summaries have a low risk of bias , publication bias can result in substantial overestimates of effect . Authors should suspect publication bias when available evidence comes from a number of small studies most of which have been commercially funded . A number of approaches based on examination of the pattern of data are available to help assess publication bias . The most popular of these is the funnel plot ; all , however , have substantial limitations . Publication bias is likely frequent , and caution in the face of early results , particularly with small sample size and number of events , is warranted",
" & NA ; Pregabalin has demonstrated efficacy in several forms of neuropathic pain , but its long‐term efficacy in central post‐stroke pain ( CPSP ) is unproven . We evaluated the efficacy and safety of pregabalin versus placebo in patients with CPSP . A 13‐week , r and omized , double‐blind , multicenter , placebo‐controlled , parallel group study of 150 to 600 mg/day pregabalin was conducted in patients aged ⩾18 years with CPSP . The primary efficacy endpoint was the mean pain score on the Daily Pain Rating Scale over the last 7 days on study drug up to week 12 or early termination visit . Secondary endpoints included other pain parameters and patient‐reported sleep and health‐related quality ‐of‐life measures . A total of 219 patients were treated ( pregabalin n = 110 ; placebo n = 109 ) . A mean pain score at baseline of 6.5 in the pregabalin group and 6.3 in the placebo group reduced at endpoint to 4.9 in the pregabalin group and 5.0 in the placebo group ( LS mean difference = –0.2 ; 95 % CI = –0.7 , 0.4 ; P = 0.578 ) . Treatment with pregabalin result ed in significant improvements , compared with placebo , on secondary endpoints including MOS‐sleep , HADS‐A anxiety , and clinician global impression of change ( CGIC ) P events were more frequent with pregabalin than with placebo and caused discontinuation in 9 ( 8.2 % ) of pregabalin patients versus 4 ( 3.7 % ) of placebo patients . Although pain reductions at endpoint did not differ significantly between pregabalin and placebo , improvements in sleep , anxiety , and CGIC suggest some utility of pregabalin in the management of CPSP . Pain reductions at endpoint did not differ significantly between pregabalin and placebo , but improvements in comorbid conditions suggest some utility of pregabalin in central post‐stroke pain management"
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Despite potential benefits , primary care clinicians may avoid using antimuscarinics in men with overactive bladder ( OAB ) symptoms because of safety concerns . To review the efficacy and safety of antimuscarinics , alone or in combination with an α-blocker , for the treatment of men with OAB symptoms , we conducted a systematic review of articles published before 22 July 2010 , using PubMed . Data from 12-week , r and omised , double-blind , placebo-controlled trials of tolterodine extended release ( ER ) , oxybutynin and solifenacin show that combined antimuscarinic+α-blocker treatment is generally more effective than monotherapy or placebo in men with OAB symptoms . The efficacy and safety of tolterodine ER+α-blocker treatment was not affected by prostate size or prostate-specific antigen ( PSA ) level . In men meeting entry criteria for OAB and benign prostatic obstruction trials , tolterodine ER alone was effective selectively in men with prostate size or PSA level below study medians . Incidence of acute urinary retention ( AUR ) in men receiving antimuscarinics with or without an α-blocker was ≤3 % in all of these trials ; changes in postvoid residual volume and maximum flow rate did not appear clinical ly meaningful . Post hoc analyses from double-blind , placebo-controlled trials and prospect i ve studies of fesoterodine , oxybutynin , propiverine , solifenacin and tolterodine also suggest that antimuscarinics are generally safe and efficacious in men . A retrospective data base study found that risk of AUR in men was the highest in the first month of treatment and decreased considerably thereafter . Antimuscarinics , alone or with an α-blocker , appear to be efficacious and safe in many men with predominant OAB symptoms or persistent OAB symptoms despite α-blocker or 5-α-reductase inhibitor treatment . However , antimuscarinics are not approved for the treatment of benign prostatic hyperplasia . Monitoring men for AUR is recommended , especially those at increased risk , and particularly within 30 days after starting antimuscarinic treatment | [
"PURPOSE VICTOR was a 12-week , double-blind , placebo controlled trial assessing the safety and tolerability of solifenacin plus tamsulosin in men with residual overactive bladder symptoms after tamsulosin monotherapy . Efficacy of solifenacin plus tamsulosin vs placebo plus tamsulosin was also evaluated . MATERIAL S AND METHODS A total of 398 men 45 years old or older were r and omized to 12 weeks of solifenacin plus tamsulosin or placebo plus tamsulosin once daily . The study population had 8 or more micturitions per 24 hours and 1 or more urgency episode per 24 hours after taking tamsulosin for 4 or more weeks , a total International Prostate Symptom Score of 13 or greater , a Patient Perception of Bladder Condition score of 3 or greater , a post-void residual of 200 ml or less and a peak flow rate of 5 ml per second or greater . Adverse events were monitored throughout the study . The primary efficacy end point was mean change from baseline to week 12 in micturitions per 24 hours . Secondary measures included mean change in urgency episodes per 24 hours , and changes in Patient Perception of Bladder Condition , Urgency Perception Scale and total International Prostate Symptom Scores . RESULTS The most frequent adverse events in the solifenacin plus tamsulosin and placebo plus tamsulosin groups were dry mouth ( 7 % and 3 % , respectively ) and dizziness ( 3 % and 2 % , respectively ) . Of the patients on solifenacin plus tamsulosin 7 ( 3 % ) reported retention and 3 required catheterization . No patients on placebo plus tamsulosin reported retention . Patients on solifenacin plus tamsulosin vs placebo plus tamsulosin showed larger reductions in frequency but not of statistical significance ( -1.05 vs -0.67 , p = 0.135 ) . However , patients on solifenacin plus tamsulosin vs placebo plus tamsulosin did show statistically significant reductions in urgency ( -2.18 vs -1.10 , p Solifenacin plus tamsulosin was well tolerated . There was a low incidence of urinary retention requiring catheterization . At week 12 solifenacin plus tamsulosin decreased daily micturitions and urgency episodes . Only urgency reached statistical significance vs placebo plus tamsulosin ",
"PURPOSE In this open label , prospect i ve study we determined the efficacy and tolerability of tolterodine extended release ( ER ) in men with benign prostatic hyperplasia ( BPH ) and lower urinary tract symptoms ( LUTS ) in whom previous alpha-blocker therapy had failed . MATERIAL S AND METHODS A total of 43 consecutive men with BPH and LUTS in whom a mean of 5.7 months of alpha-blocker therapy had failed due to adverse events ( 11 ) or a lack of efficacy ( 32 ) received tolterodine ER ( 4 mg daily ) for 6 months . Primary efficacy end points were American Urological Association symptom score , and mean daytime and nighttime micturition frequency . Secondary end points were the peak urinary flow rate , post-void residual volume , the incidence of urinary retention , total score on the erectile function domain of the International Index of Erectile Function and adverse events . RESULTS A total of 39 men ( 91 % ) with a mean age of 61 years completed the 6-month trial . Mean 24-hour micturition frequency decreased from 9.8 to 6.3 voids and nocturia decreased from 4.1 to 2.9 episodes nightly . Significant changes in mean American Urological Association symptom scores ( -6.1 ) , the peak urinary flow rate ( 1.9 ml per second ) and post-void residual volume ( -22 ml ) were also observed . Of the men 27 ( 63 % ) were potent at baseline and 29 ( 67 % ) were potent after 6 months of tolterodine ER treatment . Mean International Index of Erectile Function erectile function domain scores increased ( 6.9 ) . Four men ( 9 % ) discontinued therapy because of intolerable dry mouth . There were no reports of urinary retention . CONCLUSIONS Treatment with tolterodine ER in men with BPH and LUTS may be a reasonable therapeutic option as initial therapy or after failed treatment with alpha-blockers",
"PURPOSE We evaluated the efficacy and safety of a therapeutic modality involving propiverine combined with doxazosin in patients with overactive bladder ( OAB ) and benign prostatic obstruction . MATERIAL S AND METHODS Men 50 years or older with OAB symptoms and urodynamically proven bladder outlet obstruction ( Abrams-Griffith score greater than 20 ) were r and omized ( 1:2 ) into 2 groups , namely group 1-doxazosin controlled release gastrointestinal therapeutic system formulation ( 4 mg once daily ) only and group 2-propiverine hydrochloride ( 20 mg once daily ) plus doxazosin controlled release gastrointestinal therapeutic system formulation for an 8-week treatment regimen . RESULTS A total of 211 men , including 69 in group 1 and 142 in group 2 , were treated and 198 ( 93.8 % ) completed the 8 weeks of treatment . Significant improvements were noted in each group after treatment in urinary frequency , maximum flow rate , average micturition volume and International Prostate Symptom Score . Compared with group 1 improvement rates with regard to urinary frequency ( 23.5 % vs 14.3 % , p = 0.004 ) , average micturition volume ( 32.3 % vs 19.2 % , p = 0.004 ) , and storage ( 41.3 % vs 32.6 % , p = 0.029 ) and urgency ( p = 0.019 ) International Prostate Symptom Score symptoms were more significant in group 2 . Post-void residual urine was found to be significantly increased only in group 2 but this was not accompanied by urinary retention . Patient satisfaction rates were found to be significantly higher in group 2 than in group 1 ( p = 0.002 ) . Overall adverse event rates were higher in group 2 ( p = 0.002 ) , although discontinuation rates and discontinuation rates due to adverse events were not different between the 2 groups . CONCLUSIONS This study reveals that combination therapy consisting of alpha1-adrenoceptor antagonists with antimuscarinics represents an effective and relatively safe treatment modality in select patients with OAB coexisting with benign prostatic obstruction",
"PURPOSE We evaluated the efficacy of tolterodine extended release and /or tamsulosin on micturition related urgency episodes , urgency severity and patient reported outcomes in men who met entry criteria for prostatic enlargement and overactive bladder trials . MATERIAL S AND METHODS Men 40 years old or older with an International Prostate Symptom Score of 12 or greater , frequency ( 8 or more voids per 24 hours ) and urgency ( 3 or more episodes per 24 hours ) with or without urgency urinary incontinence were r and omized to placebo , 4 mg tolterodine extended release , 0.4 mg tamsulosin or tolterodine extended release plus tamsulosin for 12 weeks . Subjects completed 5-day diaries ; the Patient Perception of Bladder Condition and Urgency Perception Scale at baseline , and weeks 1 , 6 and 12 ; Overactive Bladder Question naire at baseline , and weeks 6 and 12 ; Perception of Treatment Satisfaction question at weeks 1 , 6 and 12 ; and Willingness to Continue question at week 12 . Subjects rated the urgency associated with each micturition on a 5-point scale and micturition related urgency episodes were those rated 3 or greater . Urgency severity was measured using frequency-urgency sum , defined as the sum of urgency ratings for all micturitions . RESULTS Compared with placebo , tolterodine extended release plus tamsulosin significantly reduced daytime and nocturnal micturition related urgency episodes as well as frequency-urgency sum at weeks 1 , 6 and 12 . It also improved Patient Perception of Bladder Condition scores at weeks 1 , 6 and 12 ; improved Urgency Perception Scale and Overactive Bladder Question naire , Symptom Bother and Health Related Quality of Life scores at weeks 6 and 12 ; and increased the percentage of subjects who reported treatment satisfaction at weeks 6 and 12 , and willingness to continue at week 12 . CONCLUSIONS Treatment with tolterodine extended release plus tamsulosin significantly improved urgency variables and patient reported outcomes in men meeting entry criteria for overactive bladder and prostatic enlargement trials ",
"PURPOSE In this open label , prospect i ve study we determined the efficacy and tolerability of tolterodine extended release ( ER ) in men with benign prostatic hyperplasia ( BPH ) and lower urinary tract symptoms ( LUTS ) in whom previous alpha-blocker therapy had failed . MATERIAL S AND METHODS A total of 43 consecutive men with BPH and LUTS in whom a mean of 5.7 months of alpha-blocker therapy had failed due to adverse events ( 11 ) or a lack of efficacy ( 32 ) received tolterodine ER ( 4 mg daily ) for 6 months . Primary efficacy end points were American Urological Association symptom score , and mean daytime and nighttime micturition frequency . Secondary end points were the peak urinary flow rate , post-void residual volume , the incidence of urinary retention , total score on the erectile function domain of the International Index of Erectile Function and adverse events . RESULTS A total of 39 men ( 91 % ) with a mean age of 61 years completed the 6-month trial . Mean 24-hour micturition frequency decreased from 9.8 to 6.3 voids and nocturia decreased from 4.1 to 2.9 episodes nightly . Significant changes in mean American Urological Association symptom scores ( -6.1 ) , the peak urinary flow rate ( 1.9 ml per second ) and post-void residual volume ( -22 ml ) were also observed . Of the men 27 ( 63 % ) were potent at baseline and 29 ( 67 % ) were potent after 6 months of tolterodine ER treatment . Mean International Index of Erectile Function erectile function domain scores increased ( 6.9 ) . Four men ( 9 % ) discontinued therapy because of intolerable dry mouth . There were no reports of urinary retention . CONCLUSIONS Treatment with tolterodine ER in men with BPH and LUTS may be a reasonable therapeutic option as initial therapy or after failed treatment with alpha-blockers",
"PURPOSE Antimuscarinic therapy for men with OAB and BOO is perceived as a potential risk for urinary retention . Using pressure flow urodynamics , we evaluated the safety of tolterodine vs placebo in men with OAB and BOO . MATERIAL S AND METHODS Men ( older than 40 years ) with BOO and confirmed detrusor overactivity were r and omized to tolterodine ( 2 mg twice daily in 149 ) or placebo ( in 72 ) for 12 weeks . Primary end points were Qmax and pdetQmax . RESULTS Median treatment differences in Qmax ( -0.7 ml per second , 95 % CI -1.6 to 0.4 ) and pdetQmax ( -7 cm H2O , 95 % CI -3 to 11 ) were comparable . Tolterodine significantly reduced the BOOI vs placebo ( -9 vs 0 , p volume to first detrusor contraction ( + 59 ml , 95 % CI 19 - 100 ) and maximum cystometric capacity ( + 67 ml , 95 % CI 35 - 103 ) , favoring tolterodine over placebo ( p Change in PVR was significantly greater among patients treated with tolterodine ( + 25 ml ) than placebo ( 0 ml , p incidence of adverse events . Urinary retention was reported by 1 patient treated with placebo . CONCLUSIONS Tolterodine did not adversely affect urinary function in men with OAB and BOO . Urinary flow rate was unaltered , and there was no evidence of clinical ly meaningful changes in voiding pressure and PVR or urinary retention . Tolterodine was well tolerated . These results suggest that antimuscarinics can be safely administered in men with BOO",
"CONTEXT Men with overactive bladder and other lower urinary tract symptoms may not respond to monotherapy with antimuscarinic agents or alpha-receptor antagonists . OBJECTIVE To evaluate the efficacy and safety of tolterodine extended release ( ER ) , tamsulosin , or both in men who met research criteria for both overactive bladder and benign prostatic hyperplasia . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial conducted at 95 urology clinics in the United States involving men 40 years or older who had a total International Prostate Symptom Score of 12 or higher and , an International Prostate Symptom Score quality -of-life ( QOL ) item score of 3 or higher , a self-rated bladder condition of at least moderate bother , and a bladder diary documenting micturition frequency ( > or=8 micturitions per 24 hours ) and urgency ( > or=3 episodes per 24 hours ) , with or without urgency urinary incontinence . Patients were recruited between November 2004 and February 2006 , and the study was completed May 2006 . INTERVENTIONS Patients were r and omly assigned to receive placebo ( n = 222 ) , 4 mg of tolterodine ER ( n = 217 ) , 0.4 mg of tamsulosin ( n = 215 ) , or both tolterodine ER plus tamsulosin ( n = 225 ) for 12 weeks . MAIN OUTCOME MEASURES Patient perception of treatment benefit , bladder diary variables , International Prostate Symptom Scores , and safety and tolerability were assessed . RESULTS A total of 172 men ( 80 % ) receiving tolterodine ER plus tamsulosin reported treatment benefit by week 12 compared with 132 patients ( 62 % ) receiving placebo ( P tolterodine ER ( P=.48 vs placebo ) . Patients receiving tolterodine ER plus tamsulosin compared with placebo experienced significant reductions in urgency urinary incontinence ( -0.88 vs -0.31 , P=.005 ) , urgency episodes without incontinence ( -3.33 vs -2.54 , P=.03 ) , micturitions per 24 hours ( -2.54 vs -1.41 , P micturitions per night ( -0.59 vs -0.39 , P.02 ) . Patients receiving tolterodine ER plus tamsulosin demonstrated significant improvements on the total International Prostate Symptom Score ( -8.02 vs placebo , -6.19 , P=.003 ) and QOL item ( -1.61 vs -1.17 , P=.003 ) . All interventions were well tolerated . The incidence of acute urinary retention requiring catheterization was low ( tolterodine ER plus tamsulosin , 0.4 % ; tolterodine ER , 0.5 % ; tamsulosin , 0 % ; and placebo , 0 % ) . CONCLUSIONS These results suggest that treatment with tolterodine ER plus tamsulosin for 12 weeks provides benefit for men with moderate to severe lower urinary tract symptoms including overactive bladder . Clinical Trials Registration clinical trials.gov Identifier : NCT00147654",
"PURPOSE We determined whether men treated with oral antimuscarinics are at increased risk for acute urinary retention . MATERIAL S AND METHODS In this population based , retrospective cohort study using a nested case-control design we analyzed data from a large primary care data base containing patient information entered by general practitioners in the United Kingdom . Our study cohort comprised men 20 to 84 years old . Cases of acute urinary retention were identified by review ing diagnostic codes and were confirmed in a r and om sample through question naires sent to the treating physician . RESULTS The overall incidence of acute urinary retention in the study cohort ( 1,844 ) was 1.0 per 1,000 person-years , with the incidence rate increasing with age . The first 30 days ( early treatment ) of antimuscarinic use was associated with a relative risk of acute urinary retention of 8.3 ( 95 % CI 4.8 - 14.2 ) and with longer term use ( more than 30 days ) the relative risk was 2.0 ( 95 % CI 1.2 - 3.1 ) . The relative risk of acute urinary retention was similar for low/medium and high antimuscarinic doses ( relative risk 2.8 vs 3.0 , 95 % CI 2.1 - 3.8 and 1.3 - 6.8 , respectively ) . The relative risk of acute urinary retention was highest during early treatment for a urogenital indication ( relative risk 14.2 , 95 % CI 6.8 - 29.6 ) . The risk of acute urinary retention was not increased when antimuscarinics were used as antispasmodics or for drug induced parkinsonism . CONCLUSIONS Men prescribed antimuscarinics , particularly for a urogenital condition , should be closely monitored during the first 30 days of treatment for signs or symptoms of urinary retention",
"BACKGROUND Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists ( alpha-blockers ) or 5alpha-reductase inhibitors . The long-term effect of these drugs , singly or combined , on the risk of clinical progression is unknown . METHODS We conducted a long-term , double-blind trial ( mean follow-up , 4.5 years ) involving 3047 men to compare the effects of placebo , doxazosin , finasteride , and combination therapy on measures of the clinical progression of benign prostatic hyperplasia . RESULTS The risk of overall clinical progression -- defined as an increase above base line of at least 4 points in the American Urological Association symptom score , acute urinary retention , urinary incontinence , renal insufficiency , or recurrent urinary tract infection -- was significantly reduced by doxazosin ( 39 percent risk reduction , P finasteride ( 34 percent risk reduction , P=0.002 ) , as compared with placebo . The reduction in risk associated with combination therapy ( 66 percent for the comparison with placebo , P doxazosin ( P risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy ( P finasteride ( P doxazosin . Doxazosin ( P finasteride ( P=0.001 ) , and combination therapy ( P scores , with combination therapy being superior to both doxazosin ( P=0.006 ) and finasteride ( P doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone . Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy",
"OBJECTIVES To evaluate the efficacy and safety of nighttime dosing with tolterodine extended release ( TER ) in men with overactive bladder ( OAB ) and nocturia . METHODS This was a post hoc analysis of data from two 12-week , double-blind , placebo-controlled trials of nighttime ( TER ( 4 mg daily ) dosing . Men with a mean micturition frequency of eight or more times in 24 hours , including a mean of 2.5 or more nocturia episodes/night , were included . For each micturition , patients used 7-day diaries to record urinary urgency on a 5-point urgency rating scale ( 1 , none ; 2 , mild ; 3 , moderate ; 4 , severe ; 5 , urgency urinary incontinence ) . Micturitions were analyzed post hoc by urgency rating categories : total ( 1 to 5 ) , non-OAB ( 1 to 2 ) , OAB ( 3 to 5 ) , and severe OAB ( 4 to 5 ) . Adverse events were recorded throughout the study . RESULTS A total of 745 men ( mean age 64 years ) were r and omized to placebo ( n = 374 ) or TER ( n = 371 ) . Of the 745 men , 73 % reported no incontinence episodes in a 7-day diary at baseline . At week 12 , the weekly values for nighttime severe OAB micturitions and 24-hour and daytime total , OAB , and severe OAB micturitions were significantly reduced in the TER group versus the placebo group . The TER-treated men also reported a significant reduction in the mean urgency rating versus placebo . Adverse events associated with TER were low and comparable to those in the placebo group , with the exception of dry mouth ( 11 % versus 4 % ) . Withdrawals because of adverse events were infrequent ( 3 % TER , 4 % placebo ) . Five men were withdrawn for symptoms suggestive of urinary retention ( 3 TER , 2 placebo ) . CONCLUSIONS Nighttime TER dosing reduced urgency-related micturitions and was well tolerated in men with OAB and nocturia",
"BACKGROUND Some men receiving alpha-blocker therapy for lower urinary tract symptoms report persistent storage symptoms suggestive of overactive bladder ( OAB ) . OBJECTIVE To evaluate the efficacy of tolterodine extended release ( ER ) in men on alpha-blocker therapy . DESIGN , SETTING , AND PARTICIPANTS This double-blind trial included men aged > or = 40 yr with frequency , urgency , and at least moderate problems reported on the Patient Perception of Bladder Condition ( PPBC ) , despite being on a stable dose of alpha-blocker for > or = 1 mo . INTERVENTIONS Subjects were r and omized to tolterodine ER 4 mg per day or placebo for 12 wk while continuing their prescribed alpha-blocker therapy . MEASUREMENTS At baseline and week 12 , subjects completed the PPBC , International Prostate Symptom Score ( IPSS ) , Overactive Bladder Question naire ( OAB-q ) , and 5-d bladder diaries using the five-point Urinary Sensation Scale ( USS ) . Frequency-urgency sum was defined as the sum of USS ratings for all micturitions . RESULTS AND LIMITATIONS PPBC improvement from baseline to week 12 was reported by 63.6 % and 61.6 % of subjects receiving tolterodine ER plus alpha-blocker and placebo plus alpha-blocker , respectively ; this treatment difference , which was the primary end point , was not statistically significant ( p>0.6699 ) . At week 12 , subjects receiving tolterodine ER plus alpha-blocker had significantly greater improvements versus placebo plus alpha-blocker in 24-h micturitions ( -1.8 vs -1.2 ; p=0.0079 ) and daytime micturitions ( -1.3 vs -0.8 ; p=0.0123 ) ; 24-h urgency episodes ( -2.9 vs -1.8 ; p=0.0010 ) , daytime urgency episodes ( -2.2 vs -1.4 ; p=0.0017 ) , and nocturnal urgency episodes ( -0.5 vs -0.3 ; p=0.0378 ) ; frequency-urgency sum ( -7.8 vs -5.1 ; p=0.0065 ) ; IPSS storage subscale ( -2.6 vs -2.1 ; p=0.0370 ) ; and OAB-q symptom bother scale ( -17.9 vs -14.4 ; p=0.0086 ) and coping domain ( 15.4 vs 12.4 ; p=0.0491 ) . Acute urinary retention requiring catheterization occurred in residual volume or maximum urinary flow rate . CONCLUSIONS Men with bothersome OAB symptoms despite continued alpha-blocker therapy showed significantly greater improvements in diary variables , IPSS Storage scores , and symptom bother when receiving additional tolterodine ER versus placebo plus alpha-blocker",
"OBJECTIVE Estimate the prevalence of urinary incontinence ( UI ) , overactive bladder ( OAB ) , and other lower urinary tract symptoms ( LUTS ) among men and women in five countries using the 2002 International Continence Society ( ICS ) definitions . METHODS This population -based , cross-sectional survey was conducted between April and December 2005 in Canada , Germany , Italy , Sweden , and the United Kingdom using computer-assisted telephone interviews . A r and om sample of men and women aged > /= 18 yr residing in the five countries and who were representative of the general population s in these countries was selected . Using 2002 ICS definitions , the prevalence estimates of storage , voiding , and postmicturition LUTS were calculated . Data were stratified by country , age cohort , and gender . RESULTS A total of 19,165 individuals agreed to participate ; 64.3 % reported at least one LUTS . Nocturia was the most prevalent LUTS ( men , 48.6 % ; women , 54.5 % ) . The prevalence of storage LUTS ( men , 51.3 % ; women , 59.2 % ) was greater than that for voiding ( men , 25.7 % ; women , 19.5 % ) and postmicturition ( men , 16.9 % ; women , 14.2 % ) symptoms combined . The overall prevalence of OAB was 11.8 % ; rates were similar in men and women and increased with age . OAB was more prevalent than all types of UI combined ( 9.4 % ) . CONCLUSIONS The EPIC study is the largest population -based survey to assess prevalence rates of OAB , UI , and other LUTS in five countries . To date , this is the first study to evaluate these symptoms simultaneously using the 2002 ICS definitions . The results indicate that these symptoms are highly prevalent in the countries surveyed",
"Background The primary objectives of the treatment for the lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) are to produce rapid , sustained , and safe improvements in the symptoms that affect the quality of life in the majority of men over 50 . In this study , we evaluated the efficacy and safety of the combined therapy with terazosin ( & agr;1‐adrenergic receptor antagonist ) and tolterodine ( anticholinergic agent ) for LUTS associated with BPH . Methods This combination study included 69 patients diagnosed with LUTS associated with BPH based on the International Prostate Symptom Scores ( IPSS ) , urinary flow rate , prostate volume , urinary residual , and their serum prostate‐specific antigen levels . Initially , 191 patients were treated with terazosin 2 mg once daily for one week . Those patients with continued LUTS after the initial treatment were allocated r and omly into two groups : terazosin group ( n=36 ) in which patients were treated with terazosin 2 mg once daily for six weeks , and combination group ( n=33 ) in which patients were treated with both terazosin 2 mg once daily and tolterodine 2 mg twice daily for 6 weeks . Results The IPSS were significantly improved in both groups after treatment , and the reduction of IPSS in the combination group was significantly greater than that in the terazosin group ( P in urgency , frequency and nocturia were the main contributory factors causing the reduction of IPSS in the combination group . The differences about the peak urinary flow rate and the residual urine from the baseline values were noted in both groups after treatment , but were not significant between the two groups . The incidence of adverse effects in the combination group was higher than that in the terazosin group . As expected the most common adverse effect was mouth dryness which was associated with anticholinergic drugs such as tolterodine . Conclusions Patients with LUTS associated BPH appear the improved IPSS after combined therapy with terazosin and tolterodine . This study , although short term and limited numbers of patients , provides evidence that the combined therapy with terazosin plus tolterodine is a good approach for meeting the objectives of rapid , sustained , and safe improvements in the LUTS associated with BPH . And the profile of patients in this study might be used as the indication of such combined therapy for LUTS associated with BPH without urodynamic evaluation",
"AIMS To describe the changes in urodynamic parameters and to assess patients ' perceptions of voiding difficulties and improvements in symptom bother after solifenacin treatment in men with overactive bladder ( OAB ) and detrusor underactivity ( DUA ) . METHODS In this prospect i ve study , 49 neurologically intact men were enrolled . DUA was defined as a bladder contractility index ( BCI ) 5 mg of solifenacin once a day for 120 days . A complete urodynamic study was carried out on the day before to the first dose of solifenacin and at day 120 . RESULTS Solifenacin treatment result ed in a decrease in Q(max ) during UDS ( -0.6 ml/sec ; P = 0.007 ) , P(det)Q(max ) ( -6.4 cmH(2)O ; P voided volume ( -7.5 ml ; P = 0.09 ) . On the contrary , PVR ( + 6 ml ; P = 0.152 ) , and maximum cystometric capacity ( + 22.9 ml ; P = 0.001 ) increased . The regression analysis suggested that changes in urodynamic parameters after solifenacin treatment were limited for BOOI ( 9.4 % ) , P(det)Q(max ) ( 8.4 % ) , and BCI ( 6.5 % ) , with no significant impact on Q(max ) during UDS , BVE , volume voided and PVR . No significant change in subjective perception of voiding difficulties was found . The incidence of AUR was 2.2 % and improvement in patient 's experience of OAB symptoms bother after solifenacin treatment was observed . CONCLUSIONS Solifenacin treatment results in changes of urodynamic parameters . These changes , however , seem not to be of clinical significance as suggested by the lack of subjective deterioration in voiding difficulties and by the low incidence of AUR",
"PURPOSE We evaluate the effect of tolterodine combined with tamsulosin on quality of life in patients with bladder outlet obstruction and concomitant detrusor instability . MATERIAL S AND METHODS The study included 50 consecutive patients with urodynamically proven mild or moderate bladder outlet obstruction and concomitant detrusor instability . All patients were initially treated with 0.4 mg . tamsulosin orally once a day . A week later the patients were r and omly allocated into group 1 - 25 who continued treatment with tamsulosin only and , group 2 - 25 who also received 2 mg . tolterodine orally twice daily . Reevaluation with a quality of life question naire and urodynamic study was performed after 3 months . RESULTS Two patients from group 2 stopped tolterodine while 1 patient from each group stopped tamsulosin because of hypotension . Analysis revealed statistically significant improvement in quality of life scores only in group 2 patients ( mean score 525.0 and 628.4 before and after treatment , respectively , 2-sided t test p = 0.0003 ) . A significant difference was noted in both groups after treatment for maximum flow rate and volume at first contraction . Additionally , in group 2 , a statistically significant difference was observed for maximum detrusor pressure and maximum unstable contraction pressure after treatment . CONCLUSIONS Combination treatment with an alpha-blocker ( tamsulosin ) plus an anticholinergic ( tolterodine ) improves quality of life in patients with bladder outlet obstruction and concomitant detrusor instability . Interestingly , no acute urinary retention was observed and tolterodine did not affect the quality of urine flow or residual urine volume . The proposed combination appears to be an effective and relatively safe treatment option in patients with bladder outlet obstruction and detrusor instability",
"OBJECTIVE Fesoterodine , a new antimuscarinic agent for overactive bladder , undergoes immediate and extensive hydrolysis by nonspecific esterases to 5-hydroxymethyl tolterodine ( 5-HMT ) , the metabolite principally responsible for its antimuscarinic activity . Formation of 5-HMT does not require cytochrome P450 (CYP)-mediated metabolism , but its further metabolism and inactivation involves CYP3A4 and CYP2D6 isoenzymes . Subject age , gender , and race can play a key role in inter-subject variability in pharmacokinetics and thus efficacy and safety of drugs . This article examines the effects of age , gender , and race on the pharmacokinetics and pharmacodynamics of fesoterodine . METHODS Data from two r and omized , double-blind , placebo-controlled , parallel-group trials in healthy subjects are presented : Study 1 investigated the effects of race ( white vs. black men ) and Study 2 investigated the effects of age ( young vs. old men ) and gender ( elderly men vs. elderly women ) on the pharmacokinetics and pharmacodynamics of single doses of fesoterodine 8 mg . In both studies , the primary endpoints were area under the concentration-time curve up to the last sample ( AUC0-tz ) and maximum concentration ( Cmax ) of 5-HMT in plasma . Pharmacodynamic variables included spontaneous salivary secretion ( Studies 1 and 2 ) and residual urine volume ( Study 2 only ) . The two studies included 5 groups of 16 subjects each ( r and omized 3 : 1 to fesoterodine or placebo ) : white men aged 18 - 45 years , black men aged 18 - 45 years ( Study 1 ) ; young white men aged 18 - 40 years , elderly white men aged > 65 years , and elderly white women aged > 65 years ( Study 2 ) . RESULTS There were no clinical ly meaningful differences in the primary endpoints between white and black subjects or between young white men , elderly white men , and elderly white women . Mean AUC0-tz was 70.7 ng/ml x h in whites and 64.1 ng/ml x h in blacks ; mean Cmax was 6.1 and 5.5 ng/ml in whites and blacks , respectively . Mean AUC0-tz in young white men , elderly white men , and elderly white women was 49 , 48 , and 54 ng/ml x h , respectively ; mean Cmax in young white men , elderly white men , and elderly white women was 4.1 , 3.8 , and 4.6 ng/ml , respectively . Consistent with the anticholinergic pharmacology of fesoterodine , declines in salivary volume were observed in both studies , and elevations in residual urinary volume were observed , especially in elderly subjects , in Study 2 . Fesoterodine was well tolerated , with common adverse events such as headache and dry mouth recognized as antimuscarinic class effects . CONCLUSIONS Subject demographics , such as age , gender , and race , do not have a clinical ly meaningful effect on 5-HMT pharmacokinetics or pharmacodynamics after single-dose administration of fesoterodine 8 mg ; thus , no dosage adjustment is required for fesoterodine based on age , gender , or race",
"PURPOSE We evaluated the correlation of lower urinary tract symptoms suggestive of detrusor instability with urodynamic findings in men . MATERIAL S AND METHODS Enrolled in our prospect i ve study were 160 consecutive neurologically intact men referred for urodynamic evaluation of persistent lower urinary tract symptoms . All patients had storage symptoms suggestive of detrusor instability . Patients were further clinical ly categorized according to the chief complaint of urge incontinence , frequency and urgency , nocturia or difficult voiding . The clinical and urodynamic diagnosis in all patients as well as specific urodynamic characteristics of those with detrusor instability were analyzed according to the these 4 clinical categories . RESULTS Mean patient age was 61 + /- 15 years . The chief complaint was urge incontinence in 28 cases ( 17 % ) , frequency and urgency in 57 ( 36 % ) , nocturia in 30 ( 19 % ) and difficult voiding in 45 ( 28 % ) . Detrusor instability was diagnosed in 68 cases ( 43 % ) . A higher incidence of detrusor instability was associated with urge incontinence than with the other clinical categories ( 75 % versus 36 % , p bladder outlet obstruction , including 50 ( 46 % ) with concomitant detrusor instability . The prevalence of bladder outlet obstruction was similar in all patients regardless of the chief complaint . All other urodynamic diagnoses were also similar in the 4 clinical categories . The mean bladder volume at which involuntary detrusor contractions occurred were lower in patients with urge incontinence and frequency and urgency than in those with nocturia and difficult voiding ( 277.1 + /- 149.4 and 267.7 + /- 221.7 versus 346.7 + /- 204.6 and 306.2 + /- 192.1 ml . , respectively , not statistically significant , p = 0.07 ) . CONCLUSIONS Detrusor instability and bladder outlet obstruction are common in men with lower urinary tract symptoms . The symptom of urge incontinence strongly correlated with detrusor instability . Other lower urinary tract symptoms did not correlate well with any urodynamic findings . Therefore , we believe that an accurate urodynamic diagnosis may enable focused and more efficient management of lower urinary tract symptoms in men",
"We evaluated the efficacy of tolterodine extended release ( ER ) for patients ' most bothersome overactive bladder ( OAB ) symptom in a primary care setting . Patients with OAB symptoms for > or=3 months received tolterodine ER ( 4 mg q.d . ) for 12 weeks . Among incontinent patients ( n = 772 ) , the most bothersome OAB symptoms were daytime frequency ( 28 % ) , urgency urinary incontinence ( UUI ; 27 % ) , nocturnal frequency ( 26 % ) and urgency ( 19 % ) ; among continent patients ( n = 91 ) , they were daytime frequency ( 47 % ) , nocturnal frequency ( 42 % ) and urgency ( 10 % ) . Sixty-nine per cent of patients had one or more comorbid conditions . By week 12 , there were significant reductions in patients ' most bothersome symptom : -80 % for UUI , -78 % for urgency episodes , -40 % for nocturnal frequency and -30 % for daytime frequency ( p dry mouth ( 10 % ) and constipation ( 4 % ) . In primary care practice , bothersome OAB symptoms can be effectively and safely treated with tolterodine ER , even in patients with comorbid conditions",
"Objective . To assess the efficacy and safety of propiverine hydrochloride ( antimuscarinic ) , naftopidil ( α1-adrenoceptor antagonist ) or both in patients with male lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia and concomitant overactive bladder ( OAB ) . Material and methods . Men aged at least 50 years who had a total International Prostate Symptom Score ( IPSS ) of 8 or higher and bladder dairy documenting micturition frequency ( more than eight micturitions/24 h ) and urgency ( more than one episode/24 h ) , with or without urgency urinary incontinence were r and omized into three groups : group N , naftopidil ( 50 mg once daily ) only ; group P , propiverine hydrochloride ( 20 mg once daily ) ; and group NP , naftopidil ( 50 mg once daily ) plus propiverine hydrochloride ( 20 mg once daily ) for a 4-week treatment regimen . Results . A total of 66 men , including 20 in group N , 23 in group P and 23 in group NP , were treated and 58 ( 87.9 % ) completed the 4 weeks of treatment . IPSS improved significantly in groups N and NP . Urinary frequency improved significantly in groups P and NP . Postvoid residual urine volume increased significantly in groups P and NP . Significant improvements in urgency episodes were noted in each group . One patient in group P required catheterization owing to acute urinary retention and another stopped medication because of difficulty in voiding . Conclusion . These results suggest that each treatment showed effectiveness for male LUTS with OAB . However , there are some possibilities of adverse effects with propiverine hydrochloride monotherapy",
"OBJECTIVES We analyzed the prevalence and characteristics of lower urinary tract symptoms ( LUTS ) in community-dwelling men aged 80 years and older . METHODS We administered the American Urological Association Symptom Index ( AUA-SI ) by mail to 291 surviving community-dwelling male participants in the Rancho Bernardo Study , a prospect i ve , community-based study of aging . We compared the prevalence , severity , and types of LUTS occurring in men who were > or = 80 years to those RESULTS The mean age was 74.6 years ( st and ard deviation [ SD ] 8.9 , range 48.3 - 97.1 ) . One third of the respondents were > or = 80 years . The mean total AUA-SI score increased steadily by decade of life ( P-trend = .002 ) . The prevalence of LUTS was 70 % in men > or = 80 years and 56 % in men or = 80 years had significantly higher mean total AUA-SI ( P = .05 ) and were more likely to complain of incomplete emptying ( odds ratio [ OR ] 2.12 , 95 % confidence interval [ CI ] 1.06 - 4.18 , P = .02 ) , frequency ( OR 1.83 , 95 % CI 1.00 - 3.31 , P = .03 ) , urgency ( OR 1.76 , 95 % CI 0.96 - 3.20 , P = .05 ) , and weak stream ( OR 1.78 , 95 % CI 1.01 - 3.12 , P = .03 ) . CONCLUSIONS In this cohort of community-dwelling men , prevalence and severity of LUTS increased into the 10th decade of life . Compared to younger men , men > or = 80 years were more likely to complain of incomplete emptying , frequency , urgency , and weak stream . Further studies of LUTS in older men are needed to better delineate these associations",
"OBJECTIVES To evaluate the efficacy of tolterodine extended release ( ER ) , tamsulosin , and tolterodine ER plus tamsulosin in men with symptoms of overactive bladder and benign prostatic hyperplasia stratified by prostate-specific antigen ( PSA ) level . METHODS We performed a post hoc analysis of data from men > or=40 years old with frequency and urgency ( with or without urge urinary incontinence ) , postvoid residual urine volume 5 mL/s , International Prostate Symptom Score ( IPSS ) of > or=12 , and quality -of-life score of > or=3 . They had been r and omized to placebo , tolterodine ER ( 4 mg ) , tamsulosin ( 0.4 mg ) , or tolterodine ER plus tamsulosin for 12 weeks . The men were stratified by the median baseline PSA level ( > or=1.3 vs bladder diary variables and IPSSs . The men rated the urgency level of each micturition , and the frequency-urgency sum was defined as the total of these ratings . RESULTS The PSA level correlated significantly with prostate size . Men with a PSA level of > or=1.3 ng/mL receiving tolterodine ER plus tamsulosin showed significantly greater improvements in 24-hour frequency , daytime frequency , the frequency-urgency sum , total IPSS , and IPSS storage score compared with those receiving placebo . Tamsulosin significantly improved the IPSS voiding scores , but tolterodine ER was ineffective . In men with a PSA level , tolterodine ER alone and tolterodine ER plus tamsulosin significantly improved the 24-hour frequency , daytime frequency , frequency-urgency sum , and IPSS storage scores compared with those receiving placebo ; tamsulosin alone was ineffective . No significant changes were found in the postvoid residual urine volume or maximal urinary flow rate in any group , and the acute urinary retention rates were low . CONCLUSIONS The results of our study have shown that tolterodine ER was efficacious in men with lower urinary tract symptoms , including overactive bladder , who had lower PSA levels ( ",
"OBJECTIVES To assess the efficacy , safety , and tolerability of fesoterodine 4 and 8 mg in men with overactive bladder . METHODS This was a sub analysis of pooled data from 358 men enrolled in 2 double-blind , placebo-controlled phase III trials . Subjects with frequency and urgency or urgency urinary incontinence ( UUI ) were r and omized to fesoterodine 4 mg , fesoterodine 8 mg , or placebo for 12 weeks . Efficacy endpoints included bladder diary variables and subject-reported treatment response . RESULTS By week 12 , men treated with fesoterodine 4 or 8 mg had significantly greater median percentage improvements in micturition frequency , urgency episodes , and UUI episodes versus placebo and significantly greater percentages reported a treatment response versus placebo . Significant increases in mean voided volume ( MVV ) per micturition versus placebo occurred with fesoterodine 8 mg only . At week 12 , fesoterodine 8 mg was significantly more efficacious than fesoterodine 4 mg in improving UUI episodes and MVV per micturition . The most commonly reported adverse events with fesoterodine 4 and 8 mg were dry mouth ( 12.5 % and 37.7 % vs 5.6 % with placebo ) and constipation ( 2.5 % and 8.8 % vs 0.8 % with placebo ) . Symptoms suggestive of urinary retention were reported in 0.8 % , 0.8 % , and 5.3 % of men in the placebo , fesoterodine 4 mg , and fesoterodine 8 mg groups , respectively ; only 1 subject , in the fesoterodine 8 mg group , was catheterized . CONCLUSIONS Fesoterodine 4 and 8 mg are generally safe , efficacious , and well tolerated for the treatment of overactive bladder symptoms in men . The 8 mg dose provides additional benefit and allows for treatment individualization",
"BACKGROUND Some men with lower urinary tract symptoms ( LUTS ) including overactive bladder ( OAB ) symptoms may benefit from antimuscarinic therapy , with or without an alpha-adrenergic antagonist . OBJECTIVES To evaluate the safety and efficacy of tolterodine extended release ( ER ) , tamsulosin , or tolterodine ER+tamsulosin in men meeting symptom entry criteria for OAB and prostatic enlargement trials , stratified by prostate size . DESIGN , SETTING , AND PARTICIPANTS Subjects with an International Prostate Symptom Score ( IPSS ) > or=12 ; frequency and urgency , with or without urgency urinary incontinence ; postvoid residual volume ( PVR ) 5 mL/s were r and omized to receive placebo , tolterodine ER ( 4 mg ) , tamsulosin ( 0.4 mg ) , or tolterodine ER+tamsulosin for 12 wk . Data were stratified by median baseline prostate volume ( or=29 mL ) . MEASUREMENTS Endpoints included week 12 changes in bladder diary variables , IPSS scores , and safety variables . RESULTS AND LIMITATIONS Among men with larger prostates , tolterodine ER+tamsulosin significantly improved frequency ( p=0.001 ) ; urgency ( p=0.006 ) ; and IPSS total ( p=0.001 ) , storage ( p voiding scores ( p Tamsulosin significantly improved IPSS voiding scores ( p=0.030 ) . Among men with smaller prostates , tolterodine ER significantly improved frequency ( p=0.016 ) , UUI episodes ( p=0.036 ) , and IPSS storage scores ( p=0.005 ) . Tolterodine ER+tamsulosin significantly improved frequency ( p=0.001 ) and IPSS storage scores ( p=0.018 ) . Tamsulosin significantly improved nocturnal frequency ( p=0.038 ) and IPSS voiding ( p=0.036 ) and total scores ( p=0.044 ) . There were no clinical ly or statistically significant changes in Q(max ) or PVR ; incidence of acute urinary retention ( AUR ) was low in all groups ( Men with smaller prostates and moderate-to-severe LUTS including OAB symptoms benefited from tolterodine ER . Therapy with tolterodine ER+tamsulosin was effective regardless of prostate size . Tolterodine ER , with or without tamsulosin , was well tolerated and not associated with increased incidence of AUR"
] | 41169340-06ff-11f0-808a-c43d1ab1c353 |
Review s of neighborhood ( macro ) environment characteristics such as the presence of sidewalks and esthetics have shown significant correlations with resident physical activity ( PA ) and sedentary ( SD ) behavior . Currently , no comprehensive review has appraised and collected available evidence on the home ( micro ) physical environment . The purpose of this review was to examine how the home physical environment relates to adult and child PA and SD behaviors . Articles were search ed during May 2014 using Medline , PsycINFO , PubMed , Scopus , and SPORTD iscus data bases which yielded 3265 potential studies . Papers were considered eligible if they investigated the presence of PA ( ie . exercise equipment , exergaming devices ) or SD ( ie . television , videogames ) equipment and PA or SD behavior . After , screening and manual cross-referencing , 49 studies ( 20 experimental and 29 observational design s ) were found to meet the eligibility criteria . Interventions that reduced sedentary time by using TV limiting devices were shown to be effective for children but the results were limited for adults . Overall , large exercise equipment ( ie . treadmills ) , and prominent exergaming material s ( exergaming bike , dance mats ) were found to be more effective than smaller devices . Observational studies revealed that location and quantity of televisions correlated with SD behavior with the latter having a greater effect on girls . This was similarly found for the quantity of PA equipment which also correlated with behavior in females . Given the large market for exercise equipment , videos and exergaming , the limited work performed on its effectiveness in homes is alarming . Future research should focus on developing stronger r and omized controlled trials , investigate the location of PA equipment , and examine mediators of the gender discrepancy found in contemporary studies | [
"Background This study aim ed to evaluate the associations of selected demographic , individual , social , and environmental factors with moderate-to-vigorous physical activity ( MVPA ) in a sample of children and adolescents . Methods MVPA was assessed among youth ( n = 294 ) 10 - 17-years-old using the ActiGraph accelerometer . Youth completed measures of demographic and individual variables related to physical activity ( PA ) , perceived social support by parents and peers , and perceived neighborhood characteristics . Parents completed the long-form of the International Physical Activity Question naire . The Physical Activity and Media Inventory was used to measure the home environment and Geographical Information Systems software was used to measure the physical neighborhood environment . Bivariate correlations and hierarchical multiple regression were conducted stratified by gender . Results Boys participated in significantly more MVPA than girls . In hierarchical analyses , peer support , home PA equipment , and temperature were significantly associated with MVPA among boys whereas distance to the school they attended was associated with MVPA among girls . The final models accounted for 25 % and 15 % of the variance in MVPA among boys and girls , respectively . Conclusions Important differences exist among the individual , social , and environmental factors related to MVPA between boys and girls . Boys ' levels of activity appear to be influenced by factors closely linked to unstructured and social types of activities whereas girls ' activities relate to internal and external barriers as well as their proximity to their schools . The prospect i ve contribution of these important individual , social , and environmental factors to changes in MVPA among children and adolescents remains to be determined",
"BACKGROUND Sedentary activities such as video gaming are independently associated with obesity . Active video games , in which players physically interact with images on screen , may help increase physical activity and improve body composition . OBJECTIVE The aim of this study was to evaluate the effect of active video games over a 6-mo period on weight , body composition , physical activity , and physical fitness . DESIGN We conducted a 2-arm , parallel , r and omized controlled trial in Auckl and , New Zeal and . A total of 322 overweight and obese children aged 10 - 14 y , who were current users of sedentary video games , were r and omly assigned at a 1:1 ratio to receive either an active video game up grade package ( intervention , n = 160 ) or to have no change ( control group , n = 162 ) . The primary outcome was the change from baseline in body mass index ( BMI ; in kg/m(2 ) ) . Secondary outcomes were changes in percentage body fat , physical activity , cardiorespiratory fitness , video game play , and food snacking . RESULTS At 24 wk , the treatment effect on BMI ( -0.24 ; 95 % CI : -0.44 , -0.05 ; P = 0.02 ) favored the intervention group . The change ( ±SE ) in BMI from baseline increased in the control group ( 0.34 ± 0.08 ) but remained the same in the intervention group ( 0.09 ± 0.08 ) . There was also evidence of a reduction in body fat in the intervention group ( -0.83 % ; 95 % CI : -1.54 % , -0.12 % ; P = 0.02 ) . The change in daily time spent playing active video games at 24 wk increased ( 10.03 min ; 95 % CI : 6.26 , 13.81 min ; P change in daily time spent playing nonactive video games ( -9.39 min ; 95 % CI : -19.38 , 0.59 min ; P = 0.06 ) . CONCLUSION An active video game intervention has a small but definite effect on BMI and body composition in overweight and obese children . This trial was registered in the Australian New Zeal and Clinical Trials Registry at http://www.anzctr.org.au/ as ACTRN12607000632493",
"Background and aims : Home-based exercise is a viable solution for frail elderly individuals with difficulties in reaching exercise facilities outside home . The aim of this study was to determine the effects of a home-based video exercise program on physiological performance , functional capacity and health-related quality of life . Methods : Community-dwelling frail women ≥75 yrs , receiving public home care , were r and omized into a training group ( n=30 ) and a control group ( n=31 ) . Participants exercised for 26 minutes , three times per week for five months . Both groups received a bi-weekly telephone call . The effect of intervention was evaluated by the physical performance test , mobility-tiredness score , maximal isometric h and grip and biceps strength , lower limb explosive power , repeated chair rise ( 5 times ) , 10-m maximal walking-speed , semi-t and em balance , and health-related quality of life , as measured by EQ-5D and self-rated health . Results : Twenty-five participants ( 83 % ) in the training group and 28 ( 90 % ) in the control group completed the project . Adherence to the training protocol was on average 89.2 % . At follow-up , between-group analysis revealed a significant difference only in EQ-5D ( valued by time-trade-off tariffs ) , result ing from a significant decrease observed in the control group and a trend towards an increase in the training group ( p=0.082 ) . Significant within-group improvements , ranging from 8–35 % , were also observed for the physical performance test , mobility-tiredness score , h and grip , biceps strength , chair rise , and 10-m maximal walking-speed in the training group , and for walking-speed and self-rated health in the control group . Conclusions : These results suggest that home-based training for frail older women using an exercise video induces lasting health-related quality -of-life ( EQ-5D ) . In addition , a tendency towards improvements in physiological performance and functional capacity was observed",
"Background The family food environment is an important influence in the development of children ’s dietary habits . Research suggests that influences of current dietary behaviour and behaviour change may differ . The aims of this paper were to : ( 1 ) investigate the association between the food environment at baseline and change in children ’s saturated fat intake ; and ( 2 ) to explore whether a change in the food environment was associated with a change in children ’s saturated fat intake . MethodS econdary analysis of a 12 week cluster r and omised controlled trial in 133 4 - 13 year old children . Families were r and omly allocated to parental education regarding changing to reduced-fat dairy foods or a comparison non-dietary behaviour . The interventions were family focused . Parents received education from a dietitian in 3x30minute sessions to facilitate behaviour change . Parents completed a comprehensive question naire capturing three domains of the food environment – Parent knowledge and attitudes ; shaping practice s ; and behaviours and role modelling . Children ’s dietary intake was assessed via multiple 24-hour recalls at baseline and week 12 . Changes in the family food environment and primary outcome ( saturated fat ) were calculated . Hierarchical linear regression models were performed to explore the association between baseline and change in food environment constructs and change in saturated fat intake . St and ardised Beta are presented ( p perceived food availability ( β=-0.2 ) at baseline was associated with greater reduction in saturated fat intake , where as higher perceived responsibility ( β=0.2 ) , restriction ( β=0.3 ) and pressure to eat ( β=0.3 ) were associated with lesser change in saturated fat . An increase in nutrition knowledge ( β=-0.2 ) , perceived responsibility ( β=-0.3 ) and restriction ( β=-0.3 ) from baseline to week 12 were associated with greater reduction in saturated fat intake . Conclusions The present study was one of the first to quantify changes in the family food environment , and identify a number of factors which were associated with a positive dietary change . Because interventions focus on behaviour change , the findings may provide specific targets for intervention strategies in the future . Trial registration Australia New Zeal and Clinical Trials Registry ACTRN12609000453280",
"OBJECTIVE : This naturalistic study tests whether children receiving a new ( to them ) active video game spontaneously engage in more physical activity than those receiving an inactive video game , and whether the effect would be greater among children in unsafe neighborhoods , who might not be allowed to play outside . METHODS : Participants were children 9 to 12 years of age , with a BMI > 50th percentile , but A r and omized clinical trial assigned children to receiving 2 active or 2 inactive video games , the peripherals necessary to run the games , and a Wii console . Physical activity was monitored by using accelerometers for 5 weeks over the course of a 13-week experiment . Neighborhood safety was assessed with a 12 item vali date d question naire . RESULTS : There was no evidence that children receiving the active video games were more active in general , or at anytime , than children receiving the inactive video games . The outcomes were not moderated by parent perceived neighborhood safety , child BMI z score , or other demographic characteristics . CONCLUSIONS : These results provide no reason to believe that simply acquiring an active video game under naturalistic circumstances provides a public health benefit to children",
"OBJECTIVE The aims of the study were to evaluate the long-term effects of a home-based smoking prevention program ' Smoke-free Kids ' during preadolescence on smoking initiation during adolescence and to test the potential moderating role of parental smoking , socioeconomic status , and asthma . METHOD In 2008 , 1478 9 - 11year old children and their mothers were recruited from 418 elementary schools in the Netherl and s. An independent statistician r and omly allocated schools to one of the two conditions using a 1:1 ratio ( single blind ) : 728 children in the intervention and 750 in the control condition . The intervention condition received five activity modules , including a communication sheet for mothers , by mail at four-week intervals and one booster module one year after baseline . The control condition received a fact-based intervention only . Intention-to-treat analysis was performed on 1398 non-smoking children at baseline . RESULTS In the intervention 10.8 % of the children started smoking compared to 12 % in the control condition . This difference was non-significant ( odds ratio=0.90 , 95 % confidence interval=0.63 - 1.27 ) . No moderating effects were found . CONCLUSION No effects on smoking initiation after 36months were found . Perhaps , the program was implemented with children that were too young . Programs closer to the age of smoking onset should be tested",
"OBJECTIVE To examine associations between television viewing , sugar-sweetened beverage consumption , eating out , physical activity , and body weight change over 1 year . DESIGN Secondary data analysis from r and omized intervention trial . SETTING Households in the community . PARTICIPANTS Adults ( n = 153 ) and adolescents ( n = 72 ) from the same households . INTERVENTION Households were r and omized to a home-based obesity prevention intervention or to a no-intervention control group for a 1-year period . MAIN OUTCOME MEASURES Self-reported television viewing ( TV ) hours , diet , and physical activity . Body mass index ( BMI ) computed from measured weight and height ( primary outcome measure ) . ANALYSIS Mixed-model regression . RESULTS Among adolescents , a significant prospect i ve association was observed between decreases in television viewing hours and lower BMI z score at 1-year follow-up ( decreased TV hours : BMI z score mean = 0.65 ; no change or increase TV hours : BMI z score = 0.92 ; P excess weight gain among adolescents",
"Even when adults meet physical activity guidelines , sitting for prolonged periods can compromise metabolic health . Television ( TV ) time and objective measurement studies show deleterious associations , and breaking up sedentary time is beneficial . Sitting time , TV time , and time sitting in automobiles increase premature mortality risk . Further evidence from prospect i ve studies , intervention trials , and population -based behavioral studies is required",
"Background : Self-efficacy is a person 's confidence in being able to successfully perform a specific activity or behavior . Self-efficacy has been shown to influence exercise capacity in patients post myocardial infa rct ion , but has not been fully explored in patients with heart failure ( HF ) . This study examined the impact of performance of a single treadmill exercise test and participation in a 3-month program of walking and resistance exercise on self-efficacy in HF patients . Methods : 24 patients were r and omized to either a home-based walking and resistance exercise program or usual care for 3 months . Prior to enrollment into the exercise program all participants performed a single treadmill exercise test with respiratory gas analysis . Self-efficacy question naires were completed at 3 time points , 1 ) prior to performance of an exercise treadmill test ; 2 ) immediately after completing an exercise test ; and 3 ) at the end of a 3-month exercise program . Results : Self-efficacy for walking ( p = 0.07 ) , climbing ( p = 0.17 ) , lifting ( p = 0.73 ) and general activity ( p = 0.15 ) did not improve after performance of a single treadmill exercise test and usual care . However , self-efficacy for walking increased after 3 months of a walking and resistance exercise program . ( p = 0.04 ) . Conclusions : The findings from this study suggest that in patients with stable mild to moderate heart failure , self-efficacy is improved with participation in a home-based walking and endurance exercise program . Self-efficacy is not enhanced by performance of a single treadmill exercise test and usual care",
"OBJECTIVE This pilot study investigated whether a home exercise video programme could improve exercise tolerance and breathlessness in patients with moderate to severe chronic obstructive pulmonary disease . METHODS Twenty subjects completed the study after being r and omized to intervention or control . The intervention group ( n=10 ) , watched a 19-min video on the benefits of exercise for patients with chronic obstructive pulmonary disease and were given a 30-min exercise video , an illustrated exercise diary and an educational booklet about chronic obstructive pulmonary disease , for use at home . They were advised to follow the exercise video programme 4 times a week for 6 weeks . The control group ( n=10 ) received the chronic obstructive pulmonary disease educational booklet only . Exercise tolerance was measured using the Incremental Shuttle Walk Test and breathlessness by the self-reported Chronic Respiratory Question naire . RESULTS The median change in the Incremental Shuttle Walk Test and breathlessness score significantly improved in the intervention group compared with the control ( + 45 m vs -15 m , p=0.013 and + 0.5 vs -0.1 Chronic Respiratory Question naire units , p=0.042 ) . The other findings for the self-reported Chronic Respiratory Question naire showed significant improvements in the intervention group for emotion ( p fatigue ( p=0.012 ) , but not mastery ( p=0.253 ) . CONCLUSION This pilot study suggests that participation in a home exercise video programme may benefit people with chronic obstructive pulmonary disease",
"The primary objective of this pilot study was to evaluate the effect of active video games on children 's physical activity levels . Twenty children ( mean ± SD age = 12 ± 1.5 years ; 40 % female ) were r and omised to receive either an active video game up grade package or to a control group ( no intervention ) . Effects on physical activity over the 12-week intervention period were measured using objective ( Actigraph accelerometer ) and subjective ( Physical Activity Question naire for Children [ PAQ-C ] ) measures . An activity log was used to estimate time spent playing active and non-active video games . Children in the intervention group spent less mean time over the total 12-week intervention period playing all video games compared to those in the control group ( 54 versus 98 minutes/day [ difference = -44 minutes/day , 95 % CI [ -92 , 2 ] ] , p = 0.06 ) . Average time spent in all physical activities measured with an accelerometer was higher in the active video game intervention group compared to the control group ( difference at 6 weeks = 194 counts/min , p = 0.04 , and at 12 weeks = 48 counts/min , p = 0.06).This preliminary study suggests that playing active video games on a regular basis may have positive effects on children 's overall physical activity levels . Further research is needed to confirm if playing these games over a longer period of time could also have positive effects on children 's body weight and body mass index . Trial Registration",
"OBJECTIVES To examine prospect ively whether higher proportions of vigorous physical activity ( VPA ) , independent of total activity volume , are associated with better outcomes in weight maintenance and physical function . METHODS We used three-year longitudinal data ( 2006/07 - 2009/10 ) of adults 45 and older ( n=32,087 ; 59.5±9.3years ) from New South Wales , Australia . Logistic regression models examined odds of weight gain and functional decline by volume and intensity of physical activity . RESULTS On average , body weight increased by 0.66 kg ( SD=5.83 , p vali date d physical function score ( MOS-PF ) decreased by 4.79 ( SD=12.56 , p the odds of weight gain for participants who reported 300min/week or more of moderate to vigorous physical activity ( MVPA ) compared to less than 150min of MVPA . The proportion of MVPA that was vigorous was not associated with weight change . With the physical functioning outcome , there were independent protective effects from volume and intensity of physical activity . Independent of total MVPA , each 1 % increase in the proportion of total activity that was vigorous was associated with a 0.3 % decrease in the odds of decline in physical function . CONCLUSION These prospect i ve findings indicate that VPA per se plays an important role in the prevention of functional decline",
"The purpose of the present study was to evaluate an intervention to prevent weight gain among households ( HHs ) in the community . Ninety HHs were r and omized to intervention or control group for 1 year . Intervention consisted of six face-to-face group sessions , placement of a television ( TV ) locking device on all home TVs , and home-based intervention activities . Measures were collected in person at baseline and 1 year . Weight , height , eating behaviors , physical activity ( PA ) , and TV viewing were measured among HH members ages ≥ 12 years . Follow-up rate at 1 year was 96 % . No significant intervention effects were observed for change in HH BMI -z score . Intervention HHs significantly reduced TV viewing , snacks/sweets intake , and dollars per person spent eating out , and increased ( adults only ) PA and self-weighing frequency compared with control HHs . A 1 year obesity prevention intervention targeting entire HHs was effective in reducing TV viewing , snack/sweets intake and eating out purchases . Innovative methods are needed to strengthen the home food environment intervention component . Longer intervention duration s also need to be evaluated",
"BACKGROUND Interactive stationary bikes provide positive affective experiences and physiological benefits ; however , research is limited . METHODS This study compared usage of GameBikes to traditional stationary bikes among families in the home following a 6-week r and omized , controlled trial design . Parents completed question naires featuring constructs of the theory of planned behavior ( TPB ) . Usage was tracked by all family members and belief elicitation with GameBike families followed the trial . RESULTS Usage across the trial was significantly different for children in favor of the GameBike group ( t36 = 2.61 , P = .01 , d = .85 ) . No differences were identified for parents . Significant time effects for parents ' ( F5,48 = 5.07 , P children 's ( F5,32 = 8.24 , P usage were found with declines across 6 weeks . Affective attitude was the only significant TPB variable between groups at both time one ( t57 = 2.53 , P = .01 ; d = .65 ) and follow-up ( t52 = 2.70 , P = .01 ; d = .74 ) in favor of the GameBike group . Elicited beliefs were primarily affective- and control-based . CONCLUSIONS The results provide support for use of interactive video games to augment current PA initiatives . Larger-scale trials with longer duration s are warranted",
"Exercise games that employ video game technology are increasing in the marketplace but have received scant research attention despite their popularity . The purpose of this study was to evaluate the effect of videobike gaming on the constructs of the theory of planned behavior ( TPB ) and adherence in comparison to a cycling condition where participants listen to self-selected music . Participants were 29 inactive young men assigned r and omly to experimental ( n = 16 ) or comparison ( n = 13 ) conditions . The recommended training regime consisted of moderate intensity activity ( 60–75 % heart rate reserve ) , 3 days/week for 30 min/day for 6 weeks . At the end of the first session , participants were asked to complete TPB measures and these were subsequently measured 6 weeks later . Attendance was used as the measure of adherence . Results showed that affective attitude and adherence across the 6 weeks significantly favored the videobike condition over the comparison condition . Regression analyses suggested partial mediation of the effect of the videobike condition on adherence via affective attitude . This is the first study to provide evidence that interactive videobikes may improve adherence over traditional cycling because the activity produces higher affective attitudes . The results are promising for exp and ing to community-based evaluation",
"Purpose . To determine the association of neighborhood design factors and recreational environments with physical activity . Methods . R and omly selected adults ( n = 102 , 52 % female , 81 % white , mean age = 48 years ) completed a survey of eight neighborhood design variables , convenient recreational facilities , and availability of home equipment . Physical activity was measured by self-report and 7 days of accelerometer monitoring . Results . Residential density and an overall environment index were significantly related to both vigorous-intensity self-reported ( r = .35 and .28 , respectively ) and objective ly measured physical activity ( r = .39 and .23 , respectively ) . Home equipment was correlated with self-reported total ( r = .34 ) and vigorous leisure-time physical activity ( r = .27 ) . The vigorous and total activity accelerometer measures were correlated with street connectivity ( r = .25 and .21 , respectively ) . Discussion . Few self-reported neighborhood design factors and recreational environment variables were correlated with physical activity , and some findings were unexpected",
"The authors used stratified r and om sampling procedures to investigate the relationships among physical activity ( PA ) , the proximity of exercise facilities , and the quantity of home exercise equipment in a sample of 411 undergraduates . To examine the data they collected from the modified Godin Leisure-Time Exercise Question naire and the Home Environment Question naire , the authors used correlational analyses and analysis of variance . Intensity and duration of PA showed a significant relationship to the proximity of exercise facilities . Intensity , frequency , and duration of PA were significantly related to the quantity of students ' home exercise equipment . Freshmen and sophomores engaged in PA closer to their residences and participated in 3 more exercise bouts per week than juniors and seniors . These findings suggest that proximity of the activity episode may have an effect on PA behavior of college students",
"OBJECTIVE We examined the feasibility of Dance Dance Revolution ( DDR ) , a dance video game , in participants ' homes , to increase physical activity ( PA ) and to decrease sedentary screen time ( SST ) . METHODS AND PROCEDURES Sixty children ( 7.5 + /- 0.5 years ) were r and omized in a 2:1 ratio to DDR or to wait-list control ( 10-week delay ) . DDR use was logged , PA was measured objective ly by accelerometry . SST was self-reported at weeks 0 and 10 . At week 28 , after both groups had access to DDR , accelerometry and SST were repeated . RESULTS Mean use of DDR was 89 + /- 82 ( range 0 - 660 min ) min per week ( mpw ) . The DDR group showed increased vigorous PA and a reduction in light PA ; the control group showed no increase in moderate and /or vigorous PA ( MVPA ) although they also had a reduction in light PA . Differences between the groups were not observed . The DDR group also reported a decrease in SST of -1.2 + /- 3.7 h per week ( hpw ) ( P SST between the groups was significant , with less SST in the DDR group . Between weeks 10 and 28 , numeric reductions in SST were reported in both groups . In the DDR group , SST at week 28 ( 8.8 + /- 6.0 hpw ) was lower than baseline ( 10.5 + /- 5.5 hpw ; P DDR reduces SST and may facilitate slight increases in vigorous PA . Further study is needed to better characterize children and context s in which DDR may promote a healthy lifestyle",
"OBJECTIVE To examine whether aspects of the family food environment were associated with body mass index ( BMI ) z-score and weight status in children , cross-sectionally and prospect ively over 3 years . METHODS Four aspects of the family food environment ( breakfast eating patterns , food consumption while watching television , parental provision of energy-dense foods and child consumption of energy-dense food at home and away from home ) were assessed with a question naire completed by parents of 161 children aged 5 - 6 years and 132 children aged 10 - 12 years in Melbourne , Australia in 2002/03 . In 2002/03 and 2006 , children 's BMI z-score and weight status ( non-overweight or overweight ) was calculated from measured height and weight . RESULTS At baseline , 19 % of younger and 21 % of older children were overweight . Three years later , a greater proportion of younger ( now aged 8 - 9 years ) compared with older ( aged 13 - 15 years ) children were classified as overweight ( 28 % versus 18 % ) . Few of the family food environment variables were associated with children 's BMI z-score and weight status cross-sectionally and longitudinally . However , among older children , more frequent dinner consumption while watching television was associated with a higher BMI z-score longitudinally ( B=0.3 , 95 % CI=0.0 , 0.6 ) , less frequent breakfast consumption was associated with higher odds of overweight longitudinally ( OR=2.2 , 95 % CI=1.1 - 4.7 ) , and more frequent fast food consumption at home was associated with higher odds of overweight cross-sectionally ( OR=3.1 , 95 % CI=1.4 - 7.0 ) . CONCLUSIONS This study found few significant associations between aspects of the family food environment and BMI z-score or weight status in a sample of Australian children",
"BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions to improve the management of cancer pain . Each study assessment was completed independently by two review ers using each tool . We analysed the inter-rater reliability of each tool 's individual domains , as well as final grade assigned to each study . RESULTS The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade . In contrast , the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade . Of interest , no agreement between the two tools was evident in their final grade assigned to each study . Although both tools were developed to assess ' quality of the evidence ' , they appear to measure different constructs . CONCLUSIONS Both tools performed quite differently when evaluating the risk of bias or method ological quality of studies in knowledge translation interventions for cancer pain . The newly introduced CCRBT assigned these studies a higher risk of bias . Its psychometric properties need to be more thoroughly vali date d , in a range of research fields , to underst and fully how to interpret results from its application",
"Active video game interventions typically provide children a single game that may become unappealing . A peripheral device ( jOG ) encourages step-powered gaming on multiple games . This trial evaluated the effect of jOG on children 's objective ly measured PA , body fat and self-reported behaviors . 42 of 58 eligible children ( 8 - 10 y ) r and omly assigned to an intervention ( jOG ) or control ( CON ) completed the trial . Intervention children received two jOG devices for home use . Analyses of covariance compared the intervention effect at 6 and 12 weeks from baseline . No differences were found between groups for counts per minute ( CPM ; primary outcome ) at 6 and 12 weeks ( p > .05 ) . Active video gaming increased ( adjusted change 0.95 ( 95 % CI 0.25 , 1.65 ) h·d⁻¹ , p decreased ( -0.34 ( -1.24 , 0.56 ) h·d⁻¹ , p > .05 ) at 6 weeks relative to CON . No body fat changes were observed between groups . Targeted changes in video game use did not positively affect PA . Larger trials are needed to verify the impact of active video games on children 's PA and health ",
"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 ",
"Purpose : Parental and intervention-specific environmental supports were examined as potential reinforcers for physical activity and use of a video game , Dance Dance Revolution ( DDR ) , among a cohort of 7- to 8-year-old children . Methods : Sixty children were r and omized to an intervention ( n = 40 ) or a control ( n = 20 ) group . Physical activity was measured with accelerometry and DDR logs . Parental support for their child ’s physical activity was assessed via a question naire . DDR-specific environmental supports were captured on an environmental home screen and the DDR log . Results : At baseline , the absence of other video games and parent DDR participation was associated with child participation in DDR . At follow-up , DDR participation of siblings and friends was associated with child participation in DDR . Conclusion : The primary findings of this study suggest that parental and peer participation in DDR may play a role in children ’s initial and sustained participation in DDR",
"OBJECTIVES This pilot study evaluated the feasibility ( recruitment , retention , and acceptability ) and preliminary efficacy of a six-week home-based electronic time monitor intervention on New Zeal and children 's television watching in 2008 . METHODS Twenty-nine children aged 9 to 12 years who watched more than 20 h of television per week ( 62 % male , mean age 10.4 years ) were r and omised to either the intervention or the control group . The intervention group received an electronic TV time monitor for 6 weeks and advice to restrict TV watching to 1 h per day or less . The control group was given verbal advice to restrict TV watching . RESULTS Participant retention at 6 weeks was 93 % . Semi-structured interviews with intervention families confirmed moderate acceptability of TV time monitors and several perceived benefits including better awareness of household TV viewing and improved time planning . Drawbacks reported included disruption to parents ' TV watching and increased sibling conflict . Time spent watching television decreased by 4.2 h ( mean change [ SD ] : -254 [ 536 ] min ) per week in the intervention group compared with no change in the control group ( -3 [ 241 ] min ) , but the difference between groups was not statistically significant , p=0.77 . Both groups reported decreases in energy intake from snacks and total screen time and increases in physical activity measured by pedometer and between-group differences were not statistically significant . CONCLUSIONS Electronic TV time monitors are feasible to use for home-based TV watching interventions although acceptability varies between families . Preliminary findings from this pilot suggest that such devices have potential to decrease children 's TV watching but a larger trial is needed to confirm effectiveness . Future research should be family-orientated ; take account of other screen time activities ; and employ TV time monitors as just one of a range of strategies to decrease sedentary behaviour",
"Purpose This study used Ecological Momentary Assessment ( EMA ) , a real-time self-report strategy , to describe the physical and social context s of adults ’ physical activity and sedentary activity during their everyday lives and to determine whether these patterns and relationships differ for men and women . Methods Data from 114 adults were collected through mobile phones across 4 days . Eight electronic EMA surveys were r and omly prompted each day asking about current activities ( e.g. , physical or sedentary activity ) , physical and social context s , and perceived outdoor environmental features ( e.g. , greenness/vegetation , safety , and traffic ) . All participants also wore accelerometers during this period to objective ly measure moderate-to-vigorous physical activity ( MVPA ) and sedentary activity . Results Home was the most common physical context for EMA-reported physical and sedentary activity . Most of these activities occurred when participants were alone . When alone , the most commonly EMA-reported physical activity and sedentary activity was walking and reading/using computer , respectively . When in outdoor home locations ( e.g. , yard and driveway ) women demonstrated higher levels of MVPA , whereas men demonstrated higher levels of MVPA when in outdoor park setting s ( ps MVPA in setting s with a greater degree of perceived greenness and vegetation ( p EMA via mobile phones and accelerometers can be combined to offer an innovative approach to assess the context s of adults ’ daily physical and sedentary activity . Future studies could consider utilizing this method in more representative sample s to gather context -specific information to inform the development of physical activity interventions"
] | 41169386-06ff-11f0-808a-c43d1ab1c353 |
Background Physical activity ( PA ) is associated with a diverse range of health benefits . International guidelines suggest that children should be participating in a minimum of 60 min of moderate to vigorous intensity PA per day to achieve these benefits . However , current guidelines are intended for healthy children , and thus may not be applicable to children with a chronic disease . Specifically , the dose of PA and disease specific exercise considerations are not included in these guidelines , leaving such children with few , if any , evidence -based informed suggestions pertaining to PA . Thus , the purpose of this narrative review was to consider current literature in the area of exercise as medicine and provide practical applications for exercise in five prevalent pediatric chronic diseases : respiratory , congenital heart , metabolic , systemic inflammatory/autoimmune , and cancer . Methods For each disease , we present the pathophysiology of exercise intolerance , summarize the pediatric exercise intervention research , and provide PA suggestions . Results Overall , exercise intolerance is prevalent in pediatric chronic disease . PA is important and safe for most children with a chronic disease , however exercise prescription should involve the entire health care team to create an individualized program . Conclusions Future research , including a systematic review to create evidence -based guidelines , is needed to better underst and the safety and efficacy of exercise among children with chronic disease | [
"BACKGROUND Aerobic training has a number of well known beneficial effects in both normal and asthmatic children . However , the impact of training on the clinical management of the underlying bronchial asthma remains controversial , particularly in the most severe patients . METHODS Clinical evaluation , spirometric tests , symptom limited maximum exercise testing , and exercise challenge tests were performed in a group of children with stable moderate to severe asthma . Forty two patients ( 24 boys ) aged 8–16 were evaluated twice : before and after supervised aerobic training ( group 1 , n = 26 ) and two months apart ( untrained group 2 , n = 16 ) . RESULTS Spirometric and maximal exercise variables in the initial evaluation were significantly reduced in group 1 ( p medication and clinical scores and the occurrence of exercise induced bronchospasm ( EIB ) did not differ between the two groups . Aerobic improvement with training ( maximal oxygen uptake and /or anaerobic threshold increment > 10 % and 100 ml ) was inversely related to the baseline level of fitness and was independent of disease severity . Although the clinical score and the occurrence of EIB did not change after training , aerobic improvement was associated with a significant reduction in the medication score and the daily use of both inhaled and oral steroids ( p CONCLUSIONS Aerobic improvement with training in less fit asthmatic children is related to a short term decrease in the daily use of inhaled and oral steroids , independent of the severity of the disease",
"The optimal exercise modality for reductions of abdominal obesity and risk factors for type 2 diabetes in youth is unknown . We examined the effects of aerobic exercise ( AE ) versus resistance exercise ( RE ) without caloric restriction on abdominal adiposity , ectopic fat , and insulin sensitivity and secretion in youth . Forty-five obese adolescent boys were r and omly assigned to one of three 3-month interventions : AE , RE , or a nonexercising control . Abdominal fat was assessed by magnetic resonance imaging , and intrahepatic lipid and intramyocellular lipid were assessed by proton magnetic resonance spectroscopy . Insulin sensitivity and secretion were evaluated by a 3-h hyperinsulinemic-euglycemic clamp and a 2-h hyperglycemic clamp . Both AE and RE prevented the significant weight gain that was observed in controls . Compared with controls , significant reductions in total and visceral fat and intrahepatic lipid were observed in both exercise groups . Compared with controls , a significant improvement in insulin sensitivity ( 27 % ) was observed in the RE group . Collapsed across groups , changes in visceral fat were associated with changes in intrahepatic lipid ( r = 0.72 ) and insulin sensitivity ( r = −0.47 ) . Both AE and RE alone are effective for reducing abdominal fat and intrahepatic lipid in obese adolescent boys . RE but not AE is also associated with significant improvements in insulin sensitivity",
"STUDY OBJECTIVE Exercise has the potential to improve the ability of a patient with cystic fibrosis ( CF ) to cope with the physical dem and s of everyday life , and may improve prognosis . The purpose of this study was to compare the effects of a home-based , semi-supervised , upper-body strength-training regimen with a similarly structured aerobic training regimen . DESIGN Data were collected during a 1-year r and omized clinical trial . SETTING Counselors conducted in-home visits with the participants once per week for the first 8 weeks followed by monthly visits for the remainder of the study . PATIENTS Sixty-seven patients with CF , aged 8 to 18 years , participated in the trial . INTERVENTION Participants in both exercise conditions were encouraged to exercise at least three times per week for 1 year . Each child in the aerobic group was given a stair-stepping machine , and each child in the upper-body strength training group was given an upper-body-only weight-resistance machine . MEASURES AND RESULTS Aerobic fitness , pulmonary function , quality of life , and strength were measured at baseline , at 6 months , and at 12 months . Strength training increased the maximum weight lifted for biceps curls significantly more than aerobic training ( p strength ( p physical work capacity ( PWC ) [ p strength and aerobic training may increase upper-body strength , and that both types of training may increase PWC for children with CF . Future trials should be conducted with no-training control subjects and larger sample s to increase statistical power",
"This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS Boston University Patricia Cortes Harvard University Claudia Goldin Swarthmore College Jennifer",
"Although exercise may be beneficial in cystic fibrosis ( CF ) , patients ' low tolerance to climatic heat stress means that physical exertion can increase morbidity and mortality . We postulated that the high salt content of CF patients ' sweat and the consequent absence of body-fluid hyperosmolality during a long episode of sweating might deprive such patients of a thirst stimulus . Eight children with CF ( four boys , four girls ; aged 9.5 - 14.1 years ) and eight controls , matched for age and sex , attended two r and omly ordered sessions of exercise ( cycling ) in a chamber at 31 - 33 degrees C , relative humidity 43 - 47 % . 20 min bouts of exercise ( at 45 % of predetermined maximum oxygen uptake ) were interspersed with 25 min rest periods . At one session , chilled water was given every 15 - 20 min to replace fluid lost ; at the other , drinking was guided by the child 's thirst . At the thirst-guided session , CF patients drank much less than the controls did ( 0.80 % vs 1.73 % initial body weight ) and lost twice as much fluid ( 1.57 % vs 0.78 % initial body weight ) . The recovery of heart rate after exercise was slower in CF patients , but there were no other signs of heat strain . The groups did not differ in any variable during the forced drinking session . We conclude that children with CF underestimate their fluid needs and undergo excessive dehydration during extended exposure to hot conditions",
"The purpose of this study was to investigate symptoms , lactate accumulation and limiting factors at peak exercise in cystic fibrosis ( CF ) patients . In total , 104 CF adults attending an adult CF centre and 27 controls performed progressive cycle ergometry to a symptom-limited maximum . Measurements taken at peak exercise included : heart rate , ventilation , oxygen uptake , carbon dioxide output , oxygen saturation and blood lactate . Symptom scores of perceived breathlessness and muscle effort were recorded using Borg scales . The CF subjects had a lower mean body mass index , forced expiratory volume in one second ( FEV1 ) and peak oxygen uptake than controls . Peak lactate concentrations were very similar to controls ( mean±sd 6.8±2.0 mmol·L−1 versus 7.4±1.0 mmol·L−1 ) . Symptom scores were no different to controls for either breathlessness ( 4.5±2.0 versus 4.3±1.0 ) or perceived muscle effort ( 6.1±2.0 versus 6.5±1.0 ) , with higher scores for muscle effort than breathlessness in both groups . In addition , peak ventilation was lower than the predicted maximum , and high peak heart rates were recorded supporting nonpulmonary factors as important in limiting peak exercise . Peak oxygen uptake was correlated with FEV1 . Comparison of CF subjects with mild or moderate pulmonary disease and controls revealed similar exercise responses . In contrast , those CF patients with severe lung disease ( FEV1 higher breathlessness , lower muscle effort scores , lower peak lactate , lower peak heart rate and a mean ventilation exceeding predicted , thus confirming that ventilation was the major factor limiting exercise . In conclusion , cystic fibrosis subjects have a reduced peak exercise capacity , but their exercise response is similar to controls in generating high blood-lactate concentrations and symptoms of muscle effort in excess of dyspnoea . Nonpulmonary factors influence peak performance more in those without severe disease",
"We determined the effect of a school-based exercise training ( ET ) without dietary intervention , on body composition , fitness and cardiovascular risk in overweight/obese children . Subjects were 51 overweight/obese 6.5- to 12.5-year-old children ( 23 boys , 28 girls ; BMI 25.6+/-4.3 kg/m 2 ) , of whom 48 completed the program . Participants were enrolled in a 15-week aerobic training ( three 60-minute sessions/week ) . Working heart rate was between 120 - 185 beats/minute . Participation rate was 87 % . BMI , waist circumference , body composition ( bioimpedance ) , aerobic capacity ( treadmill ) , blood pressure , lipids and insulin sensitivity ( HOMA ) were assessed . Waist circumference ( 85.9+/-12.4 vs. 80.9+/-10.2 cm ) , muscle mass ( 32.4+/-6.2 vs. 33.7+/-6.1 kg ) , maximal oxygen consumption ( 37.0+/-3.9 vs. 42.6+/-11.2 ml/kg per minute ) , systolic blood pressure ( 113.3+/-11.2 vs. 106.7+/-11.6 mmHg ) and LDL cholesterol ( 2.4+/-0.6 vs. 1.9+/-0.6 mM/l ) improved significantly . Number of children with abdominal obesity ( 29 vs. 20 ) , hypertension ( 10 vs. 5 ) and elevated triglyceride ( 18 vs. 14 ) also declined significantly over time . We concluded that as a result of high attendance and appropriate training program , cardiovascular fitness and abdominal obesity improved in overweight/obese children along with the improvement in metabolic risk factor profile",
"OBJECTIVE To examine the effectiveness of high-intensity aerobic training compared with low-intensity training in terms of energy cost of locomotion , peak oxygen uptake , peak power , and self-reported physical function in children with juvenile idiopathic arthritis ( JIA ) . METHODS Eighty children with JIA , ages 8 - 16 years , were enrolled in a r and omized , single-blind controlled trial . Both groups participated in a 12-week , 3-times-weekly training program consisting of high-intensity aerobics in the experimental group and qigong in the control group . Subjects underwent exercise testing measuring submaximal oxygen uptake at 3 km/hour ( VO(2submax ) ) as the primary outcome , maximal oxygen uptake , and peak power at the beginning and end of the program . Physical function was measured using the Child Health Assessment Question naire ( C-HAQ ) . RESULTS The exercise program was well tolerated in both groups . There was no difference in VO(2submax ) or any other exercise testing measures between the groups through the study period and no indication of improvement . Both groups showed significant improvements in C-HAQ with no difference between the groups . Adherence was higher in the control group than the experimental group . CONCLUSION Our findings suggest that activity programs with or without an aerobic training component are safe and may result in an important improvement in physical function . The intensity of aerobic training did not seem to provide any additional benefits , but higher adherence in the qigong program may suggest that less intensive regimens are easier for children with JIA to comply with , and provide a degree of benefit equivalent to more intensive programs",
"OBJECTIVES The aim of this study was to determine the effects of physical activity on systemic blood pressure ( BP ) and early markers of atherosclerosis in pre-pubertal obese children . BACKGROUND Hypertension and endothelial dysfunction are premature complications of obesity . METHODS We performed a 3-month r and omized controlled trial with a modified crossover design : 44 pre-pubertal obese children ( age 8.9 + or - 1.5 years ) were r and omly assigned ( 1:1 ) to an exercise ( n = 22 ) or a control group ( n = 22 ) . We recruited 22 lean children ( age 8.5 + or - 1.5 years ) for baseline comparison . The exercise group trained 60 min 3 times/week during 3 months , whereas control subjects remained relatively inactive . Then , both groups trained twice/week during 3 months . We assessed changes at 3 and 6 months in office and 24-h BP , arterial intima-media thickness ( IMT ) and stiffness , endothelial function ( flow-mediated dilation ) , body mass index ( BMI ) , body fat , cardiorespiratory fitness ( maximal oxygen consumption [ VO(2)max ] ) , physical activity , and biological markers . RESULTS Obese children had higher BP , arterial stiffness , body weight , BMI , abdominal fat , insulin resistance indexes , and C-reactive protein levels , and lower flow-mediated dilation , VO(2)max , physical activity , and high-density lipoprotein cholesterol levels than lean subjects . At 3 months , we observed significant changes in 24-h systolic BP ( exercise -6.9 + or - 13.5 mm Hg vs. control 3.8 + or - 7.9 mm Hg , -0.8 + or - 1.5 st and ard deviation score [ SDS ] vs. 0.4 + or - 0.8 SDS ) , diastolic BP ( -0.5 + or - 1.0 SDS vs. 0 + or - 1.4 SDS ) , hypertension rate ( -12 % vs. -1 % ) , office BP , BMI z-score , abdominal fat , and VO(2)max . At 6 months , change differences in arterial stiffness and IMT were significant . CONCLUSIONS A regular physical activity program reduces BP , arterial stiffness , and abdominal fat ; increases cardiorespiratory fitness ; and delays arterial wall remodeling in pre-pubertal obese children . ( Effects of Aerobic Exercise Training on Arterial Function and Insulin Resistance Syndrome in Obese Children : A R and omized Controlled Trial ; NCT00801645 )",
"Background . Obesity has become the most common pediatric chronic disease in the modern era . Early prevention and treatment of childhood and adolescent obesity is m and ated . Surprisingly , however , only a minor fraction of obese children participate in weight reduction interventions , and the longer-term effects of these weight-reduction interventions among children have not been eluci date d. Objective . To examine prospect ively the short- and long-term effects of a 3-month , combined dietary-behavioral-physical activity intervention on anthropometric measures , body composition , dietary and leisure-time habits , fitness , and lipid profiles among obese children . Methods . In this r and omized prospect i ve study , 24 obese subjects completed the 3-month intervention and were compared with 22 obese , age- and gender-matched , control subjects . Results . At 3 months , there were significant differences in changes in body weight ( −2.8 ± 2.3 kg vs 1.2 ± 2.2 kg ) , BMI ( −1.7 ± 1.1 kg/m2 vs −0.2 ± 1.0 kg/m2 ) , body fat percentage ( from skinfold tests ; −3.3 ± 2.6 % vs 1.4 ± 4.7 % ) , serum total cholesterol level ( −24.6 ± 15.1 mg/dL vs 0.8 ± 18.7 mg/dL ) , low-density lipoprotein cholesterol level ( −23.3 ± 15.2 mg/dL vs −3.7 ± 17.3 mg/dL ) , and fitness ( 215 ± 107 seconds vs 50 ± 116 seconds ) in the intervention group versus the control group . After a 1-year follow-up period , there were significant differences between the intervention group ( n = 20 ) and the control group ( n = 20 ) in body weight ( 0.6 ± 6.0 kg vs 5.3 ± 2.7 kg ) , BMI ( −1.7 ± 2.3 kg/m2 vs 0.6 ± 0.9 kg/m2 ) , and body fat percentage . There was a significant increase in leisure-time physical activity among the intervention participants , compared with a decrease among the control subjects . Conclusions . Our data demonstrate the short- and longer-term beneficial effects of a combined dietary-behavioral-physical activity intervention among obese children . These results highlight the importance of multidisciplinary programs for the treatment of childhood obesity and emphasize their encouraging long-term effects",
"BACKGROUND Children 's physical activity patterns are characterized by short-term anaerobic activities . Anaerobic exercise performance in children with cystic fibrosis ( CF ) has received little attention compared to aerobic performance . This study investigated the effects of anaerobic training in children with CF . DESIGN AND METHODS Twenty patients were r and omly assigned to the training group ( TG ) [ 11 patients ; mean ( + /- SD ) age , 13.6 + /- 1.3 years ; mean FEV(1 ) , 75.2 + /- 20.7 % predicted ] or the control group ( CG ) [ 9 patients ; mean age , 14.2 + /- 2.1 years ; FEV(1 ) , 82.1 + /- 19.1 % predicted ] . The TG trained 2 days per week for 12 weeks , with each session lasting 30 to 45 min . The training program consisted of anaerobic activities lasting 20 to 30 s. The control subjects were asked not to change their normal daily activities . Body composition , pulmonary function , peripheral muscle force , habitual physical activity , aerobic and anaerobic exercise performance , and quality of life were reevaluated at the end of the training program , and again after a 12-week follow-up period . RESULTS Patients in the TG significantly improved their anaerobic performance , aerobic performance , and quality of life . No significant changes were seen in other parameters , and no improvements were found in CG . After the follow-up period , only anaerobic performance and quality of life in TG were significantly higher compared to pretraining values . CONCLUSIONS Anaerobic training has measurable effects on aerobic performance ( although not sustained ) , anaerobic performance , and health-related quality of life in children with CF . Therefore , anaerobic training could be an important component of therapeutic programs for CF patients",
"The purpose of this review is to summarize literature that describes the impact of exercise on health and physical function among children during and after treatment for cancer . Relevant studies were identified by entering the following search terms into Pubmed : aerobic training ; resistance training ; stretching ; pediatric ; children ; AND cancer . Reference lists in retrieved manuscripts were also review ed to identify additional trials . We include fifteen intervention trials published between 1993 and 2011 that included children younger than age 21 years with cancer diagnoses . Nine included children with an acute lymphoblastic leukemia ( ALL ) diagnosis , and six children with mixed cancer diagnoses . Generally , interventions tested were either in-hospital supervised exercise training or home based programs design ed to promote physical activity . Early evidence from small studies indicates that the effects of exercise include increased cardiopulmonary fitness , improved muscle strength and flexibility , reduced fatigue and improved physical function . Generalizations to the entire childhood cancer and childhood cancer survivor population s are difficult as most of the work has been done in children during treatment for and among survivors of ALL . Additional r and omized studies are needed to confirm these benefits in larger population s of children with ALL , and in population s with cancer diagnoses other than ALL",
"PURPOSE The purpose of our study was to assess the effects of an 8-wk intrahospital combined circuit weight and aerobic training program performed by children with cystic fibrosis ( of low-moderate severity and stable clinical condition ) on the following outcomes : cardiorespiratory fitness ( VO2peak ) and muscle strength ( five-repetition maximum ( 5RM ) bench press , 5RM leg press , and 5RM seated row ) ( primary outcomes ) and pulmonary function ( forced vital capacity , forced expiratory volume in 1 s ) , weight , body composition , functional mobility ( Timed Up and Down Stairs and 3-m Timed Up and Go tests ) , and quality of life ( secondary outcomes ) . We also determined the effects of a detraining period ( 4 wk ) on the aforementioned outcomes . METHODS We performed a r and omized controlled trial design . Eleven participants in each group ( controls : 7 boys , age = 11 ± 3 yr , body mass index = 17.2 ± 0.8 kg · m(-2 ) ( mean ± SEM ) ; intervention : 6 boys , age = 10 ± 2 yr , body mass index = 18.4 ± 1.0 kg · m(-2 ) ) started the study . RESULTS Adherence to training averaged 95.1 % ± 7.4 % . We observed a significant group × time interaction effect ( P = 0.036 ) for VO2peak . In the intervention group , VO2peak significantly increased with training by 3.9 mL · kg(-1 ) · min(-1 ) ( 95 % confidence interval = 1.8 - 6.1 mL · kg(-1 ) · min(-1 ) , P = 0.002 ) , whereas it decreased during the detraining period ( -3.4 mL · kg(-1 ) · min(-1 ) , 95 % confidence interval = -5.7 to -1.7 mL · kg(-1 ) · min(-1 ) , P = 0.001 ) . In contrast , no significant changes were observed during the study period within the control group . Although significant improvements were also observed after training for all 5RM strength tests ( P for the interaction effect ) , the training improvements were not significantly decreased after the detraining period in the intervention group ( all P > 0.1 for after training vs detraining ) . We found no significant training benefits in any of the secondary outcomes . CONCLUSIONS A short-term combined circuit weight and aerobic training program performed in a hospital setting induces significant benefits in the cardiorespiratory fitness and muscle strength of children with cystic fibrosis",
"Objectives To ascertain if motivational techniques and a structured exercise programme can increase activity in adolescents afflicted with congenital heart disease ( CHD ) . Design Prospect i ve r and omised controlled trial . Setting One hundred and forty-three patients aged 12–20 years attending the tertiary centre for paediatric cardiology in Northern Irel and . Main outcome measures Increase in exercise capacity as assessed by duration of exercise stress test , and number of minutes spent in moderate to vigorous physical activity ( MVPA ) per day . Results Eighty-six patients were men ( 60 % ) , mean age was 15.60±2.27 years . Seventy-three percent were considered to have major CHD . Seventy-two participants were r and omised to the intervention group . Following intervention , duration of exercise test increased by 1 min 5 s for the intervention group ( p value 0.02 ) along with increase in predicted VO2Max ( p value 0.02 ) . There was a significant increase in minutes of MVPA per day for the intervention group from baseline to re assessment ( p value MVPA remained much the same for the control group . Fourteen patients met the current recommendation for more than 60 min MVPA per day at baseline . This doubled to 29 participants at re assessment . There were no adverse effects or mortalities reported . Conclusions Exercise training is safe , feasible and beneficial in adolescents with CHD . Psychological techniques can be employed to maximise the impact of interventions . Trial Registration Number IS RCT N27986270",
"OBJECTIVE To assess the effect of a training protocol on aerobic and anaerobic fitness in children with asthma . STUDY DESIGN Sixteen boys ( mean age : 13 years ; range : 10 - 16 years ) with mild-to-moderate asthma participated in a rehabilitation program that included 6 weeks of individualized training on a cycle ergometer . Two groups were r and omly formed : the control group ( CG , n = 7 ) and the training group ( TG , n = 9 ) , which exercised at an intensity set at the heart rate corresponding to the ventilatory threshold , with 1-minute sprints against the maximal aerobic power ( MAP ) every 4 minutes . Session duration was 45 minutes , 3 sessions per week . Changes in maximal oxygen uptake ( VO(2)max ) , MAP , short-term peak power ( PP ) , and pulmonary function were assessed . RESULTS Two patients of the training group did not complete the study . Pulmonary function remained unchanged in both groups . Improvement in both aerobic and anaerobic fitness was significant only in the training group ( TG vs CG ) : VO(2)max + 18 % + /- 2.1 % versus + 9 % + /- 4.5 % ( P MAP + 32 % + /- 5 % versus 12 % + /- 7 % ( P PP + 21 % + /- 5.7 % versus + 8.8 % + /- 10 % ( P Exercise training with high-intensity bouts is well tolerated in children with mild-to-moderate asthma . When included in a global rehabilitation program , this type of training improves both aerobic and anaerobic fitness . Anaerobic activities should be considered in sports rehabilitation programs for children with asthma",
"Raised blood pressure ( BP ) response during exercise independently predicts future hypertension . Subjects with higher BP in childhood also have elevated BP later in life . Therefore , the factors related to the regulation of exercise BP in children needs to be well understood . We hypothesized that physiological cardiovascular disease ( CVD ) risk factors would influence BP response during exercise in children and adolescents . This is a cross-sectional study of 439 Danish third- grade children and 364 ninth- grade adolescents . Systolic blood pressure ( SBP ) was measured with sphygmomanometer during a maximal aerobic fitness test . Examined CVD risk factors were high-density lipoprotein (HDL)- and low-density lipoprotein (LDL)-cholesterol , triglyceride , homeostasis model of assessment of insulin resistance ( HOMA-IR ) score , body mass index ( BMI ) , waist circumference , and aerobic fitness . A r and om effect model was used to test the hypotheses . In boys , HOMA-IR score and BMI were positively related to SBP response during exercise ( β = 1.03 , P = 0.001 , and β = 0.58 , P = 0.017 , respectively ) . The effects sizes of HOMA-IR score and BMI and the significance levels only changed slightly ( β = 0.91 , P = 0.004 , and β = 0.43 , P = 0.08 , respectively ) when the two variables were added in the same model . A significant positive association was observed between aerobic fitness and SBP response in girls ( β = 3.13 and P = 0.002 ) . HOMA-IR score and BMI were found to be positively related to the SBP response in male children and youth . At least partly , adiposity and insulin sensitivity seem to influence exercise SBP through different mechanisms . The positive relationship observed between aerobic fitness and SBP response in girls remains unexplainable for us , although post hoc analyses revealed that it was the case in the ninth grade rs only",
"PURPOSE Aerobic training has been shown to be effective in improving cardiopulmonary fitness in asthmatic children . However , the actual impact of physical training on clinical indicators of disease control remains controversial . METHODS Thirty-eight children with moderate to severe persistent asthma were r and omly assigned to control ( N=17 ) and training ( N=21 ) groups . Spirometry , exercise challenge , and maximum incremental cardiopulmonary exercise tests were performed 16 wk apart . Daily doses of inhaled steroids and Pediatric Asthma Quality of Life Question naire ( PAQLQ ) scores were also recorded . RESULTS Physical training was associated with significant improvements in physiological variables at peak and submaximal exercise ( P Severity of exercise-induced bronchoconstriction ( EIB ) and postexercise breathlessness were significantly lessened in trained patients ; improvement in fitness and EIB , however , were not linearly related ( P>0.05 ) . In addition , PAQLQ scores improved only in trained children ( P Daily doses of inhaled steroids were reduced in trained patients ( 52 % ) , but they remained unchanged or increased in controls ( 70.6 % ) ( P=0.07 ) . CONCLUSION Supervised exercise training might be associated with beneficial effects on disease control and quality of life in asthmatic children . These data suggest an adjunct role of physical conditioning on clinical management of patients with more advanced disease",
"Abstract This study examined the effects of a 6-week intermittent exercise training , at different intensities , on body composition , functional walking and aerobic endurance in overweight children . Forty-eight overweight children ( age : 10.4 ± 0.9 years ) were r and omly assigned to either intervention or control group . Lower and higher intensity intermittent exercise groups ( LIIE and HIIE ) performed intermittent running three times a week . LIIE performed more intervals at a lower intensity [ 16 intervals at 100 % of individual maximal aerobic speed ( MAS ) , 8 minutes in total ] , and HIIE performed fewer intervals at a higher intensity ( 12 intervals at 120 % of MAS , 6 minutes in total ) . Each interval consisted of a 15-second run at the required speed , followed by a 15-second passive recovery . After 6 weeks , HIIE had a significantly ( p 0.05 ) higher percentage reduction in sum of skinfolds ( i.e. calf and triceps ) , and significantly ( p performance , as compared with LIIE and control group . Significant improvement ( p in intermittent aerobic endurance for HIIE as compared to the control group . Higher intensity intermittent training is an effective and time-efficient intervention for improving body composition , functional walking and aerobic endurance in overweight children",
"OBJECTIVE . Children participating in a dietary clinical trial were studied to ( 1 ) assess physical activity patterns in boys and girls longitudinally from late childhood through puberty and ( 2 ) determine the association of level of physical activity on systolic blood pressure , low-density lipoprotein cholesterol , and BMI . PATIENTS AND METHODS . In the Dietary Intervention Study in Childhood , a r and omized clinical trial of a reduced saturated fat and cholesterol diet in 8- to 10-year-olds with elevated low-density lipoprotein , a question naire that determined time spent in 5 intensity levels of physical activity was completed at baseline and at 1 and 3 years . An estimated-metabolic-equivalent score was calculated for weekly activity ; hours per week were calculated for intense activities . We hypothesized that weekly self-reported physical activity would be associated with lower systolic blood pressure , low-density lipoprotein , and BMI over 3 years . Longitudinal data analyses were performed for each outcome ( systolic blood pressure , low-density lipoprotein , and BMI ) by using generalized estimating equations with estimated-metabolic-equivalent score per week as the independent variable adjusted for visit , gender , and Tanner stage ( BMI was included in models for systolic blood pressure and low-density lipoprotein ) . RESULTS . The initial study cohort comprised 663 youths ( 362 boys [ mean age : 9.7 years ] and 301 girls [ mean age : 9.0 years ) , of whom 623 ( 94 % ) completed the 3-year visit . For every 100 estimated-metabolic-equivalent hours of physical activity , there was a decrease of 1.15 mmHg of systolic blood pressure . There was a 1.28 mg/dL decline in low-density lipoprotein for a similar energy expenditure . For BMI , an analysis of intense physical activity showed that for every 10 hours of intense activity , there was a trend toward significance with a 0.2 kg/m2 decrease . CONCLUSIONS . Children with elevated cholesterol levels who lead a more physically active lifestyle have lower systolic blood pressure and a trend toward lower low-density lipoprotein over a 3-year interval . Long-term participation in intense physical activity may reduce BMI as well",
"To investigate the anaerobic capacity in children with bronchial asthma , eight male children with atopic asthma ( age : 12 + /- 1.7 yr ) and seven healthy control subjects ( age : 12 + /- 1 yr ) performed a 30-s all-out exercise test : the Wingate anaerobic test ( WanT ) . Post-exercise plasma epinephrine ( E ) , norepinephrine ( NE ) , venous blood lactate ( La ) , and blood pH levels were determined . Peak power ( Ppeak ) , mean power ( Pm ) , and total energy expenditure ( Wtot ) during the WanT were assessed . The relative importance of aerobic ( WO2 ) and anaerobic ( Wana ) energy release during the WanT was also evaluated . In comparison with control subjects , the children with asthma exhibited lower Ppeak ( W.kg-1 ) : 6 + /- 1.14 vs 7.3 + /- 0.5 , P contribution of WO2 ( 26 % ) and Wana ( 74 % ) to the Wtot was identical in both groups . Blood lactate and pH kinetics revealed significantly lower La values and less acidosis in the asthmatic group ( P E ( pg.ml-1 ) concentrations were lower in the asthmatic group : 274.96 + /- 84.58 vs 901.28 + /- 604.76 , P reduced anaerobic capacity in children with asthma . A diminished adrenergic response to exhausting exercise , leading to a decreased anaerobic glycolysis , could partly account for this phenomenon",
"The purpose of this study was to determine if an eight-week intrahospital supervised , conditioning program improves functional capacity and quality of life ( QOL ) in children ( 4 boys , 4 girls ) ( mean [ SD ] age : 10.9 [ 2.8 ] years [ range : 8 - 16 ] ) who have undergone bone marrow transplantation ( BMT ) for leukemia treatment within the last 12 months . A group of 8 age and gender-matched healthy children served as controls . The experimental group performed 3 weekly sessions of resistance and aerobic training inside an intra-hospital gymnasium . A significant combined effect of group and time ( p muscle functional capacity ( Timed Up and Down Stairs [ TUDS ] test ) and peak oxygen uptake ( V.O(2peak ) ) , i.e. , with BMT children showing greater improvements than controls ( V.O(2peak ) at pre- and post-training of 25.9 ( 8.2 ) and 31.1 ( 7.6 ) mL/kg/min in diseased children ) . Muscle strength ( 6 RM test for bench and leg press and seated row ) also improved after training ( p BMT group . Concerning QOL , a significant combined effect of group and time ( p children 's self-report of comfort and resilience and for parents ' report of their children 's satisfaction and achievement . In summary , children who have received BMT experience physical and overall health benefits after a relatively short-term ( 8 weeks ) supervised exercise training program",
"OBJECTIVE To 1 ) assess the safety and feasibility of laboratory-based exercise testing in juvenile idiopathic arthritis ( JIA ) , 2 ) test the safety and feasibility of a 3-month exercise program in JIA , 3 ) assess pain during exercise in JIA , 4 ) compare ratings of perceived effort ( RPE ) with heart rate ( HR ) achieved , and 5 ) estimate the training effect on metabolic efficiency of gait as measured by submaximal exercise testing . METHODS Nine children with JIA were enrolled in a 12-week circuit training program involving pool , stationary bicycle , treadmill , and Fitball . They underwent formal exercise testing before and after the program , underwent a full joint assessment , were administered the Childhood Health Assessment Question naire and Juvenile Arthritis Functional Status Index , and were assessed for overall quality of life and health-related quality of life . A visual analog scale was used to assess pain during testing and training , and the Borg scale was used to measure RPE . RESULTS Children with JIA were able to participate in exercise testing without any significant problems . Children with severe hip disease dropped out of the exercise program due to pain during the exercise sessions and worsened arthritis symptoms . Target HR was achieved and correlated with RPE in the bicycle and treadmill sessions . Submaximal exercise testing showed an improvement with a small to moderate effect size . CONCLUSION This study suggests that it is safe , feasible , and acceptable for children with arthritis , in the absence of severe hip involvement , to participate in formal exercise testing and structured fitness programs",
"The aim of this study was to compare aerobic and resistance training in children with cystic fibrosis ( CF ) admitted to hospital with an intercurrent pulmonary infection with a control group . The subjects were r and omized into three groups on the first day of admission . The fat-free mass ( FFM ) was calculated , using the skin fold thickness from four sites ( biceps , triceps , subscapular , and iliac crest ) . Pulmonary function tests were performed within 36 hr of admission and repeated on discharge from the hospital , and again at 1 month after discharge . All subjects performed an incremental treadmill exercise test , using a modified Bruce protocol . Lower limb strength was measured using a Cybex dynamometer . An assessment of quality of life was made using the Quality of Well Being Scale , as previously reported . Activity levels were measured using a 7-day activity diary , and subjects also wore an accelerometer on their hips . There were no significant differences between the three groups in terms of disease severity , and length of stay in hospital . Subjects in all three groups received intravenous antibiotics and nutritional supplementation as determined by the physician . Children r and omized to the aerobic training group participated in aerobic activities for five sessions , each of 30-min duration , a week . The children r and omized to the resistance training group exercised both upper and lower limbs against a grade d resistance machine . Subjects in the control group received st and ard chest physiotherapy . Our study demonstrated that children who received aerobic training had significantly better peak aerobic capacity , activity levels , and quality of life than children who received the resistance training program . Children who received resistance training had better weight gain ( total mass , as well as fat-free mass ) , lung function , and leg strength than children who received aerobic training . A combination of aerobic and resistance training may be the best training program , and future studies to assess optimal training programs for CF patients are indicated",
"Background The purpose of this study ( r and omised controlled trial ) was to assess the effects of an 8-week combined ‘ whole muscle ’ ( resistance+aerobic ) and inspiratory muscle training ( IMT ) on lung volume , inspiratory muscle strength ( PImax ) and cardiorespiratory fitness ( VO2 peak ) ( primary outcomes ) , and dynamic muscle strength , body composition and quality of life in paediatric out patients with CF ( cystic fibrosis , secondary outcomes ) . We also determined the effects of a detraining period . Methods Participants were r and omly allocated with a block on gender to a control ( st and ard therapy ) or intervention group ( initial n=10 ( 6 boys ) in each group ; age 10±1 and 11±1 years ) . The latter group performed a combined programme ( IMT ( 2 sessions/day ) and aerobic+strength exercises ( 3 days/week , in-hospital ) ) that was followed by a 4-week detraining period . All participants were evaluated at baseline , post-training and detraining . Results Adherence to the training programme averaged 97.5%±1.7 % . There was a significant interaction ( group × time ) effect for PImax , VO2peak and five-repetition maximum strength ( leg-press , bench-press , seated-row ) ( all ( p also for % fat ( p and % fat-free mass ( p=0.001 ) , with training exerting a significant beneficial effect only in the intervention group , which was maintained after detraining for PImax and leg-press . Conclusion The relatively short-term ( 8-week ) training programme used here induced significant benefits in important health phenotypes of paediatric patients with CF . IMT is an easily applicable intervention that could be included , together with supervised exercise training in the st and ard care of these patients",
"Exercise training is currently advocated as part of the treatment of patients with cystic fibrosis ( CF ) . However , data are few that document physiologic benefits or changes in patients ' perceptions of long-term training programs in children with CF . The aim of this study was to investigate the effects and acceptability of a home cycling program in children with CF . Fourteen patients ( 9 boys , 5 girls ) with CF , mean ( SD ) age 14.1 ( 2.0 ) years , with mild to moderate impairment of lung function ( forced expiratory volume in 1 s , mean ( SD ) 58.3 (16.3)% of predicted ) were studied for 1 year . The first half of the study year was used to obtain baseline values at 0 and 6 months . During the second half of the year , a cycle program was carried out 5 times a week , for 20 min each day at a level of work that result ed in a heart rate of 140 - 160 beats/min . Once a week the cycle program was supervised by a physiotherapist . Measurements were repeated at 12 months . Effects of the exercise program were measured in terms of lung function , nutritional status , growth , muscle strength , exercise performance , perceived competence , and attitude towards the training program . Differences between the changes during the 6-month training period as compared to the 6-month control period were analyzed by multivariate statistics and nonparametric tests . Statistically significant differences ( P muscle strength of knee extensors and ankle dorsiflexors , and with respect to maximal oxygen consumption per kg body weight as well as per kg fat free mass . All changes were positive . No adverse effects were found . Perceived competence showed significant positive changes in feelings about physical appearance , general self-worth , and Total Perceived Competence Score . Scores concerning perceived acceptability of the program were significantly lower at the end of the training period ; however , patients reported that they did want to continue with other sorts of training . We conclude that an exercise training program in the home can produce beneficial effects on oxygen consumption , muscle force , and perceived competence in children with CF . However , acceptability of the program was low , suggesting that long-term adherence would be poor , and hence , other sorts of training need to be identified",
"OBJECTIVES The present study aim ed to assess the effect of a 6-month exercise program in obese children on flow-mediated vasodilation ( FMD ) carotid intima-media thickness ( IMT ) and cardiovascular risk factors ( RF ) . BACKGROUND Childhood obesity contributes to adult obesity and subsequent cardiovascular disease . Physical inactivity is a major RF for obesity , endothelial dysfunction , and elevated carotid IMT , culminating in early atherosclerotic disease . METHODS Sixty-seven obese subjects ( age 14.7 + /- 2.2 years ) were r and omly assigned to 6 months ' exercise or non-exercise protocol . We examined the influence of exercises ( 1 h , 3 times/week ) on FMD , IMT , and cardiovascular risk profile . RESULTS Compared with lean control subjects , obese children demonstrated at baseline significantly impaired FMD ( 4.09 + /- 1.76 % vs. 10.65 + /- 1.95 % , p increased IMT ( 0.48 + /- 0.08 mm vs. 0.37 + /- 0.05 mm , p obesity-related cardiovascular RF . Significant improvements were observed in the exercise group for IMT ( 0.44 + /- 0.08 mm , p = 0.012 , -6.3 % ) and FMD ( 7.71 + /- 2.53 % , p body mass index st and ard deviation scores , body fat mass , waist/hip ratio , ambulatory systolic blood pressure , fasting insulin , triglycerides , low-density lipoprotein/high-density lipoprotein ratio , and low-degree inflammation ( C-reactive protein , fibrinogen ) . CONCLUSIONS The present study documented increased IMT , impaired endothelial function , and various elevated cardiovascular RF in young obese subjects . Regular exercise over 6 months restores endothelial function and improves carotid IMT associated with an improved cardiovascular risk profile in obese children",
"UNLABELLED The aim of this study is to estimate the prevalence of overweight and obesity in a current , nationally representative , r and om sample of pre-school-aged children in Pol and and to compare their overweight and obesity rates with their peers from the US and Norway . MATERIAL AND METHODS The height and weight were measured in a total of 5026 r and omly sample d children aged 2 - 6 years and their Body Mass Index was calculated . The prevalence of overweight including obesity was determined using three definitions , i.e. those formulated by the International Obesity Task Force ( IOTF ) , the World Health Organization ( WHO ) and the Centers for Disease Control and Prevention ( CDC ) . RESULTS The overall prevalence of overweight including obesity in boys was 12.2 % , 12.2 % , 17.2 % and in girls 15.0 % , 10.0 % , 19.1 % according to the IOTF , WHO , CDC definition , respectively , and did not significantly differ in comparison with their US and Norwegian peers . The overall prevalence of obesity in boys was : 4.4 % , 4.9 % , 8.9 % and in girls : 3.8 % , 3.4 % , 7.6 % , according to the IOTF , WHO , CDC definition , respectively . Among Polish girls the obesity rate was higher compared to the female US peers . The obesity rate was higher in Polish boys compared to their Norwegian peers . CONCLUSION The estimates of the prevalence of overweight and obesity varied substantially by age group , gender and depending on the definition used . Obesity rates among Polish girls and boys were higher compared to their American and Norwegian peers . The influence of overweight definitions should be taken into account when study ing childhood overweight and obesity . Overweight and obesity preventive programs should be implemented at preschool age",
"BACKGROUND In cystic fibrosis ( CF ) patients the right ventricle ( RV ) suffers a progressive deterioration , but it is not clear when these changes begin . The aim of this study was to analyze the RV function in CF patients with mild respiratory disease . METHODS Color-Doppler-Echocardiographic studies were prospect ively performed in CF adolescent patients and an age-matched control group . Findings were correlated with pulmonary function tests ( PFT ) , genotype , chronic bacterial colonization , pancreatic status and clinical scores . Only patients with mild CF were selected . RESULTS Thirty seven CF patients and 40 healthy controls were recruited . In CF patients all echocardiographic parameters were abnormal compared to controls . Doppler analysis showed slightly elevated pulmonary artery pressure values , and abnormal relaxation and systolic function for all indexes . No correlation was found with any of the features studied . CONCLUSIONS In CF patients , abnormalities in the structure and function of the RV may be present at early stages of the disease . These abnormalities are sub clinical and do not correlate with clinical scores , PFT , genotype , chronic bacterial colonization or pancreatic insufficiency",
"Background Altered nutrient intake and decreased exercise in response to cancer therapies and their side effects , particularly corticosteroids , may be key factors in the increased body weight and differences in physical fitness reported in survivors of childhood acute lymphoblastic leukemia ( ALL ) . Purpose To assess ( 1 ) the effect of a home-based nutrition and exercise intervention program on cardiovascular fitness , strength , and flexibility in children with ALL during maintenance therapy and ( 2 ) the feasibility of conducting and evaluating a home-based exercise and nutrition program in this patient population . Design Children ages 4 to 10 years with st and ard-risk ALL were r and omized when starting maintenance therapy to a 12-month home-based exercise and nutrition program ( n=6 , 3 males/3 females ) or control ( n=7 , 4 males/3 females ) group . Assessment of anthropometrics , dietary intake , physical activity , and fitness was performed at baseline and 6 and 12 months of study . Results Although age , body size , and nutrient intakes were similar between both subject groups at 0 , 6 , and 12 months , exercise and nutrition program children had greater improvement in physical activity and cardiovascular fitness between 6 and 12 months than control children . Conclusions These results suggest that a home-based exercise intervention during maintenance therapy encouraged greater physical activity and improved cardiovascular fitness in children with st and ard-risk ALL . Further investigation involving larger population s of children with ALL is warranted",
"Design Non-r and omised non-blinded school-based intervention study . Setting Two schools in the cities of Pune and Nasik , India . Participants The intervention group comprised children attending a Pune school from 7–10 years until 12–15 years of age . Two control groups comprised children of the same age attending a similar school in Nasik , and children in the Pune intervention school but aged 12–15 years at the start of the study . Intervention A 5-year multi-intervention programme , covering three domains : physical activity , diet and general health , and including increased extracurricular and intracurricular physical activity sessions ; daily yoga-based breathing exercises ; making physical activity a ‘ scoring ’ subject ; nutrition education ; healthier school meals ; removal of fast-food hawkers from the school environs ; and health and nutrition education for teachers , pupils and families . Main outcome measures Body mass index ( BMI ) , waist circumference , physical fitness according to simple tests of strength , flexibility and endurance ; diet ; and lifestyle indicators ( time watching TV , study ing and actively playing ) . Results After 5 years the intervention children were fitter than controls in running , long jump , sit-up and push-up tests ( p spending less time sedentary ( watching TV and study ing ) , more time actively playing and eating fruit more often ( p reduce BMI or the prevalence of overweight/obesity , but waist circumference was lower than in the Pune controls ( p=0.004 ) . Conclusions It was possible to achieve multiple health-promoting changes in an academically competitive Indian school . These changes result ed in improved physical fitness , but had no impact on the children 's BMI or on the prevalence of overweight/obesity ",
"PURPOSE Insulin resistance is thought to be a core defect in the pathophysiology of obesity-related comorbidities in children , such as type 2 diabetes . Exercise training is known to improve insulin resistance and reduce the risk of type 2 diabetes in adults . However , very little is known regarding the effects of exercise on insulin resistance in youth . Therefore , we examined the effects of a 16-wk resistance training exercise intervention on insulin sensitivity in youth at high risk for developing type 2 diabetes . METHODS Twenty-two overweight Latino adolescent males were r and omly assigned to either a twice-per-week resistance training group ( RT=11 ) or a nonexercising control group ( C=11 ) for 16 wk . Strength was assessed by one-repetition maximum , body composition was quantified by dual-energy x-ray absorptiometry , and insulin sensitivity was determined by the frequently sample d intravenous glucose tolerance test with minimal modeling . RESULTS Significant increases in upper- and lower-body strength were observed in the RT compared with the C group . The RT group significantly increased insulin sensitivity compared with the C group ( P baseline values , insulin sensitivity increased 45.1+/-7.3 % in the RT group versus -0.9+/-12.9 % in controls ( P resistance training program can significantly increase insulin sensitivity in overweight Latino adolescent males independent of changes in body composition",
"OBJECTIVE To investigate the effects of regular submaximal exercise on quality of life , exercise capacity and pulmonary function in asthmatic children . PATIENTS AND METHODS Sixty-two children with mild-moderate asthma ( mean age 10.4 ( SD 2.1 ) years ) were r and omly allocated into exercise and control groups . The exercise group underwent a moderately intensive basketball training program for 8 weeks . A home respiratory exercise program was advised to both groups . Pediatric Asthma Quality of Life Question naire ( PAQLQ ) was used for the evaluation of activity limitation , symptoms and emotional functions . Exercise capacity was evaluated through the physical work capacity ( PWC 170 test ) on a cycle ergometer and 6-minute walk test . Spirometric tests were also performed and medication and symptom scores were recorded . RESULTS Although PAQLQ scores improved in both groups , the improvement in the exercise group was significantly higher . The exercise group performed better in the PWC 170 and 6-minute walk tests , whereas no improvement was detected in the control group at the end of the trial . Medication scores improved in both groups , but symptom scores improved only in the exercise group . No significant changes were detected in pulmonary function in either group , except for peak expiratory flow values in the exercise group . CONCLUSION Eight weeks of regular submaximal exercise has beneficial effects on quality of life and exercise capacity in children with asthma . Submaximal basketball training is an effective alternative exercise program for asthmatic children",
"PURPOSE Data from the general population suggest that habitual exercise decreases bronchial responsiveness , but the possible role of exercise in asthmatics is undefined . The leukotriene receptor antagonist montelukast decreases bronchial responsiveness and exercise-induced symptoms in asthmatic children . This r and omized study in children with mild asthma evaluated the combined effects of aerobic training for 12 wk and montelukast or placebo on bronchial responsiveness ( BHR ) to methacholine , exercise-induced bronchoconstriction ( EIB ) , inflammatory markers in exhaled breath condensate ( EBC ) , and asthma exacerbations . METHODS Fifty children ( mean age + /- SD : 10.2 + /- 2.4 yr ) with mild stable asthma were r and omly assigned to placebo ( N = 25 ) or montelukast ( N = 25 ) . Before and after training , we assessed BHR and EIB and markers of airway inflammation-that is , exhaled nitric oxide ( eNO ) , pH , and cysteinyl-leukotriene concentration-in EBC . RESULTS Training increased maximal workload and peak minute ventilation . After training , the methacholine dose causing a 20 % fall in FEV1 ( PD20 ) increased in both groups . A decreased slope of FEV1 decline at increasing methacholine dose was found only in montelukast-treated children . EIB prevalence halved after training in both groups ( EIB + children , placebo group : 10 pretraining , 4 posttraining ; EIB + children , montelukast group : 8 pretraining , 5 posttraining ; P Resting eNO was unaffected , whereas the pH of EBC decreased after training in both groups . Cysteinyl-leukotriene concentrations were low in most children at both times . During training , montelukast-treated children showed fewer asthma exacerbations compared with the same period of the previous year . CONCLUSIONS In children with mild stable asthma , exercise training decreased bronchial responsiveness to methacholine . Montelukast also decreased bronchial reactivity ( FEV1 slope ) and protected against exacerbations , suggesting a beneficial synergistic action of these two interventions in mild asthma",
"BACKGROUND The purpose of this study was to examine the effects of physical therapy intervention in children with acute lymphoblastic leukemia ( ALL ) . PROCEDURE Twenty-eight children aged 4 - 15 years were r and omly assigned to an intervention or control group . The intervention group received five sessions of physical therapy and was instructed to perform an individualized home exercise program consisting of ankle dorsiflexion stretching , lower extremity strengthening , and aerobic exercise . RESULTS After 4 months children who received physical therapy intervention had significantly improved ankle dorsiflexion active range of motion and knee extension strength ( P Physical therapy intervention for children with ALL receiving maintenance chemotherapy improved two body functions important for normal gait . Physical therapy programs initiated earlier in treatment and with greater emphasis on endurance activities may also improve stamina and quality of life ( QOL )"
] | 411693e0-06ff-11f0-808a-c43d1ab1c353 |
CONTEXT Few studies in subjects over 50 yr of age have evaluated the influence of variable doses of vitamin D supplementation on serum 25-hydroxyvitamin D levels . OBJECTIVE We performed a meta- analysis of changes in circulating 25-hydroxyvitamin D level associated with vitamin D supplementation in Caucasian subjects over 50 yr old . DATA SOURCES We conducted a systematic search in literature data bases and in references of past review s. STUDY SELECTION R and omized placebo or open-label trials that evaluated the influence of vitamin D supplementation on clinical outcomes were included in the study . DATA EXTRACTION We review ed trial characteristics and serum 25-hydroxyvitamin D concentrations at baseline and during the trial . DATA SYNTHESIS Seventy-six trials published from 1984 to March 2011 included 6207 subjects allocated to 101 intervention groups that tested supplement doses ranging from 5 to 250 μg/d ( median , 20 μg/d ) . For similar doses , trials could obtain increases in 25-hydroxyvitamin D three to four times lower than other trials . A meta-regression showed that in the absence of concomitant use of calcium supplements , the average increase in serum 25-hydroxyvitamin D concentrations was 0.78 ng/ml ( 1.95 nmol/liter ) per microgram of vitamin D3 supplement per day . Compared to the vitamin D3 , the vitamin D2 was associated with significantly lower increases ( P = 0.03 ) . Concomitant use of calcium supplementation and high 25-hydroxyvitamin D concentration at baseline was nonsignificantly associated with lower increases in 25-hydroxyvitamin D concentrations . CONCLUSIONS Dietary recommendations and r and omized trials on vitamin D supplementation should evaluate whether increases in circulating 25-hydroxyvitamin D levels match expectations -- for instance , the average increases obtained by trials on vitamin D3 without concomitant calcium supplements | [
"BACKGROUND Different dosing protocol s have been used for vitamin D supplementation , but there has been a lack of comparative data among them . OBJECTIVE Our objective was to determine whether the same cumulative dose of vitamin D3 produces different effects if it is given daily , weekly , or monthly . DESIGN Women , age 81 + /- 8 yr ( + /- sd , n = 48 ) , who had undergone surgery to repair hip fracture were r and omized to vitamin D3-supplementation protocol s at 1,500 IU daily , or 10,500 IU once weekly , or 45,000 IU once every 28 d. The primary outcome measure was the serum 25-hydroxyvitamin D [ 25(OH)D ] concentration attained . RESULTS Initially , serum 25(OH)D concentrations for daily , weekly , and monthly groups were , respectively , 15.13 + /- 6.9 , 15.7 + /- 10.1 , and 16.2 + /- 10.1 ng/ml . By d 7 , these had increased significantly in all the groups ( P serum 25(OH)D and serum 1,25-dihydroxyvitamin D had increased significantly ( P serum 25(OH)D with daily , weekly , and monthly dosing were , respectively , 33.2 + /- 8.5 , 29.2 + /- 8.9 , and 37.1 + /- 10.3 ng/ml ; there were no significant differences among these values . CONCLUSIONS Supplementation with vitamin D can be achieved equally well with daily , weekly , or monthly dosing frequencies . Therefore , the choice of dose frequency can be based on whichever approach will optimize an individual 's adherence with long-term vitamin D supplementation",
" The Cohort Consortium Vitamin D Pooling Project of Rarer Cancers ( VDPP ) brought together 10 cohorts to conduct a prospect i ve study of the association between vitamin D status , measured as serum concentrations of 25-hydroxyvitamin D ( 25(OH)D ) , and the development of 7 rarer cancer sites : endometrial , esophageal , gastric , kidney , non-Hodgkin lymphoma , ovarian , and pancreatic cancers . The cohorts come from 3 continents , with participants from a wide range of latitude who are racially diverse . Across each cancer site , there was no evidence of a protective association between higher concentrations of 25-hydroxyvitamin D ( > 75 nmol/L ) and cancer outcome . An increased risk at very high levels ( ≥100 nmol/L ) was noted for pancreatic cancer , confirming previous reports . The articles included in this issue detail the overall design and governance of the project , correlates of vitamin D status , and results from the cancer site-specific investigations . The Vitamin D Pooling Project realizes a major goal of consortium efforts , namely , to rigorously test hypotheses for rarer cancer outcomes that may not be adequately addressed in any one prospect i ve cohort study . The results of this study have application for the planning and conduct of intervention trials , especially in determining potential risks",
"Objective : Assessment of the effectiveness and safety of high daily 125 μg ( 5000 IU ) or 250 μg ( 10 000IU ) doses of vitamin D2 during 3 months , in rapidly obtaining adequate 25 hydroxyvitamin D ( 25OHD ) levels . Design : Longitudinal study .Subjects : Postmenopausal osteopenic/osteoporotic women ( n=38 ) were studied during winter and spring . Median age ( 25–75th percentile ) was 61.5 ( 57.00–66.25 ) years , and mean bone mineral density ( BMD ) was 0.902 (0.800–1.042)g/cm2 . Subjects were r and omly divided into three groups : control group ( n=13 ) : no vitamin D2 , 125 μg/day ( n=13 ) and 250 μg/day ( n=12 ) of vitamin D2 groups , all receiving 500 mg calcium/day . Serum calcium , phosphate , bone alkaline phosphatase ( BAP ) , C-telopeptide ( CTX ) , 25OHD , mid-molecule parathyroid hormone ( mmPTH ) , daily urinary calcium and creatinine excretion were determined at baseline and monthly . Results : For all subjects ( n=38 ) , the median baseline 25 hydroxyvitamin D ( 25OHD ) level was 36.25 ( 27.5–48.12 ) nmol/l . After 3 months , 8 % of the patients in the control group , 50 % in the 125 μg/day group and 75 % in the 250 μg/day group had 25OHD values above 85 nmol/l ( 34 ng/ml ) . Considering both vitamin D2 groups together , mmPTH and BAP levels diminished significantly after 3 months ( P CTX . Serum calcium remained within normal range during the follow-up . Conclusions : The oral dose of vitamin D2 required to rapidly achieve adequate levels of 25OHD is seemingly much higher than the usual recommended vitamin D3 dose ( 20 μg/day ) . During 3 months , 250 μg/day of vitamin D2 most effectively raised 25OHD levels to 85 nmol/l in 75 % of the postmenopausal osteopenic/osteoporotic women treated",
"Experimental and epidemiological studies suggest that calcium and vitamin D supplements may lower blood pressure . We examined the effect of calcium plus vitamin D supplementation on blood pressure and the incidence of hypertension in postmenopausal women . The Women 's Health Initiative Calcium/Vitamin D Trial r and omly assigned 36 282 postmenopausal women to receive 1000 mg of elemental calcium plus 400 IU of vitamin D3 daily or placebo in a double-blind fashion . Change in blood pressure and the incidence of hypertension were ascertained . Over a median follow-up time of 7 years , there was no significant difference in the mean change over time in systolic blood pressure ( 0.22 mm Hg ; 95 % CI : −0.05 to 0.49 mm Hg ) and diastolic blood pressure ( 0.11 mm Hg ; 95 % CI : −0.04 to 0.27 mm Hg ) between the active and placebo treatment groups . This None result was robust in analyses accounting for nonadherence to study pills and in baseline subgroups of interest , including black subjects and women with hypertension or high levels of blood pressure , with low intakes of calcium and vitamin D or low serum levels of vitamin D. In 17 122 nonhypertensive participants at baseline , the hazard ratio for incident hypertension associated with calcium/vitamin D treatment was 1.01 ( 95 % CI : 0.96 to 1.06 . ) In postmenopausal women , calcium plus vitamin D3 supplementation did not reduce either blood pressure or the risk of developing hypertension over 7 years of follow-up",
" The objective of the present trial was to assess the effects of vitamin D supplementation on serum 25-hydroxyvitamin D [ 25(OH)D ] and high-density lipoprotein cholesterol ( HDL-C ) in subjects with high waist circumference . Subjects were r and omly assigned a daily multivitamin and mineral ( MVM ) supplement or a MVM supplement plus vitamin D 1,200 IU/day ( MVM+D ) for 8 weeks . There was a significant difference in mean change for 25(OH)D between the MVM and MVM+D treatment groups ( − 1.2 ± 2.5 nmol/l vs. 11.7 ± 3.0 nmol/l , respectively ; P = 0.003 ) . Vitamin D 1,200 IU/day did not increase 25(OH)D to a desirable level ( ≥ 75 nmol/l ) in 61 % of participants . There were no significant changes in cardiovascular disease risk markers . Thus , vitamin D supplementation with 1,200 IU/day was insufficient to achieve desirable serum 25(OH)D in most participants and did not affect cardiovascular disease risk markers ",
"Objective : Coronary artery calcified plaque is a marker for atheromatous plaque burden and predicts future risk of cardiovascular events . The relationship between calcium plus vitamin D ( calcium/D ) supplementation and coronary artery calcium ( CAC ) has not been previously assessed in a r and omized trial setting . We compared CAC scores after trial completion between women r and omized to calcium/vitamin D supplementation and women r and omized to placebo . Methods : In an ancillary sub study of women r and omized to calcium carbonate ( 1,000 mg of elemental calcium daily ) plus vitamin D3 ( 400 IU daily ) or placebo , nested within the Women 's Health Initiative trial of estrogen among women who underwent hysterectomy , we measured CAC with cardiac CT in 754 women aged 50 to 59 years at r and omization . Imaging for CAC was performed at 28 of 40 centers after a mean of 7 years of treatment , and scans were read central ly . CAC scores were measured by a central reading center with masking to r and omization assignments . Results : Posttrial CAC measurements were similar in women r and omized to calcium/D supplementation and those receiving placebo . The mean CAC score was 91.6 for women receiving calcium/D and 100.5 for women receiving placebo ( rank test P value = 0.74 ) . After adjustment for coronary risk factors , multivariate odds ratios for increasing CAC score cutpoints ( CAC > 0 , ≥10 , and ≥100 ) for calcium/D versus placebo were 0.92 ( 95 % CI , 0.64 - 1.34 ) , 1.29 ( 0.88 - 1.87 ) , and 0.90 ( 0.56 - 1.44 ) , respectively . Corresponding odds ratios among women with a 50 % or higher adherence to study pills and for higher levels of CAC ( > 300 ) were similar . Conclusions : Treatment with moderate doses of calcium plus vitamin D3 did not seem to alter coronary artery calcified plaque burden among postmenopausal women . Whether higher or lower doses would affect this outcome remains uncertain",
"BACKGROUND Adequate intakes of calcium and vitamin D reduce bone loss and fracture risk in the elderly . Other nutrients also affect bone health , and adequate intakes may influence bone turnover and balance . OBJECTIVE We compared the long-term effects on bone turnover markers and calciotropic hormones of a multinutrient supplement , a calcium and vitamin D supplement , and dietary instruction aim ed at increasing calcium intake through foods . DESIGN Ninety-nine healthy postmenopausal women participated in a 3-y , r and omized trial , receiving either 1 ) supplemental calcium ( 1450 mg/d ) and vitamin D [ 10 microg ( 400 IU)/d ] , 2 ) calcium , vitamin D , and other nutrients ( multinutrient supplement ) , or 3 ) dietary instruction ( dietary control group ) . Data are from 83 subjects who completed the trial . RESULTS Increases over baseline in calcium intakes and serum 25-hydroxyvitamin D concentrations were sustained over 3 y in all treatment groups . Circulating parathyroid hormone concentrations were reduced at year 1 in all treatment groups but trended toward baseline thereafter . Bone turnover markers followed a similar pattern , and none of the changes in biochemical concentrations differed significantly between groups . CONCLUSIONS All 3 interventions offer long-term feasibility for increasing calcium intake and serum 25-hydroxyvitamin D concentrations . The dietary addition of micronutrients implicated in skeletal physiology confers no obvious bone-sparing effect in healthy postmenopausal women beyond that of calcium and vitamin D alone . The attenuation over time in suppression of parathyroid hormone and bone turnover might help explain why nutrient intervention tends to have less of a bone-sparing effect than do skeletally active medications such as estrogen or bisphosphonates",
"Introduction Osteoporotic fractures in older people are a major and increasing public health problem . We examined the effect of vitamin D supplementation on fracture rate in people living in sheltered accommodation . Methods In a pragmatic double blind r and omised controlled trial of 3 years duration , we examined 3,440 people ( 2,624 women and 816 men ) living in residential or care home . We used four-monthly oral supplementation using 100,000 IU vitamin D2 ( ergocalciferol ) . As a main outcome measure , we used the incidence of first fracture using an intention to treat analysis . This was a multicentre study in 314 care homes or sheltered accommodation complexes in South Wales , UK . Results The vitamin D and placebo groups had similar baseline characteristics . In intention-to-treat analysis , 205 first fractures occurred in the intervention group during a total of 2,846 person years of follow-up ( 7 fractures per 100 people per year of follow-up ) , with 218 first fractures in the control group over 2,860 person years of follow-up . The hazard ratio of 0.95 ( 95 % confidence interval 0.79–1.15 ) for intervention compared to control was not statistically significant . ConclusionS upplementation with four-monthly 100,000 IU of oral vitamin D2 is not sufficient to affect fracture incidence among older people living in institutional care",
"BACKGROUND Although some observational studies have associated higher calcium intake and especially higher vitamin D intake and 25-hydroxyvitamin D levels with lower breast cancer risk , no r and omized trial has evaluated these relationships . METHODS Postmenopausal women ( N = 36 282 ) who were enrolled in a Women 's Health Initiative clinical trial were r and omly assigned to 1000 mg of elemental calcium with 400 IU of vitamin D(3 ) daily or placebo for a mean of 7.0 years to determine the effects of supplement use on incidence of hip fracture . Mammograms and breast exams were serially conducted . Invasive breast cancer was a secondary outcome . Baseline serum 25-hydroxyvitamin D levels were assessed in a nested case-control study of 1067 case patients and 1067 control subjects . A Cox proportional hazards model was used to estimate the risk of breast cancer associated with r and om assignment to calcium with vitamin D(3 ) . Associations between 25-hydroxyvitamin D serum levels and total vitamin D intake , body mass index ( BMI ) , recreational physical activity , and breast cancer risks were evaluated using logistic regression models . Statistical tests were two-sided . RESULTS Invasive breast cancer incidence was similar in the two groups ( 528 supplement vs 546 placebo ; hazard ratio = 0.96 ; 95 % confidence interval = 0.85 to 1.09 ) . In the nested case-control study , no effect of supplement group assignment on breast cancer risk was seen . Baseline 25-hydroxyvitamin D levels were modestly correlated with total vitamin D intake ( diet and supplements ) ( r = 0.19 , P Baseline 25-hydroxyvitamin D levels were not associated with breast cancer risk in analyses that were adjusted for BMI and physical activity ( P(trend ) = .20 ) . CONCLUSIONS Calcium and vitamin D supplementation did not reduce invasive breast cancer incidence in postmenopausal women . In addition , 25-hydroxyvitamin D levels were not associated with subsequent breast cancer risk . These findings do not support a relationship between total vitamin D intake and 25-hydroxyvitamin D levels with breast cancer risk",
"Background — Individuals with vascular or valvular calcification are at increased risk for coronary events , but the relationship between calcium consumption and cardiovascular events is uncertain . We evaluated the risk of coronary and cerebrovascular events in the Women ’s Health Initiative r and omized trial of calcium plus vitamin D supplementation . Methods and Results — We r and omized 36 282 postmenopausal women 50 to 79 years of age at 40 clinical sites to calcium carbonate 500 mg with vitamin D 200 IU twice daily or to placebo . Cardiovascular disease was a prespecified secondary efficacy outcome . During 7 years of follow-up , myocardial infa rct ion or coronary heart disease death was confirmed for 499 women assigned to calcium/vitamin D and 475 women assigned to placebo ( hazard ratio , 1.04 ; 95 % confidence interval , 0.92 to 1.18 ) . Stroke was confirmed among 362 women assigned to calcium/vitamin D and 377 assigned to placebo ( hazard ratio , 0.95 ; 95 % confidence interval , 0.82 to 1.10 ) . In subgroup analyses , women with higher total calcium intake ( diet plus supplements ) at baseline were not at higher risk for coronary events ( P=0.91 for interaction ) or stroke ( P=0.14 for interaction ) if assigned to active calcium/vitamin D. Conclusions — Calcium/vitamin D supplementation neither increased nor decreased coronary or cerebrovascular risk in generally healthy postmenopausal women over a 7-year use period",
"Summary The effect of equivalent oral doses of vitamin D3 600 IU/day , 4200 IU/week and 18,000 IU/month on vitamin D status was compared in a r and omized clinical trial in nursing home residents . A daily dose was more effective than a weekly dose , and a monthly dose was the least effective . Introduction It is assumed that equivalent daily , weekly or monthly doses of vitamin D3 equally influence vitamin D status . This was investigated in a r and omized clinical trial in nursing home residents . Methods The study was performed in ten nursing homes including 338 subjects ( 76 male and 262 female ) , with a mean age of 84 ( ± SD 6.3 years ) . They received oral vitamin D3 either 600 IU/day , or 4200 IU/week , or 18,000 IU/month or placebo . After 4 months , calcium was added during 2 weeks , 320 mg/day or 640 mg/day or placebo . Outcome : serum levels of 25-hydroxyvitamin D ( 25(OH)D ) , parathyroid hormone ( PTH ) and bone turnover markers . Statistical approach : linear multilevel analysis . Results At baseline , mean serum 25(OH)D was 25.0 nmol/L ( SD 10.9 ) , and in 98 % , it was lower than 50 nmol/L. After 4 months , mean serum 25(OH)D levels increased to 62.5 nmol/L ( after daily vitamin D3 69.9 nmol/L , weekly 67.2 nmol/L and monthly 53.1 nmol/L , P groups ) . Median serum PTH levels decreased by 23 % ( p 0.001 ) . Bone turnover markers did not decrease . Calcium supplementation had no effect on serum PTH and bone turnover . Conclusion Daily vitamin D was more effective than weekly , and monthly administration was the least effective",
"BACKGROUND Higher intake of calcium and vitamin D has been associated with a reduced risk of colorectal cancer in epidemiologic studies and polyp recurrence in polyp-prevention trials . However , r and omized-trial evidence that calcium with vitamin D supplementation is beneficial in the primary prevention of colorectal cancer is lacking . METHODS We conducted a r and omized , double-blind , placebo-controlled trial involving 36,282 postmenopausal women from 40 Women 's Health Initiative centers : 18,176 women received 500 mg of elemental calcium as calcium carbonate with 200 IU of vitamin D3 [ corrected ] twice daily ( 1000 mg of elemental calcium and 400 IU of vitamin D3 ) and 18,106 received a matching placebo for an average of 7.0 years . The incidence of pathologically confirmed colorectal cancer was the design ated secondary outcome . Baseline levels of serum 25-hydroxyvitamin D were assessed in a nested case-control study . RESULTS The incidence of invasive colorectal cancer did not differ significantly between women assigned to calcium plus vitamin D supplementation and those assigned to placebo ( 168 and 154 cases ; hazard ratio , 1.08 ; 95 percent confidence interval , 0.86 to 1.34 ; P=0.51 ) , and the tumor characteristics were similar in the two groups . The frequency of colorectal-cancer screening and abdominal symptoms was similar in the two groups . There were no significant treatment interactions with baseline characteristics . CONCLUSIONS Daily supplementation of calcium with vitamin D for seven years had no effect on the incidence of colorectal cancer among postmenopausal women . The long latency associated with the development of colorectal cancer , along with the seven-year duration of the trial , may have contributed to this None finding . Ongoing follow-up will assess the longer-term effect of this intervention . ( Clinical Trials.gov number , NCT00000611 . )",
"A r and omized double-blind controlled trial of the effect of vitamin D supplementation on the abilities of elderly hospital patients to carry out basic activities of daily life is described . Those patients included in the trial had plasma 25-hydroxyvitamin D concentrations which were low or low normal as judged by the normal range in young adults . After 2 to 9 months on the trial there was no significant difference in the performance of the control and treatment groups",
"BACKGROUND The efficacy of calcium with vitamin D supplementation for preventing hip and other fractures in healthy postmenopausal women remains equivocal . METHODS We recruited 36,282 postmenopausal women , 50 to 79 years of age , who were already enrolled in a Women 's Health Initiative ( WHI ) clinical trial . We r and omly assigned participants to receive 1000 mg of elemental [ corrected ] calcium as calcium carbonate with 400 IU of vitamin D3 daily or placebo . Fractures were ascertained for an average follow-up period of 7.0 years . Bone density was measured at three WHI centers . RESULTS Hip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group ( P calcium plus vitamin D supplementation had a hazard ratio of 0.88 for hip fracture ( 95 percent confidence interval , 0.72 to 1.08 ) , 0.90 for clinical spine fracture ( 0.74 to 1.10 ) , and 0.96 for total fractures ( 0.91 to 1.02 ) . The risk of renal calculi increased with calcium plus vitamin D ( hazard ratio , 1.17 ; 95 percent confidence interval , 1.02 to 1.34 ) . Censoring data from women when they ceased to adhere to the study medication reduced the hazard ratio for hip fracture to 0.71 ( 95 percent confidence interval , 0.52 to 0.97 ) . Effects did not vary significantly according to prer and omization serum vitamin D levels . CONCLUSIONS Among healthy postmenopausal women , calcium with vitamin D supplementation result ed in a small but significant improvement in hip bone density , did not significantly reduce hip fracture , and increased the risk of kidney stones . ( Clinical Trials.gov number , NCT00000611 . )",
"Chronic immobilization could markedly affect calcium and bone metabolism in elderly people . To investigate this , and to test the theory of ' type II ' osteoporosis in bedridden elderly patients with low vitamin D status , 55 such subjects were examined . Serum concentrations of ionized calcium ( Ca++ ) , intact parathyrin ( PTH ) and two novel markers of bone collagen formation ( carboxyterminal propeptide of type I procollagen ; PICP ) and resorption ( carboxyterminal crosslinked telopeptide of type I collagen ; ICTP ) were measured . The effects on these parameters after 40 weeks of supplementation with vitamin D ( 1000 IU d-1 ) and /or calcium ( 1 g d-1 ) were subsequently prospect ively evaluated . Despite low ( mean 11.6 nmoll-1 ) serum 25-hydroxyvitamin D levels ( 25-OHD ) , those of 1,25-dihydroxy-vitamin D ( 1,25-(OH)2D ) were mostly normal . Neither correlated with Ca++ or PTH . PTH correlated negatively not only with Ca++ ( r = -0.328 , P ICTP ( r = -0.306 , P Mean PICP was normal but ICTP was elevated and tended to correlate positively with Ca++ ( r = 0.268 , P = 0.06 ) . Vitamin D supplementation did not change PICP or ICTP considerably , despite slightly increased 1,25-(OH)2D and slightly decreased PTH . Ca++ values were normal and remained stable . In conclusion , Ca++ and PTH are poor indicators of vitamin D status in chronically immobilized elderly subjects . Furthermore , the results suggest that the increased bone resorption is not due to ' type II ' secondary hyperparathyroidism ; rather the resorption is primarily increased . Correction of vitamin D deficiency does not seem to benefit ageing bones unless adequate mechanical loading is provided",
"BACKGROUND Current unitage for the calciferols suggests that equimolar quantities of vitamins D(2 ) ( D2 ) and D(3 ) ( D3 ) are biologically equivalent . Published studies yield mixed results . OBJECTIVE The aim of the study was to compare the potencies of D2 and D3 . DESIGN The trial used a single-blind , r and omized design in 33 healthy adults . Calciferols were dosed at 50,000 IU/wk for 12 wk . Principal outcome variables were area under the curve for incremental total 25-hydroxyvitamin D [ 25(OH)D ] and change in calciferol content of sc fat . RESULTS Incremental mean ( sd ) 25(OH)D area under the curve at 12 wk was 1366 ng · d/ml ( 516 ) for the D2-treated group and 2136 ( 606 ) for the D3 ( P 0.001 ) . Mean ( sd ) steady-state 25(OH)D increments showed similar differences : 24 ng/ml for D2 ( 10.3 ) and 45 ng/ml ( 16.2 ) for D3 ( P 0.001 ) . Subcutaneous fat content of D2 rose by 50 μg/kg in the D2-treated group , and D3 content rose by 104 μg/kg in the D3-treated group . Total calciferol in fat rose by only 33 ng/kg in the D2-treated , whereas it rose by 104 μg/kg in the D3-treated group . Extrapolating to total body fat D3 , storage amounted to just 17 % of the administered dose . CONCLUSION D3 is approximately 87 % more potent in raising and maintaining serum 25(OH)D concentrations and produces 2- to 3-fold greater storage of vitamin D than does equimolar D2 . For neither was there evidence of sequestration in fat , as had been postulated for doses in this range . Given its greater potency and lower cost , D3 should be the preferred treatment option when correcting vitamin D deficiency",
"OBJECTIVES To determine the effectiveness of vitamin D and home-based quadriceps resistance exercise on reducing falls and improving the physical health of frail older people after hospital discharge . DESIGN Multicenter , r and omized , controlled trial with a factorial design . SETTING Five hospitals in Auckl and , New Zeal and , and Sydney , Australia . PARTICIPANTS Two hundred forty-three frail older people . INTERVENTIONS Patients were r and omized to receive a single dose of vitamin D ( calciferol , 300,000 IU ) or placebo tablets and 10 weeks of high-intensity home-based quadriceps resistance exercise or frequency-matched visits . MEASUREMENTS The primary endpoints were physical health according to the short-form health survey at 3 months and falls over 6 months . Physical performance and self-rated function were secondary endpoints . Assessment s took place in the participants ' homes at 3 and 6 months after r and omization and were performed by blinded assessors . RESULTS There was no effect of either intervention on physical health or falls , but patients in the exercise group were at increased risk of musculoskeletal injury ( risk ratio = 3.6 , 95 % confidence interval = 1.5 - 8.0 ) . Vitamin D supplementation did not improve physical performance , even in those who were vitamin D deficient ( vitamin D supplementation nor a home-based program of high-intensity quadriceps resistance exercise improved rehabilitation outcomes in frail older people after hospitalization . There was no effect of vitamin D on physical performance , and the exercises increased the risk of musculoskeletal injury . These findings do not support the routine use of these interventions at these dosages in the rehabilitation of frail older people",
"Background : Vitamin D insufficiency poses a problem in many parts of the world , the elderly being an especially vulnerable group . This insufficiency results from an inadequate amount of sunshine and a low dietary intake of vitamin D. Typically , insufficiency is accompanied with high intact parathyroid hormone , ( S-iPTH ) concentrations . Aims of the Study : We studied how serum 25-hydroxy vitamin D ( S-25-OHD ) concentrations respond to different doses of vitamin D3 supplementation . Secondly to determine the smallest efficient dose to maintain serum 25-OHD concentration above the insufficiency level . We also studied which dose would be efficient in decreasing S-iPTH concentration in these subjects . Subjects and Methods : Forty-nine 65- to 85-year-old women participated . The women were r and omly assigned into one of four groups receiving 0 ( placebo ) , 5 , 10 or 20 μg of vitamin D3 daily for 12 weeks . Fasting morning blood was drawn at the beginning of the study , and thereafter every second week . Calciotropic variables were assessed from serum and urine sample s. Results : The S-25-OHD concentration increased significantly ( p Equilibrium in S-25-OHD concentration was reached in all groups after 6 weeks of supplementation at 57.7 ( 8.9 ) nmol/L , 59.9 ( 8.9 ) nmol/L and 70.9 ( 8.9 ) nmol/L in the groups with increasing vitamin D supplementation . The dose-response to supplementation decreased with increasing vitamin D status at baseline , r = −0.513 , p = 0.002 . S-iPTH tended to decrease in those with highest dose response to supplementation . Conclusions : A clear dose response was noted in S-25-OHD to different doses of vitamin D3 . The recommended dietary intake of 15 μg is adequate to maintain the S-25-OHD concentration around 40–55 nmol/L during winter , but if the optimal S-25-OHD is higher than that even higher vitamin D intakes are needed . Interestingly , subjects with lower vitamin D status at baseline responded more efficiently to supplementation than those with more adequate status",
"BACKGROUND Knowledge gaps have contributed to considerable variation among international dietary recommendations for vitamin D. OBJECTIVE We aim ed to establish the distribution of dietary vitamin D required to maintain serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations above several proposed cutoffs ( ie , 25 , 37.5 , 50 , and 80 nmol/L ) during wintertime after adjustment for the effect of summer sunshine exposure and diet . DESIGN A r and omized , placebo-controlled , double-blind 22-wk intervention study was conducted in men and women aged 20 - 40 y ( n = 238 ) by using different supplemental doses ( 0 , 5 , 10 , and 15 microg/d ) of vitamin D(3 ) throughout the winter . Serum 25(OH)D concentrations were measured by using enzyme-linked immunoassay at baseline ( October 2006 ) and endpoint ( March 2007 ) . RESULTS There were clear dose-related increments ( P serum 25(OH)D with increasing supplemental vitamin D(3 ) . The slope of the relation between vitamin D intake and serum 25(OH)D was 1.96 nmol x L(-1 ) x microg(-1 ) intake . The vitamin D intake that maintained serum 25(OH)D concentrations of > 25 nmol/L in 97.5 % of the sample was 8.7 microg/d . This intake ranged from 7.2 microg/d in those who enjoyed sunshine exposure , 8.8 microg/d in those who sometimes had sun exposure , and 12.3 microg/d in those who avoided sunshine . Vitamin D intakes required to maintain serum 25(OH)D concentrations of > 37.5 , > 50 , and > 80 nmol/L in 97.5 % of the sample were 19.9 , 28.0 , and 41.1 microg/d , respectively . CONCLUSION The range of vitamin D intakes required to ensure maintenance of wintertime vitamin D status [ as defined by incremental cutoffs of serum 25(OH)D ] in the vast majority ( > 97.5 % ) of 20 - 40-y-old adults , considering a variety of sun exposure preferences , is between 7.2 and 41.1 microg/d"
] | 41169426-06ff-11f0-808a-c43d1ab1c353 |
Background Yoga has been recommended as a muscle strengthening and balance activity in national and global physical activity guidelines . However , the evidence base establishing the effectiveness of yoga in improving physical function and health related quality of life ( HRQoL ) in an older adult population not recruited on the basis of any specific disease or condition , has not been systematic ally review ed . The objective of this study was to synthesis e existing evidence on the effects of yoga on physical function and HRQoL in older adults not characterised by any specific clinical condition . Methods The following data bases were systematic ally search ed in September 2017 : MEDLINE , PsycInfo , CINAHL Plus , Scopus , Web of Science , Cochrane Library , EMBASE , SPORTD iscus , AMED and ProQuest Dissertations & Theses Global . Study inclusion criteria : Older adult participants with mean age of 60 years and above , not recruited on the basis of any specific disease or condition ; yoga intervention compared with inactive controls ( example : wait-list control , education booklets ) or active controls ( example : walking , chair aerobics ) ; physical function and HRQoL outcomes ; and r and omised/cluster r and omised controlled trials published in English . A vote counting analysis and meta- analysis with st and ardised effect sizes ( Hedges ’ g ) computed using r and om effects models were conducted . Results A total of 27 records from 22 RCTs were included ( 17 RCTs assessed physical function and 20 assessed HRQoL ) . The meta- analysis revealed significant effects ( 5 % level of significance ) favouring the yoga group for the following physical function outcomes compared with inactive controls : balance ( effect size ( ES ) = 0.7 ) , lower body flexibility ( ES = 0.5 ) , lower limb strength ( ES = 0.45 ) ; compared with active controls : lower limb strength ( ES = 0.49 ) , lower body flexibility ( ES = 0.28 ) . For HRQoL , significant effects favouring yoga were found compared to inactive controls for : depression ( ES = 0.64 ) , perceived mental health ( ES = 0.6 ) , perceived physical health ( ES = 0.61 ) , sleep quality ( ES = 0.65 ) , and vitality ( ES = 0.31 ) ; compared to active controls : depression ( ES = 0.54 ) . Conclusion This review is the first to compare the effects of yoga with active and inactive controls in older adults not characterised by a specific clinical condition . Results indicate that yoga interventions improve multiple physical function and HRQoL outcomes in this population compared to both control conditions . This study provides robust evidence for promoting yoga in physical activity guidelines for older adults as a multimodal activity that improves aspects of fitness like strength , balance and flexibility , as well as mental wellbeing . Trial registration PROSPERO registration number : CRD42016038052 | [
"BACKGROUND There has been limited study of yoga training as a complementary exercise strategy to manage the symptom of dyspnea in patients with chronic obstructive pulmonary disease ( COPD ) . PURPOSE The primary purpose of this pilot study was to evaluate a yoga program for its safety , feasibility , and efficacy for decreasing dyspnea intensity ( DI ) and dyspnea-related distress ( DD ) in older adults with COPD . METHODS Clinical ly stable patients with COPD ( n = 29 ; age 69.9 + /- 9.5 ; forced expiratory volume in 1 second ( FEV(1 ) ) 47.7 + /- 15.6 % predicted ; female = 21 ) were r and omized to a 12-week yoga program specifically design ed for people with COPD or usual-care control ( UC ) . The twice-weekly yoga program included asanas ( yoga postures ) and visama vritti pranayama ( timed breathing ) . Safety measure outcomes included heart rate , oxygen saturation , dyspnea , and pain . Feasibility was measured by patient-reported enjoyment , difficulty , and adherence to yoga sessions . At baseline and at 12 weeks , DI and DD were measured during incremental cycle ergometry and a 6-minute walk ( 6MW ) test . Secondary efficacy outcomes included physical performance , psychologic well-being , and health-related quality of life ( HRQoL ) . RESULTS Yoga training was safe and feasible for patients with COPD . While yoga training had only small effects on DI after the 6MW test ( effect size [ ES ] , 0.20 ; p = 0.60 ) , there were greater reductions in DD in the yoga group compared to UC ( ES , 0.67 ; p = 0.08 ) . Yoga training also improved 6MW distance ( + 71.7 + /- 21.8 feet versus -27.6 + /- 36.2 feet ; ES = 0.78 , p = 0.04 ) and self-reported functional performance ( ES = 0.79 , p = 0.04 ) compared to UC . There were small positive changes in muscle strength and HRQoL. CONCLUSIONS Elderly patients with COPD participated safely in a 12-week yoga program especially design ed for patients with this chronic illness . After the program , the subjects tolerated more activity with less DD and improved their functional performance . These findings need to be confirmed in a larger , more sufficiently powered efficacy study",
"OBJECTIVE health-related quality of life ( HRQOL ) and mental well-being are associated with healthy ageing . Physical activity positively impacts both HRQOL and mental well-being . Yoga is a physical activity that can be modified to suits the needs of older people and is growing in popularity . We conducted a systematic review with meta- analysis to determine the impact of yoga-based exercise on HRQOL and mental well-being in people aged 60 + . METHODS search es were conducted for relevant trials in the following electronic data bases ; MEDLINE , EMBASE , Cochrane Central Register of Controlled Trials , CINAHL , Allied and Complementary Medicine Data base , PsycINFO and the Physiotherapy Evidence Data base ( PEDro ) from inception to January 2017 . Trials that evaluated the effect of physical yoga on HRQOL and /or on mental well-being in people aged 60 + years were included . Data on HRQOL and mental well-being were extracted . St and ardised mean differences and 95 % confidence intervals ( CI ) were calculated using r and om effects models . Method ological quality of trials was assessed using the PEDro scale . RESULTS twelve trials of high method ological quality ( mean PEDro score 6.1 ) , totalling 752 participants , were identified and provided data for the meta- analysis . Yoga produced a medium effect on HRQOL ( Hedges ' g = 0.51 , 95 % CI 0.25 - 0.76 , 12 trials ) and a small effect on mental well-being ( Hedges ' g = 0.38 , 95 % CI 0.15 - 0.62 , 12 trials ) . CONCLUSION yoga interventions result ed in small to moderate improvements in both HRQOL and mental well-being in people aged 60 + years . Further , research is needed to determine the optimal dose of yoga to maximise health impact . PROSPERO REGISTRATION NUMBER ( CRD42016052458 )",
"BACKGROUND Despite yoga 's popularity , few clinical trials have employed rigorous methodology to systematic ally explore its functional benefits compared with more established forms of exercise . The objective of this study was to compare the functional benefits of yoga with the conventional stretching-strengthening exercises recommended for adults . METHODS Sedentary healthy adults ( N = 118 ; M age = 62.0 ) participated in an 8-week ( three times a week for 1 hour ) r and omized controlled trial , which consisted of a Hatha yoga group ( n = 61 ) and a stretching-strengthening exercise group ( n = 57 ) . St and ardized functional fitness tests assessing balance , strength , flexibility , and mobility were administered at baseline and postintervention . RESULTS A repeated measures multivariate analysis of variance showed a significant time effect for measures of balance [ F(3,18 ) = 4.88 , p ] , strength [ F(2,19 ) = 15.37 , p .001 , partial η(2 ) = .62 ] , flexibility [ F(4,17 ) = 8.86 , p .68 ] , and mobility [ F(2,19 ) = 8.54 , p improvements on measures of balance ( left-right leg and four square step ) ; strength ( chair st and s and arm curls ) ; flexibility ( back scratch and sit- and -reach ) ; and mobility ( gait speed and 8-feet up and go ) , with partial η(2 ) ranging from .05 to .47 . CONCLUSIONS These data suggest that regular yoga practice is just as effective as stretching-strengthening exercises in improving functional fitness . To our knowledge , this is the first study to examine functional benefits of yoga in comparison with stretching-strengthening exercises in sedentary , healthy , community-dwelling older adults . These findings have clinical implication s as yoga is a more amenable form of exercise than strengthening exercises as it requires minimal equipment and can be adapted for individuals with lower levels of functioning or disabilities",
"There is growing evidence that yoga may offer a safe and cost-effective intervention for Type 2 Diabetes mellitus ( DM 2 ) . However , systematic review s are lacking . This article critically review s the published literature regarding the effects of yoga-based programs on physiologic and anthropometric risk profiles and related clinical outcomes in adults with DM 2 . We performed a comprehensive literature search using four computerized English and Indian scientific data bases . The search was restricted to original studies ( 1970–2006 ) that evaluated the metabolic and clinical effects of yoga in adults with DM 2 . Studies targeting clinical population s with cardiovascular disorders that included adults with comorbid DM were also evaluated . Data were extracted regarding study design , setting , target population , intervention , comparison group or condition , outcome assessment , data analysis and presentation , follow-up , and key results , and the quality of each study was evaluated according to specific predetermined criteria . We identified 25 eligible studies , including 15 uncontrolled trials , 6 non-r and omized controlled trials and 4 r and omized controlled trials ( RCTs ) . Overall , these studies suggest beneficial changes in several risk indices , including glucose tolerance and insulin sensitivity , lipid profiles , anthropometric characteristics , blood pressure , oxidative stress , coagulation profiles , sympathetic activation and pulmonary function , as well as improvement in specific clinical outcomes . Yoga may improve risk profiles in adults with DM 2 , and may have promise for the prevention and management of cardiovascular complications in this population . However , the limitations characterizing most studies preclude drawing firm conclusions . Additional high- quality RCTs are needed to confirm and further eluci date the effects of st and ardized yoga programs in population s with DM 2",
"The effect of practicing yoga for the management of type II Diabetes was assessed in this systematic review through search ing related electronic data bases and the grey literature to the end of May 2007 using Ovid . All r and omized controlled clinical trials ( RCTs ) comparing yoga practice with other type of intervention or with regular practice or both , were included regardless of language or type of publication . Each study was assessed for quality by two independent review ers . Mean difference was used for summarizing the effect of each study outcomes with 95 % confidence intervals . Pooling of the studies did not take place due to the wide clinical variation between the studies . Publication bias was assessed by statistical methods . Five trials with 363 participants met the inclusion criteria with medium to high risk of bias and different intervention characteristics . The studies ’ results show improvement in outcomes among patients with diabetes type II . These improvements were mainly among short term or immediate diabetes outcomes and not all were statistically significant . The results were inconclusive and not significant for the long-term outcomes . No adverse effects were reported in any of the included studies . Short-term benefits for patients with diabetes may be achieved from practicing yoga . Further research is needed in this area . Factors like quality of the trials and other method ological issues should be improved by large r and omized control trials with allocation concealment to assess the effectiveness of yoga on diabetes type II . A definitive recommendation for physicians to encourage their patients to practice yoga can not be reached at present",
"BACKGROUND AND OBJECTIVE Sleep in older persons is characterized by decreased ability to stay asleep , result ing in fragmented sleep and reduced daytime alertness . Pharmacological treatment of insomnia in older persons is associated with hazardous side effects . Hence , the present study was design ed to compare the effects of Yoga and Ayurveda on the self rated sleep in a geriatric population . METHODS Of the 120 residents from a home for the aged , 69 were stratified based on age ( five year intervals ) and r and omly allocated to three groups i.e. , Yoga ( physical postures , relaxation techniques , voluntarily regulated breathing and lectures on yoga philosophy ) , Ayurveda ( a herbal preparation ) , and Wait-list control ( no intervention ) . The groups were evaluated for self- assessment of sleep over a one week period at baseline , and after three and six months of the respective interventions . RESULTS The Yoga group showed a significant decrease in the time taken to fall asleep ( approximate group average decrease : 10 min , P total number of hours slept ( approximate group average increase : 60 min , P feeling of being rested in the morning based on a rating scale ( P Yoga practice improved different aspects of sleep in a geriatric population",
"CONTEXT There are potential benefits of mind-body techniques on cognitive function because the techniques involve an active attentional or mindfulness component , but this has not been fully explored . OBJECTIVE To determine the effect of yoga on cognitive function , fatigue , mood , and quality of life in seniors . DESIGN R and omized , controlled trial comparing yoga , exercise , and wait-list control groups . PARTICIPANTS One hundred thirty-five generally healthy men and women aged 65 - 85 years . INTERVENTION Participants were r and omized to 6 months of Hatha yoga class , walking exercise class , or wait-list control . Subjects assigned to classes also were asked to practice at home . MAIN OUTCOME MEASURES Outcome assessment s performed at baseline and after the 6-month period included a battery of cognitive measures focused on attention and alertness , the primary outcome measures being performance on the Stroop Test and a quantitative electroencephalogram ( EEG ) measure of alertness ; SF-36 health-related quality of life ; Profile of Mood States ; Multi-Dimensional Fatigue Inventory ; and physical measures related to the interventions . RESULTS One hundred thirty-five subjects were recruited and r and omized . Seventeen subjects did not finish the 6-month intervention . There were no effects from either of the active interventions on any of the cognitive and alertness outcome measures . The yoga intervention produced improvements in physical measures ( eg , timed 1-legged st and ing , forward flexibility ) as well as a number of quality -of-life measures related to sense of well-being and energy and fatigue compared to controls . CONCLUSIONS There were no relative improvements of cognitive function among healthy seniors in the yoga or exercise group compared to the wait-list control group . Those in the yoga group showed significant improvement in quality -of-life and physical measures compared to exercise and wait-list control groups",
"Objectives . Overview the quality , direction , and characteristics of yoga interventions for treatment of acute and chronic health conditions in adult population s. Methods . We search ed for systematic review s in 10 online data bases , bibliographic references , and h and - search es in yoga-related journals . Included review s satisfy Oxman criteria and specify yoga as a primary intervention in one or more r and omized controlled trials for treatment in adults . The AMSTAR tool and GRADE approach evaluated the method ological quality of review s and quality of evidence . Results . We identified 2202 titles , of which 41 full-text articles were assessed for eligibility and 26 systematic review s satisfied inclusion criteria . Thirteen systematic review s include quantitative data and six papers include meta- analysis . The quality of evidence is generally low . Sixteen different types of health conditions are included . Eleven review s show tendency towards positive effects of yoga intervention , 15 review s report unclear results , and no , review s report adverse effects of yoga . Yoga appears most effective for reducing symptoms in anxiety , depression , and pain . Conclusion . Although the quality of systematic review s is high , the quality of supporting evidence is low . Significant heterogeneity and variability in reporting interventions by type of yoga , setting s , and population characteristics limit the generalizability of results",
"BACKGROUND Sleep disturbances , depression , and low perception of health status are commonly seen in elderly population ; however , clinicians tend to underestimate or overlook the presence of these symptoms and assume them to be a part of normal aging . Non-pharmacological methods that promote a mind-body interaction should be tested to enhance the mental health of older adults . OBJECTIVE To test the effects of 6 months of silver yoga exercises in promoting the mental health of older adults in senior activity centers , especially their sleep quality , depression , and self-perception of health status . DESIGN Cluster r and omized trial . SETTING S Eight senior activity centers , southern Taiwan . PARTICIPANTS A sample of 139 participants was recruited , and 128 of them completed the study . INCLUSION CRITERIA ( 1 ) community-dwelling older adults ages 60 and over , ( 2 ) no previous training in yoga , ( 3 ) able to walk without assistance , ( 4 ) cognitively alert based on the Short Portable Mental Status Question naire ( SPMSQ ) score of eight or higher , and ( 5 ) independent or mildly dependent in self-care based on a Barthel Index ( BI ) score of 91 or higher . The mean age of the participants was 69.20 + /- 6.23 years , and the average number of chronic illness was 0.83 + /- 0.90 . The average BI score of the participants was 99.92 + /- 0.62 , and the mean SPMSQ score was 9.90 + /- 0.30 . METHODS Participants were r and omly assigned into either the experimental ( n=62 ) or the control ( n=66 ) group based on attendance at selected senior activity centers . A 70-min silver yoga exercise program was implemented three times per week for 6 months as the intervention for the participants in the experimental group . RESULTS Most of the mental health indicators of the participants in the experimental group had significantly improved after the silver yoga interventions , and many of the indicators improved after 3 months of intervention and were maintained throughout the 6 months study . The mental health indicators of the participants in the experimental group were all better than the participants in the control group ( all p silver yoga exercises , the sleep quality , depression , and health status of older adults were all improved",
"BACKGROUND Exercise that challenges balance can improve mobility and prevent falls in older adults . Yoga as a physical activity option for older adults is not well studied . This trial evaluated the feasibility and effect of a 12-week Iyengar yoga program on balance and mobility in older people . METHODS We conducted a blinded , pilot r and omized controlled trial with intention-to-treat analysis . Participants were 54 community dwellers ( mean age 68 years , SD 7.1 ) not currently participating in yoga or tai chi . The intervention group ( n = 27 ) participated in a 12-week , twice-weekly yoga program focused on st and ing postures and received a fall prevention education booklet . The control group ( n = 27 ) received the education booklet only . Primary outcome was st and ing balance component of the short physical performance battery with addition of one-legged stance time ( st and ing balance ) . Secondary outcomes were the timed sit-to-st and test , timed 4-m walk , one-legged st and with eyes closed , and Short Falls Efficacy Scale-International . Feasibility was measured by recording class attendance and adverse events . RESULTS Fifty-two participants completed follow-up assessment s. The intervention group significantly improved compared with control group on st and ing balance ( mean difference = 1.52 seconds , 95 % CI 0.10 - 2.96 , p = .04 ) , sit-to-st and test ( mean difference = -3.43 seconds , 95 % CI -5.23 to -1.64 , p 4-m walk ( mean difference = -0.50 seconds , 95 % CI -0.72 to -0.28 , p one-legged st and with eyes closed ( mean difference = 1.93 seconds , 95 % CI 0.40 - 3.46 , p = .02 ) . Average class attendance was 20 of 24 classes ( 83 % ) . No serious adverse events occurred . CONCLUSIONS This trial demonstrates the balance and mobility-related benefits and feasibility of Iyengar yoga for older people . The fall prevention effect of Iyengar yoga warrants further investigation",
"AIMS AND OBJECTIVES Promoting physical fitness of young-older adults is essential in reducing healthcare expenditures which would occur in the future for those with chronic health problems . The silver yoga exercise programme was developed to accommo date the reduced body flexibility experienced by many older adults and was critically review ed by experts and pilot-tested with community-dwelling older adults . This study aim ed to test older adults ' physical fitness after a 24-week silver yoga exercise programme and to examine whether the programme could be further shortened to fit senior activity centres ' programme design s. DESIGN A quasi-experimental , pre-post tests design was used : baseline , at 12-week and at 24-week periods . METHODS Convenience sample s of 204 subjects were recruited from eight senior activity centres and 176 subjects completed the study . Subjects were r and omly assigned into three groups based on the centres : ( 1 ) Experiment I : complete silver yoga with stretching and meditation , ( 2 ) Experiment II : shortened silver yoga without the guided-imagery meditation and ( 3 ) Wait-list control . The interventions were conducted three times per week for 24 weeks . Physical fitness indicators included body compositions , cardiovascular-respiratory functions , physical functions and the range of motion . RESULTS At the end of the 24-week period , the physical fitness of subjects in Experiments I and II had significantly improved whether or not guided-imagery meditation was used and all had better physical fitness than subjects in the control group ( all p physical fitness of older adults in both the 70-minute complete silver yoga group and the 55-minute shortened silver yoga group had significantly improved after the interventions . It was recommended that the silver yoga programme be shortened by eliminating the guided-imagery meditation . RELEVANCE TO CLINICAL PRACTICE The shortened silver yoga exercise programme is recommended to be incorporated as an activity programme in community- setting s to promote the physical fitness of older adults ",
"Background : Promoting the health of transitional frail elders ( e.g. , through therapeutic-based yoga exercises ) is essential to reduce healthcare expenditures caused by chronic health problems . Objective : The purpose of this study was to determine the efficacy of 24 weeks of the senior-tailored silver yoga ( SY ) exercise program for transitional frail elders . Methods : A convenience sample of 69 elders in assisted living facilities were assigned r and omly to the SY group ( n = 38 ) or to the control group ( n = 31 ) on the basis of the facilities where they resided , and 55 of them completed this quasi-experimental pretest and posttest study . Intervention was conducted three times per week , 70 minutes per session , for 24 weeks . Physical fitness ( body composition , cardiovascular-respiratory functions , body flexibility , muscle power and endurance , balance , and agility ) were examined at baseline , at 12 weeks , and at the end of the 24th week of the study . Results : At the end of the study , the physical fitness indicators of participants in the SY group had improved significantly , and they had better physical fitness than participants in the control group ( all p values SY exercises be incorporated as an activity program in assisted living facilities to promote the physical fitness of transitional frail elders",
"OBJECTIVES To determine the effects of up to 14 months of aerobic exercise on measures of bone density in older adults . DESIGN R and omized controlled trial with subjects assigned to either an aerobic exercise condition , non-aerobic yoga , or a wait list non-exercise control group for 4 months . Aerobic fitness and bone density were evaluated in all subjects at baseline ( Time 1 ) and after 4 months ( Time 2 ) . A semi-crossover design was utilized with all subjects completing 4 months of aerobic exercise , followed by another evaluation ( Time 3 ) . All subjects were then given the option of 6 additional months of aerobic exercise , after which they had a fourth evaluation ( Time 4 ) . SETTING An outpatient exercise rehabilitation facility at a large , major medical center . SUBJECTS One-hundred-one healthy men ( n = 50 ) and women ( n = 51 ) over age 60 ( Mean age = 67.0 ) , recruited from the community . INTERVENTION The exercise program included stretching , cycle ergometry , and walking three times per week for 60 minutes throughout the course of the study . OUTCOME MEASURES Aerobic fitness ( VO2max ) as assessed by cycle ergometry , and bone density ( bone mineral content ) measured by single photon absorptiometry . RESULTS Subjects achieved a 10%-15 % increase in VO2max after 4 months of exercise training , and 1%-6 % further improvement with additional training . Aerobic fitness was associated with significant increases in bone density in men , but not women , who maintained aerobic exercise for 14 months",
"OBJECTIVE To compare the effect of a custom- design ed yoga program with 2 other balance training programs . DESIGN R and omized controlled trial . SETTING Research laboratory . PARTICIPANTS A group of older adults ( N=39 ; mean age , 74.15 ± 6.99 y ) with a history of falling . INTERVENTIONS Three different exercise interventions ( Tai Chi , st and ard balance training , yoga ) were given for 12 weeks . MAIN OUTCOME MEASURES Balance performance was examined during pre- and posttest using field tests , including the 8-foot up- and -go test , 1-leg stance , functional reach , and usual and maximal walking speed . The static and dynamic balances were also assessed by postural sway and dynamic posturography , respectively . RESULTS Training produced significant improvements in all field tests ( P For postural sway , significant decreases in the area of the center of pressure with eyes open ( P=.001 ) and eyes closed ( P=.002 ) were detected after training . For eyes open , maximum medial-lateral velocity significantly decreased for the sample ( P=.013 ) . For eyes closed , medial-lateral displacement decreased for Tai Chi ( P For dynamic posturography , significant improvements in overall score ( P=.001 ) , time on the test ( P=.006 ) , and 2 linear measures in lateral ( P=.001 ) and anterior-posterior ( P CONCLUSIONS Yoga was as effective as Tai Chi and st and ard balance training for improving postural stability and may offer an alternative to more traditional programs",
"A ten-week yoga program was implemented with sixty-one white and forty-five low-income black elders at two community sites , along with a pretest-posttest control group research design with r and om assignment at each site . White elders attended class regularly , practice d yoga on their own on a daily basis , improved psychological well-being , and lowered their systolic blood pressure level , in comparison to a control group . Black elders , on the other h and , attended the once-a-week class regularly but did not practice on their own on a daily basis . Thus , they did not improve psychological well-being nor reduce blood pressure level in comparison to a control group . Social analysts suggest that low-income minority elders need more frequent contact with structured leadership in order to adhere to a daily routine that may lead to psychological and physical change . Other directions for controlled follow-up studies are suggested",
"UNLABELLED In younger people the increase in aerobic capacity following training is related , in part , to blood volume ( BV ) expansion and the consequent improvements in maximal cardiac output . This training-induced hypervolemia is associated with a decrease in cardiopulmonary baroreflex ( CPBR ) control of peripheral vascular tone . PURPOSE To test the hypothesis that improvement in peak oxygen consumption ( VO2peak ) during training in older women is associated with specific central adaptations , such as BV expansion and a reduction in CPBR control of vascular tone . METHODS Seventeen healthy older women were r and omized into training ( N = 9 , 71 + /- 2 yr ) and control ( N = 8 , 73 + /- 3 yr ) groups . The training group exercised three to four times per wk for 30 min at 60 % peak heart rate for 12 wk and then 40 - 50 min at 75 % peak heart rate for 12 wk . The control group participated in yoga exercises over the same time period . We measured resting BV ( Evans blue dye ) , VO2peak , and the forearm vascular resistance response to unloading low pressure mechanoreceptors during low levels of lower body negative pressure ( through -20 mm Hg ) before and after aerobic training . The slope of the increase in forearm vascular resistance ( response ) per unit decrease in central venous pressure ( stimulus ) was used to assess CPBR responsiveness . RESULTS Aerobic training increased VO2peak 14.2 % from 24.2 mL x kg(-1 ) x min(-1 ) to 27.7 mL x kg(-1 ) x min(-1 ) ( P younger subjects . Blood volume ( 59.9 + /- 1.9 and 60.9 + /- 1.9 mL x kg[-1 ] ) and CPBR function ( -3.98 + /- 0.92 and -3.46 + /- 0.94 units x mm(-1 ) Hg ) were similar before and after training . CONCLUSIONS These data indicate that the inability to induce adaptations in CPBR function may limit BV expansion during training in older women . In addition , the absence of these specific adaptations may contribute to the relatively poor improvements in VO2peak in older women during short ( 10 - 12 wk ) periods of training",
"It is unclear whether the age-associated reduction in baroreflex sensitivity is modifiable by exercise training . The effects of aerobic exercise training and yoga , a non-aerobic control intervention , on the baroreflex of elderly persons was determined . Baroreflex sensitivity was quantified by the alpha-index , at high frequency ( HF ; 0.15 - 0.35 Hz , reflecting parasympathetic activity ) and mid-frequency ( MF ; 0.05 - 0.15 Hz , reflecting sympathetic activity as well ) , derived from spectral and cross-spectral analysis of spontaneous fluctuations in heart rate and blood pressure . Twenty-six ( 10 women ) sedentary , healthy , normotensive elderly ( mean 68 years , range 62 - 81 years ) subjects were studied . Fourteen ( 4 women ) of the sedentary elderly subjects completed 6 weeks of aerobic training , while the other 12 ( 6 women ) subjects completed 6 weeks of yoga . Heart rate decreased following yoga ( 69 + /- 8 vs. 61 + /- 7 min-1 , P aerobic training ( 66 + /- 8 vs. 63 + /- 9 min-1 , P = 0.29 ) . VO2 max increased by 11 % following yoga ( P aerobic training ( P alpha MF ( 6.5 + /- 3.5 vs. 6.2 + /- 3.0 ms mmHg-1 , P = 0.69 ) or alpha HF ( 8.5 + /- 4.7 vs. 8.9 + /- 3.5 ms mmHg-1 , P = 0.65 ) occurred after aerobic training . Following yoga , alpha HF ( 8.0 + /- 3.6 vs. 11.5 + /- 5.2 ms mmHg-1 , P alpha MF ( 6.5 + /- 3.0 vs. 7.6 + /- 2.8 ms mmHg-1 , P = 0.29 ) increased . Short- duration aerobic training does not modify the alpha-index at alpha MF or alpha HF in healthy normotensive elderly subjects . alpha HF but not alpha MF increased following yoga , suggesting that these parameters are measuring distinct aspects of the baroreflex that are separately modifiable",
"OBJECTIVES Compare two 12-week low-intensity exercise regimens on components of physical function and quality of life in community-dwelling healthy yet sedentary adults aged over 60 . DESIGN This study used a r and omised , multi-arm , controlled trial design . METHODS Thirty-nine sedentary participants ( 29 women ) , aged 67.7±6.7 years were r and omly allocated to either a 12-week Thai Yoga ( TY ) or Tai Chi ( TC ) for 90min twice per week , or telephone counselling Control ( C ) . A Senior Fitness Test ( chair-st and , arm-curl , sit-&-reach , back-scratch , 8-foot up-&-go and 6-min walk ) and Short-Form 36 Health Survey , Centre for Epidemiological Studies of Depression , Physical Activity Scale for the Elderly and the Physical Activity Enjoyment Scale were assessed at baseline , six , 12 weeks , and three months after the completion of the regimen . RESULTS After 12 weeks , chair-st and ( mean difference , 2.69 ; 95 % CI , 0.97 - 4.41 ; P ( 2.23 ; 95 % CI , 0.06 - 4.52 ; P=0.009 ) , sit-&-reach ( 1.25 ; 95 % CI , 0.03 - 2.53 ; P=0.013 ) , back-scratch ( 2.00 ; 95 % CI , 0.44 - 3.56 ; P=0.005 ) , 8-foot up-&-go ( -0.43 ; 95 % CI , -0.85 to 0.01 ; P=0.013 ) , 6-min walk ( 57.5 ; 95 % CI , 20.93 - 94.07 ; P vitality ( 13.27 ; 95 % CI , 2.88 - 23.66 ; P=0.050 ) and enjoyment ( 7.96 ; 95 % CI , 3.70 - 12.23 ; P=0.001 ) significantly improved in TY compared to C , however no change was observed in TC compared to C. TY improved in chair-st and ( 2.31 ; 95 % CI , 0.59 - 4.03 ; P=0.007 ) , sit-&-reach ( 1.38 ; 95 % CI , 0.10 - 2.66 ; P=0.007 ) , 6-min walk ( 32.31 ; 95 % CI , -4.26 - 68.88 ; P=0.015 ) , vitality ( 12.88 ; 95 % CI , 2.50 - 23.27 ; P=0.040 ) and enjoyment ( 5.65 ; 95 % CI , 1.39 - 9.92 ; P=0.010 ) compared to TC after 12 weeks . CONCLUSIONS The findings suggest that older adults can make significant improvements in their health and well-being by engaging in low intensity Thai Yoga exercise",
"The cardiovascular and behavioral adaptations associated with a 4-month program of aerobic exercise training were examined in 101 older men and women ( mean age = 67 years ) . Subjects were r and omly assigned to an Aerobic Exercise group , a Yoga and Flexibility control group , or a Waiting List control group . Prior to and following the 4-month program , subjects underwent comprehensive physiological and psychological evaluations . Physiological measures included measurement of blood pressure , lipids , bone density , and cardiorespiratory fitness including direct measurements of peak oxygen consumption ( VO2 ) and anaerobic threshold . Psychological measures included measures of mood , psychiatric symptoms , and neuropsychological functioning . This study demonstrated that 4 months of aerobic exercise training produced an overall 11.6 % improvement in peak VO2 and a 13 % increase in anaerobic threshold . In contrast , the Yoga and Waiting List control groups experienced no change in cardiorespiratory fitness . Other favorable physiological changes observed among aerobic exercise participants included lower cholesterol levels , diastolic blood pressure levels , and for subjects at risk for bone fracture , a trend toward an increase in bone mineral content . Although few significant psychological changes could be attributed to aerobic exercise training , participants in the two active treatment groups perceived themselves as improving on a number of psychological and behavioral dimensions",
"The effects of yoga and ayurveda on geriatric depression were evaluated in 69 persons older than 60 who were living in a residential home . Participants were stratified by age and gender and r and omly allocated to three groups : Yoga , Ayurveda , or Wait-list Control . The 15-item Geriatric Depression Scale was used to assess depressive symptoms prior to the intervention , and after 3 months and 6 months post-intervention . Participation in one of the three groups lasted 24 weeks . The yoga program ( 7 hours 30 minutes per week ) included physical postures , relaxation techniques , regulated breathing , devotional songs , and lectures . The Ayurveda Group received an herbal preparation twice daily for the whole period . The depression symptom scores of the Yoga Group at both 3 and 6 months decreased significantly , from a group average baseline of 10.6 to 8.1 and 6.7 , respectively ( p . Hence , an integrated approach of yoga including the mental and philosophical aspects in addition to the physical practice s was useful for institutionalized older persons",
"Data regarding perceived change were collected as part of a study of the effects of aerobic exercise training on psychological , cognitive , and physiological functioning among 101 healthy older adults . Subjects were assigned r and omly to an aerobic exercise group , a yoga control group , or a waiting list group for 16 weeks , after which all subjects participated in aerobic exercise for another 16 weeks . Exercise participants perceived positive changes in a wide range of significant life areas , and perceived improvement was more closely related to objective improvement for physiological indicators than for indicators of cognitive functioning or psychological well-being",
"Background : Being relocated to an assisted living facility can result in sleep disturbances and depression in elders . This may be attributed to or worsened by lack of regular physical activity . Appropriate exercise programs may be an important component of quality of life in this group of transitional frail elders . Purpose : This study aim ed to test the effects of a 6-month yoga exercise program in improving sleep quality and decreasing depression in transitional frail elders living in assisted living facilities . Methods : A quasi-experimental pretest- and -posttest design was used . A convenience sample of 69 elderly residents of assisted living facilities was divided r and omly into a yoga exercise ( n = 38 ) and control group ( n = 31 ) based on residence location . A total of 55 participants completed the study . The intervention was implemented in three small groups , and each practice group was led by two pretrained certified yoga instructors three times per week at 70 min per practice session for 24 weeks . The outcome measures of sleep quality ( Pittsburgh Sleep Quality Index ) and depression state ( Taiwanese Depression Question naire ) were examined at baseline , at the 12th week , and at the 24th week of the study . Results : After 6 months of performing yoga exercises , participants ' overall sleep quality had significantly improved , whereas depression , sleep disturbances , and daytime dysfunction had decreased significantly ( p outcome indicators than those of participants in the control group ( p yoga exercise be incorporated as an activity program in assisted living facilities or in other long-term care facilities to improve sleep quality and decrease depression in institutionalized elders",
"Almost all studies are prone to error — they use sample s drawn from a population to estimate what is occurring or what might occur in the whole population . These errors can broadly be divided into two : r and om error and systematic error . R and om error is the play of chance and results in an estimate of effect ( for example , relative risk ) being equally likely to be above or below the true value . Its role is assessed with statistical measures such as p values and confidence intervals . Systematic error is called bias , and also leads to the estimate being above or below the true value . Systematic error can be further divided into information bias , which relates to the misclassification of data , and selection bias , which is the focus of this article . # # # Bias Any trend in the collection , analysis , interpretation , publication or review of data that can lead to conclusions that are systematic ally different from the truth . ( Last J. A dictionary of epidemiology , 2001 ) Bias limits the conclusions that can be drawn from an analysis . It is particularly problematic because , unlike confounding , little can be done to “ allow ” or “ control ” for it once the data have been collected . As such it is in many ways an issue of study design , planning and practice . Selection bias in epidemiological studies occurs when there is a systematic difference between the characteristics of those selected for the study and those who are not . It also occurs in intervention studies when there are systematic",
"The effects of aerobic exercise training in a sample of 85 older adults were investigated . Ss were assigned r and omly to either an aerobic exercise group , a nonaerobic exercise ( yoga ) group , or a waiting-list control group . Following 16 weeks of the group-specific protocol , all of the older Ss received 16 weeks of aerobic exercise training . The older adults demonstrated a significant increase in aerobic capacity ( cardiorespiratory fitness ) . Performance on reaction-time tests of attention and memory retrieval was slower for the older adults than for a comparison group of 24 young adults , and there was no improvement in the older adults ' performance on these tests as a function of aerobic exercise training . Results suggest that exercise-related changes in older adults ' cognitive performance are due either to extended periods of training or to cohort differences between physically active and sedentary individuals",
"Background Yoga is a holistic therapy of exp and ing popularity , which has the potential to produce a range of physical , mental and social benefits . This trial evaluated the feasibility and effects of an adapted yoga programme on physical function and health-related quality of life in physically-inactive older adults . Methods In this r and omised controlled pilot trial , 52 older adults ( 90 % female ; mean age 74.8 years , SD 7.2 ) were r and omised 1:1 to a yoga programme or wait-list control . The yoga group ( n = 25 ) received a physical activity education booklet and were invited to attend ten yoga sessions during a 12-week period . The control group ( n = 27 ) received the education booklet only . Measures of physical function ( e.g. , Short Physical Performance Battery ; SPPB ) , health status ( EQ-5D ) and mental well-being ( Warwick-Edinburgh Mental Well-being Scale ; WEMWBS ) were assessed at baseline and 3 months . Feasibility was assessed using course attendance and adverse event data , and participant interviews . Results Forty-seven participants completed follow-up assessment s. Median class attendance was 8 ( range 3 to 10 ) . At the 3-month follow-up , the yoga group had a higher SPPB total score compared with the control group ( mean difference 0.9 , 95 % confidence interval [ CI ] -0.3 to 2.0 ) , a faster time to rise from a chair five times ( mean difference − 1.73 s , 95 % CI −4.08 to 0.62 ) , and better performance on the chair sit- and -reach lower-limb flexibility test ( mean difference 5 cm , 95 % CI 0 to 10 ) . The yoga group also had superior health status and mental well-being ( vs. control ) at 3 months , with mean differences in EQ-5D and WEMWBS scores of 0.12 ( 95 % CI , 0.03 to 0.21 ) and 6 ( 95 % CI , 1 to 11 ) , respectively . The interviews indicated that participants valued attending the yoga programme , and that they experienced a range of benefits . Conclusions The adapted yoga programme appeared to be feasible and potentially beneficial in terms of improving mental and social well-being and aspects of physical function in physically-inactive older adults . An appropriately-powered trial is required to confirm the findings of the present study and to determine longer-term effects . Trial registration Clinical Trials.govNCT02663726",
"BACKGROUND The objective of this study was to assess the effect of a yoga intervention on psychological health in older adults . METHOD A r and omized controlled trial study , conducted at 2 North Florida facilities for older adults . Subjects were 98 older adults , ages 65 to 92 . Participants were r and omly assigned to chair yoga , chair exercise , and control groups and assessed preintervention , postintervention , and 1-month follow-up on the State Anger Expression Inventory , State Anxiety Inventory , Geriatric Depression Scale , Lawton 's PGC Morale Scale , General Self-Efficacy Scale , Chronic Disease Self-Efficacy Scales , and Self- Control Schedule . RESULTS Yoga participants improved more than both exercise and control participants in anger ( Cohen 's d = 0.89 for yoga versus exercise , and 0.90 for yoga versus control , pretest to posttest ; and d = 0.90 and 0.72 , pretest to follow-up ) , anxiety ( d = 0.27 , 0.39 and 0.62 , 0.63 ) , depression ( d = 0.47 , 0.49 and 0.53 , 0.51 ) , well-being ( d = 0.14 , 0.49 and 0.25 , 0.61 ) , general self-efficacy ( d = 0.63 , 1.10 and 0.30 , 0.85 ) , and self-efficacy for daily living ( d = 0.52 , 0.81 and 0.27 , 0.42 ) . Changes in self-control moderated changes in psychological health . CONCLUSIONS Over a 6-week period , our findings indicate yoga 's potential for improving psychological health in older adults ",
"OBJECTIVE To determine the effect of yoga on balance and fear of falling in older adults . DESIGN R and omized controlled trial . SETTING Jah and idegan Center in Shiraz , southern Iran . PARTICIPANTS Forty persons ( 17 men and 23 women ) between the ages of 60 - 74 years with a Modified Falls Efficacy Scale ( MFES ) score Berg Balance Scale ( BBS ) score After completing the MFES question naire and BBS measurement , the participants were divided into intervention and control groups . BBS measurement and the MFES question naire were completed again immediately after the intervention . INTERVENTION The intervention group participated in 2 yoga practice sessions per week for 8 weeks . The control group received no intervention . MAIN OUTCOME MEASUREMENTS Fear of falling was measured with the MFES and balance was measured with the BBS . RESULTS We found significant changes in both variables ( P Mean differences before and after the intervention for the BBS for yoga and control groups were 10.19 and -1.16 , respectively . Mean differences before and after the intervention for the MFES for yoga and control groups were 1.62 and -0.21 , respectively . CONCLUSION Yoga is a potential intervention to reduce fear of falling and improve balance in older adults",
"Context : Yoga as a life-style practice has demonstrated beneficial effects . The role of yoga in the elderly for such benefits merits investigation . Aims : The aim of this study is to examine the effects of yoga intervention on quality -of-life ( QOL ) and sleep quality in the elderly living in old age homes . Setting s and Design : Single blind controlled study with block r and omization of elderly homes . Material s and Methods : A total of 120 subjects from nine elderly homes were r and omized in to yoga group ( n=62 ) and waitlist group ( n=58 ) . Subjects in the yoga group were given yoga intervention daily for 1 month and weekly until 3 months and were encouraged to practice yoga without supervision until for 6 months . Subjects in waitlist group received no intervention during this period . Subjects were evaluated with World Health Organization Quality of Life (WHOQOL)-BREF for measuring QOL and Pittsburgh Sleep Quality Index for sleep quality in the baseline and after 6 months . Statistical Analysis : Independent t-test and repeated measures analysis of covariance respectively was used to measure the difference in outcome measures between the two groups at baseline and after the study period . Results : Subjects in the yoga group had significantly higher number of years of formal education . Subjects in the yoga group had significant improvement in all the domains of QOL and total sleep quality after controlling for the effect of baseline difference in education between the two groups . Conclusion : Yoga intervention appears to improve the QOL and sleep quality of elderly living in old age homes . There is a need for further studies overcoming the limitations in this study to confirm the benefits of yoga for elderly in QOL and sleep quality"
] | 4116946c-06ff-11f0-808a-c43d1ab1c353 |
We conducted a systematic review of the literature about home telemonitoring compared with usual care . An electronic literature search was conducted to identify studies of home telemonitoring use in congestive heart failure ( CHF ) patients . Twenty-one original studies on home telemonitoring for patients with CHF were included ( 3082 patients ) . A r and om effects model was used to compute treatment efficacy to measure the average effect of the intervention across all studies where the quantitative pooling of results was appropriate . Home telemonitoring reduced mortality ( risk ratio = 0.64 ; 95 % CI : 0.48–0.85 ) compared with usual care . Several studies suggested that home telemonitoring also helped to lower the number of hospitalizations and the use of other health services . Patient quality of life and satisfaction with home telemonitoring were similar or better than with usual care . More studies of higher method ological quality are required to give more precise information about the potential clinical effectiveness of home telehealth interventions | [
"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",
"Heart failure ( HF ) is the leading cause of rehospitalization in older adults . The purpose of this pilot study was to examine whether telemonitoring by an advanced practice nurse reduced subsequent hospital readmissions , emergency department visits , costs , and risk of hospital readmission for patients with HF . One hundred two patient/caregiver dyads were r and omized into 2 groups postdischarge ; 84 dyads completed the study . Hospital readmissions , emergency department visits , costs , and days to readmission were abstract ed from medical records . Participants were interviewed soon after discharge and 3 months later about effects of telemonitoring on depressive symptoms , quality of life , and caregiver mastery . There were no significant differences due to telemonitoring for any outcomes . Caregiver mastery , informal social support , and electronic home monitoring were not significant predictors for risk of hospital readmission . Further studies should address the interaction between the advanced practice nurse and follow-up intervention with telemonitoring of patients with HF to better target those who are most likely to benefit",
"Background .The high cost of caring for patients with congestive heart failure ( CHF ) results primarily from frequent hospital readmissions for exacerbations . Home nurse visits after discharge can reduce readmissions , but the intervention costs are high . Objectives .To compare the effectiveness of three hospital discharge care models for reducing CHF-related readmission charges : 1 ) home telecare delivered via a 2-way video-conference device with an integrated electronic stethoscope ; 2 ) nurse telephone calls ; and 3 ) usual outpatient care . Research Design . One-year r and omized trial . Subjects . English-speaking patients 40 years of age and older with a primary hospital admission diagnosis of CHF . Measures .Our primary outcome was CHF-related readmission charges during a 6-month period after r and omization . Secondary outcomes included all-cause readmissions , emergency department ( ED ) visits , and associated charges . Results .Thirty-seven subjects were r and omized : 13 to home telecare , 12 each telephone care and 12 to usual care . Mean CHF-related readmission charges were 86 % lower in the telecare group ( $ 5850 , SD $ 21,094 ) and 84 % lower in the telephone group ( $ 7320 , SD $ 24,440 ) than in the usual care group ( $ 44,479 , SD $ 121,214 ) . However , the between-group difference was not statistically significant . Both intervention groups had significantly fewer CHF-related ED visits ( P = 0.0342 ) and charges ( P = 0.0487 ) than the usual care group . Trends favoring both interventions were noted for all other utilization outcomes . Conclusions .Substantial reductions in hospital readmissions , emergency visits , and cost of care for patients with CHF might be achieved by widespread deployment of distance technologies to provide posthospitalization monitoring . Home telecare may not offer incremental benefit beyond telephone follow-up and is more expensive",
"OBJECTIVES We sought to identify whether home telemonitoring ( HTM ) improves outcomes compared with nurse telephone support ( NTS ) and usual care ( UC ) for patients with heart failure who are at high risk of hospitalization or death . BACKGROUND Heart failure is associated with a high rate of hospitalization and poor prognosis . Telemonitoring could help implement and maintain effective therapy and detect worsening heart failure and its cause promptly to prevent medical crises . METHODS Patients with a recent admission for heart failure and left ventricular ejection fraction ( LVEF ) were assigned r and omly to HTM , NTS , or UC in a 2:2:1 ratio . HTM consisted of twice-daily patient self-measurement of weight , blood pressure , heart rate , and rhythm with automated devices linked to a cardiology center . The NTS consisted of specialist nurses who were available to patients by telephone . Primary care physicians delivered UC . The primary end point was days dead or hospitalized with NTS versus HTM at 240 days . RESULTS Of 426 patients r and omly assigned , 48 % were aged > 70 years , mean LVEF was 25 % ( SD , 8) and median plasma N-terminal pro-brain natriuretic peptide was 3,070 pg/ml ( interquartile range 1,285 to 6,749 pg/ml ) . During 240 days of follow-up , 19.5 % , 15.9 % , and 12.7 % of days were lost as the result of death or hospitalization for UC , NTS , and HTM , respectively ( no significant difference ) . The number of admissions and mortality were similar among patients r and omly assigned to NTS or HTM , but the mean duration of admissions was reduced by 6 days ( 95 % confidence interval 1 to 11 ) with HTM . Patients r and omly assigned to receive UC had higher one-year mortality ( 45 % ) than patients assigned to receive NTS ( 27 % ) or HTM ( 29 % ) ( p = 0.032 ) . CONCLUSIONS Further investigation and refinement of the application of HTM are warranted because it may be a valuable role for the management of selected patients with heart failure",
"BACKGROUND Outcomes related to chronic heart failure ( HF ) remain relatively poor , despite advances in pharmacological therapy and medical and nursing care . Experts agree that outpatient care may be among the factors that affect HF outcomes . We hypothesized that the method by which outpatient care is delivered may affect outcomes in this patient population . METHODS A prospect i ve , r and omized design was used to compare HF outcomes from 216 patients r and omized to 1 of 2 home health care delivery methods for 3 months after discharge . Care was delivered by the home nurse visit ( HNV ) or the nurse telemanagement ( NTM ) method . In the latter , patients used transtelephonic home monitoring devices to measure their weight , blood pressure , heart rate , and oxygen saturation . These data were transmitted daily to a secure Internet site . An advanced- practice nurse worked collaboratively with a cardiologist and subsequently treated patients via the telephone . Both delivery methods used the same HF-specific clinical guidelines to direct care . Outcomes include HF readmissions and length of stay , anxiety , depression , self-efficacy , and quality of life . Data were primarily tested using a 2-group analysis of variance ( ANOVA ) . We used a repeated- measures ANOVA to conduct preintervention-postintervention analyses . RESULTS After 3 months , patients in the NTM group ( n = 108 ; mean + /- SD age , 62.9 + /- 13.2 years ; 83 % African American ; 64 % female ) had fewer HF readmissions ( 13 vs 24 ; P lengths of stay ( 49.5 vs 105.0 days ; P HNV group ( n = 108 ; mean + /- SD age , 63.2 + /- 12.6 years ; 89 % African American ; 62 % female ) . Hospitalization charges at 3 months were less in the NTM group compared with the HNV group ( $ 65 023 vs $ 177 365 ; P cumulative readmission charges in the NTM group were also less ( $ 223 638 vs $ 500 343 [ P Quality of life was significantly improved for both groups when we compared postintervention and preintervention scores . CONCLUSION The adaptation of state-of-the-art computerized technology to closely monitor patients with HF with advanced- practice nurse care under the guidance of a cardiologist significantly improves HF management while reducing the cost of care",
"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",
"BACKGROUND Patients with chronic heart failure characteristically have multiple hospital admissions for symptom control , deleteriously affecting their quality of life and imposing a burden on national healthcare costs . We assessed the effect of a novel transtelephonic monitoring and follow-up program on the admission rate and length of hospital stay as well as changes in their subjectively rated quality of life of patients with chronic heart failure . METHODS This prospect i ve 1-year study was conducted on compliant subscribers to ' SHL ' , a telecardiological service with > 60,000 subscribers , who were admitted > or = 2 times during the previous year for recurrent pulmonary edema or deterioration in heart failure . Their heart rate , blood pressure and body weight measurements were now automatically transmitted daily to ' SHL\"s data bank and added to stored and up date d medical records . A question naire survey acquired information on their quality of life . RESULTS The study cohort included 118 patients , mean age 75 years ( range 49 - 89 years ) , 65 % males , a II-IV class functional capacity and a 25 % ( range 10 - 39 % ) mean ejection fraction . There was a 66 % reduction in the total hospitalization days ( from 1623 in the year preceding study entry to 558 during the study period , p quality of life . CONCLUSIONS Data are provided to demonstrate that a transtelephonic system allowing primary care at the patient 's home can significantly reduce hospitalization rate and length of stay and significantly enhance the quality of life of patients with chronic heart failure",
"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",
"BACKGROUND Web-based home care monitoring systems can assess medication compliance , health status , quality of life , and physiologic parameters . They may help overcome some of the limitations associated with current congestive heart failure management models . OBJECTIVES This pilot study compared the effects of a self-care and medication compliance device , linked to a Web-based monitoring system , to the effects of usual care alone on compliance with recommended self-care behaviors ; medication taking ; quality of life ; distance walked during a 6-minute walk test ; and New York Heart Association Functional Class . We also assessed patient experiences living with the compliance device . METHODS We enrolled 18 patients with Functional Class II-III congestive heart failure in an urban VA Medical Center . The patients were r and omized into 2 groups . Group A received usual care plus the compliance device . Group B ( controls ) received usual care only . Data were collected using the compliance device , the Heart Failure Self-Care Behavior Scale , pill counts , 6-minute walk test , and the Minnesota Living with Heart Failure Question naire at baseline and at 3 months follow-up . RESULTS At baseline and at 3 months , there were no differences between the compliance device group and the usual care group in self-care behaviors , pill counts , 6-minute walk-test distance , or Functional Class . However , quality of life improved significantly from baseline to 3-month follow-up ( ANOVA , P = .006 ) . This difference was due to an improvement in quality of life for the monitor group ( P = .002 ) but not the usual care only group ( P = .113 ) . Patients in the compliance device group had a 94 % medication compliance rate , 81 % compliance with daily blood pressure monitoring , and 85 % compliance with daily weight monitoring as compared to 51 % for blood pressure monitoring and 79 % for weight monitoring in the usual care group ( P = NS ) . CONCLUSION These are promising pilot results that , if replicated in a larger sample , may significantly improve care and outcomes for patients with heart failure",
"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",
"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",
"Patients with chronic conditions are heavy users of the health care system . There are opportunities for significant savings and improvements to patient care if patients can be maintained in their homes . A r and omized control trial tested the impact of 3 months of telehome monitoring on hospital readmission , quality of life , and functional status in patients with heart failure or angina . The intervention consisted of video conferencing and phone line transmission of weight , blood pressure , and electrocardiograms . Telehome monitoring significantly reduced the number of hospital readmissions and days spent in the hospital for patients with angina and improved quality of life and functional status in patients with heart failure or angina . Patients found the technology easy to use and expressed high levels of satisfaction . Telehealth technologies are a viable means of providing home monitoring to patients with heart disease at high risk of hospital readmission to improve their self-care abilities",
"BACKGROUND Chronic heart failure ( CHF ) remains a common cause of disability , death and hospital admission . Several investigations support the usefulness of programs of disease management for improving clinical outcomes . However , the effect of home-based telemanagement programs on the rate of hospital readmission is still unclear and the cost-effectiveness ratio of such programs is unknown . The aim of the study was to determine whether a home-based telemanagement ( HBT ) programme in CHF patients decreased hospital readmissions and hospital costs in comparison with the usual care ( UC ) follow-up programme over a one-year period . METHODS AND RESULTS Four hundred-sixty CHF patients ( pts ) , aged 57+/-10 years were r and omised to two management strategies : 230 pts to HBT programme and 230 pts to UC programme . The HBT pts received a portable device , transferring , by telephone , a one-lead trace to a receiving station where a nurse was available for interactive teleconsultation . The UC pts were referred to their primary care physicians and cardiologists . The primary objective of the study was one-year hospital readmission for cardiovascular reasons . During one-year follow-up 55 pts ( 24 % ) in HBT group and 83 pts ( 36 % ) in UC group had at least one readmission ( RR=0.56 ; 95 % CI : 0.38 - 0.82 ; p=0.01 ) . After adjusting for clinical and demographic characteristics , the HBT group had a significantly lower risk of readmission compared with the UC group ( HR=0.50 , 95 % CI : 0.34 - 0.73 ; p=0.01 ) . The intervention was associated with a 36 % decrease in the total number of hospital readmissions ( HBT group : 91 readmissions ; UC group : 142 readmissions ) and a 31 % decrease in the total number of episodes of hemodynamic instability ( 101 in HBT group vs 147 in UC group ) . The rate of hearth failure-related readmission was 19 % ( 43 pts ) in HBT group and 32 % ( 73 pts ) in UC group ( RR=0.49 , 95 % [ CI ] : 0.31 - 0.76 ; p=0.0001 ) . No significant difference was found on cardiovascular mortality between groups . Mean cost for hospital readmission was significantly lower in HBT group ( euro 843+/-1733 ) than in UC group ( euro 1298+/-2322 ) , ( -35 % , p hospital readmissions and costs in CHF patients"
] | 411694b2-06ff-11f0-808a-c43d1ab1c353 |
Graphical abstract Figure . No caption available . A : Meta‐ analysis of the effect of resveratrol supplementation on total cholesterol . B : Meta‐ analysis of the effect of resveratrol supplementation on low‐density lipoprotein . C : Meta‐ analysis of the effect of resveratrol supplementation on high‐density lipoprotein . D : Meta‐ analysis of the effect of resveratrol supplementation on triglyceride after removing the study by Zortea et al. & NA ; Despite the notion that resveratrol can significantly reduce plasma lipids , the result of r and omized clinical trials ( RCTs ) on resveratrol effect and the serum lipid profile are contradictory . Our objective was to conduct a systematic review and meta‐ analysis on r and omized clinical trials ( RCTs ) and assess the effect of resveratrol on lipids . ISI web of science , Ovid , PubMed / Medline , SCOPUS , and Google Scholar data bases were search ed up to Jun 2017 . RCTs that assessed resveratrol effects on lipid profile among adult participants were chosen . Treatment effects were considered as weighted mean difference ( WMD ) and the corresponding st and ard error ( SE ) in concentrations of serum lipids . To estimate the overall summary effect , we used r and om‐effects model . The protocol was registered with PROSPERO ( No. CRD42017072365 ) . This meta‐ analysis was performed on twenty‐one trials . Our results indicated that resveratrol ca n't significantly change total cholesterol ( TC ) ( WMD = −0.08 mmol/l , 95 % CI : −0.23 , 0.08 ; P = .349 , I2 = 87.8 % ) , low‐density lipoprotein ( LDL‐C ) ( WMD : −0.04 mmol/l , 95 % CI : −0.21 , 0.12 ; P = .620 , I2 = 93.4 % ) , and high density lipoprotein ( HDL‐C ) ( WMD : −0.01 mmol/l , 95 % CI : −0.04 , 0.02 ; P = .269 , I2 = 88.6 % ) . Its effect on triacylglycerol ( TG ) ( WMD : 0.58 mmol/l , 95 % CI : 0.34 , 0.82 ; P BMI , resveratrol dosage , and intervention duration could not change the results . We conclude that resveratrol does not change lipid profile concentration . Confirmation of this conclusion will require more studies exclusively on dyslipidemic patients in which the intake of lipid lowering agents is among the exclusion criteria | [
"ABSTRACT Objective “ The obesity epidemic ” has led to an increase in obesity-related conditions including non-alcoholic fatty liver disease ( NAFLD ) , for which effective treatments are in dem and . The polyphenol resveratrol prevents the development of experimental NAFLD through modulation of cellular pathways involved in calorie restriction . We aim ed to test the hypothesis that resveratrol alleviates NAFLD in a r and omised , clinical trial . Material s and methods A total of 28 overweight patients with transaminasemia and histological NAFLD were r and omised 1:1 to placebo or resveratrol 1.5 g daily for 6 months . Twenty-six participants completed the trial and underwent repeated clinical investigation , blood work , MR spectroscopy ; and 19 participants agreed to a repeat liver biopsy . Results Resveratrol treatment was generally not superior to placebo in improving plasma markers of liver injury ( primary outcome : alanine transaminase , p = 0.51 ) . Resveratrol-treated patients showed a 3.8 % decrease in liver lipid content ( p = 0.03 ) , with no difference between the two treatment arms ( p = 0.38 ) and no improvement of histological features . Resveratrol treatment was not associated with improvements in insulin sensitivity or markers of the metabolic syndrome , except for a transient decrease in systolic BP . Microarray analysis and qRT-PCR revealed no major changes in expression profile . Also , we report a serious adverse event in a patient who developed fever and bicytopenia . Conclusions In this placebo-controlled , high-dose and long-term study , resveratrol treatment had no consistent therapeutic effect in alleviating clinical or histological NAFLD , though there may be a small ameliorating effect on liver function tests and liver fat accumulation ",
"Ageing is thought to be associated with decreased vascular function partly due to oxidative stress . Resveratrol is a polyphenol , which in animal studies has been shown to decrease atherosclerosis , and improve cardiovascular health and physical capacity , in part through its effects on Sirtuin 1 signalling and through an improved antioxidant capacity . We tested the hypothesis that resveratrol supplementation enhances training-induced improvements in cardiovascular health parameters in aged men . Twenty-seven healthy physically inactive aged men ( age : 65 ± 1 years ; body mass index : 25.4 ± 0.7 kg m(-2 ) ; mean arterial pressure ( MAP ) : 95.8 ± 2.2 mmHg ; maximal oxygen uptake : 2488 ± 72 ml O2 min(-1 ) ) were r and omized into 8 weeks of either daily intake of either 250 mg trans-resveratrol ( n = 14 ) or of placebo ( n = 13 ) concomitant with high-intensity exercise training . Exercise training led to a 45 % greater ( P increase in maximal oxygen uptake in the placebo group than in the resveratrol group and to a decrease in MAP in the placebo group only ( -4.8 ± 1.7 mmHg ; P was lower in the resveratrol than in the placebo group after training ( 980 ± 90 vs. 1174 ± 121 pg ml(-1 ) ; P synthase was higher in the resveratrol group after training ( P administration also abolished the positive effects of exercise on low-density lipoprotein , total cholesterol/high-density lipoprotein ratio and triglyceride concentrations in blood ( P did not alter the effect of exercise training on the atherosclerosis marker vascular cell adhesion molecule 1 ( VCAM-1 ) . Sirtuin 1 protein levels were not affected by resveratrol supplementation . These findings indicate that , whereas exercise training effectively improves several cardiovascular health parameters in aged men , concomitant resveratrol supplementation can blunt these effects",
"Resveratrol is a naturally occurring polyphenolic compound . Numerous animal studies have been reported on its wide-ranging beneficial effects in the biological system including diabetes mellitus ( DM ) . We hypothesized , therefore , that oral supplementation of resveratrol would improve the glycemic control and the associated risk factors in patients with type 2 diabetes mellitus ( T2DM ) . The present clinical study was therefore carried out to test the hypothesis . Sixty-two patients with T2DM were enrolled from Government Headquarters Hospital , Ootacamund , India , in a prospect i ve , open-label , r and omized , controlled trial . Patients were r and omized into control and intervention groups . The control group received only oral hypoglycemic agents , whereas the intervention group received resveratrol ( 250 mg/d ) along with their oral hypoglycemic agents for a period of 3 months . Hemoglobin A(1c ) , lipid profile , urea nitrogen , creatinine , and protein were measured at the baseline and at the end of 3 months . The results reveal that supplementation of resveratrol for 3 months significantly improves the mean hemoglobin A(1c ) ( means ± SD , 9.99 ± 1.50 vs 9.65 ± 1.54 ; P ( mean ± SD , 139.71 ± 16.10 vs 127.92 ± 15.37 ; P ( mean ± SD , 4.70 ± 0.90 vs 4.33 ± 0.76 ; P ( mean ± SD , 75.6 ± 4.6 vs 72.3 ± 6.2 ; P No significant changes in body weight and high-density lipoprotein and low-density lipoprotein cholesterols were observed . Oral supplementation of resveratrol is thus found to be effective in improving glycemic control and may possibly provide a potential adjuvant for the treatment and management of diabetes",
"Background : Patients with schizophrenia ( SZ ) are generally overweight or obese and have several metabolic disorders . Additionally , such patients have a lower life expectancy and the main cause of their increased mortality is cardiovascular disease ( CVD ) . The objective of this study was to determine the efficacy of resveratrol supplementation on serum glucose and CVD risk factors in individuals with SZ . Methods and Results : This is a four-week r and omized , double-blind controlled trial ( registration No. : NCT 02062190 ) in which 19 men with a diagnosis of SZ , aged 18 to 65 , were assigned to either a resveratrol supplement group ( 200 mg/day ) or a placebo group ( 200 mg/day ) . In short , we did not observe significant changes after resveratrol supplementation . In the placebo group , we found a significant increase in total cholesterol levels ( p = 0.024 ) and in LDL-cholesterol ( p = 0.002 ) , as well as a decrease in body fat percentage ( p = 0.038 ) . The placebo group also showed an increase in triglycerides ( 9.19 % ) and a reduction in HDL-cholesterol ( 4.88 % ) . In the resveratrol group , triglycerides decreased ( 7.64 % ) . Conclusion : In summary , oral resveratrol in reasonably low dosages ( 200 mg daily ) brought no differences to body weight , waist circumference , glucose , and total cholesterol . It was possible to note that the lipid profile in the placebo group worsened and , although no significant differences were found , we can assume that resveratrol might prevent lipid profile damage and that the intervention affected the lipoprotein metabolism at various levels",
"To assess the effect on exercise capacity and tolerability of resveratrol , 13 healthy , sedentary adult volunteers were enrolled in a r and omized crossover study comparing resveratrol and placebo over two 4-week periods , with a 2-week time between periods when subjects received no treatment . No significant changes in exercise duration or aerobic capacity ( peak oxygen uptake ) were observed . Gastrointestinal side effects were more common during resveratrol treatment ( 77 % vs. 15 % , p = 0.0048 ) . A small reduction in fasting glucose and small but statistically significant increases in liver enzymes , total cholesterol , and triglycerides were observed , although mean results remained within normal limits . There was no change in complete blood count , inflammatory markers , renal function , or other measures of liver function",
"Background : Exercise can lead to acute oxidative stress , which can result in oxidative damage and induce inflammation . Resveratrol may reduce the levels of inflammatory cytokines . Thus , we investigated the effects of this compound on the plasma levels of tumor necrosis factor-α ( TNF-α ) and interleukin 6 ( IL-6 ) in male professional basketball players . Methods : Twenty healthy male professional basketball players were r and omized into two groups ( 10 each ) . For 6 weeks , they received daily either 200 mg of polygonum cuspidatum extract ( PCE ) st and ardized to contain 20 % trans-resveratrol equivalent to 40 mg trans-resveratrol or placebo . Indices of inflammation were measured before and after 6 weeks of supplementation . Results : There was a significant reduction in plasma levels of TNF-a and IL-6 after 6 weeks of supplementation ; while no change was observed in these markers in the control group . Conclusions : Present study shows that 6 weeks of PCE containing resveratrol supplementation reduces the inflammation in male professional basketball players",
"The polyphenol resveratrol is considered to exert many beneficial actions , such as antioxidant , anti-inflammatory , insulin-sensitizer and anticancer effects . Its benefits in patients with type 2 diabetes mellitus ( T2DM ) are controversial . Our aims were to determine whether resveratrol supplementation at two different dosages ( 500 and 40mg/day ) for 6 months i ) reduced the concentrations of C-reactive-protein ( CRP ) and ii ) ameliorated the metabolic pattern of T2DM patients . In the present double-blind , r and omized , placebo-controlled trial , 192 T2DM patients were r and omized to receive resveratrol 500mg/day ( Resv500arm ) , resveratrol 40mg/day ( Resv40arm ) or placebo for 6-months . At baseline and at the trial end , CRP values , anthropometric , metabolic and liver parameters were determined . No serious adverse event occurred . A dose-dependent , though not significant , CRP decrease of 5.6 % ( Resv40arm ) and 15.9 % ( Resv500arm ) was observed vs placebo . We failed to detect significant differences in weight , BMI , waist circumference , and values of arterial blood pressure , fasting glucose , glycated hemoglobin , insulin , C-peptide , free fatty acids , liver transaminases , uric acid , adiponectin , interleukin-6 , in both the Resv500 and Resv40 arms vs placebo . Total cholesterol and triglycerides slightly increased in the Resv500arm . Subgroup analyses revealed that lower diabetes duration ( in both Resv500 and Resv40arms ) , and , in the Resv500arm , younger age , aspirin use and being a smoker were associated with a significantly higher CRP reduction vs placebo . The supplementations with 40mg/day or 500mg/day resveratrol did neither reduce CRP concentrations , nor improve the metabolic pattern of T2DM patients",
"CONTEXT Polycystic ovary syndrome ( PCOS ) is the most common endocrinopathy affecting women of reproductive age . Hyper and rogenism is the central feature of PCOS . Studies on isolated ovarian theca-interstitial cells suggest that resveratrol , a natural polyphenol , reduces and rogen production . OBJECTIVE This study was design ed to evaluate endocrine and metabolic effects of resveratrol on PCOS . DESIGN AND SETTING This was a r and omized ( 1:1 ) double-blind , placebo-controlled trial that evaluated the effects of resveratrol over a period of 3 months in an academic hospital . PATIENTS AND OTHER PARTICIPANTS Subjects with PCOS were identified according to the Rotterdam criteria . Thirty-four subjects were enrolled and 30 subjects completed the trial . Evaluations were performed at baseline and repeated after 3 months of treatment . INTERVENTION Resveratrol ( 1,500 mg p.o . ) or placebo were administered daily . MAIN OUTCOME MEASURE Primary outcome was the change in the serum total T. RESULTS Resveratrol treatment led to a significant decrease of total T by 23.1 % ( P = .01 ) . In parallel , resveratrol induced a 22.2 % decrease of dehydroepi and rosterone sulfate ( P = .01 ) , a decrease of fasting insulin level by 31.8 % ( P = .007 ) and an increase of the Insulin Sensitivity Index ( Matsuda and DeFronzo ) by 66.3 % ( P = .04 ) . Levels of gonadotropins , the lipid profile as well as markers of inflammation and endothelial function were not significantly altered . CONCLUSIONS Resveratrol significantly reduced ovarian and adrenal and rogens . This effect may be , at least in part , related to an improvement of insulin sensitivity and a decline of insulin level",
"Background : Quercetin , which is considered as a health-promoting antioxidant , belongs to the broad flavonoids group . Numerous experimental studies have proved that quercetin and vitamin C provide anti-inflammatory and antioxidant properties . The aim of this study is to assess the effects of both quercetin and vitamin C on lipid profile and muscle damage in human subjects . Methods : A r and omized , placebo-controlled , double-blind clinical trial was carried out on 60 males for eight weeks . The subjects were r and omly assigned to one of the four groups : 1 ) quercetin + vitamin C ( 500 mg/day quercetin + 200 mg/day vitamin C ) 2 ) quercetin ( 500 mg/day quercetin + 200 mg/day placebo ) 3 ) vitamin C ( 500 mg/day vitamin C + 200 mg/day placebo ) and 4 ) placebo ( 500 mg/day placebo + 200 mg/day placebo ) . Blood sample s , body weight and percent of body fat were measured before and after intervention . In addition , dietary intake was estimated using 24-h recall . Results : No significant changes occurred in high-density lipoprotein levels between groups and in the four groups before and after supplementation . Low density lipoprotein values decreased significantly ( P = 0.048 ) in the “ Quercetin + Vit C ” group but decrease was not considerable in other groups before and after intervention and among groups . Fat-soluble vitamins ' intake was significantly high among 4 groups . Conclusions : Quercetin and vitamin C supplementation may not be beneficial in lipid profile improvement , although it may reduce induce muscle damage and body fat percent",
"OBJECTIVES Type 2 diabetes ( T2D ) may be caused by elevated oxidative stress , inflammation , and hyperglycemia . The phytochemicals in several herbal medicines are reported to effectively improve diabetes and to ameliorate diabetic complications . The aim of the present study was to determine the effects of cinnamon , cardamom , saffron , and ginger as supplementary remedies in T2D . METHODS This r and omized controlled , clinical trial included 204 T2D patients . The participants were r and omly assigned to four intervention groups receiving 3 glasses of black tea and either 3 g cardamom , or cinnamon , or ginger , or 1 g saffron and one control group which consumed only 3 tea glasses without any herbal medicine for 8 weeks . Markers of inflammation , oxidative stress , fasting blood sugar , lipid profile , and anthropometric measures were evaluated at baseline and after 8 weeks of intervention . RESULTS After 8 weeks of intervention , cinnamon , cardamom , ginger , and saffron consumption had significant effects on total cholesterol , LDL , and HDL levels ( p measures of glycemic control , anthropometry , inflammation , and oxidative stress . In within-group comparisons only , cinnamon intake significantly decreased fasting blood sugar ( FBS ) . CONCLUSIONS The herbal remedies examined had significantly beneficial effects on cholesterol , but not on measures of glycemic control , oxidative stress , and inflammation . Based on the contradictory results reported in the literature , the effects of herbal medicine in diabetic patients should undergo further detailed investigation",
"BACKGROUND Despite their powerful biologic activities conducive to protection against atherosclerosis , cancer and inflammatory diseases demonstrated in vitro , there is considerable doubt whether the polyphenolic constituents present in red wine and other dietary components are effective in vivo . OBJECTIVE We have tested the absorptive efficiency of three of these constituents ( trans-resveratrol , [+]-catechin and quercetin ) when given orally to healthy human subjects in three different media . DESIGN Twelve healthy males aged 25 to 45 were r and omly assigned to three different groups consuming orally one of the following polyphenols : trans-resveratrol , 25 mg/70 kg ; [+]-catechin 25 mg/70 kg ; quercetin 10 mg/70 kg . Each polyphenol was r and omly administered at 4-week intervals in three different matrices : white wine ( 11.5 % ethanol ) , grape juice , and vegetable juice/homogenate . Blood was collected at zero time and at four intervals over the first four hours after consumption ; urine was collected at zero time and for the following 24-h . The sums of free and conjugated polyphenols were measured in blood serum and urine by a gas-chromatographic method . RESULTS All three polyphenols were present in serum and urine predominantly as glucuronide and sulfate conjugates , reaching peak concentrations in the former around 30-min after consumption . The free polyphenols accounted for 1.7 to 1.9 % ( trans-resveratrol ) , 1.1 to 6.5 % ( [+]-catechin ) and 17.2 to 26.9 % ( quercetin ) of the peak serum concentrations . The absorption of trans-resveratrol was the most efficient as judged by peak serum concentration , area-under-the curve ( 4 h ) and urinary 24-h excretion ( 16 - 17 % of dose consumed ) . [+]-Catechin was the poorest by these criteria ( urine 24-h excretion 1.2%-3.0 % of dose consumed ) , with quercetin being intermediate ( urine 24-h excretion 2.9%-7.0 % of dose consumed ) . Some significant matrix effects were observed for the serum polyphenol concentrations , but in the case of urine no matrix promoted significantly higher excretion than the other two . CONCLUSIONS The absorption of these three polyphenols is broadly equivalent in aqueous and alcoholic matrices but , at peak concentrations of 10 to 40 nmol/L , is inadequate to permit circulating concentrations of 5 to 100 micromol/L consistent with in vitro biologic activity . The voluminous literature reporting powerful in vitro anticancer and antiinflammatory effects of the free polyphenols is irrelevant , given that they are absorbed as conjugates",
"OBJECTIVE Smokers are characterized by a low- grade systemic inflammatory state and an oxidant-antioxidant imbalance . Few human studies were conducted on the effects of resveratrol , a natural compound with anti-inflammatory and antioxidant properties , and no trial on smokers has been performed to date . We evaluated whether resveratrol has beneficial effects on markers of inflammation and oxidative stress in smokers . METHODS AND RESULTS A r and omized , double- blind , cross-over trial was performed in 50 healthy adult smokers : 25 were r and omly allocated to \" resveratrol-first \" ( 30-days : 500 mg resveratrol/day , 30-days wash-out , 30-days placebo ) and 25 to \" placebo-first \" ( 30-days placebo , 30-days wash-out , 30-days 500 mg resveratrol/day ) . Resveratrol significantly reduced C-reactive protein ( CRP ) and triglyceride concentrations , and increased Total Antioxidant Status ( TAS ) values . After analyzing data with general linear models to assess period and carry-over effects , the ratios of the values after resveratrol to those after placebo were respectively : 0.47 ( 95%CI 0.38 - 0.59 ) -CRP- and 0.71 ( 95%CI 0.65 - 0.78 ) -triglycerides- , while TAS increased by 74.2 μmol/L ( 95%CI 60.8 - 87.6 ) . Uric acid , glucose , insulin , cholesterol , liver enzyme concentrations , and weight , waist circumference , and blood pressure values did not significantly change after resveratrol supplementation . CONCLUSIONS Because resveratrol has anti-inflammatory , anti-oxidant , and hypotriglyceridemic effects , its supplementation may beneficially affect the increased cardiovascular risk of healthy smokers",
"OBJECTIVE This study aim ed to evaluate the effects of short-term ( 60-d ) oral supplementation with calcium fructoborate , resveratrol , and their combination on the clinical and biological statuses of subjects with stable angina pectoris . METHODS A r and omized , double-blinded , active-controlled , parallel clinical trial was conducted in three groups of subjects . Of the total number of subjects included in study ( n = 166 ) , 87 completed the 60-d test treatment study period and 29 followed in parallel their usual medical care and treatment . The primary outcomes were inflammation biomarkers ( high-sensitivity C-reactive protein ) , left ventricular function markers ( N-terminal prohormone of brain natriuretic peptide ) , and lipid markers ( total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , and triacylglycerols ) . Quality of life was assessed by the Canadian Cardiovascular Society angina class and the number of angina attacks per week . RESULTS There was a significant decrease of high-sensitivity C-reactive protein in all groups at the 30-d and 60-d visits . This decrease was greater ( 39.7 % at 60 d ) for group 3 ( calcium fructoborate ) , followed by group 2 ( resveratrol plus calcium fructoborate , 30.3 % at 60 d ) . The N-terminal prohormone of brain natriuretic peptide was significantly lowered by resveratrol ( group 1 , 59.7 % at 60 d ) and by calcium fructoborate ( group 3 , 52.6 % at 60 d ) . However , their combination ( group 2 ) was the most effective and induced a decrease of 65.5 % . Lipid markers showed slight changes from baseline in all groups . The improvement in the quality of life was best observed for subjects who received the resveratrol and calcium fructoborate mixture ( group 2 ) . CONCLUSION The results indicate that the combination of resveratrol and calcium fructoborate has beneficial effects in patients with",
"The search for complementary treatments in primary prevention of cardiovascular disease ( CVD ) is a high-priority challenge . Grape and wine polyphenol resveratrol confers CV benefits , in part by exerting anti-inflammatory effects . However , the evidence in human long-term clinical trials has yet to be established . We aim ed to investigate the effects of a dietary resveratrol-rich grape supplement on the inflammatory and fibrinolytic status of subjects at high risk of CVD and treated according to current guidelines for primary prevention of CVD . Seventy-five patients undergoing primary prevention of CVD participated in this triple-blinded , r and omized , parallel , dose-response , placebo-controlled , 1-year follow-up trial . Patients , allocated in 3 groups , consumed placebo ( maltodextrin ) , a resveratrol-rich grape supplement ( resveratrol 8 mg ) , or a conventional grape supplement lacking resveratrol , for the first 6 months and a double dose for the next 6 months . In contrast to placebo and conventional grape supplement , the resveratrol-rich grape supplement significantly decreased high-sensitivity C-reactive protein ( -26 % , p = 0.03 ) , tumor necrosis factor-α ( -19.8 % , p = 0.01 ) , plasminogen activator inhibitor type 1 ( -16.8 % , p = 0.03 ) , and interleukin-6/interleukin-10 ratio ( -24 % , p = 0.04 ) and increased anti-inflammatory interleukin-10 ( 19.8 % , p = 0.00 ) . Adiponectin ( 6.5 % , p = 0.07 ) and soluble intercellular adhesion molecule-1 ( -5.7 % , p = 0.06 ) tended to increase and decrease , respectively . No adverse effects were observed in any patient . In conclusion , 1-year consumption of a resveratrol-rich grape supplement improved the inflammatory and fibrinolytic status in patients who were on statins for primary prevention of CVD and at high CVD risk ( i.e. , with diabetes or hypercholesterolemia plus ≥1 other CV risk factor ) . Our results show for the first time that a dietary intervention with grape resveratrol could complement the gold st and ard therapy in the primary prevention of CVD",
"Non-alcoholic fatty liver disease ( NAFLD ) is usually associated with insulin resistance , central obesity , reduced glucose tolerance , type 2 diabetes mellitus and hypertriacylglycerolaemia . The beneficial effects of resveratrol on metabolic disorders have been shown previously . The aim of this study was to evaluate the effects of resveratrol supplementation on cardiovascular risk factors in patients with NAFLD . In this r and omised double-blinded placebo-controlled clinical trial , fifty NAFLD patients were supplemented with either a 500-mg resveratrol capsule or a placebo capsule for 12 weeks . Both groups were advised to follow an energy-balanced diet and physical activity recommendations . resveratrol supplementation reduced alanine aminotransferase ( ALT ) and hepatic steatosis significantly more than placebo ( P0·05 ) . There were no significant changes in blood pressure , insulin resistance markers and TAG in either group ( P>0·05 ) . Our data have shown that 12-week supplementation of 500 mg resveratrol does not have any beneficial effect on anthropometric measurements , insulin resistance markers , lipid profile and blood pressure ; however , it reduced ALT and hepatic steatosis in patients with NAFLD",
"Abstract High cholesterol is one of the risk factors for atherogenesis , leading to oxidative stress and cardiovascular disease ( CVD ) . The focus of this study was to evaluate the role and the pathways of action of a natural antioxidant , resveratrol , in asymptomatic hypercholesterolemic ( AHC ) individuals . Forty healthy AHCs and normocholesterolemics ( NCs ) participated in the study . They received r and om-order resveratrol and placebo capsules for four weeks . Total antioxidant capacity ( TAC ) , vitamin E and total cholesterol ( TC ) were measured at baseline and at the end of each intervention . Resveratrol provided a direct antioxidant effect in healthy NC individuals , but in AHC individuals , with a higher dem and for antioxidant activity due to higher cholesterol levels , it acted by facilitating an increase in vitamin E. Our findings suggest that resveratrol acts synergistically with other antioxidants against oxidative stress and highlights the importance of hypercholesterolemic individuals consuming natural antioxidants instead of medications to reduce the risk of CVD , while the situation is still reversible",
"Probiotic therapies are going to be an effective alternative therapeutic strategy in the treatment and management of diabetes . The mechanism behind the essential effects of probiotic therapies in diabetic patients was not fully understood . The objective of this study was to evaluate the effects of probiotic soy milk containing Lactobacillus planetarum A7 on inflammation , lipid profile , fasting blood glucose , and serum adiponectin among patients with type 2 diabetes mellitus . Forty patients with type 2 diabetes , at the age of 35–68 years old , were assigned to two groups in this r and omized , double-blind , controlled clinical trial . The patients in the intervention group consumed 200 ml/day of probiotic soy milk containing L. planetarum A7 and those in control group consumed 200 ml/day of pure soy milk for 8 weeks . Serum TNF-α , C reactive protein , adiponectin , lipid profile , and fasting blood glucose were determined before and after intervention . In intervention group , serum adiponectin in pre- and post-treatment did not show any significant changes ( 2.52 ± 0.74 vs 2.84 ± 0.61 , P = 0.658 ) , as well as changes in serum TNF-α and C reactive protein ( 172.44 ± 5.7 vs 172.83 ± 7.6 , P = 0.278 , 4.2 ± 1.4 vs 4.5 ± 1.9 , P = 0.765 , respectively ) . Low-density cholesterol and high-density cholesterol changed significantly ( P = 0.023 , P = 0.017 , respectively ) , but fasting blood glucose did not show any significant changes . The results of this study showed that consumption of probiotic soy milk and soy milk has no effect on serum adiponectin and inflammation , but it can change lipid profile among type 2 diabetic patients",
"The aim of this study was to investigate the impact of resveratrol supplementation along with non-surgical periodontal treatment on blood glucose , insulin , insulin resistance , triglyceride ( TG ) , and periodontal markers in patients with type 2 diabetes with periodontal disease . In this double-blind clinical trial study , 43 patients with diabetes with chronic periodontitis were participated . Subjects were r and omly allocated to intervention and control groups . The intervention and control groups received either 480 mg/day of resveratrol or placebo capsules ( two pills ) for 4 weeks . Fasting blood glucose , insulin , insulin resistance ( homeostasis model assessment of insulin resistance ) , TGs , and pocket depth were measured in all subjects ' pre-intervention and post-intervention . The mean serum levels of fasting insulin and insulin resistance ( homeostasis model assessment of insulin resistance ) were significantly lower in the intervention group compared with control group ( 10.42 ± 0.28 and 10.92 ± 0.9 ; 3.66 ± 0.97 and 4.49 ± 1.56 , respectively ) . There was a significant difference in the mean pocket depth between intervention and control groups ( 2.35 ± 0.6 and 3.38 ± 0.5 , respectively ) following intervention . No significant differences were observed in the mean levels of fasting blood glucose and TGs between two groups ' post-intervention . It is recommended that resveratrol supplementation may be beneficial as adjuvant therapy along with non-surgical periodontal treatment in insulin resistance and improving periodontal status among patients with diabetes with periodontal disease . Copyright © 2016 John Wiley & Sons ,",
"BACKGROUND Sirtuin 1 ( Sirt1 ) plays an important role in vascular biology , and influences aspects of age-dependent atherosclerosis . In animals , the sirtuin system is strongly influenced by resveratrol and caloric restriction , but its expression in humans is controversial . This study investigated the effects of resveratrol and caloric restriction on Sirt1 serum concentrations and vascular biomarkers in a healthy human population . METHODS AND RESULTS Forty-eight healthy participants ( 24 women ) aged 55 - 65years were r and omized to either 30days of resveratrol administration ( 500mg/day ) or caloric restriction ( 1000cal/day ) . Blood was collected at baseline and day 30 . Laboratory data analyzed were triglycerides , total cholesterol , HDL , VLDL , LDL , apolipoprotein A1 , apolipoprotein B , lipoprotein ( a ) , non-esterified fatty acids ( NEFA ) , glucose , insulin , oxidative stress , C-reactive protein , and Sirt1 . Expression of the Sirt1 gene was analyzed using real-time PCR . Caloric restriction diminished the abdominal circumference and improved the lipid profile , but not resveratrol intervention . Resveratrol and caloric restriction increased serum concentrations of Sirt1 , from 1.06±0.71 to 5.75±2.98ng/mL ; p respectively . Sirt1 increased in women and men in both interventions . On the other h and expression of Sirt1 mRNA was not different after caloric restriction and resveratrol treatment . CONCLUSIONS Caloric restriction and resveratrol significantly increased plasma concentrations of Sirt1 . The long-term impact of these interventions on atherosclerosis should be assessed",
"SCOPE The cardioprotective role of resveratrol as part of the human diet is not yet clear . Our aim was to investigate the effect of a grape supplement containing 8 mg resveratrol in oxidized LDL ( LDLox ) , apolipoprotein-B ( ApoB ) , and serum lipids on statin-treated patients in primary cardiovascular disease prevention ( PCP ) . METHODS AND RESULTS A triple-blind , r and omized , placebo-controlled trial was conducted . Seventy-five patients ( three parallel arms ) consumed one capsule ( 350 mg ) daily for 6 months containing resveratrol-enriched grape extract ( GE-RES , Stilvid ® ) , grape extract ( GE , similar polyphenolic content but no resveratrol ) , or placebo ( maltodextrin ) . After 6 months , no changes were observed in the placebo group and only LDL cholesterol ( LDLc ) decreased by 2.9 % ( p = 0.013 ) in the GE group . In contrast , LDLc ( -4.5 % , p = 0.04 ) , ApoB ( -9.8 % , p = 0.014 ) , LDLox ( -20 % , p = 0.001 ) , and LDLox/ApoB ( -12.5 % , p = 0.000 ) decreased in the Stilvid ® group , whereas the ratio non-HDLc ( total atherogenic cholesterol load)/ApoB increased ( 8.5 % , p = 0.046 ) . No changes were observed in hepatic , thyroid , and renal function . No adverse effects were observed in any of the patients . CONCLUSION This GE-RES reduced atherogenic markers and might exert additional cardioprotection beyond the gold-st and ard medication in patients from PCP . The presence of resveratrol in the GE was necessary to achieve these effects",
"PURPOSE The purpose of this study was to determine the plasma metabolic response and certain indicators of oxidative stress ( antioxidant system and oxidative stress biomarkers ) in plasma and erythrocytes of Brazilian military firefighters supplemented or not with resveratrol ( RES ) for 90 days ( 100 mg/day ) . The analyses were performed before and after a typical physical fitness test ( FT ) used to induce oxidative stress . METHODS / RESULTS In this placebo-controlled double-blinded study , we observed that RES supplementation did not present hepatic consequences compared with the placebo group following analysis of AST , ALT and GGT plasma activities . Plasma glucose and triglycerides levels were increased after the FT in firefighters supplemented with RES but were not elevated at baseline . Neither total nor cholesterol fractions were modified by RES supplementation . CK levels were increased after the firefighters performed the FT ; however , no differences were determined between the placebo and RES groups . Ferric-reducing ability of plasma as well as uric acid was increased after the FT , but was not modified by RES supplementation . Plasma oxidative stress biomarkers , such as thiol content , 8-isoprostane and 8OHdG , showed no modifications , while IL-6 and TNF-α were decreased in the RES group after the FT . Among antioxidant enzyme activities determined in erythrocytes from the firefighters , only GPx activity was reduced by RES supplementation both before and after the FT . CONCLUSION In summary , the most pronounced effect of RES supplementation is its anti-inflammatory effect , which reduced IL-6 and TNF-α level . The FT applied to Brazilian military firefighters was not sufficient to challenge the antioxidant defense systems , and , therefore , 100 mg of RES for three months did not induce significant effects"
] | 411694f8-06ff-11f0-808a-c43d1ab1c353 |
Background Perioperative systemic steroid administration for rapid recovery in total knee and hip arthroplasty ( TKA/THA ) is an important and controversial topic . We conducted this systematic review and meta- analysis to evaluate the overall benefits and harms of perioperative systemic steroid in patients undergoing TKA and THA . Methods A comprehensive search was performed on PubMed , OVID , and Web of Science data bases , and a systematic approach was carried out starting from the PRISMA recommendations . Relevant r and omized controlled trials ( RCTs ) were selected . The risk of bias was evaluated according to the Cochrane H and book for Systematic Review s of Interventions version . Data were extracted and meta-analyzed or qualitatively synthesized for all the outcomes . Results Data were extracted from 11 trials involving 774 procedures . Meta- analysis showed that high-dose systemic steroid ( dexamethasone > 0.1 mg/kg ) rather than low dose is effective to reduce postoperative nausea and vomiting and postoperative acute pain ( within 24 h ) . In addition , systemic steroid is associated within faster functional rehabilitation and greater inflammation control . On the other h and , systemic steroid is associated with a higher level of postoperative serum glucose on the operation day . The complications between groups are similarly low . Conclusions Our study suggests that by providing lower incidence of postoperative nausea and vomiting and less postoperative acute pain , high-dose systemic steroid plays a critical role in rapid recovery to TKA and THA . The preliminary results also show the superior possibility of systemic steroid in functional rehabilitation and inflammation control . More large , high- quality studies that investigate the safety and dose – response relationship are necessary | [
"BACKGROUND High-dose glucocorticoid may reduce postsurgical pain and improve recovery . We hypothesized that 125 mg methylprednisolone ( MP ) would reduce time to meet functional discharge criteria after total hip arthroplasty ( THA ) . METHODS Forty-eight patients undergoing unilateral THA under spinal anaesthesia were consecutively included in this r and omized , double-blind , placebo-controlled trial receiving preoperative i.v . MP or saline . All patients received a st and ardized , multimodal analgesic regime with paracetamol , celecoxib , and gabapentin . The primary outcome was time to meet well-defined functional discharge criteria . Secondary outcomes were h and grip strength and endurance , pain , nausea , vomiting , fatigue , sleep quality , and rescue analgesic- , antiemetic- , and hypnotic medicine requirements . The inflammatory response measured by C-reactive protein ( CRP ) and actual length of stay were also registered . Discharge criteria were assessed twice daily ( at 09:00 and 14:00 h ) until discharge . Other outcomes were assessed at 2 , 4 , 6 , 8 , and 24 h after operation , and also in a question naire from postoperative day ( POD ) 1 - 4 . RESULTS Time to meet discharge criteria was [ median ( IQR ) ( 95 % CI ) , MP vs placebo ] : 23.5 ( 23.3 - 23.7 ) ( 17.8 - 43.8 ) vs 23.5 ( 23.0 - 23.8 ) ( 20.0 - 46.8 ) h , the mean difference ( 95 % CI ) being -1.3 ( -4.7 to 2.2 ) h , P=0.65 . Overall pain for the first 24 h after surgery was significantly reduced in the MP vs the placebo group ( P drug-related complications were observed at follow-up on POD30 . CONCLUSIONS MP 125 mg i.v . before surgery added to a multimodal oral analgesic regime did not reduce time to meet functional discharge criteria after THA , but improved analgesia for the first 24",
"Abstract Current trends in orthopaedic surgery have explored different forms of adjuvant treatments to minimize postoperative pain and the risk of nausea and vomiting . A small single preoperative dose of dexamethasone , as part of a comprehensive multimodal analgesic regimen in low-risk patients undergoing total hip arthroplasty ( THA ) , provides antiemetic and opioid-sparing effects but the longer-term effects on pain , complications , or function are not known . We therefore asked whether such a routine would affect longer-term pain , complications , or function . Fifty patients undergoing elective primary THA using spinal anesthesia were initially r and omized to receive either dexamethasone ( 40 mg intravenous ) or saline placebo . The patients , anesthesiologists , nurses , and research coordinators were blinded to the study arms . The functional outcome was measured using the Harris hip score . Outcomes were assessed 6 weeks and 1 year postoperatively . We observed no difference in resting pain between the two groups at either time period . Both groups had similar functional outcome scores for the total Harris hip score and individual scoring items at each followup interval . There were no wound complications , deep infections , or osteonecrosis in the contralateral hip at 1-year followup . We recommend the addition of a small single preoperative dose of dexamethasone to a comprehensive multimodal analgesic regimen in low-risk patients given its immediate antiemetic and opioid-sparing effects , and absence of subsequent effects . Level of Evidence : Level II , therapeutic study ( prospect i ve comparative study ) . See the Guidelines for Authors for a complete description of levels of evidence",
"Background Dexamethasone is a potent analgesic and antiemetic . However , the benefit of dexamethasone after TKA is unclear , as is the efficacy in a current multimodal regime . Questions / purpose sWe determined ( 1 ) whether the addition of dexamethasone to a protocol including ramosetron further reduces postoperative emesis compared with ramosetron alone ; ( 2 ) whether it reduces postoperative pain ; and ( 3 ) whether it increases the risk for wound complications in a current multimodal regime after TKA . Methods We r and omized 269 patients undergoing TKAs to receive dexamethasone ( 10 mg ) 1 hour before surgery and ramosetron immediately after surgery ( Dexa-Ra group , n = 135 ) , or ramosetron alone ( Ra group , n = 134 ) . We recorded the incidence of postoperative nausea and vomiting ( PONV ) , severity of nausea , incidence of antiemetic requirement , complete response , pain level , and opioid consumption . Patients were assessed 0 to 6 , 6 to 24 , 24 to 48 , and 48 to 72 hours postoperatively . In addition , patients were evaluated for wound complications and periprosthetic joint infections at a minimum of 1 year after surgery . Results The Dexa-Ra group had a lower incidence of PONV during the entire 72-hour evaluation period and experienced less severe nausea for the first 6 hours after TKA , although not between 6 to 72 hours . Overall use of a rescue antiemetic was less frequent , and complete response was more frequent in the Dexa-Ra group . Patients in the Dexa-Ra group experienced lower pain and consumed less opioids during the 6- to 24-hour period and during the overall study period . No differences were found in wound complications between the groups , and each group had one case of periprosthetic joint infection . Conclusions Patients who received prophylactic dexamethasone in addition to ramosetron had reduced postoperative emesis and pain without increased risks for wound complications , compared with patients who received ramosetron alone in patients managed using a multimodal regimen after TKA.Level of Evidence Level I , therapeutic study . See the Guidelines for Authors for a complete description of levels of evidence",
"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",
"UNLABELLED This double-blind , r and omized , placebo-controlled study evaluated the minimum effective dose of dexamethasone for postoperative antiemesis . One-hundred fifty women scheduled for major gynecological surgery were r and omly assigned to receive dexamethasone 10 mg ( D10 ) , 5 mg ( D5 ) , 2.5 mg ( D2.5 ) , 1.25 mg ( D1.25 ) , or placebo ( P ) before the induction of general anesthesia . A st and ardized general anesthesia technique was used . Postoperative pain was treated with bolus IV doses of morphine via a patient-controlled analgesia device . Patients were assessed for incidence of vomiting at 4 , 8 , 12 , and 24 h after surgery . A total of 6 , 6 , 8 , 15 , and 19 patients in Groups D10 , D5 , D2.5 , D1.25 , and Group P experienced vomiting at least once within the first postoperative 24 h , respectively . Dexamethasone 10 mg , 5 mg , and 2.5 mg was more effective than dexamethasone 1.25 mg or placebo for antiemesis ( P difference in antiemetic effect among the 10 mg , 5 mg , and 2.5 mg groups was similar . The results suggest that 2.5 mg is the minimum effective dose of dexamethasone for postoperative antiemesis in patients undergoing general anesthesia for major gynecological surgery . IMPLICATION S Although dexamethasone is effective for antiemesis , major side effects may accompany its perioperative use . To achieve the best antiemesis with the fewest side effects , dexamethasone 10 mg , 5 mg , 2.5 mg , and 1.25 mg were compared with placebo in surgical patients . We found 2.5 mg to be the minimum effective dose without discernible side effects",
"BACKGROUND Total knee arthroplasty ( TKA ) is associated with severe pain and inflammation despite an extensive multimodal analgesic approach , but the effect of high-dose glucocorticoid administration has not been studied . METHODS Forty-eight patients undergoing unilateral TKA were included in a r and omized , double-blind , placebo-controlled trial receiving preoperative methylprednisolone ( MP ) 125 mg i.v . or saline . All surgery was performed under lumbar spinal anaesthesia and patients received a st and ardized , multimodal analgesic regime . The primary endpoint was pain during walking 24 h after surgery , and secondary endpoints were pain at rest , pain upon hip flexion , and pain upon knee flexion . Pain assessment s were performed repeatedly for the first 48 h after surgery , in a question naire from days 2 to 10 , and at follow-up on days 21 and 30 . Tertiary endpoints were postoperative nausea and vomiting ( PONV ) , plasma C-reactive protein ( CRP ) concentrations , fatigue , sleep quality , and rescue analgesic and antiemetic requirements . RESULTS Pain during walking was significantly lower in the MP group up to 32 h after operation . Overall pain and cumulative pain scores ( 2 - 48 h ) were lower for all pain assessment s ( P Consumption of rescue oxycodone was lower from 0 to 24 h ( P=0.02 ) and PONV , consumption of ondansetron reduced ( P CRP concentrations were lower at 24 h ( P Fatigue throughout the day of surgery was lower ( P=0.02 ) , but sleep quality was worse on the first night ( P=0.002 ) . No side-effects or complications were observed in other respects . CONCLUSIONS MP 125 mg before surgery improves analgesia and immediate recovery after TKA , even when combined with a multimodal analgesic regime . These findings call for further studies on safety aspects",
"Background : In previous studies on glucocorticoids for postoperative pain , the test drug has been given perioperatively , usually before measurement of baseline pain . In order to evaluate the time course and magnitude of the analgesic effect of a glucocorticoid in well‐established postoperative pain , we compared methylprednisolone with ketorolac and placebo , after assessment of baseline pain on the first postoperative day",
"BACKGROUND : Preoperative glucocorticoids reduce postoperative nausea but may also improve analgesia and decrease opioid consumption . METHODS : Fifty consecutive patients undergoing elective , unilateral , primary total hip arthroplasty under spinal anesthesia with propofol sedation received in a r and omized , double-blind , placebo-controlled manner either 40 mg of dexamethasone or saline placebo IV before the start of surgery . IV patient-controlled analgesia morphine , ibuprofen 400 mg po q6 h and acetaminophen 650 mg po q6 h were given for 48 h. Pain ( 0–10 numeric rating scale , NRS ) at rest , side effects , and total cumulative patient-controlled analgesia morphine consumption were recorded q4 h for 48 h. Dynamic pain NRS score was recorded at 24 h. C-reactive protein levels were measured in a subgroup of 25 patients at 48 h. RESULTS : The intraoperative sedation requirement with propofol was significantly increased in the dexamethasone group ( 234.6 ± 160.1 vs 138.8 ± 122.7 mg , P = 0.02 ) . Dynamic pain was greatly reduced in the dexamethasone group ( NRS score : 2.7 , 95 % CI : 2.2–3.1 vs 6.8 , 6.4–7.2 ; P on pain at rest or cumulative morphine consumption at any time . C-reactive protein levels at 48 h were markedly reduced by dexamethasone ( 52.4 mg/mL , 28.2–76.6 vs 194.2 , 168.9–219.4 ; P for nausea ( P = 0.05 ) . CONCLUSIONS : A single , preoperative IV dose of dexamethasone 40 mg has a prolonged suppressive effect on the inflammatory response and decreases dynamic pain 24 h after total hip arthroplasty",
"Controlling postoperative pain and nausea after total joint arthroplasty remains an important challenge . We conducted a prospect i ve , r and omized controlled trial with 120 patients to determine if the addition of perioperative dexamethasone to a multimodal regimen improves antiemetic and analgesic control , enhances mobility , and shortens hospital length of stay after total hip and knee arthroplasty . Patients administered 10 mg of intravenous dexamethasone intraoperatively consumed less daily rescue anti-emetic and analgesic medication , reported superior VAS nausea and pain scores , ambulated further distances , and had a significantly shorter length of stay compared to the control group ( P intravenous dexamethasone provided significant additional pain and nausea control and further reduced length of stay ( P No adverse events were detected with the administration of the intraoperative and /or postoperative dexamethasone",
"The association between corticosteroid therapy and subsequent infections was calculated by pooling data from 71 controlled clinical trials . The overall rate of infectious complications was 12.7 % in the 2,111 patients r and omly allocated to systemic corticosteroids and 8.0 % in the 2,087 controls ( relative risk [ RR ] , 1.6 ; 95 % confidence interval [ CI ] , 1.3 - 1.9 ; P less than .001 ) . The risk of infection was particularly high in patients with neurologic diseases ( RR , 2.8 ; 95 % CI , 1.9 - 4.3 ; P less than .001 ) and less pronounced in patients with intestinal ( RR , 1.4 ; 95 % CI , 1.1 - 1.7 ; P = .02 ) , hepatic ( RR , 1.4 ; 95 % CI , 0.9 - 2.3 ; P = .25 ) , and renal ( RR greater than 1 ; P = .03 ) diseases . The rate was not increased in patients given a daily dose of less than 10 mg or a cumulative dose of less than 700 mg of prednisone . With increasing doses the rate of occurrence of infectious complications increased in patients given corticosteroids as well as in patients given placebo , a finding suggesting that not only the corticosteroid but also the underlying disease state account for the steroid-associated infectious complications observed in clinical practice",
"BACKGROUND Postoperative emetic symptoms ( nausea , retching , and vomiting ) are common following total joint replacement , with an incidence as high as 83 % when no prophylactic antiemetic is provided . However , most antiemetics currently used in Japan , such as antihistamines ( eg , hydroxyzine ) , butyrophenones ( eg , droperidol ) , and dopamine receptor antagonists ( eg , metoclopramide ) , have been associated with adverse effects ( AEs ) , such as excessive sedation , hypotension , dry mouth , dysphoria , hallucinations , and extrapyramidal symptoms . OBJECTIVE The aim of this study was to assess the efficacy and tolerability of 3 doses of intravenous dexamethasone monotherapy versus vehicle in preventing emetic symptoms after total knee replacement performed under combined general and epidural anesthesia . METHODS This prospect i ve , r and omized , double-blind , vehicle-controlled trial was conducted at the Department of Anesthesiology , University of Tsukuba Institute of Clinical Medicine , Tsukuba , Japan . Adult Japanese patients scheduled to undergo total knee replacement were eligible . Patients were r and omly assigned to 1 of 4 treatment groups : dexamethasone 4 , 8 , or 16 mg , or vehicle ( control ) . Patients received combination anesthesia with sevoflurane and nitrous oxide in pure oxygen ( general ) and lidocaine ( epidural ) . Study drugs were administered intravenously after the completion of surgery . An investigator blinded to treatment assignment monitored patients for emetic symptoms for 24 hours after the patient awoke . Patients rated their satisfaction with the study drug using a linear , 11-point scale ( 0 = complete satisfaction to 10 = complete dissatisfaction ) . Tolerability was assessed by the study investigator using spontaneous reporting and patient interview . RESULTS A total of 80 patients were enrolled ( 58 women , 22 men ; mean [ SD ] age , 59 [ 10 ] years ; mean [ SD ] height , 154 [ 7 ] cm ; mean [ SD ] body weight , 55 [ 7 ] kg ; 20 patients per treatment group ) . The demographic , clinical , and surgical data were comparable between the 4 treatment groups . The rates of emesis-free patients were 35 % ( 7 patients ) , 70 % ( 14 ) , and 75 % ( 15 ) with dexamethasone 4 , 8 , and 16 mg , respectively , compared with 30 % ( 6 ) with vehicle ( P = NS , 0.013 , and 0.005 , respectively ) . Median ( range ) patient satisfaction scores were significantly higher in the groups receiving dexamethasone 8 and 16 mg ( both , 0.0 [ 0 - 9 ] ) compared with controls ( 6.0 [ 0 - 10 ] ) ( P = 0.013 and 0.008 , respectively ) . This effect was not found with the 4-mg dose . No clinical ly serious AEs attributed to the study drug were observed in any of the 4 treatment groups . CONCLUSIONS In this study of a small , select group of adult Japanese patients undergoing total knee replacement , the rates of emesis-free patients were higher with dexamethasone 8 and 16 mg compared with vehicle 24 hours after anesthesia induction . This effect was not found with the 4-mg dose . All treatments were well tolerated",
"Venous thromboembolism ( VTE ) remains an important complication after total knee arthroplasty ( TKA ) . Systemic thrombin generation starts perioperatively . Inflammation , characterized by a rise in interleukin-6 ( IL6 ) , initiates the coagulation cascade , but low-dose steroids can reduce post-TKA IL6 levels . This double-blinded , r and omized , placebo-controlled study enrolled 30 patients undergoing unilateral TKA to assess the effect of perioperative steroids on serum prothrombin fragment ( PF1.2 ) , a marker of thrombin generation , and plasmin-alpha-2-antiplasmin complex ( PAP ) , a marker of fibrinolysis . Study patients received 100 mg of intravenous hydrocortisone 2 h prior to surgery , and controls received normal saline . Blood sample s , drawn pre-incision and at 4 h post tourniquet release , were assayed for PF1.2 and PAP . The study group had significantly lower mean PF1.2 at 4 h compared to controls ( 616 ± 358 pMol/L vs. 936 ± 332 pMol/L , p = 0.037 ) . The mean rise in PF1.2 in the control group was significantly greater compared to the study group ( 672 ± 173 pMol/L vs. 350 ± 211 pMol/L , p was higher in the study group at 4 h ( 1639 ± 823 µg/L vs. 1087 ± 536 µg/L ) , but did not reach statistical significance ( p = 0.07 ) . These results may have clinical implication s in terms of postoperative VTE risk and management",
"BACKGROUND The perioperative inflammatory response as measured by elevated levels of interleukin-6 ( IL-6 ) has been linked to acute respiratory distress syndrome , postoperative confusion , and fever . Because of the extent of surgery , patients undergoing bilateral total knee arthroplasty may be at high risk of complications . We had found a significant decrease in IL-6 in patients having bilateral total knee replacement who received two doses of 100 mg of hydrocortisone eight hours apart ; however , by twenty-four hours , IL-6 levels were equal to those in the group that received a placebo . In the present study , we investigated whether the administration of three doses would reduce IL-6 levels at twenty-four hours and affect other outcomes such as desmosine level , a marker of lung injury . METHODS After institutional review board approval , a total of thirty-four patients ( seventeen patients and seventeen control subjects ) were enrolled in this double-blind , r and omized , placebo-controlled study . Three doses of intravenous hydrocortisone ( 100 mg ) or placebo were given eight hours apart . Urinary desmosine levels were obtained at baseline and at one and three days postoperatively . The level of IL-6 was measured at baseline and at six , ten , twenty-four , and forty-eight hours postoperatively . Pain scores , presence of fever , and functional outcomes were recorded . RESULTS The level of IL-6 increased in both groups , but was significantly higher in the control group , peaking at twenty-four hours ( mean and st and ard deviation , 623.74 ± 610.35 pg/mL versus 148.13 ± 119.35 pg/mL ; p = 0.006 ) . Urinary desmosine levels significantly increased by twenty-four hours in the control group , but remained unchanged in the study group ( 134.75 ± 67.88 pmol/mg and 79.45 ± 46.30 pmol/mg , respectively ; p = 0.006 ) . Pain scores at twenty-four hours were significantly lower in the study group ( 1.4 ± 0.9 versus 2.4 ± 1.2 ; p = 0.01 ) as was the presence of fever ( 11.8%versus 47.1 % ; p = 0.03 ) . Range of motion at the knee was significantly greater in the study group ( 81.6 ± 11.6 versus 70.6 ± 14.0 in the right knee [ p = 0.02 ] and 81.4 ± 11.3 versus 73.4 ± 9.4 in the left knee [ p = 0.03 ] ) . CONCLUSIONS Hydrocortisone ( 100 mg ) given over three doses , each eight hours apart , decreased and maintained a lower degree of inflammation with bilateral total knee replacement as measured by IL-6 level . Corticosteroids decreased the prevalence of fever , lowered visual analog pain scores , and improved knee motion . The significantly lower values of desmosine in the study group suggest that this treatment may be protective against lung injury",
"Background : Interleukin 6 ( IL-6 ) , a marker of inflammation , is one of the major cytokines released during joint replacement . In the orthopedic patient population , high levels have been linked to many adverse effects including acute respiratory distress syndrome , postoperative mental status changes , and fever . We looked to assess the efficacy of low-dose steroids on the postinflammatory response as measured by IL-6 in patients undergoing bilateral total knee replacement ( BTKR ) . The role of steroids has never been evaluated before in that setting . Methods : Double-blind , r and omized , placebo-controlled study of 30 patients undergoing BTKR . The study was powered in order to detect at least a 25 % decrease in IL-6 from control . Hydrocortisone ( 100 mg ) or placebo was given at 2 doses 8 hrs apart to the study and control group respectively . Clinical outcome was assessed as well . Results : Levels of IL-6 were 40 % lower in the study group by 10 hrs ( P = 0.0037 ) but were similar to the control group at 24 hrs . Greater hemodynamic stability was noted in the study group with fewer episodes of hypotension postoperatively ( P = 0.031 ) . Range of motion gained on discharge was also greatest in the study group ( P = 0.049 ) . Absence of infection and normal wound healing were noted in all patients . Conclusions : The use of hydrocortisone significantly decreased the inflammatory response in patients undergoing BTKR as measured by IL-6 production . Further studies looking at clinical implication s of such findings in a larger patient population and with a longer course of steroids are warranted",
"Background We have developed a multimodal technique for the control of pain following knee and hip surgery , called \" local infiltration analgesia \" ( LIA ) . It is based on systematic infiltration of a mixture of ropiva-caine , ketorolac , and adrenaline into the tissues around the surgical field to achieve satisfactory pain control with little physiological disturbance . The technique allows virtually immediate mobilization and earlier discharge from hospital . Patients and methods In this open , nonr and omized case series , we used LIA to manage postoperative pain in all 325 patients presenting to our service from Jan 1 , 2005 to Dec 31,2006 for elective hip resurfacing ( HRA ) , primary total hip replacement ( THR ) , or primary total knee replacement arthroplasty ( TKR ) . We recorded pain scores , mobilization times , and morphine usage for the entire group . Results Pain control was generally satisfactory ( numerical rating scale pain score range 0–3 ) . No morphine was required for postoperative pain control in two-thirds of the patients . Most patients were able to walk with assistance between 5 and 6 h after surgery and independent mobility was achieved 13–22 h after surgery . Orthostatic hypotension , nausea , and vomiting were occasionally associated with st and ing for the first time , but other side effects were unremarkable . 230 ( 71 % ) of the 325 patients were discharged directly home after a single overnight stay in hospital . Interpretation Local infiltration analgesia is simple , practical , safe , and effective for pain management after knee and hip surgery",
"BACKGROUND Surgery produces a rapid rise in interleukin 6 ( IL-6 ) which may increase the risk of deep vein thrombosis and medical complications . Perioperative corticosteroids suppress IL-6 release in patients undergoing total knee arthroplasty . This study evaluates the effects of a perioperative corticosteroid regimen on IL-6 formation , thrombogenesis , fibrinolysis , and clinical outcomes in patients undergoing unilateral , uncemented , total hip arthroplasty . METHODS Twenty-seven patients ( 14 placebo and 13 study ) were enrolled in this r and omized , double-blind , placebo-controlled trial . The study group received 20 mg of prednisone orally followed by 2 doses of intravenous hydrocortisone , each 8 hours apart . Blood was drawn at several time points for IL-6 , prothrombin fragment 1.2 , and plasmin-alpha-2-antiplasmin complex , a marker of fibrinolysis . In-hospital visual analog pain ( visual analog scale ) scores , patient-controlled analgesia use , and ability to climb stairs were recorded . RESULTS Mean serum IL-6 levels at 6 and 24 hours postoperatively were significantly lower for the study group , whereas serum prothrombin fragment 1.2 and plasmin-alpha-2-antiplasmin were not statistically different at any study time point . Average pain scores were similar ( P > .05 ) , but study group experience less severe pain ( P patient-controlled analgesia ( P = .02 ) . At 3 months , 4 patients in the placebo and 1 patient in the study group had difficulty going up and down staircases ( P = .08 ) . CONCLUSION The use of corticosteroids was associated with a statistically significant decrease in IL-6 at 6 and 24 hours postoperatively but did not affect thrombogenic markers . The study group had improved postoperative analgesia and a trend toward improved functional outcome at 3 months postoperatively"
] | 4116953e-06ff-11f0-808a-c43d1ab1c353 |
Causal links between vitamin D status [ 25(OH)D ] and systemic inflammation were examined through a systematic review of r and omized controlled trials ( RCTs ) . Selected RCTs were ⩾12 weeks , conducted in adults free of acute inflammatory disease , and of high- quality ( Jadad score ⩾3 ) . Of 14 studies that met our criteria , 9 studies ( 15 study arms ) permitted extraction of data . There was no effect on the weighted mean difference ( WMD ) of IL-6 ( WMD ( 95 % confidence interval)=0.1 , ( −0.166 , 0.366 ) pg/ml , P=0.462 ) or C-reactive protein ( CRP ) ( WMD=−0.324 , ( −1.007 , 0.359 ) mg/l , P=0.352 ) . Subgroup analyses of trials achieving ⩾80 nmol/l indicated a trend for lower CRP ( WMD=−0.834 , ( −1.726 , 0.058 ) mg/l , P=0.067 ) , however heterogeneity was significant ( I2=66.7 % , P=0.017 ) . Studies employing a low dose ( showed increased CRP ( WMD=0.615 , ( 0.132 , 1.098 ) , P=0.013 ) . In contrast , ⩾1000 IU/d had a favourable effect on CRP ( WMD=−0.939 , ( −1.805 , −0.073 ) , P=0.034 ) but heterogeneity was significant ( I2=61.3 % , P=0.017 ) . Meta-regression indicated that older age predicted a significant decrease in IL−6 ( β=−0.02 , ( −0.034 , −0.006 ) pg/ml , P=0.013 ) and CRP ( β=−0.06 , ( −0.103 , −0.017 ) , P=0.01 ) , whereas a greater percentage of females ( β=0.027 , ( 0.011 , 0.044 ) , P=0.004 ) and longer study duration independently predicted a higher WMD for CRP ( β=0.049 , ( 0.018 , 0.079 ) , P=0.005 ) . Available high- quality RCTs did not support a beneficial effect of cholecalciferol on systemic IL-6 and CRP . Future studies should consider the confounding effects of age , gender and study duration , while possibly targeting an achieved 25(OH)D ⩾80 nmol/l | [
"Introduction Vitamin D has potential benefits for extraskeletal health . These could include an anti-inflammatory effect as well as a reduction in endothelial dysfunction . We aim to provide quality evidence for the hypothesis that supplementation with vitamin D will improve endothelial function ( EF ) , possibly through the abrogation of systemic inflammation . Methods and analysis We will conduct a systematic review of all r and omised controlled trials on vitamin D supplementation and EF lasting 12 weeks or more . The search will cover the period 2000–2015 and include studies that describe direct measures of EF , markers of endothelial cell ( EC ) activation and if concurrently reported , indicators of systemic inflammation . Study selection will follow the Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) guidelines and study quality will be assessed by the Jadad score in addition to an evaluation of allocation concealment and data analysis . If sufficient data are available , a meta- analysis will be conducted . The effect sizes will be generated using Hedges ’ g score , for both fixed and r and om effect models . I2 statistics and Galbraith plots will be used to assess heterogeneity and identify their potential sources . Potential publication and small sample size bias will be assessed by visual inspections of funnel plots and also Egger 's test . Meta-regression analysis ( if feasible ) will be conducted with restricted maximum likelihood ( REML ) estimation method , controlling for potential confounders ( demographics , study methods , location , etc ) . A backward elimination process will be applied in the regression modelling procedure . Subgroup analysis , conditional on number of studies retrieved and their sample size , will be stratified on participant disease category , total dose administered , degree of 25(OH)D change and type of supplement used . Ethics and dissemination Formal ethical approval is not required as primary data will not be collected . The results will be disseminated through a peer- review ed publication , conference presentation and the popular press . Trial registration number International Prospect i ve Register for Systematic Review s ( PROSPERO ) number CRD42014013523",
"Low serum 25-hydroxyvitamin D ( 25(OH)D ) has been shown to correlate with increased risk of type 2 diabetes . Small , observational studies suggest an action for vitamin D in improving insulin sensitivity and /or insulin secretion . The objective of the present study was to investigate the effect of improved vitamin D status on insulin resistance ( IR ) , utilising r and omised , controlled , double-blind intervention administering 100 microg ( 4000 IU ) vitamin D(3 ) ( n 42 ) or placebo ( n 39 ) daily for 6 months to South Asian women , aged 23 - 68 years , living in Auckl and , New Zeal and . Subjects were insulin resistant - homeostasis model assessment 1 (HOMA1)>1.93 and had serum 25(OH)D concentration vitamin D supplementation > 25 microg ( 1000 IU)/d . The HOMA2 computer model was used to calculate outcomes . Median ( 25th , 75th percentiles ) serum 25(OH)D(3 ) increased significantly from 21 ( 11 , 40 ) to 75 ( 55 , 84 ) nmol/l with supplementation . Significant improvements were seen in insulin sensitivity and IR ( P = 0.003 and 0.02 , respectively ) , and fasting insulin decreased ( P = 0.02 ) with supplementation compared with placebo . There was no change in C-peptide with supplementation . IR was most improved when endpoint serum 25(OH)D reached > or = 80 nmol/l . Secondary outcome variables ( lipid profile and high sensitivity C-reactive protein ) were not affected by supplementation . In conclusion , improving vitamin D status in insulin resistant women result ed in improved IR and sensitivity , but no change in insulin secretion . Optimal vitamin D concentrations for reducing IR were shown to be 80 - 119 nmol/l , providing further evidence for an increase in the recommended adequate levels . Registered Trial No. ACTRN12607000642482",
"Vitamin D ( VitD ) supplementation has been advocated for cardiovascular risk reduction ; however , supporting data are sparse . The objective of this study was to determine whether VitD supplementation reduces cardiovascular risk . Subjects in this prospect i ve , r and omized , double-blind , placebo-controlled trial of post-menopausal women with serum 25-hydroxyvitamin D concentrations > 10 and to Vitamin D3 2500 IU or placebo , daily for 4 months . Primary endpoints were changes in brachial artery flow-mediated vasodilation ( FMD ) , carotid-femoral pulse wave velocity ( PWV ) , and aortic augmentation index ( AIx ) . The 114 subjects were mean ( st and ard deviation ) 63.9 ( 3.0 ) years old with a 25-hydroxyvitamin D level of 31.3 ( 10.6 ) ng/mL. Low VitD ( higher body-mass index , systolic blood pressure , glucose , CRP , and lower FMD ( all p 4 months , 25-hydroxyvitamin D levels increased by 15.7 ( 9.3 ) ng/mL on vitamin D3 vs. −0.2 ( 6.1 ) ng/mL on placebo ( p in changes in FMD ( 0.3 [ 3.4 ] vs. 0.3 [ 2.6 ] % , p = 0.77 ) , PWV ( 0.00 [ 1.06 ] vs. 0.05 [ 0.92 ] m/s , p = 0.65 ) , AIx ( 2.7 [ 6.3 ] vs. 0.9 [ 5.6 ] % , p = 0.10 ) , or CRP ( 0.3 [ 1.9 ] vs. 0.3 [ 4.2 ] mg/L , p = 0.97 ) . Multivariable models showed no significant interactions between treatment group and low VitD status ( for changes in FMD ( p = 0.65 ) , PWV ( p = 0.93 ) , AIx ( p = 0.97 ) , or CRP ( p = 0.26).In conclusion , VitD supplementation did not improve endothelial function , arterial stiffness , or inflammation . These observations do not support use of VitD supplementation to reduce cardiovascular disease risk . Trial Registration Clinical Trials.gov NCT00690417 Trial Registration Clinical Trials.gov",
"OBJECTIVE In observational studies , low serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations have been associated with insulin resistance and other risk factors for cardiovascular disease . RESEARCH DESIGN AND METHODS We present 1-year data from an ongoing 5-year trial in 511 individuals with impaired fasting glucose ( IFG ) and /or impaired glucose tolerance ( IGT ) r and omly assigned to 20,000 IU/week vitamin D3 or placebo . An oral glucose tolerance test was performed at baseline and after 1 year . RESULTS Mean baseline serum 25(OH)D was 59.9 nmol/L and 61.1 nmol/L in the vitamin D and placebo groups , respectively , and increased by 45.8 nmol/L and 3.4 nmol/L , respectively . With adjustment for baseline concentrations , no differences in measures of glucose metabolism , insulin secretion or sensitivity , blood pressure , or hs-CRP were found after 1 year . There was a slight , but significant decrease in total and LDL cholesterol in the vitamin D group compared with the placebo group , but as there was also a decrease in HDL cholesterol , the change in the total/HDL cholesterol ratio did not differ significantly . Only analyzing subjects with 25(OH)D vitamin D supplementation does not improve glycemic indices , blood pressure , or lipid status in subjects with IFG and /or IGT ",
"CONTEXT Observational studies show an association between low vitamin D status assessed by circulating 25-hydroxyvitamin D and cardiovascular events and mortality . Data from r and omized controlled trials are limited . OBJECTIVE The aim of this study was to test whether daily doses of vitamin D(3 ) at 400 or 1000 IU/d for 1 yr affected conventional markers of cardiovascular disease ( CVD ) risk . DESIGN We conducted a parallel-group , double-blind , placebo-controlled r and omized controlled trial . R and omization was computer generated . Participants and study investigators were blinded to intervention groupings throughout the trial . SETTING The study was conducted at the Clinical Research Facility , University of Aberdeen , United Kingdom . PARTICIPANTS A total of 305 healthy postmenopausal women aged 60 - 70 yr were recruited for the study . INTERVENTION Each woman received a daily capsule of 400 or 1000 IU vitamin D(3 ) or placebo r and omly allocated . MAIN OUTCOME MEASURES Primary outcomes were serum lipid profile [ total , high-density lipoprotein , and low-density lipoprotein cholesterol ; triglycerides ; and apolipoproteins A-1 and B100 ] , insulin resistance ( homeostatic model assessment ) , inflammatory biomarkers ( high-sensitivity C-reactive protein , IL-6 , soluble intracellular adhesion molecule-1 ) , and blood pressure . RESULTS A total of 265 ( 87 % ) participants completed all study visits . Small differences between groups for serum apolipoprotein B100 change [ repeated measures ANOVA , P=0.04 ; mean ( sd ) , -1.0 ( 10.0 ) mg/dl ( 400 IU ) ; -1.0 ( 10.0 ) mg/dl ( 1000 IU ) ; and + 0.02 ( 10.0 ) mg/dl ( placebo ) ] were not considered clinical ly significant . Other systemic markers for CVD risk remained unchanged . There was significant seasonal variation in systolic and diastolic blood pressure independent of vitamin D dose ( P ( sd ) reduction in systolic blood pressure from winter to summer was -6.6 ( 10.8 ) mm Hg . CONCLUSIONS Improving vitamin D status through dietary supplementation is unlikely to reduce CVD risk factors . Confounding of seasonality should be recognized and addressed in future studies of vitamin",
"The prevalence of vitamin D deficiency varies , with the groups at greatest risk including housebound , community-dwelling older and /or disabled people , those in residential care , dark-skinned people ( particularly those modestly dressed ) , and other people who regularly avoid sun exposure or work indoors . Most adults are unlikely to obtain more than 5%-10 % of their vitamin D requirement from dietary sources . The main source of vitamin D for people residing in Australia and New Zeal and is exposure to sunlight . A serum 25-hydroxyvitamin D ( 25-OHD ) level of ≥ 50 nmol/L at the end of winter ( 10 - 20 nmol/L higher at the end of summer , to allow for seasonal decrease ) is required for optimal musculoskeletal health . Although it is likely that higher serum 25-OHD levels play a role in the prevention of some disease states , there is insufficient evidence from r and omised controlled trials to recommend higher targets . For moderately fair-skinned people , a walk with arms exposed for 6 - 7 minutes mid morning or mid afternoon in summer , and with as much bare skin exposed as feasible for 7 - 40 minutes ( depending on latitude ) at noon in winter , on most days , is likely to be helpful in maintaining adequate vitamin D levels in the body . When sun exposure is minimal , vitamin D intake from dietary sources and supplementation of at least 600 IU ( 15 µg ) per day for people aged ≤ 70 years and 800 IU ( 20 µg ) per day for those aged > 70 years is recommended . People in high-risk groups may require higher doses . There is good evidence that vitamin D plus calcium supplementation effectively reduces fractures and falls in older men and women",
"The aim of this study was to investigate the effects of vitamin D supplementation on serum aminotransferases , insulin resistance , oxidative stress , and inflammatory biomarkers in adult patients with non-alcoholic fatty liver disease ( NAFLD ) . Fifty-three patients with NAFLD were enrolled in a parallel , double-blind , placebo-controlled study . The patients were r and omly allocated to receive either one oral pearl consisting of 50,000 IU vitamin D3 ( n = 27 ) or a placebo ( n = 26 ) , every 14 days for 4 months . Serum aminotransferases , high-sensitive C-reactive protein ( hs-CRP ) , tumor necrosis factor α , malondialdehyde ( MDA ) , total antioxidant capacity , transforming growth factor β1 , as well as grade of hepatic steatosis and homeostasis model assessment of insulin resistance were assessed pre- and post-intervention . In patients who received vitamin D supplement compared to the controls , the median of serum 25(OH)D3 significantly increased ( 16.2 vs. 1.6 ng/ml , P decrease in serum MDA ( −2.09 vs. −1.23 ng/ml , P = 0.03 ) and near significant changes in serum hs-CRP ( −0.25 vs. 0.22 mg/l , P = 0.06 ) . These between-group differences remained significant even after controlling for baseline covariates . Other variables showed no significant changes . Improved vitamin D status led to amelioration in serum hs-CRP and MDA in patients with NAFLD . This might be considered as an adjunctive therapy to attenuate systemic inflammation and lipid peroxidation alongside other treatments for NAFLD patients",
"Background Vitamin D is believed to play an important role outside the endocrine system in the regulation of the immune system , and in cellular proliferation and differentiation . The aim of the study was to investigate the impact of vitamin D levels on innate immunity . Methods Participants for this prospect i ve , longitudinal study were recruited amongst otherwise healthy staff of a large hospital in Victoria , Australia . Those fulfilling the inclusion criteria , including a vitamin D level of , were supplemented . Using flow cytometry , expression of the innate immune receptors TLR2 , TLR4 and CD86 was measured on peripheral blood mononuclear cells ( P BMC s ) collected prior to vitamin D treatment and then at 1 and 3 months . Additonally , P BMC s at each timepoint were stimulated with specific TLR lig and s and result ant supernatants were assayed for the cytokines TNFα , IL-6 , IFN-α and IP-10 . Results In participants whose vitamin D level was > 100 nmol/L post supplementation ( n=11 ) , TLR2 expression on P BMC s increased significantly , with no change noted in TLR4 or CD86 expression . Stimulation of vitamin D deficient sample s with TLR lig and s produced a number of proinflammatory cytokines , which were significantly reduced upon vitamin D normalisation . In patients whose levels returned to a deficient level at 3 months despite ongoing low-level supplementation , an increase in the pro-inflamamtory state returned . This suggests that vitamin D may play an important role in ensuring an appropriate baseline pro-inflammatory state . Conclusions This ex-vivo pilot study adds clinical evidence supporting a possibly important role for vitamin D in innate immunity . If confirmed , this unique clinical study has potentially significant implication s for the treatment of a variety of inflammatory conditions , where achieving optimal vitamin D levels may help reduce inflammation",
"BACKGROUND Inflammatory reactions in coronary plaques play an important role in the pathogenesis of acute atherothrombotic events ; inflammation elsewhere is also associated with both atherogenesis generally and its thrombotic complications . Recent studies indicate that systemic markers of inflammation can identify subjects at high risk of coronary events . METHODS AND RESULTS We used a sensitive immunoradiometric assay to examine the association of serum C-reactive protein ( CRP ) with the incidence of first major coronary heart disease ( CHD ) event in 936 men 45 to 64 years of age . The subjects , who were sample d at r and om from the general population , participated in the first MONICA Augsburg survey ( 1984 to 1985 ) and were followed for 8 years . There was a positive and statistically significant unadjusted relationship , which was linear on the log-hazards scale , between CRP values and the incidence of CHD events ( n=53 ) . The hazard rate ratio ( HRR ) of CHD events associated with a 1-SD increase in log-CRP level was 1.67 ( 95 % CI , 1.29 to 2 . 17 ) . After adjustment for age , the HRR was 1.60 ( 95 % CI , 1.23 to 2 . 08 ) . Adjusting further for smoking behavior , the only variable selected from a variety of potential confounders by a forward stepping process with a 5 % change in the relative risk of CRP as the selection criterion , yielded an HRR of 1.50 ( 95 % CI , 1.14 to 1.97 ) . CONCLUSIONS These results confirm the prognostic relevance of CRP , a sensitive systemic marker of inflammation , to the risk of CHD in a large , r and omly selected cohort of initially healthy middle-aged men . They suggest that low- grade inflammation is involved in pathogenesis of atherosclerosis , especially its thrombo-occlusive complications",
"Objectives To evaluate the risk of bias tool , introduced by the Cochrane Collaboration for assessing the internal validity of r and omised trials , for inter-rater agreement , concurrent validity compared with the Jadad scale and Schulz approach to allocation concealment , and the relation between risk of bias and effect estimates . Design Cross sectional study . Study sample 163 trials in children . Main outcome measures Inter-rater agreement between review ers assessing trials using the risk of bias tool ( weighted κ ) , time to apply the risk of bias tool compared with other approaches to quality assessment ( paired t test ) , degree of correlation for overall risk compared with overall quality scores ( Kendall ’s τ statistic ) , and magnitude of effect estimates for studies classified as being at high , unclear , or low risk of bias ( metaregression ) . Results Inter-rater agreement on individual domains of the risk of bias tool ranged from slight ( κ=0.13 ) to substantial ( κ=0.74 ) . The mean time to complete the risk of bias tool was significantly longer than for the Jadad scale and Schulz approach , individually or combined ( 8.8 minutes ( SD 2.2 ) per study v 2.0 ( SD 0.8 ) , P correlation between risk of bias overall compared with the Jadad scores ( P=0.395 ) and Schulz approach ( P=0.064 ) . Effect sizes differed between studies assessed as being at high or unclear risk of bias ( 0.52 ) compared with those at low risk ( 0.23 ) . Conclusions Inter-rater agreement varied across domains of the risk of bias tool . Generally , agreement was poorer for those items that required more judgment . There was low correlation between assessment s of overall risk of bias and two common approaches to quality assessment : the Jadad scale and Schulz approach to allocation concealment . Overall risk of bias as assessed by the risk of bias tool differentiated effect estimates , with more conservative estimates for studies at low risk",
"Background . The role of vitamin D in the body 's ability to fight influenza and URI 's may be dependent on regulation of specific cytokines that participate in the host inflammatory response . The aim of this study was to test the hypothesis that vitamin D can influence intracellular signaling to regulate the production of cytokines . Subjects and Methods . This study was a 3-month prospect i ve placebo-controlled trial of vitamin D3 supplementation in ambulatory adults [ Li-Ng et al. , 2009 ] . 162 volunteers were r and omized to receive either 50 μg/d ( 2000 IU ) of vitamin D3 or matching placebo . 25(OH)D and the levels of 10 different cytokines ( IL-2 , 4 , 5 , 6 , 8 , 10 , 13 , GM-CSF , IFN-γ , TNF-α ) were measured in the serum of participants at baseline and the final visit . There were 6 drop-outs from the active vitamin D group and 8 from the placebo group . Results . In the active vitamin D group , we found a significant median percent decline in levels of GM-CSF ( −62.9 % , P , IFN-γ ( −38.9 % , P , IL-4 ( −50.8 % , P = .001 ) , IL-8 ( −48.4 % , P ) , and IL-10 ( −70.4 % , P for GM-CSF ( −53.2 % , P = .0007 ) and IFN-γ ( −34.4 % , P = .0011 ) . For each cytokine , there was no significant difference in the rate of decline between the two groups . 25(OH)D levels increased in the active vitamin D group from a mean of 64.3 ± 25.4 nmol/L to 88.5 ± 23.2 nmol/L. Conclusions . The present study did not show that vitamin D3 supplementation changed circulating cytokine levels among healthy adults",
"OBJECTIVE Although calcitriol ( 1,25(OH)2D ) is considered the biologically active vitamin D metabolite , several studies have shown that calcidiol ( 25OHD ) is the vitamin D metabolite that is most closely linked to parathyroid function and indices of calcium homeostasis . Moreover , low levels of 25OHD have been associated with increased risk of different diseases including cancer , diabetes , and myopathy . DESIGN Cross-sectional study . METHODS We studied relations between plasma concentrations of 25OHD , 1,25(OH)2D , and parathyroid hormone ( PTH ) in fasting plasma sample s from 315 healthy postmenopausal women r and omly selected from the local background population . RESULTS P-1,25(OH)2D levels varied in a concentration-dependent manner with P-25OHD levels ( P P-1,25(OH)2D levels were the lowest in women with vitamin D insufficiency , i.e. , P-1,25(OH)2D levels were reduced by approximately one-third in subjects with P-25OHD levels below 25 nmol/l compared with levels above 80 nmol/l ( P P-25OHD concentrations below 80 nmol/l , whereas no major increase in P-1,25(OH)2D was observed at P-25OHD concentrations above 80 nmol/l . In multiple regression analysis , PTH was a minor although significant predictor of P-1,25(OH)2D levels . CONCLUSIONS In normal postmenopausal women , the conversion of 25OHD to active vitamin D depends on the substrate concentration . Our data support that vitamin D insufficiency should be considered at P-25OHD levels below 80 nmol/l",
"IMPORTANCE Observational data link low 25-hydroxyvitamin D levels to both prevalent blood pressure and incident hypertension . No clinical trial has yet examined the effect of vitamin D supplementation in isolated systolic hypertension , the most common pattern of hypertension in older people . OBJECTIVE To test whether high-dose , intermittent cholecalciferol supplementation lowers blood pressure in older patients with isolated systolic hypertension . DESIGN Parallel group , double-blind , placebo-controlled r and omized trial . SETTING Primary care clinics and hospital clinics . PARTICIPANTS Patients 70 years and older with isolated systolic hypertension ( supine systolic blood pressure > 140 mm Hg and supine diastolic blood pressure INTERVENTIONS A total of 100,000 U of oral cholecalciferol or matching placebo every 3 months for 1 year . MAIN OUTCOMES AND MEASURES Difference in office blood pressure , 24-hour blood pressure , arterial stiffness , endothelial function , cholesterol level , insulin resistance , and b-type natriuretic peptide level during 12 months . RESULTS A total of 159 participants were r and omized ( mean age , 77 years ) . Mean baseline office systolic blood pressure was 163/78 mm Hg . Mean baseline 25-hydroxyvitamin D level was 18 ng/mL. 25-Hydroxyvitamin D levels increased in the treatment group compared with the placebo group ( + 8 ng/mL at 1 year , P ) office blood pressure ( −1 [ −6 to 4]/−2 [ −4 to 1 ] mm Hg at 3 months and 1 [ −2 to 4]/0 [ −2 to 2 ] mm Hg overall treatment effect ) . No significant treatment effect was evident for any of the secondary outcomes ( 24-hour blood pressure , arterial stiffness , endothelial function , cholesterol level , glucose level , and walking distance ) . There was no excess of adverse events in the treatment group , and the total number of falls was nonsignificantly lower in the group receiving vitamin D ( 36 vs 46 , P = .24 ) . CONCLUSIONS AND RELEVANCE Vitamin D supplementation did not improve blood pressure or markers of vascular health in older patients with isolated systolic hypertension . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N92186858",
"BACKGROUND Low vitamin D levels are common , and are associated with a higher incidence of future vascular events . We tested whether vitamin D supplementation could improve endothelial function and other markers of vascular function in patients with a history of myocardial infa rct ion . METHODS Parallel group , placebo-controlled , double-blind r and omised trial . Patients with a history of myocardial infa rct ion were r and omised to receive 100,000 units of oral vitamin D3 or placebo at baseline , 2 months and 4 months . Outcomes were measured at baseline , 2 and 6 months . Reactive hyperaemia index on fingertip plethysmography was the primary outcome . Secondary outcome measures included blood pressure , cholesterol , C-reactive protein , von Willebr and factor , tumour necrosis factor alpha , E-selectin , B-type natriuretic peptide , thrombomodulin and 25-hydroxyvitamin D levels . RESULTS 75 patients were r and omised , mean age 66 years . 74/75 ( 99 % ) completed 6 month follow-up . 25 hydroxyvitamin D levels increased in the intervention group relative to placebo ( + 13 vs + 1 nmol/L , p=0.04 ) . There was no between-group difference in change in reactive hyperaemia index between baseline and 6 months ( -0.18 vs -0.07 , p=0.40 ) . Of the secondary outcomes , only C-reactive protein showed a significant decline in the intervention arm relative to placebo at 6 months ( -1.3 vs 2.0mg/L , p=0.03 ) . Systolic blood pressure ( + 1.4 vs + 2.3 mmHg , p=0.79 ) , diastolic blood pressure ( + 2.0 vs + 0.8 mmHg , p=0.54 ) and total cholesterol ( + 0.26 vs + 0.24 mmol/L , p=0.88 ) showed no between-group difference at 6 months . CONCLUSIONS Supplementation with vitamin D did not improve markers of vascular function in patients with a history of myocardial infa rct ion",
"BACKGROUND Suboptimal vitamin D status is associated with endothelial dysfunction and an increased risk of cardiovascular diseases but it is unclear whether vitamin D supplementation is beneficial . The aim was to investigate the effect of vitamin D supplementation on endothelial function in patients with type 2 diabetes mellitus ( DM ) . METHODS In a double-blind , placebo-controlled trial , we r and omized 100 type 2 DM patients to vitamin D supplement ( 5000 IU/day , n = 50 ) or placebo ( controls , n = 50 ) for 12 weeks . Assessment of vascular function with brachial artery flow-mediated dilatation ( FMD ) , circulating levels of endothelial progenitor cells ( EPCs ) and brachial-ankle pulse wave velocity , and metabolic parameter , high-sensitivity C-reactive protein ( hsCRP ) and oxidative stress markers were performed before and after the supplementation . RESULTS After 12 weeks , vitamin D treated patients had significant increases in serum 25-hydroxyvitamin D [ 25(OH)D ] concentration ( treatment effect 34.7 ng/mL , 95 % CI 26.4 - 42.9 , P serum ionized calcium ( treatment effect 0.037 mmol/L , 95 % CI 0.007 - 0.067 , P = 0.018 ) ; decreased serum parathyroid hormone concentration ( treatment effect -0.55 pmol/L , 95 % CI -1.08 to -0.02 , P = 0.042 ) compared to patients who received placebo . Nevertheless , vitamin D supplementation did not improve vascular function as determined by FMD , circulating EPC count or baPWV ( all P > 0.05 ) . Furthermore , hsCRP , oxidative stress markers , low- and high-density lipoprotein and glycated hemoglobin were also similar between two groups ( all P > 0.05 ) . CONCLUSION In patients with type 2 DM , 12 weeks oral supplementation of vitamin D did not significantly affect vascular function or serum biomarkers of inflammation and oxidative stress . CLINICAL TRIAL NUMBER HKCTR-867 , www.hk clinical trials.com"
] | 41169584-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Inconsistent fat-free mass ( FFM ) and muscle strength responses have been reported in r and omized clinical trials ( RCTs ) administering testosterone replacement therapy ( TRT ) to middle-aged and older men . Our objective was to conduct a meta- analysis to determine whether TRT improves FFM and muscle strength in middle-aged and older men and whether the muscular responses vary by TRT administration route . METHODS Systematic literature search es of MEDLINE / PubMed and the Cochrane Library were conducted from inception through 31 March 2017 to identify double-blind RCTs that compared intramuscular or transdermal TRT vs. placebo and that reported assessment s of FFM or upper-extremity or lower-extremity strength . Studies were identified , and data were extracted and vali date d by three investigators , with disagreement resolved by consensus . Using a r and om effects model , individual effect sizes ( ESs ) were determined from 31 RCTs reporting FFM ( sample size : n = 1213 TRT , n = 1168 placebo ) and 17 reporting upper-extremity or lower-extremity strength ( n = 2572 TRT , n = 2523 placebo ) . Heterogeneity was examined , and sensitivity analyses were performed . RESULTS When administration routes were collectively assessed , TRT was associated with increases in FFM [ ES = 1.20 ± 0.15 ( 95 % CI : 0.91 , 1.49 ) ] , total body strength [ ES = 0.90 ± 0.12 ( 0.67 , 1.14 ) ] , lower-extremity strength [ ES = 0.77 ± 0.16 ( 0.45 , 1.08 ) ] , and upper-extremity strength [ ES = 1.13 ± 0.18 ( 0.78 , 1.47 ) ] ( P TRT than for transdermal formulations vs. respective placebos , for all outcomes evaluated . Specifically , intramuscular TRT was associated with a 5.7 % increase in FFM [ ES = 1.49 ± 0.18 ( 1.13 , 1.84 ) ] and 10 - 13 % increases in total body strength [ ES = 1.39 ± 0.12 ( 1.15 , 1.63 ) ] , lower-extremity strength [ ES = 1.39 ± 0.17 ( 1.07 , 1.72 ) ] , and upper-extremity strength [ ES = 1.37 ± 0.17 ( 1.03 , 1.70 ) ] ( P increase in FFM [ ES = 0.98 ± 0.21 ( 0.58 , 1.39 ) ] and only 2 - 5 % increases in total body [ ES = 0.55 ± 0.17 ( 0.22 , 0.88 ) ] and upper-extremity strength [ ES = 0.97 ± 0.24 ( 0.50 , 1.45 ) ] ( P no change in lower-extremity strength vs. placebo [ ES = 0.26 ± 0.23 ( -0.19 , 0.70 ) , P = 0.26 ] . Subanalyses of RCTs limiting enrolment to men ≥60 years of age produced similar results . CONCLUSIONS Intramuscular TRT is more effective than transdermal formulations at increasing LBM and improving muscle strength in middle-aged and older men , particularly in the lower extremities | [
"CONTEXT Testosterone in Older Men with Mobility Limitations Trial determined the effects of testosterone on muscle performance and physical function in older men with mobility limitation . Trial 's Data and Safety Monitoring Board recommended enrollment cessation due to increased frequency of adverse events in testosterone arm . The changes in muscle performance and physical function were evaluated in relation to participant 's perception of change . METHODS Men aged 65 years and older , with mobility limitation , total testosterone 100 - 350 ng/dL , or free testosterone less than 50 pg/mL , were r and omized to placebo or 10 g testosterone gel daily for 6 months . Primary outcome was leg-press strength . Secondary outcomes included chest-press strength , stair-climb , 40-m walk , muscle mass , physical activity , self-reported function , and fatigue . Proportions of participants exceeding minimally important difference in study arms were compared . RESULTS Of 209 r and omized participants , 165 had follow-up efficacy measures . Mean ( SD ) age was 74 ( 5.4 ) years and short physical performance battery score 7.7 ( 1.4 ) . Testosterone arm exhibited greater improvements in leg-press strength , chest-press strength and power , and loaded stair-climb than placebo . Compared with placebo , significantly greater proportion of men receiving testosterone improved their leg-press and chest-press strengths ( 43 % vs 18 % , p = .01 ) and stair-climbing power ( 28 % vs 10 % , p = .03 ) more than minimally important difference . Increases in leg-press strength and stair-climbing power were associated with changes in testosterone levels and muscle mass . Physical activity , walking speed , self-reported function , and fatigue did not change . CONCLUSIONS Testosterone administration in older men with mobility limitation was associated with patient-important improvements in muscle strength and stair-climbing power . Improvements in muscle strength and only some physical function measures should be weighed against the risk of adverse events in this population",
"Serum and rogen levels decline with aging in normal males , such that a significant number of men over 60 yr of age will have a mean serum total testosterone ( T ) level near the low end of the normal adult range . It is not known whether lower T levels in older men have an effect on and rogen-responsive organ systems , such as muscle , bone , bone marrow , and prostate , nor are there data to evaluate the relative benefits and risks of T supplementation in older men . We assessed the physiological and biochemical effects of T therapy in 13 healthy men , 57 - 76 yr old , who had low or borderline low serum T levels ( Intramuscular testosterone enanthate ( TE ; 100 mg weekly ) and placebo injections were given for 3 months each . Before treatment and at the end of both 3-month treatment regimens , lean body mass , body fat , biochemical parameters of bone turnover , hematological parameters , lipoprotein profiles , and prostate parameters [ such as prostate-specific antigen ( PSA ) ] were evaluated . Serum T levels rose in all subjects with TE treatment , such that the lowest level of T during a week 's period was 19.7 + /- 0.7 nmol/L ( mean + /- SE ) . After 3 months of TE treatment , lean body mass was significantly increased , and urinary hydroxyproline excretion was significantly depressed . With TE treatment , there was a significant increase in hematocrit , a decline in total cholesterol and low density lipoprotein cholesterol , and a sustained increase in serum PSA levels . Placebo treatment led to no significant changes in any of these parameters . We conclude that short term ( 3 months ) TE supplementation to healthy older men who have serum T levels near or below the lower limit of normal for young adult men results in an increase in lean body mass and possibly a decline in bone resorption , as assessed by urinary hydroxyproline excretion , with some effect on serum lipoproteins , hematological parameters , and PSA . The sustained stimulation of PSA and the increase in hematocrit that occur with physiological TE supplementation suggest that older men should be screened carefully and followed periodically throughout T therapy",
"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",
"Aging in men is associated with loss of bone mass , impaired physical function and altered body composition . The objective of this proof‐of‐concept r and omized , double‐blind , placebo‐controlled , parallel‐group , single‐center trial was to determine the relative effects of testosterone ( T ) and estradiol ( E2 ) on bone mineral density , body composition , and physical performance in older men . The primary outcome was lumbar spine bone mineral density ( BMD ) , and secondary outcomes were body composition , muscle strength , gait speed , and sex hormone concentrations . Forty three men ( age range , 65–82 years ; mean age 71 years ) with low total T levels to one of three groups : 5 g transdermal testosterone gel ( TT ) ( N = 16 ) , anastrozole ( AI ) 1 mg ( N = 14 ) or placebo daily ( N = 13 ) for 12 months . Outcomes were assessed at baseline , 3 , 6 , and 12 months . Both TT and AI increased serum TT levels ( > 500 ng/dL , p primary outcome of lumbar spine BMD ( p interventions improved knee strength at 12 months compared to baseline ( p while lean body mass significantly increased only in the AI group at 6 and 12 months ( 1.49 ± 0.38 kg , p TT improved fast gait speed at 3 and 12 months ( p maintaining BMD in older men with low‐T levels . The trial also uncovered the novel finding that aromatization of T is required for improvement in fast gait speed , an observation that needs to be verified in future studies",
"Context : Findings of studies of testosterone ’s effects on muscle strength and physical function in older men have been inconsistent ; its effects on muscle power and fatigability have not been studied . Objective : To determine the effects of testosterone administration for 3 years in older men on muscle strength , power , fatigability , and physical function . Design , Setting , and Participants : This was a double-blind , placebo-controlled , r and omized trial of healthy men ≥60 years old with total testosterone levels of 100 to 400 ng/dL or free testosterone levels Interventions : R and om assignment to 7.5 g of 1 % testosterone or placebo gel daily for 3 years . Outcome Measures : Loaded and unloaded stair-climbing power , muscle strength , power , and fatigability in leg press and chest press exercises , and lean mass at baseline , 6 , 18 , and 36 months . Results : The groups were similar at baseline . Testosterone administration for 3 years was associated with significantly greater performance in unloaded and loaded stair-climbing power than placebo ( mean estimated between-group difference , 10.7 W [ 95 % confidence interval ( CI ) , −4.0 to 25.5 ] , P = 0.026 ; and 22.4 W [ 95 % CI , 4.6 to 40.3 ] , P = 0.027 ) , respectively . Changes in chest-press strength ( estimated mean difference , 16.3 N ; 95 % CI , 5.5 to 27.1 ; P 0.001 ) and power ( mean difference 22.5 W ; 95 % CI , 7.5 to 37.5 ; P were significantly greater in men r and omized to testosterone than in those r and omized to placebo . Lean body mass significantly increased more in the testosterone group . Conclusion : Compared with placebo , testosterone replacement in older men for 3 years was associated with modest but significantly greater improvements in stair-climbing power , muscle mass , and power . Clinical meaningfulness of these treatment effects and their impact on disability in older adults with functional limitations remains to be studied",
"OBJECTIVES To examine the effect of strength training and testosterone therapy on mechanical muscle function and lean body mass ( LBM ) in aging men with low-normal testosterone levels in a r and omized , double-blind , placebo-controlled 24-week study . DESIGN R and omized , double-blind , placebo-controlled . SETTING Odense , Denmark . PARTICIPANTS Men aged 60 to 78 , with bioavailable testosterone levels of less than 7.3 nmol/L and a waist circumference greater than 94 cm were r and omized to testosterone ( 50 - 100 mg/d , n = 22 ) placebo ( n = 23 ) or strength training ( n = 23 ) for 24 weeks . The strength training group was r and omized to addition of testosterone or placebo after 12 weeks . Subjects performed supervised strength training ( 2 - 3 sets with 6- to 10-repetition maximum loads , 3 times per week ) . MEASUREMENTS Testosterone levels , maximal voluntary contraction and rate of force development , and LBM were obtained at 0 and at Weeks 12 and 24 of the intervention . RESULTS No changes in any variables were recorded with placebo . In the strength training group , maximal voluntary contraction increased 8 % after 12 weeks ( P = .005 ) . During the following 12 weeks of strength training rate of force development increased by 10 % ( P = .04 ) and maximal voluntary contraction further increased ( P Mechanical muscle function was unchanged in men receiving only testosterone for 24 weeks . LBM increased only in men receiving testosterone ( P = .004 ) . CONCLUSION Strength training in aging men with low-normal testosterone levels may improve mechanical muscle function , but this effect occurs without a significant increase in LBM . Clinical ly , only the combination of testosterone therapy and strength training result ed in an increase in mechanical muscle function and LBM",
"Background Uncontrolled studies show fatigue , anorexia , depression , and mortality are associated with low testosterone in men with cancer . Testosterone replacement improves quality of life and diminishes fatigue in patients with non-cancer conditions . The primary objective was to evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer , by the Functional Assessment of Chronic Illness Therapy-Fatigue subscale ( FACIT-Fatigue ) at day 29 . Methods This is a r and omized , double-blinded placebo-controlled trial . Out patients with advanced cancer , bioavailable testosterone ( BT ) 3/10 on the Edmonton Symptom Assessment Scale were eligible . Intra-muscular testosterone or sesame seed oil placebo was administered every 14 days to achieve BT levels 70–270 ng/dL. Results Sixteen placebo and 13 testosterone-treated subjects were evaluable . No statistically significant difference was found for FACIT-fatigue scores between arms ( −2 ± 12 for placebo , 4 ± 8 for testosterone , p = 0.11 ) . Sexual Desire Inventory score ( p = 0.054 ) and performance status ( p = 0.02 ) improved in the testosterone group . Fatigue subscale scores were significantly better ( p = 0.03 ) in those treated with testosterone by day 72 . Conclusions Four weeks of intramuscular testosterone replacement in hypogonadal male patients with advanced cancer did not significantly improve quality of life . Larger studies of longer duration are warranted",
"BACKGROUND A large proportion of men over 65 years of age have bioavailable testosterone levels below the reference range of young adult men . The impact of this on musculoskeletal health and the potential for improvement in function in this group with testosterone supplementation require investigation . METHODS Sixty-seven men ( mean age 76 + /- 4 years , range 65 - -87 ) with bioavailable testosterone levels below 4.44 nmol/l ( lower limit for adult normal range ) were r and omized to receive transdermal testosterone ( two 2.5-mg patches per day ) or placebo patches for 1 year . All men received 500 mg supplemental calcium and 400 IU vitamin D. Outcome measures included sex hormones ( testosterone , bioavailable testosterone , sex-hormone binding globulin [ SHBG ] , estradiol , and estrone ) , bone mineral density ( BMD ; femoral neck , Ward 's triangle , trochanter , lumbar spine , and total body ) , bone turnover markers , lower extremity muscle strength , percent body fat , lean body mass , hemoglobin , hematocrit , prostate symptoms , and prostate specific antigen ( PSA ) levels . RESULTS Twenty-three men ( 34 % ) withdrew from the study ; 44 men completed the trial . In these men , bioavailable testosterone levels increased from 3.2 + /- 1.2 nmol/l ( SD ) to 5.6 + /- 3.5 nmol/l ( p estradiol levels in either group , estrone levels increased in the testosterone group ( 103 + /- 26 pmol/l to 117 + /- 33 pmol/l ; p femoral neck BMD , whereas the control group lost 1.6 % over 12 months ( p = .015 ) . No significant changes were seen in markers of bone turnover in either group . Improvements in muscle strength were seen in both groups at 12 months compared with baseline scores . Strength increased 38 % ( p = .017 ) in the testosterone group and 27 % in the control group ( p = .06 ) , with no statistical difference between the groups . In the testosterone group , body fat decreased from 26.3 + /- 5.8 % to 24.6 + /- 6.5 % ( p = .001 ) , and lean body mass increased from 56.2 + /- 5.3 kg to 57.2 + /- 5.1 kg ( p = .001 ) , whereas body mass did not change . Men receiving testosterone had an increase in PSA from 2.0 + /- 1.4 microg/l to 2.6 + /- 1.8 microg/l ( p = .04 ) , whereas men receiving placebo had an increase in PSA from 1.9 + /- 1.0 microg/l to 2.2 + /- 1.5 microg/l ( p = .09 ) . No significant differences between groups were seen in hemoglobin , hematocrit , symptoms or signs of benign prostate hyperplasia , or PSA levels . CONCLUSIONS Transdermal testosterone ( 5 mg/d ) prevented bone loss at the femoral neck , decreased body fat , and increased lean body mass in a group of healthy men over age 65 with low bioavailable testosterone levels . In addition , both testosterone and placebo groups demonstrated gains in lower extremity muscle strength , possibly due to the beneficial effects of vitamin D. Testosterone did result in a modest increase in PSA levels but result ed in no change in signs or symptoms of prostate hyperplasia",
"The indication for testosterone therapy in aging hypogonadal men without hypothalamic , pituitary , or testicular disease remains to be eluci date d. The aim of this study was to investigate the effect of testosterone therapy on insulin sensitivity , substrate metabolism , body composition , and lipids in aging men with low normal bioavailable testosterone levels using a predefined cutoff level for bioavailable testosterone . A r and omized , double-blinded , placebo-controlled study of testosterone treatment ( gel ) was done on 38 men , aged 60–78 years , with bioavailable testosterone 94 cm . Insulin-stimulated glucose disposal ( Rd ) and substrate oxidation were assessed by euglycemic hyperinsulinemic clamps combined with indirect calorimetry . Lean body mass ( LBM ) and total fat mass ( TFM ) were measured by dual x-ray absorptiometry , and serum total testosterone was measured by t and em mass spectrometry . Bioavailable testosterone was calculated . Coefficients ( b ) represent the placebo-controlled mean effect of intervention . LBM ( b = 1.9 kg , p = 0.003 ) increased while HDL – cholesterol ( b = −0.12 mmol/l , p = 0.043 ) and TFM decreased ( b = −1.2 kg , p = 0.038 ) in the testosterone group compared to placebo . Basal lipid oxidation ( b = 5.65 mg/min/m2 , p = 0.045 ) increased and basal glucose oxidation ( b = −9.71 mg/min/m2 , p = 0.046 ) decreased in response to testosterone therapy even when corrected for changes in LBM . No significant changes in insulin-stimulated Rd was observed ( b = −0.01mg/min/m2 , p = 0.92 ) . Testosterone therapy increased muscle mass and lipid oxidation in aging men with low normal bioavailable testosterone levels ; however , our data did not support an effect of testosterone on whole-body insulin sensitivity using the euglycemic hyperinsulinemic clamp technique",
"Long-term glucocorticoid therapy in men is associated with loss of bone and muscle mass as well as a decrease in serum testosterone . We tested the effect of two and rogens , testosterone and its minimally aromatizable analog n and rolone , on muscle mass ( dual x-ray absorptiometry ) , muscle strength ( knee flexion and extension by isokinetic dynamometry ) , bone mineral density ( BMD ) , and quality of life ( Qualeffo-41 question naire ) in 51 men on a mean daily prednisone dose of 12.6 + /- 2.2 mg . Men were r and omized , double blind , to testosterone ( 200 mg mixed esters ) , n and rolone decanoate ( 200 mg ) , or placebo given every fortnight by i m injection for 12 months . At 12 months , both and rogens increased muscle mass ( mean change from baseline + 3.5 % , + 5.8 % , and -0.9 % in testosterone , n and rolone , and placebo groups , respectively , P muscle strength ( P Lumbar spine BMD increased significantly only in men treated with testosterone ( 4.7 + /- 1.1 % , P hip or total body BMD . Testosterone , but not n and rolone or placebo , improved overall quality of life ( P and rogen therapy may have a role in ameliorating adverse effects of glucocorticoid therapy such as muscle and bone loss and aromatization is necessary for and rogen action on bone but not on muscle",
"The pharmacokinetics , efficacy , and safety of the And roderm testosterone ( T ) transdermal system ( TTD ) and intramuscular T enanthate injections ( i.m . ) for the treatment of male hypogonadism were compared in a 24-week multicenter , r and omized , parallel-group study . Sixty-six adult hypogonadal men ( 22 - 65 years of age ) were withdrawn from prior i.m . treatment for 4 - 6 weeks and then r and omly assigned to treatment with TTD ( two 2.5-mg systems applied nightly ) or i.m . ( 200 mg injected every 2 weeks ) ; there were 33 patients per group . Twenty-six patients in the TTD group and 32 in the i.m . group completed the study . TTD treatment produced circadian variations in the levels of total T , bioavailable T , dihydrotestosterone , and estradiol within the normal physiological ranges . i.m . treatment produced supraphysiological levels of T , bioavailable T , and estradiol ( but not dihydrotestosterone ) for several days after each injection . Mean morning sex hormone levels were within the normal range in greater proportions of TTD patients ( range , 77 - 100 % ) than i.m . patients ( range , 19 - 84 % ) . Both treatments normalized LH levels in approximately 50 % of patients with primary hypogonadism ; however , LH levels were suppressed to the subnormal range in 31 % of i.m . patients vs. 0 % of TTD patients . Both treatments maintained sexual function ( assessed by question naire and Rigiscan ) and mood ( Beck Depression Inventory ) at the prior treatment levels . Prostate-specific antigen levels , prostate volumes , and lipid and serum chemistry parameters were comparable in both treatment groups . Transient skin irritation from the patches was reported by 60 % of the TTD patients , but caused only three patients ( 9 % ) to discontinue treatment . i.m . treatment produced local reactions in 33 % of patients and was associated with significantly more abnormal hematocrit elevations ( 43.8 % of patients ) compared with TTD treatment ( 15.4 % of patients ) . Gynecomastia resolved more frequently during TTD treatment ( 4 of 10 patients ) than with i.m . treatment ( 1 of 9 patients ) . Although both treatments seem to be efficacious for replacing T in hypogonadal men , the more physiological sex hormone levels and profiles associated with TTD may offer possible advantages over i.m . in minimizing excessive stimulation of erythropoiesis , preventing/ameliorating gynecomastia , and not over-suppressing gonadotropins",
"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",
"Abstract Background Ultrasound is a non‐invasive and readily available tool that can be prospect ively applied at the bedside to assess muscle mass in clinical setting s. The four‐site protocol , which images two anatomical sites on each quadriceps , may be a viable bedside method , but its ability to predict musculature has not been compared against whole‐body reference methods . Our primary objectives were to ( i ) compare the four‐site protocol 's ability to predict appendicular lean tissue mass from dual‐energy X‐ray absorptiometry ; ( ii ) optimize the predictability of the four‐site protocol with additional anatomical muscle thicknesses and easily obtained covariates ; and ( iii ) assess the ability of the optimized protocol to identify individuals with low lean tissue mass . Methods This observational cross‐sectional study recruited 96 university and community dwelling adults . Participants underwent ultrasound scans for assessment of muscle thickness and whole‐body dual‐energy X‐ray absorptiometry scans for assessment of appendicular lean tissue . Ultrasound protocol s included ( i ) the nine‐site protocol , which images nine anterior and posterior muscle groups in supine and prone positions , and ( ii ) the four‐site protocol , which images two anterior sites on each quadriceps muscle group in a supine position . Results The four‐site protocol was strongly associated ( R 2 = 0.72 ) with appendicular lean tissue mass , but Bl and –Altman analysis displayed wide limits of agreement ( −5.67 , 5.67 kg ) . Incorporating the anterior upper arm muscle thickness , and covariates age and sex , alongside the four‐site protocol , improved the association ( R 2 = 0.91 ) with appendicular lean tissue and displayed narrower limits of agreement ( −3.18 , 3.18 kg ) . The optimized protocol demonstrated a strong ability to identify low lean tissue mass ( area under the curve = 0.89 ) . Conclusions The four‐site protocol can be improved with the addition of the anterior upper arm muscle thickness , sex , and age when predicting appendicular lean tissue mass . This optimized protocol can accurately identify low lean tissue mass , while still being easily applied at the bedside",
"Abstract Background Although muscle mass declines with testosterone deficiency in men , previous studies of muscle function have not demonstrated consistent deficits , likely due to relatively insensitive methodology . Our objective was to determine the effects of testosterone deprivation on the biomechanical function of individual lower‐limb muscles . Methods We conducted a 12‐month prospect i ve , observational case – control study of 34 men newly commencing and rogen deprivation treatment ( ADT ) for prostate cancer and 29 age‐matched prostate cancer controls . Participants were assessed at 0 , 6 , and 12 months while walking in a biomechanics laboratory . We combined video‐based motion capture and ground reaction force data with computerized musculoskeletal modelling to assess the following primary outcomes : ( i ) peak joint torques at the hip , knee and ankle , and corresponding individual muscle forces ; ( ii ) individual muscle contributions to acceleration of the body 's centre of mass ; and ( iii ) walking speed , stride length , and step width . A linear mixed model was used to compare mean differences between groups . Results Compared with controls over 12 months , men receiving ADT had a mean reduction in total testosterone level from 14.1 to 0.4 nmol/L , and demonstrated more marked decreases in peak hip flexor torque by 14 % [ mean difference −0.11 N/kg ( −0.19 , −0.03 ) , P = 0.01 ] and peak knee extensor torque by 16 % [ −0.11 N/kg ( −0.20 , −0.02 ) , P = 0.02 ] of the initial mean value . Correspondingly , iliopsoas force decreased by 14 % ( P = 0.006 ) , and quadriceps force decreased by 11 % , although this narrowly missed statistical significance ( P = 0.07 ) . Soleus decreased contribution to forward acceleration of the body 's centre of mass by 17 % [ mean difference −0.17 m/s2 ( −0.29 , −0.05 ) , P observed in other joint torques or individual muscle contributions to acceleration of the body . Step width increased by 18 % [ mean adjusted difference 1.4 cm ( 0.6 , 27.4 ) , P = 0.042 ] in the ADT group compared with controls , with no change in stride length or walking speed . Conclusions Testosterone deprivation selectively decreases lower‐limb muscle function , predominantly affecting muscles that support body weight , accelerate the body forwards during walking , and mediate balance . Future exercise and pro‐myogenic interventional studies to mitigate ADT‐associated sarcopenia should target these deficits",
"Dysfunction of the muscles of ambulation contributes to exercise intolerance in chronic obstructive pulmonary disease ( COPD ) . Men with COPD have high prevalence of low testosterone levels , which may contribute to muscle weakness . We determined effects of testosterone supplementation ( 100 mg of testosterone enanthate injected weekly ) with or without resistance training ( 45 minutes three times weekly ) on body composition and muscle function in 47 men with COPD ( mean FEV(1 ) = 40 % predicted ) and low testosterone levels ( mean = 320 ng/dl ) . Subjects were r and omized to 10 weeks of placebo injections + no training , testosterone injections + no training , placebo injections + resistance training , or testosterone injections + resistance training . Testosterone injections yielded a mean increase of 271 ng/dl in the nadir serum testosterone concentration ( to the middle of the normal range for young men ) . The lean body mass ( by dual-energy X-ray absorptiometry ) increase averaged 2.3 kg with testosterone alone and 3.3 kg with combined testosterone and resistance training ( p Increase in one-repetition maximum leg press strength averaged 17.2 % with testosterone alone , 17.4 % with resistance training alone , and 26.8 % with testosterone + resistance training ( p tolerated with no abnormalities in safety measures . Further studies are required to determine long-term benefits of adding testosterone supplementation and resistance training to rehabilitative programs for carefully screened men with COPD and low testosterone levels",
"Testosterone ( T ) therapy in older men with low serum T levels increases lean body mass and decreases fat mass . These changes might improve physical performance and strength ; however , it has not been established whether T therapy improves functional outcome in older men . Moreover , concerns exist about the impact of T therapy on the prostate in older men . The administration of finasteride ( F ) , which partially blocks the conversion of T to the more potent and rogen , dihydrotestosterone , attenuates the impact of T replacement on prostate size and prostate-specific antigen . We hypothesized that T replacement in older , hypogonadal men would improve physical function and that the addition of F to this regimen would continue to provide the T-induced improvements in physical performance , strength , and body composition . Seventy men with low serum T ( , were r and omly assigned to receive one of three regimens for 36 months : 1 ) T enanthate , 200 mg i m every 2 wk , with placebo pills daily ( T-only ) ; 2 ) T enanthate , 200 mg every 2 wk , with 5 mg F daily ( T + F ) ; or 3 ) placebo injections and pills ( placebo ) . We obtained serial measurements of timed physical performance , grip strength , lower extremity strength , body composition ( by dual-energy x-ray absorptiometry ) , fasting cholesterol profiles , and hormones . Fifty men completed the 36-month protocol . After 36 months , T therapy significantly improved performance in a timed functional test when compared with baseline and placebo [ 4.3 + /- 1.6 % ( mean + /- sem , T-only ) and 3.8 + /- 1.0 % ( T + F ) vs. -5.6 + /- 1.9 % for placebo ( P h and grip strength compared with baseline and placebo ( P lean body mass [ 3.77 + /- 0.55 kg ( T-only ) and 3.64 + /- 0.56 kg ( T + F ) vs. -0.21 + /- 0.55 kg for placebo ( P decreased fat mass , and significantly decreased total cholesterol , low-density lipoprotein , and leptin , without affecting high-density lipoprotein , adiponectin , or fasting insulin levels . These results demonstrate that T therapy in older men with low serum T improves physical performance and strength over 36 months , when administered alone or when combined with F , and suggest that high serum levels of dihydrotestosterone are not essential for these beneficial effects of T in men",
"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",
"CONTEXT Declines in GH and testosterone ( Te ) secretion may contribute to the detrimental aging changes of elderly men . OBJECTIVE To assess the effects of near-physiological GH with/without Te administration on lean body mass , total body fat , midthigh muscle cross-section area , muscle strength , aerobic capacity , condition-specific quality of life ( Age-Related Hormone Deficiency-Dependent Quality of Life question naire ) , and generic health status ( 36-Item Short-Form Health Survey ) of older men . DESIGN , SETTING S , AND PARTICIPANTS A 6-month , r and omized , double-blind , placebo-controlled trial was performed on 80 healthy , community-dwelling , older men ( age , 65 - 80 yr ) . INTERVENTIONS Participants were r and omized to receive 1 ) placebo GH or placebo Te , 2 ) recombinant human GH ( rhGH ) and placebo Te ( GH ) , 3 ) Te and placebo rhGH ( Te ) , or 4 ) rhGH and Te ( GHTe ) . GH doses were titrated over 8 wk to produce IGF-I levels in the upper half of the age-specific reference range . A fixed dose of Te ( 5 mg ) was given by transdermal patches . RESULTS Lean body mass increased with GHTe ( P = 0.008 ) and GH ( P = 0.004 ) , compared with placebo . Total body fat decreased with GHTe only ( P = 0.02 ) . Midthigh muscle ( P = 0.006 ) and aerobic capacity ( P Muscle strength changes were variable ; one of six measures significantly increased with GHTe . Significant treatment group by time interactions indicated an improved Age-Related Hormone Deficiency-Dependent Quality of Life question naire score ( P = 0.007 ) in the GH and GHTe groups . Bodily pain increased with GH alone , as determined by the Short-Form Health Survey ( P = 0.003 ) . There were no major adverse effects . CONCLUSION Coadministration of low dose GH with Te result ed in beneficial changes being observed more often than with either GH or Te alone",
"BACKGROUND Lower muscle mass has been correlated with poor physical function ; however , no studies have examined this relationship prospect ively . This study aims to investigate whether low muscle mass , low muscle strength , and greater fat infiltration into the muscle predict incident mobility limitation . METHODS Our study cohort included 3075 well-functioning black and white men and women aged 70 - 79 years participating in the Health , Aging , and Body Composition study . Participants were followed for 2.5 years . Muscle cross-sectional area and muscle tissue attenuation ( a measure of fat infiltration ) were measured by computed tomography at the mid-thigh , and knee extensor strength by using a KinCom dynamometer . Incident mobility limitation was defined as two consecutive self-reports of any difficulty walking one-quarter mile or climbing 10 steps . RESULTS Mobility limitations were developed by 22.3 % of the men and by 31.8 % of the women . Cox 's proportional hazards models , adjusting for demographic , lifestyle , and health factors , showed a hazard ratio of 1.90 [ 95 % confidence interval ( CI ) , 1.27 - 2.84 ] in men and 1.68 ( 95 % CI , 1.23 - 2.31 ) in women for the lowest compared to the highest quartile of muscle area ( p muscle strength were 2.02 ( 95 % CI , 1.39 - 2.94 ) and 1.91 ( 95 % CI , 1.41 - 2.58 ) , p muscle attenuation were 1.91 ( 95 % CI , 1.31 - 2.83 ) and 1.68 ( 95 % CI , 1.20 - 2.35 ) , p muscle attenuation and muscle strength independently predicted mobility limitation ( p blacks and whites . CONCLUSION Lower muscle mass ( smaller cross-sectional thigh muscle area ) , greater fat infiltration into the muscle , and lower knee extensor muscle strength are associated with increased risk of mobility loss in older men and women . The association between low muscle mass and functional decline seems to be a function of underlying muscle strength",
"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",
"Introduction : The clinical significance of low to low-normal testosterone ( T ) levels in men remains debated . Aim : To analyze the effects of raising serum T on lean body mass ( LBM ) , fat mass ( FM ) , total body mass , and health-related quality -of-life ( HRQoL ) . Methods : R and omized , double-blind , placebo-controlled study . Men , aged 50–80 years , with serum total T 36 , received 6 months treatment with transdermal 1 % T gel ( 5–7.5 mg/day ; n = 183 ) or placebo gel ( n = 179 ) , followed by 12 months open-label with T in all . Results : After 6 months , LBM increased in T- treated patients by 1.28 ± 0.15 kg ( mean ± SE ) and FM decreased by 1.16 ± 0.16 kg , with minor changes with placebo ( LBM + 0.02 ± 0.10 kg and FM −0.14 ± 0.12 kg ; all p subgroups of age , baseline total testosterone , and baseline BMI . Total HRQoL improved compared with placebo ( p 1 % T gel improved body composition and HRQoL in symptomatic men with low to low-normal T , with further improvements over the following 12 months",
"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",
"CONTEXT Symptoms of fluid retention in GH-deficient patients during GH replacement are greater in men than in women , suggesting that testosterone may augment or estradiol may attenuate the antinatriuretic actions of GH . The mechanisms underlying the sodium-retaining effects of GH are poorly understood . AIM The aim of this study was to investigate the effects of GH and testosterone , alone and in combination , on extracellular water ( ECW ) and the hormonal mechanisms involved . DESIGN Two separate , open-label , r and omized , two-period , crossover studies were performed ; the first compared the effects of GH alone with those of GH and testosterone , and the second compared the effects of testosterone alone with those of GH and testosterone . PARTICIPANTS Twelve hypopituitary men with GH deficiency and hypogonadism were studied . INTERVENTION During the weeks of intervention , GH ( 0.5 mg/d ) and testosterone enanthate ( 250 mg ) were administered by i m injection . OUTCOME MEASURES The outcome measures were ECW , IGF-I , plasma renin activity ( PRA ) , aldosterone ( Aldo ) , and atrial natriuretic peptide ( ANP ) . RESULTS GH treatment significantly increased ( P IGF-I and ECW , and these changes were enhanced by cotreatment with testosterone ( P = 0.07 for both ) . PRA , Aldo , and ANP levels did not change . Testosterone treatment alone did not change the IGF-I concentration , whereas cotreatment with GH induced a marked increase . Testosterone alone increased ( P ECW , and the effect was augmented ( P PRA and ANP did not change , plasma Aldo decreased after single and combined treatments . CONCLUSION GH and testosterone exerted independent and additive effects on ECW . The mechanisms of fluid retention for both hormones are likely to be exerted on the renal tubules . This is the first direct evidence that testosterone increases ECW",
"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",
"As men age , serum testosterone concentrations decrease , the percentage of body mass that is fat increases , the percentage of lean body mass decreases , and muscle strength decreases . Because these changes are similar to those that occur in hypogonadal men , we hypothesized that increasing the serum testosterone concentration of men over 65 yr of age to that in young men would decrease their fat mass , increase their lean mass , and increase their muscle strength . We r and omized 108 men over 65 yr of age to wear either a testosterone patch or a placebo patch in a double blind study for 36 months . We measured body composition by dual energy x-ray absorptiometry and muscle strength by dynamometer before and during treatment . Ninety-six men completed the entire 36-month protocol . Fat mass decreased ( -3.0+/-0.5 kg ) in the testosterone-treated men during the 36 months of treatment , which was significantly different ( P = 0.001 ) from the decrease ( -0.7+/-0.5 kg ) in the placebo-treated men . Lean mass increased ( 1.9+/-0.3 kg ) in the testosterone-treated men , which was significantly different ( P decrease in fat mass in the testosterone-treated men was principally in the arms ( -0.7+/-0.1 kg ; P lean mass was principally in the trunk ( 1.9+/-0.3 kg ; P strength of knee extension and flexion at 60 degrees and 180 degrees angular velocity during treatment , however , was not significantly different between the two groups . We conclude that increasing the serum testosterone concentrations of normal men over 65 yr of age to the midnormal range for young men decreased fat mass , principally in the arms and legs , and increased lean mass , principally in the trunk , but did not increase the strength of knee extension and flexion , as measured by dynamometer",
"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",
"OBJECTIVE One of the factors that may promote deterioration in quality of life and body composition in elderly men is the relative decline in serum testosterone levels with aging . In this study , we assessed the effects of modest doses of testosterone and a home-based strengthening program on quality of life and body composition in elderly men with relative testosterone insufficiency . DESIGN Double-blind , placebo-controlled r and omized study ( testosterone ) , and additional r and omization to a resistance exercise program or no additional exercise for 12 weeks in men between ages of 65 and 85 years with relative testosterone insufficiency . METHODS Seventy sedentary , community dwelling men were r and omized to a 5 mg testoderm transdermal system applied daily vs placebo system , and additionally r and omized to a home-based resistance exercise program . Subjects were r and omized to Group 1 ( testosterone plus exercise ) , Group 2 ( testosterone plus no exercise ) , Group 3 ( placebo plus exercise ) , and Group 4 ( placebo plus no exercise ) . Endpoints included quality of life ( assessed by the short form-36 question naire ) and body composition ( measured by dual x-ray absorptiometry scan ) . RESULTS Serum testosterone increased by a mean of 10.0 + /- 1.9 , 6.6 + /- 1.6 , 0.52 + /- 0.6 , and 0.5 + /- 0.6 nmol/l in Groups 1 , 2 , 3 , and 4 respectively . There was a significant interaction of testosterone and exercise on quality of life in the domains of physical functioning ( P = 0.03 ) , role physical ( P = 0.01 ) , general health ( P = 0.049 ) , and social functioning ( P = 0.04 ) . There were no effects of testosterone or exercise on quality of life alone , nor in body composition parameters . CONCLUSIONS Modest testosterone supplementation to elderly men with relative testosterone insufficiency improved quality of life when accompanied by an exercise program . The combination of testosterone and exercise may be an important strategy in the elderly , though further studies are necessary to determine the long-term impact on body composition and function and for analysis of risk/benefit ratios as well",
"Dual-energy X-ray absorptiometry ( DEXA ) provides a measure of lean soft tissue ( LST ) . LST hydration , often assumed to be constant , is relevant to several aspects of DEXA body composition estimates . The aims of this study were to develop a theoretical model of LST total body water ( TBW ) content and to examine hydration effects with empirically derived model coefficients and then to experimentally test the model 's prediction that , in healthy adults , LST hydration is not constant but varies as a function of extra- and intracellular water distribution ( E/I ) . The initial phase involved TBW/LST model development and application with empirically derived model coefficients . Model predictions were then tested in a cross-sectional study of 215 healthy adults . LST was measured by DEXA , extracellular water ( ECW ) by NaBr dilution , intracellular water ( ICW ) by whole body (40)K counting , and TBW by (2)H(2)O dilution . TBW estimates , calculated as ECW + ICW , were highly correlated with ( r = 0.97 , SEE = 2.1 kg , P Model-predicted TBW/LST was almost identical to experimentally derived values ( means + /- SD ) in the total group ( 0.767 vs. 0.764 + /- 0.028 ) . LST hydration was significantly correlated with E/I ( total group , r = 0.30 , SEE = 0.027 , P E/I increased with age ( men , r = 0.48 ; women , r = 0.37 ; both P TBW/LST and age was nonsignificant . Hydration of the DEXA-derived LST compartment is thus not constant but varies predictably with ECW and ICW distribution . This observation has implication s for the accuracy of body fat measurements by DEXA and the use of TBW as a means of checking DEXA system calibration",
"Muscle wasting in older men may be related to and rogen deficiency . We have assessed the effect of testosterone replacement therapy on muscle function in the upper and lower limbs of older ( age > 60 years ) men with blood testosterone levels received testosterone enanthate 200 mg i.m . or placebo every 2 weeks in a double blind study over a 12-week period and underwent muscle testing every 4 weeks . A significant increase in blood levels of testosterone and a reduction in levels of sex hormone binding globulin occurred in the treatment group . Total body mass , haemoglobin and packed cell volume also increased significantly ( p h and grip strength , isometric strength of knee flexors and extensors or leg extensor power were seen in either group . Wide variability in all measures of muscle function were observed in these elderly men suggesting that very large study groups would be required to determine potential treatment benefits on muscle function",
"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",
"CONTEXT Age-specific estimates of mean testosterone ( T ) concentrations appear to vary by year of observation and by birth cohort , and estimates of longitudinal declines in T typically outstrip cross-sectional decreases . These observations motivate a hypothesis of a population -level decrease in T over calendar time , independent of chronological aging . OBJECTIVE The goal of this study was to establish the magnitude of population -level changes in serum T concentrations and the degree to which they are explained by secular changes in relative weight and other factors . DESIGN We describe a prospect i ve cohort study of health and endocrine functioning in r and omly selected men of age 45 - 79 yr . We provide three data collection waves : baseline ( T1 : 1987 - 1999 ) and two follow-ups ( T2 : 1995 - 1997 , T3 : 2002 - 2004 ) . SETTING This was an observational study of r and omly selected men residing in greater Boston , Massachusetts . PARTICIPANTS Data obtained from 1374 , 906 , and 489 men at T1 , T2 , and T3 , respectively , totaling 2769 observations taken on 1532 men . MAIN OUTCOME MEASURES The main outcome measures were serum total T and calculated bioavailable T. RESULTS We observe a substantial age-independent decline in T that does not appear to be attributable to observed changes in explanatory factors , including health and lifestyle characteristics such as smoking and obesity . The estimated population -level declines are greater in magnitude than the cross-sectional declines in T typically associated with age . CONCLUSIONS These results indicate that recent years have seen a substantial , and as yet unrecognized , age-independent population -level decrease in T in American men , potentially attributable to birth cohort differences or to health or environmental effects not captured in observed data",
"BACKGROUND Trials of testosterone therapy in aging men have demonstrated increases in fat-free mass ( FFM ) and skeletal muscle and decreases in fat mass ( FM ) but have not reported the impact of baseline body composition . OBJECTIVE The objective of the study was to determine the effect , in nonobese aging men with symptoms of and rogen deficiency and low-normal serum testosterone levels , of testosterone therapy on total and regional body composition and hormonal and metabolic indices . METHODS Sixty healthy but symptomatic , nonobese men aged 55 yr or older with total testosterone ( TT ) levels less than 15 nm were r and omized to transdermal testosterone patches or placebo for 52 wk . Body composition , by dual-energy x-ray absorptiometry ( FM , FFM , skeletal muscle ) and magnetic resonance imaging ( abdominal sc and visceral adipose tissue , thigh skeletal muscle , and intermuscular fat ) and hormonal and metabolic parameters were measured at wk 0 and 52 . RESULTS Serum TT increased by 30 % ( P = 0.01 ) , and LH decreased by 50 % ( P total body FFM ( P = 0.03 ) and skeletal muscle ( P = 0.008 ) were increased and thigh skeletal muscle loss was prevented ( P = 0.045 ) with testosterone therapy and visceral fat accumulation decreased ( P = 0.001 ) without change in total body or abdominal sc FM ; change in visceral fat was correlated with change in TT levels ( r2 = 0.36 ; P = 0.014 ) . There was a trend to increasing total and low-density lipoprotein cholesterol with placebo . CONCLUSION Testosterone therapy , relative to placebo , selectively lessened visceral fat accumulation without change in total body FM and increased total body FFM and total body and thigh skeletal muscle mass . Further studies are needed to determine the impact of these body compositional changes on markers of metabolic and cardiovascular risk",
"In the present cross-sectional study of 403 independently living elderly men , we tested the hypothesis that the decreases in bone mass , body composition , and muscle strength with age are related to the fall in circulating endogenous testosterone ( T ) and estrogen concentrations . We compared various measures of the level of bioactive and rogen and estrogen to which tissues are exposed . After exclusion of subjects with severe mobility problems and signs of dementia , 403 healthy men ( age , 73 - 94 yr ) were r and omly selected from a population -based sample . Total T ( TT ) , free T ( FT ) , estrone ( E1 ) , estradiol ( E2 ) , and sex hormone-binding globulin ( SHBG ) were determined by RIA . Levels of non-SHBG-bound T ( non-SHBG-T ) , FT ( calc-FT ) , the TT/SHBG ratio , non-SHBG-bound E2 , and free E2 were calculated . Physical characteristics of aging included muscle strength measured using dynamometry , total body bone mineral density ( BMD ) , hip BMD , and body composition , including lean mass and fat mass , measured by dual-energy x-ray absorptiometry . In this population of healthy elderly men , calc-FT , non-SHBG-T , E1 , and E2 ( total , free , and non-SHBG bound ) decreased significantly with age . T ( total and non-SHBG-T ) was positively related with muscle strength and total body BMD ( for non-SHBG-T , respectively , beta = 1.93 + /- 0.52 , P T and fat mass ( beta = -0.53 + /- 0.15 , P muscle strength , BMD , and fat mass than TT and were also significantly related to hip BMD . E1 and E2 were both positively , independently associated with BMD ( for E2 , beta = 0.21 + /- 0.08 , P BMD than total E2 . The positive relation between T and BMD was independent of E2 . E1 and E2 were not related with muscle strength or body composition . In summary , bioavailable T , E1 , total E2 , and bioavailable E2 all decrease with age in healthy old men . In this cross-sectional study in healthy elderly men , non-SHBG-bound T seems to be the best parameter for serum levels of bioactive T , which seems to play a direct role in the various physiological changes that occur during aging . A positive relation with muscle strength and BMD and a negative relation with fat mass was found . In addition , both serum E1 and E2 seem to play a role in the age-related bone loss in elderly men , although the cross-sectional nature of the study precludes a definitive conclusion . Non-SHBG-bound E2 seems to be the best parameter of serum bioactive E2 in describing its positive relation with BMD",
"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",
"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 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 ] . )",
"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"
] | 411695c0-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND The purpose of this review was to investigate the efficacy and safety of yoga interventions in treating patients with major depressive disorder . METHODS MEDLINE , Scopus , and the Cochrane Library were screened through December 2016 . R and omized controlled trials ( RCTs ) comparing yoga to inactive or active comparators in patients with major depressive disorder were eligible . Primary outcomes included remission rates and severity of depression . Anxiety and adverse events were secondary outcomes . Risk of bias was assessed using the Cochrane tool . RESULTS Seven RCTs with 240 participants were included . Risk of bias was unclear for most RCTs . Compared to aerobic exercise , no short- or medium-term group differences in depression severity was found . Higher short-term depression severity was found for yoga compared to electro-convulsive therapy ; remission rates did not differ between groups . No short-term group differences occurred when yoga was compared to antidepressant medication . Conflicting evidence was found when yoga was compared to attention-control interventions , or when yoga as an add-on to antidepressant medication was compared to medication alone . Only two RCTs assessed adverse events and reported that no treatment-related adverse events were reported . LIMITATIONS Few RCTs with low sample size . CONCLUSIONS This review found some evidence for positive effects beyond placebo and comparable effects compared to evidence -based interventions . However , method ological problems and the unclear risk-benefit ratio preclude definitive recommendations for or against yoga as an adjunct treatment for major depressive disorder . Larger and adequately powered RCTs using non-inferiority design s are needed | [
"Sahaj Yoga is a meditative technique that has been found to have beneficial effects in some psycho-somatic illnesses . The study was carried out on 30 cases ( 19 Males , 11 females , age 18 - 45 years ) of major depression diagnosed on the basis of DSM IV criteria . The patients were then r and omly divided into two groups : Group 1 : ( 10 Males & 5 Females ) Patients who were practising Sahaj Yoga and also received conventional anti-depressants . Group 2 : ( 9 Males & 6 Females ) Patients who were only receiving conventional anti-depressants . Training in Sahaj yoga was conducted under the supervision of a trained Sahaj Yogi for 8 weeks . At start of the study , all the patients were subjected to Hamilton Rating Scale for Depression ( HAM-D ) and Hamilton Rating Scale for Anxiety ( HAM-A ) . Above scales were again assessed after two months of treatment . There was significant improvement in HAM-D as well as HAM-A scores in both Group 1 and Group 2 patients ( P improvement in HAM-D scores and HAM-A scores in patients receiving Sahaj Yoga was significantly higher than in Group 2 patients . The number of patients who went into remission after two months of intervention were also significantly higher in Group 1 patients ( P=0.02 ) . The present study demonstrates that Sahaj Yoga has got a potential role as a component in the management of depressive disorders",
"OBJECTIVE To evaluate feasibility , efficacy , and tolerability of Sudarshan Kriya yoga ( SKY ) as an adjunctive intervention in patients with major depressive disorder ( MDD ) with inadequate response to antidepressant treatment . METHODS Patients with MDD ( defined by DSM-IV-TR ) who were depressed despite ≥ 8 weeks of antidepressant treatment were r and omized to SKY or a waitlist control ( delayed yoga ) arm for 8 weeks . The primary efficacy end point was change in 17-item Hamilton Depression Rating Scale ( HDRS-17 ) total score from baseline to 2 months . The key secondary efficacy end points were change in Beck Depression Inventory ( BDI ) and Beck Anxiety Inventory ( BAI ) total scores . Analyses of the intent-to-treat ( ITT ) and completer sample were performed . The study was conducted at the University of Pennsylvania between October 2014 and December 2015 . RESULTS In the ITT sample ( n = 25 ) , the SKY arm ( n = 13 ) showed a greater improvement in HDRS-17 total score compared to waitlist control ( n = 12 ) ( -9.77 vs 0.50 , P = .0032 ) . SKY also showed greater reduction in BDI total score versus waitlist control ( -17.23 vs -1.75 , P = .0101 ) . Mean changes in BAI total score from baseline were significantly greater for SKY than waitlist ( ITT mean difference : -5.19 ; 95 % CI , -0.93 to -9.34 ; P = .0097 ; completer mean difference : -6.23 ; 95 % CI , -1.39 to -11.07 ; P = .0005 ) . No adverse events were reported . CONCLUSIONS Results of this r and omized , waitlist-controlled pilot study suggest the feasibility and promise of an adjunctive SKY-based intervention for patients with MDD who have not responded to antidepressants . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT02616549",
"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 This study examined the effects of brief daily yogic meditation on mental health , cognitive functioning , and immune cell telomerase activity in family dementia caregivers with mild depressive symptoms . METHODS Thirty-nine family dementia caregivers ( mean age 60.3 years old ( SD = 10.2 ) ) were r and omized to practicing Kirtan Kriya or listening to relaxation music for 12 min per day for 8 weeks . The severity of depressive symptoms , mental and cognitive functioning were assessed at baseline and follow-up . Telomerase activity in peripheral blood mononuclear cells ( PMBC ) was examined in peripheral P BMC pre-intervention and post-intervention . RESULTS The meditation group showed significantly lower levels of depressive symptoms and greater improvement in mental health and cognitive functioning compared with the relaxation group . In the meditation group , 65.2 % showed 50 % improvement on the Hamilton Depression Rating scale and 52 % of the participants showed 50 % improvement on the Mental Health Composite Summary score of the Short Form-36 scale compared with 31.2 % and 19 % , respectively , in the relaxation group ( p telomerase activity compared with 3.7 % in the relaxation group ( p = 0.05 ) . CONCLUSION This pilot study found that brief daily meditation practice s by family dementia caregivers can lead to improved mental and cognitive functioning and lower levels of depressive symptoms . This improvement is accompanied by an increase in telomerase activity suggesting improvement in stress-induced cellular aging . These results need to be confirmed in a larger sample",
"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",
"Objectives Chronic low back pain ( CLBP ) affects millions of people worldwide , and appears to be increasing in prevalence . It is associated not only with pain , but also with increased disability , psychological symptoms , and reduced quality of life . There are various treatment options for CLBP , but no single therapy st and s out as being the most effective . In the past 10 years , yoga interventions have been studied as a CLBP treatment approach . The objective of this paper is to review the current literature supporting the efficacy of yoga for CLBP . Methods A literature search through the beginning of 2015 was conducted in Pub Med for r and omized control trials addressing treatment of CLBP with yoga . Results In this review we evaluate the use of yoga as a treatment for CLBP . Specifically we evaluate how yoga impacts physical functioning and disability , pain , and associated psychological symptoms . We also evaluate possible mediators of the effect of yoga and the safety of yoga . Discussion With few exceptions , previous studies and the recent r and omized control trials ( RCTs ) indicate that yoga can reduce pain and disability , can be practice d safely , and is well received by participants . Some studies also indicate that yoga may improve psychological symptoms , but these effects are currently not as well established",
"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",
"This r and omized pilot study investigated the effects of meditation with yoga ( and psychoeducation ) versus group therapy with hypnosis ( and psychoeducation ) versus psychoeducation alone on diagnostic status and symptom levels among 46 individuals with long-term depressive disorders . Results indicate that significantly more meditation group participants experienced a remission than did controls at 9-month follow-up . Eight hypnosis group participants also experienced a remission , but the difference from controls was not statistically significant . Three control participants , but no meditation or hypnosis participants , developed a new depressive episode during the study , though this difference did not reach statistical significance in any case . Although all groups reported some reduction in symptom levels , they did not differ significantly in that outcome . Overall , these results suggest that these two interventions show promise for treating low- to moderate-level depression"
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OBJECTIVE The RTI International-University of North Carolina at Chapel Hill Evidence -based Practice Center ( RTI-UNC EPC ) systematic ally review ed evidence on efficacy of treatment for anorexia nervosa ( AN ) , harms associated with treatments , factors associated with treatment efficacy , and differential outcome by sociodemographic characteristics . METHOD We search ed six major data bases for studies on the treatment of AN from 1980 to September 2005 , in all language s against a priori inclusion /exclusion criteria focusing on eating , psychiatric or psychological , or biomarker outcomes . RESULTS Thirty-two treatment studies involved only medications , only behavioral interventions , and medication plus behavioral interventions for adults or adolescents . The literature on medication treatments and behavioral treatments for adults with AN is sparse and inconclusive . Cognitive behavioral therapy may reduce relapse risk for adults with AN after weight restoration , although its efficacy in the underweight state remains unknown . Variants of family therapy are efficacious in adolescents , but not in adults . CONCLUSION Evidence for AN treatment is weak ; evidence for treatment-related harms and factors associated with efficacy of treatment are weak ; and evidence for differential outcome by sociodemographic factors is nonexistent . Attention to sample size and statistical power , st and ardization of outcome measures , retention of patients in clinical trials , and developmental differences in treatment appropriateness and outcome is required | [
"A controlled trial comparing family therapy with individual supportive therapy in anorexia nervosa and bulimia nervosa was undertaken . Eighty patients ( 57 with anorexia nervosa ; 23 with bulimia nervosa ) were first admitted to a specialized unit to restore their weight to normal . Before discharge , they were r and omly allocated to family therapy or the control treatment ( individual supportive therapy ) . After one year of psychological treatment , they were reassessed , using body weight , menstrual function , and ratings on the Morgan and Russell scales . Family therapy was found to be more effective than individual therapy in patients whose illness was not chronic and had begun before the age of 19 years . A more tentative finding was the greater value of individual supportive therapy in older patients . To our knowledge , this is the first controlled trial of family therapy in anorexia nervosa and clarifies the specific indications for this treatment",
"OBJECTIVE Selective serotonin reuptake inhibitor ( SSRI ) medication does not appear to be effective in ill , malnourished anorexia nervosa ( AN ) patients . However , it may be effective in preventing relapse after weight restoration . The purpose of this study was to determine whether nutritional supplements could potentiate the effects of fluoxetine in underweight AN subjects . METHOD Twenty-six subjects with AN participated in a trial of fluoxetine . In a double-blind , placebo-controlled manner , subjects received either nutritional supplements or a nutritional placebo . The nutritional supplement included tryptophan ( the precursor of serotonin ) , vitamins , minerals , and essential fatty acids believed to influence serotonin pathway function . RESULTS There was no significant difference in weight gain between subjects treated with fluoxetine plus nutritional supplements versus fluoxetine plus a nutritional placebo . Moreover , there were no significant differences between groups on mean changes in anxiety or obsessive and compulsive symptoms . DISCUSSION The results of this study suggest that supplement strategies are not a substitute for adequate nutrition and are ineffective in increasing the efficacy of fluoxetine in underweight AN subjects",
"Fifteen women with bulimia nervosa were treated with a 4-month course of combined cognitive-behavioral , nutritional and antidepressant therapy ( 5 with amineptine and 10 with fluvoxamine ) . Patients were monitored before and after 1 , 2 and 4 months of therapy for body mass index ( BMI ) , for eating disorder symptoms by the Eating Disorder Inventory ( EDI ) and the Bulimic Investigation Test ( BITE ) , and for depression and anxiety by the Hamilton Rating Scale for Depression and for Anxiety ( HRS-D and -A ) . BITE symptoms and gravity improved significantly and equally in the two groups during the 4 months of therapy . Global EDI scores , depression and anxiety decreased but not significantly . BMI was normal before therapy and did not change during treatment",
"BACKGROUND Currently , without systematic evidence , psychotherapy for anorexia nervosa in adults draws on psychodynamic , cognitive and systemic theories . AIMS To assess effectiveness of specific psychotherapies in out-patient management of adult patients with anorexia nervosa . METHOD Eighty-four patients were r and omised to four treatments : three specific psychotherapies - ( a ) a year of focal psychoanalytic psychotherapy ; ( b ) 7 months of cognitive-analytic therapy ( CAT ) ; ( c ) family therapy for 1 year - and ( d ) low contact , ' routine ' treatment for 1 year ( control ) . RESULTS At 1 year , there was symptomatic improvement in the whole group of patients . This improvement was modest , several patients being significantly undernourished at follow-up . Psychoanalytic psychotherapy and family therapy were significantly superior to the control treatment ; CAT tended to show benefits . CONCLUSIONS Psychoanalytic and family therapy are of specific value in the out-patient treatment of adult patients with anorexia",
"OBJECTIVE To determine whether a grade d exercise program used in the treatment of anorexia nervosa improves quality of life and does not decrease the rate of gain of body fat . METHODS A r and omized controlled trial with outcome measures : change in percent body fat , body mass index ( BMI ) , and Medical Outcomes Survey Short Form 36-item Quality of Life question naire . RESULTS Fifteen females and one male meeting the DSM-IV criteria for the diagnosis of anorexia nervosa were r and omized . There was no difference in change in BMI or percent body fat at 3 months . Quality of life outcomes improved from baseline in the experimental group compared with the control group . However , this difference was not statistically significant . DISCUSSION Incorporation of a grade d exercise program may increase compliance with treatment , but it did not reduce the short-term rate of gain of body fat or BMI . Longer studies with more subjects are necessary to determine the usefulness of a grade d exercise program in anorexia nervosa",
"OBJECTIVE Research suggests that family treatment for adolescents with anorexia nervosa may be effective . This study was design ed to determine the optimal length of such family therapy . METHOD Eighty-six adolescents ( 12 - 18 years of age ) diagnosed with anorexia nervosa were allocated at r and om to either a short-term ( 10 sessions over 6 months ) or long-term treatment ( 20 sessions over 12 months ) and evaluated at the end of 1 year using the Eating Disorder Examination ( EDE ) between 1999 and 2002 . RESULTS Although adequately powered to detect differences between treatment groups , an intent-to-treat analysis found no significant differences between the short-term and long-term treatment groups . Although a nonsignificant finding does not prove the None hypothesis , in no instance does the confidence interval on the effect size on the difference between the groups approach a moderate .5 level . However , post hoc analyses suggest that subjects with severe eating-related obsessive-compulsive features or who come from nonintact families respond better to long-term treatment . CONCLUSIONS A short-term course of family therapy appears to be as effective as a long-term course for adolescents with short- duration anorexia nervosa . However , there is a suggestion that those with more severe eating-related obsessive-compulsive thinking and nonintact families benefit from longer treatment",
"There are no controlled studies of the long term impact of treatment on the evolution of anorexia nervosa , although it is clear that life can sometimes be saved in the short term and that a variety of pharma cological and behavioural approaches can have a short term and limited effect on the low body weight control mechanisms of the patient . During the past 20 years , the second author has run an established in patient combined behaviour and psychotherapeutic treatment programme for patients with anorexia nervosa involving restoration of body weight to matched population levels coupled with individual and family psychotherapy ( Crisp , 1967 ) . He believes that this approach does have an impact on the course of the disorder ( Crisp , 1980 ) . However , it is difficult to evaluate it in total in a controlled experimental fashion since , in the event , it is impossible to deny any patient a treatment which almost always has the short term . effect of her gaining weight back to normal adult levels . In recent years , therefore , an alternative strategy has developed in the unit in which specific treatments ( e.g. the impact of tricyclic drugs ( Lacey and Crisp , 1980 ) are experimentally superimposed on the basic treatment programme . This paper reports the impact of a social skills programme exhibited on this basis . Two case reports ( Lang , 1965 and Argyle et a ! , 1974a ) describe the efficacy of behavioural social anxiety treatment for anorexia nervosa . These studies are limited in diag nostic detail . Wolpe ( 1975 ) advocates the value of the comprehensiveness of a behavioural analysis in treating anorexianervosathatwould includean assessment of the symptom of social anxiety within the clinical condition . A controlled study by Argyle et a ! ( 1974b ) indicates the efficiency of social skills treat ment as well as brief psychotherapy in positively influencing social ease in a patient population . How ever , no experimental studies are reported on the impact of a behaviourally orientated treatment for social anxiety on the course of recovery for anorexia nervosa . This treatment was introduced because anorectics are known to be socially isolated and to have low self-esteem ( Crisp , 1970 ; Pillay and Crisp , 1977 ) . Furthermore , previous follow-up studies have revealed that those who have recovered often become socially anxious despite their involvement in psycho therapy directed at this area of difficulty ( Stonehill and Crisp , 1977 ; Crisp , 1980 ) . The hypothesis was that social skills training within the established in-patient treatment programme would lead to a greater degree of recovery from anorexia nervosa at one year follow-up as measured by the percentage matched population mean weight of the patients , and furthermore that these patients would be less socially anxious than those who had not received suchtreatment",
"The tricyclic antidepressant drug amitriptyline was evaluated as a short-term treatment of anorexia nervosa patients . In a 5-week double-blind , placebo-controlled study 11 patients were given amitriptyline and 14 received placebo . In addition , 18 patients who refused to participate in the drug trial and received only psychosocial treatment were used as an additional comparison group . Overall , patients in the three groups showed little improvement . No statistically significant differences favoring amitriptyline were found in any of the outcome variables . Plasma levels varied widely among patients receiving similar doses . No association was found between plasma levels and improvement in either psychiatric symptomatology or weight . Amitriptyline patients did not manifest any tendency for a reduction of depressive symptomatology . In addition , amitriptyline treatment was associated with substantial discomfort and adverse affects",
"INTRODUCTION Anorexia nervosa ( AN ) still lacks a defined treatment . Since fluoxetine proved effective in weight-restored anorexics , this pilot study evaluates the efficacy of another SSRI , citalopram , in restricting-type AN . EXPERIMENTAL PROCEDURES Fifty-two female anorectic out patients were r and omized in the citalopram ( n=26 ) and waiting list ( n=26 ) as a control group . Efficacy was assessed using Eating Disorder Inventory-2 , Eating Disorder Inventory-Symptom Checklist , State-Trait Anger Expression Inventory , Beck Depression Inventory , Symptom Checklist-90 and Structured Clinical Interview for DSM-IV Axis II Disorders . RESULTS Thirteen patients dropped-out , thus 19 patients received citalopram and 20 remained in the control group . After 3 months of treatment , the citalopram group showed a decrease on BDI and SCL-90 Depression subscale and an improvement of baseline obsessive compulsive features on SCL-90 , EDI-2 impulsiveness and Trait-anger on STAXI . Weight gain was similar in the two groups . DISCUSSION These preliminary results support the efficacy of citalopram in anorectics . Citalopram seems to improve depression , obsessive-compulsive symptoms , impulsiveness and Trait-anger",
"Ninety subjects with DSM-III-R anorexia nervosa were r and omly allocated to four treatment options , one inpatient , two outpatient , and one comprising an assessment interview only . Twenty were thus offered a package of outpatient individual and family psychotherapy . At 2-year follow-up , 12 of the 20 were classed as well , or very nearly well , according to operationally defined criteria . Statistically significant improvements over time were obtained for weight , mean body mass index ( BMI ) , and also for psychological , sexual , and socioeconomic adjustments . Weight and BMI changes were significantly better than for the assessment only group , some of whom had received extensive treatment elsewhere . The style of the outpatient therapy and compliance with it are described in some detail and prognostic indicators for the treated and untreated groups presented . Lower weights at presentation and vomiting were associated with poorer outcome , although age and length of history were not",
"This study was undertaken to investigate whether a cognitive-behavioural treatment procedure was superior to a st and ard behavioural treatment , in the outpatient therapy of patients with anorexia nervosa . The two treatments were also compared with a control treatment procedure consisting of routine outpatient management . Each group consisted of eight subjects . All the groups showed some improvement , but the findings did not provide support for the prediction that cognitive-behavioural treatment , design ed specifically to manipulate both attitudes and behaviour , was superior to the other types of treatment . The implication s of the findings are considered",
"OBJECTIVE In anorexia nervosa ( AN ) , medical stabilization and nutritional repletion are pivotal steps toward physical and psychological recovery . Nutritional stabilization is often difficult in this patient group . Recombinant human growth hormone ( rhGH ) has been safely used as adjuvant therapy in other groups of malnourished patients . We hypothesize that rhGH treatment will hasten medical stabilization in AN patients . STUDY DESIGN Fifteen patients admitted for inpatient treatment for AN , ages 12 - 18 years , were enrolled in a 28-day r and omized , double-blind , placebo-controlled study . Patients received rhGH ( 0.05 mg/kg subcutaneously ) or an equivalent volume of placebo daily . Outcome measures included time to reach medical/cardiovascular stability , rate of weight gain , and duration of hospitalization . All patients received a st and ard refeeding protocol . RESULTS Mean admission body mass index was 14.5 kg/m2 . The rhGH and placebo groups did not differ significantly in admission weight , BMI or daily caloric intake . Patients treated with rhGH reached medical/cardiovascular stability more rapidly than those treated with placebo ( median 17 vs. 37 days , p = 0.02 ) . Numerical but not statistically significant improvements were seen in weight gain and length of hospitalization in the rhGH group . CONCLUSION Patients treated with rhGH achieved medical/cardiovascular stability more rapidly than those treated with placebo , and this , in turn , decreased the length of stay",
"OBJECTIVE Few r and omized , controlled trials have examined the efficacy of treatments for anorexia nervosa . Cognitive behavior therapy and interpersonal psychotherapy are effective in a related disorder , bulimia nervosa . There are theoretical and treatment indications for these therapies in anorexia nervosa . METHOD Fifty-six women with anorexia nervosa diagnosed by using strict and lenient weight criteria were r and omly assigned to three treatments . Two were specialized psychotherapies ( cognitive behavior therapy and interpersonal psychotherapy ) , and one was a control treatment combining clinical management and supportive psychotherapy ( nonspecific supportive clinical management ) . Therapy consisted of 20 sessions over a minimum of 20 weeks . RESULTS For the total study group ( intent-to-treat group ) , there were significant differences among therapies in the primary global outcome measure . Nonspecific supportive clinical management was superior to interpersonal psychotherapy , while cognitive behavior therapy was intermediate , neither worse than nonspecific supportive clinical management nor better than interpersonal psychotherapy . For the women completing therapy , nonspecific supportive clinical management was superior to the two specialized therapies . CONCLUSIONS The finding that nonspecific supportive clinical management was superior to more specialized psychotherapies was opposite to the primary hypothesis and challenges assumptions about the effective ingredients of successful treatments for anorexia nervosa",
"To study the effects of prolonged anorexia nervosa on bone density ( BD ) and to determine whether estrogen administration prevents bone loss in women with this disorder , 48 amenorrheic women with anorexia nervosa ( mean age , 23.7 yr ) were r and omized to receive estrogen and progestin replacement ( n = 22 ) or no replacement ( n = 26 ) . Clinical variables , biochemical indices , and spinal trabecular BD were measured every 6 months for a mean of 1.5 yr . Initial mean BD ( 130 + /- 27 mg K2HPO4/cm3 , + /- 1 SD ) was significantly ( P 48 women . Forty-four women completed the study ( 19 in the estrogen group and 25 in the control group ) . The mean duration of follow-up was comparable in the estrogen-treated ( 1.57 + /- 0.89 yr ) vs. the control group ( 1.41 + /- 0.69 yr ) . The estrogen-treated group had no significant change in BD compared with the control group ; however , there was a 4.0 % increase in mean BD in patients with an initial ideal body weight of less than 70 % who were treated with estrogen . In contrast , control patients with comparably low initial weight had a 20.1 % decrease in BD . Women in the control group with spontaneous resumption of menses , all of whom had an initial percent ideal body weight of greater than 70 % , had a 19.3 % increase in bone mass . It is concluded that : 1 ) estrogen replacement can not prevent progressive osteopenia in young women with anorexia nervosa ; 2 ) a subset of patients may have improved BD with estrogen and progestin administration depending on initial body weight ; and 3 ) recovery from anorexia nervosa is associated with significantly improved BD",
"CONTEXT There have been very few r and omized controlled treatment studies of anorexia nervosa . OBJECTIVE To evaluate factors leading to nonacceptance and noncompletion of treatment for 2 specific therapies and their combination in the treatment of anorexia nervosa . DESIGN R and omized prospect i ve study . SETTING Weill-Cornell Medical Center , White Plains , NY ; University of Minnesota , Minneapolis ; and Stanford University , Stanford , Calif. Patients One hundred twenty-two patients meeting DSM-IV criteria for anorexia nervosa . INTERVENTIONS Treatment with cognitive-behavioral therapy , fluoxetine hydrochloride , or their combination for 1 year . MAIN OUTCOME MEASURES Dropout rate and acceptance of treatment ( defined as staying in treatment at least 5 weeks ) . RESULTS Of the 122 r and omized cases , 21 ( 17 % ) were withdrawn ; the overall dropout rate was 46 % ( 56/122 ) in the remaining patients . Treatment acceptance occurred in 89 ( 73 % ) of the 122 r and omized cases . Of the 41 assigned to medication alone , acceptance occurred in 23 ( 56 % ) . In the other 2 groups , acceptance rate was differentiated by high and low obsessive preoccupation scores ( rates of 91 % and 60 % , respectively ) . The only predictor of treatment completion was high self-esteem , which was associated with a 51 % rate of treatment acceptance . CONCLUSION Acceptance of treatment and relatively high dropout rates pose a major problem for research in the treatment of anorexia nervosa . Differing characteristics predict dropout rates and acceptance , which need to be carefully studied before comparative treatment trials are conducted",
"1 . The study evaluated the efficacy of amisulpride , fluoxetine and clomipramine at the beginning of the re-feeding phase of the treatment of restricting anorexia nervosa according to DSM-IV criteria . 2 . 13 patients , mean weight 37.61 kg + /- 9.80 SD , were treated with clomipramine at a mean dosage of 57.69 mg + /- 25.79 SD ; 10 patients , mean weight 40.90 kg + /- 6.98 SD , were treated with fluoxetine at a mean dosage of 28.00 mg + /- 10.32 SD ; 12 patients , mean weight 38.41 kg + /- 8.33 SD , were treated with amisulpride at a mean dosage of 50.00 mg + /- 0.00 SD . 3 . Clinical evaluation was carried out under single-blind condition at basal time and after three months by a structured clinical interview , the Eating Disorder Interview based on Long Interval Follow-up Evaluation ( LIFE II BEI ) . 4 . Patients treated with amisulpride showed a more significant increase ( p=0.016 ) of mean weight . Concerning weight phobia , body image disturbance and amenorrhoea , no significant difference result ed",
"To determine the efficacy of cisapride , 10 mg three times daily , in improving gastric emptying , reducing distress during meals , and facilitating weight gain in anorexia nervosa , we conducted an 8-week , r and omized , double-blind , placebo-controlled trial on 29 in patients . Measures included scintigraphic gastric emptying studies at 0 , 2 , 4 , and 8 weeks ; subjective distress during meals measured by visual analogue scales ; self-rating of degree of global improvement in symptoms associated with eating at end of study ; and weight measured weekly . Gastric emptying improved significantly but equally in both groups over the study period . Yet subjective measures were better in the cisapride group ; they rated themselves as more hungry ( p = .02 ) and more improved on the global measure of change in symptoms ( p = .02 ) . Even so , the cisapride group did not gain more weight . The correlation between gastric emptying and weight gain was modest ( r = .30 ; p = .11 ) , and between gastric emptying and the subjective measures , virtually absent",
"OBJECTIVE This study provides what the authors believe is the first empirical evaluation of cognitive behavior therapy as a posthospitalization treatment for anorexia nervosa in adults . METHOD After hospitalization , 33 patients with DSM-IV anorexia nervosa were r and omly assigned to 1 year of outpatient cognitive behavior therapy or nutritional counseling . RESULTS The group receiving nutritional counseling relapsed significantly earlier and at a higher rate than the group receiving cognitive behavior therapy ( 53 % versus 22 % ) . The overall treatment failure rate ( relapse and dropping out combined ) was significantly lower for cognitive behavior therapy ( 22 % ) than for nutritional counseling ( 73 % ) . The criteria for \" good outcome \" were met by significantly more of the patients receiving cognitive behavior therapy ( 44 % ) than nutritional counseling ( 7 % ) . CONCLUSIONS Cognitive behavior therapy was significantly more effective than nutritional counseling in improving outcome and preventing relapse . To the authors ' knowledge , these data provide the first empirical documentation of the efficacy of any psychotherapy , and cognitive behavior therapy in particular , in posthospitalization care and relapse prevention of adult anorexia nervosa",
"Ninety patients with severe anorexia nervosa fulfilling DSM-III-R criteria were assessed in depth in terms of their family developmental psychopathology and then r and omly allocated to either one of three treatment groups or to no treatment . In three treatment regimes , a behavioural approach to diet and weight gain was coupled with individual and family psychotherapy directed at the adolescent maturational problems . All three treatment regimes were highly significantly effective at one year in terms of weight gain , return of menstruation , and aspects of social and sexual adjustment . Body weights above those at pubertal onset were achieved for the group mean maximum and one-year follow-up weights for all three treatment groups but not the control group",
"OBJECTIVE While pharmacological interventions are of established utility in bulimia nervosa , medications have no clear role in the treatment of anorexia nervosa . Because patients with anorexia nervosa frequently exhibit mood disturbances and symptoms of obsessive-compulsive disorder , the authors tested the utility of fluoxetine in the treatment of women participating in an inpatient program for anorexia nervosa . METHOD The authors conducted a r and omized , placebo-controlled , double-blind , 7-week study of fluoxetine at a target daily dose of 60 mg in 31 women with anorexia nervosa receiving treatment for their eating disorder on a clinical research unit . Body weight and measures of eating behavior and psychological state were obtained at baseline and at termination . RESULTS There were no significant differences in clinical outcome on any measure between patients receiving fluoxetine and patients receiving placebo . CONCLUSIONS Fluoxetine does not appear to add significant benefit to the inpatient treatment of anorexia nervosa",
"The efficacy of venlafaxine and fluoxetine in the treatment of atypical anorexia nervosa ( AN ) was compared in a controlled trial . A consecutive series of 24 atypical anorectic females was assigned to either venlafaxine ( 75 mg/day ) or fluoxetine ( 40 mg/day ) plus cognitive-behavioural therapy ( CBT ) . Eating Disorder Examination ( EDE12.0D ) , Beck Depression Inventory ( BDI ) and State and Trait Anxiety Inventory ( STAI ) scores were compared before and after 6 months of treatment . Venlafaxine and fluoxetine determined an increase of body mass index ( BMI ) and a significant reduction of EDE12.0D and BDI scores venlafaxine alone reduced STAI scores . It would seem that venlafaxine is as effective as fluoxetine when combined with CBT in the treatment of atypical AN",
"BACKGROUND Anorexia nervosa is an often chronic disorder with high morbidity and mortality . Many people relapse after weight restoration . This study was design ed to determine whether a selective serotonin reuptake inhibitor would improve outcome and reduce relapse after weight restoration by contributing to maintenance of a healthy normal weight and a reduction of symptoms . METHODS We administered a double-blind placebo-controlled trial of fluoxetine to 35 patients with restricting-type anorexia nervosa . Anorexics were r and omly assigned to fluoxetine ( n = 16 ) or a placebo ( n = 19 ) after inpatient weight gain and then were observed as out patients for 1 year . RESULTS Ten of 16 ( 63 % ) subjects remained on fluoxetine for a year , whereas only three of 19 ( 16 % ) remained on the placebo for a year ( p = .006 ) . Those subjects remaining on fluoxetine for a year had reduced relapse as determined by a significant increase in weight and reduction in symptoms . CONCLUSIONS This study offers preliminary evidence that fluoxetine may be useful in improving outcome and preventing relapse of patients with anorexia nervosa after weight restoration",
"Objective : To compare the effects of 4 months of 2 family-oriented treatments , family therapy and family psychoeducation , on female adolescents with newly diagnosed restrictive eating disorders . Method : Twenty-five female adolescents requiring hospitalization were r and omized into either family therapy or family group psychoeducation . Outcome measures included medical ( body weight ) and psychosocial ( specific and nonspecific eating disorder psychopathology ) variables at baseline and after 4 months of treatments every 2 weeks . Results : A significant time effect was found in both treatment groups for the restoration of body weight ( percentage of ideal body weight , P ideal body weight before treatment to 91 % to 96 % after it . A time effect was also seen on the Family Assessment Measure ( P family psychopathology at the end of treatment . No significant group differences were found on any of the self-report measures of specific and nonspecific eating disorder pathology . Conclusions : Weight restoration was achieved following the 4-month period of treatment in both the family therapy and family psychoeducation groups , but no significant change was reported in psychological functioning by either adolescents or parents . Family group psychoeducation , the less expensive form of treatment , is an equally effective method of providing family-oriented treatment to newly diagnosed , medically compromised anorexia nervosa patients and their families",
"This study evaluated the impact on family relations of behavioral family systems therapy ( BFST ) versus ego-oriented individual therapy ( EOIT ) as treatments for adolescents with anorexia nervosa . Twenty-two adolescents meeting DSM-III-R anorexia nervosa criteria were r and omly assigned to receive approximately 16 months of either BFST or EOIT along with a common medical and dietary regimen . BFST emphasized parental control over eating , cognitive restructuring , and problem-solving communication training . EOIT emphasized building ego strength , adolescent autonomy , and insight . Measures including body mass index , self-reported general and eating-related conflict , and observed general and eating-related communication . Both treatments produced significant reductions in negative communication and parent-adolescent conflict , with some differences between condition and between eating and non-eating related measures ; the improvements in eating-related conflict were maintained at a 1-year follow-up . The study demonstrated that structured therapies for adolescent anorexia do impact family relations , even when the family is never seen as a unit during the therapy",
"Thirty out- patients with severe anorexia nervosa were r and omly allocated to either 12 sessions of dietary advice or 12 sessions of combined individual and family psychotherapy . At one-year follow-up both groups showed significant overall improvement , and the dietary advice group showed significant weight gain . A similar mean weight gain for the psychotherapy patients did not reach statistical significance , but this group made significant improvements in sexual and social adjustment",
"BACKGROUND There is evidence that specific psychological treatments are effective in patients with eating disorders . Our goal was to determine by means of a controlled trial whether psychological treatments , previously found to be effective in anorexia nervosa , gave rise to enduring benefits . METHODS A 5-year follow-up was conducted on patients who had participated in a previous trial of family therapy for anorexia and bulimia nervosa . Family therapy or individual supportive therapy had been administered to 80 out patients for 1 year beginning on discharge from hospital after weight restoration . The 80 patients had been subdivided into 4 prognostically homogeneous groups of which 2 turned out to be the most important : patients with early onset and short history of anorexia nervosa , and patients with late-onset anorexia nervosa . At the 5-year follow-up , the efficacy of the outpatient therapies was again assessed by the maintenance of weight , and the categories of general outcome and dimensions of clinical functioning defined by the Morgan-Russell scales . RESULTS Significant improvements were found in the group of 80 patients as a whole , mainly attributable to the natural outcome of anorexia nervosa , and most evident in the early onset and short history group , as expected . Within 2 of the prognostic groups , significant benefits attributable to previous psychological treatments were still evident , favoring family therapy for patients with early onset and short history of anorexia nervosa and favoring individual supportive therapy for patients with late-onset anorexia nervosa . CONCLUSIONS Much of the improvements found at a 5-year follow-up can be attributed to the natural outcome of the illness . Nevertheless , it was still possible to detect long-term benefits of psychological therapies completed 5 years previously",
"Patients with anorexia nervosa have concurrent problems of emaciation and depression . Therefore , treatment with medications affecting both weight gain and depression seemed reasonable . Seventy-two anorectic patients were r and omly assigned in a double-blind study to receive cyproheptadine hydrochloride , a weight-inducing drug , amitriptyline hydrochloride , a tricyclic antidepressant , or placebo . Overall , cyproheptadine had a marginal effect on decreasing the number of days necessary to achieve a normal weight . There was a differential drug effect present in the bulimic subgroups of the anorectic patients : cyproheptadine significantly increased treatment efficiency for the nonbulimic patients and significantly impaired treatment efficiency for the bulimic patients when compared with the amitriptyline- and placebo-treated groups . The differential cyproheptadine effect on the anorectic bulimic subgroups is the first pharmacologic evidence of the validity of these subgroups . Cyproheptadine had an anti-depressant effect demonstrated by a significant decrease in the Hamilton depression ratings",
"OBJECTIVE To compare the effectiveness of behavioral family systems therapy ( BFST ) with that of ego-oriented individual therapy ( EOIT ) as treatments for adolescents with anorexia nervosa . METHOD Thirty-seven adolescents meeting DSM-III-R criteria for anorexia nervosa were r and omly assigned to receive BFST or EOIT , in addition to a common medical and dietary regimen . In BFST , the family was seen conjointly , the parents were placed in control of the adolescent 's eating , distorted beliefs were targeted through cognitive restructuring , and strategic/behavioral interventions were used to change family interactions . In EOIT , the adolescent was seen individually , with an emphasis on building ego strength and uncovering the dynamics blocking eating ; parents were seen collaterally . Measures administered before , after , and at 1-year follow-up tapped body mass index , menstruation , eating attitudes , ego functioning , depression , and family interactions . RESULTS BFST produced greater weight gain and higher rates of resumption of menstruation than EOIT . Both treatments produced comparably large improvements in eating attitudes , depression , and eating-related family conflict , but very few changes occurred on ego functioning . CONCLUSIONS BFST and EOIT proved to be effective treatments for adolescents with anorexia nervosa , but BFST produced a faster return to health",
"There is a remarkable lack of controlled investigations about the usefulness of psychotropic drugs in anorexia nervosa despite the popular use of neuroleptics in these patients . Inspired by a previous study using pimozide , a double-blind placebo-controlled cross-over study with sulpiride was carried out in 18 female anorexia nervosa in patients . No direct effect of sulpiride has been established with regard to behavioural and attitudinal characteristics as measured by behaviour observation scales as well as by two self-report question naires ( Eating Attitudes Test , Body Attitudes Test ) . Regarding daily weight gain , sulpiride was on the whole superior to placebo , especially in the first treatment period of three weeks . In the cross-over analysis , however , this effect did not reach statistical significance",
"The aim of this study was to compare two forms of outpatient treatment , educational behavioural treatment and cognitive analytical therapy for adult anorexia nervosa . Thirty patients were r and omly allocated to the two treatments . At one year , the group had gained 6.8 kg , 19/30 ( 63 % ) had a good or intermediate recovery in terms of nutritional outcome . The group given cognitive analytical treatment reported significantly greater subjective improvement but there were no differences in other outcome parameters . In conclusion outpatient treatment of adult onset anorexia nervosa leads to an improvement in two thirds of cases . Larger studies will be needed to determine the most effective form of treatment in this group",
"Zinc supplementation of anorexia nervosa ( AN ) patients has been reported to increase the weight gain of AN patients in open trials . In this r and omized , double-blind , placebo-controlled trial 100 mg of zinc gluconate , or placebo , was given daily to 35 female AN in patients until they achieved a 10 % increase in body mass index ( BMI ) . The rate of increase in BMI of the zinc supplemented group ( n = 16 ) was twice that of the placebo group ( n = 19 ) , and this difference was statistically significant ( p = .03 ) . The use of zinc supplementation should be considered in the treatment of AN patients",
"Behavioral family systems therapy ( BFST ) was compared with ego-oriented individual therapy ( EOIT ) in a controlled , r and om-assignment investigation involving 22 young adolescents with anorexia nervosa . Each adolescent and her parents received approximately 16 months of outpatient therapy along with a common medical and dietary regimen . BFST emphasized parental control over eating and weight gain , coupled with cognitive restructuring and problem-solving communication training . EOIT emphasized building ego strength , adolescent autonomy , and insight into the emotional blocks to eating . BFST produced greater change on body-mass index than did EOIT , but both treatments produced comparable improvements on eating attitudes , body shape dissatisfaction , interoceptive awareness , depression/internalizing psychopathology , and eating-related family conflict . The implication s of these results for the clinician who treats adolescents with anorexia nervosa are discussed . J Dev Behav Pediatr 15:111–116 , 1994 . Index terms : anorexia nervosa , adolescents , family therapy , individual therapy",
"OBJECTIVE To determine if warming therapy increases the rate of weight gain in patients with anorexia nervosa ( AN ) who are hospitalized for refeeding . METHOD Patients admitted to an eating disorders unit of a university teaching hospital were r and omized to treatment and control arms . All patients wore a heating vest for 3 hr a day for 21 days . In the experimental arm , the vest was set to medium heat and in the control arm it was set in the off position . RESULTS Twenty-one females were recruited . They had an average age of 28.4 + /- 6.6 years , a body mass index ( BMI ) of 17.7 + /- 2.8 , and the duration of AN lasted 13.6 + /- 6.7 years . Ten subjects were r and omized to the treatment arm and 11 to the control arm . Of the 18 completers , there was no difference in the change in BMI . DISCUSSION Our study did not demonstrate an increase in the rate of weight gain with warming"
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INTRODUCTION Circulating lipoprotein ( a ) ( Lp(a ) ) is a recognized risk factor for cardiovascular disease ( CVD ) . Tibolone , a synthetic steroid , may lower Lp(a ) levels ; however , evidence of the effects of tibolone on Lp(a ) still remain to be defined . Therefore , we investigated the effects of tibolone treatment on circulating Lp(a ) levels in postmenopausal women . METHODS The search included PUBMED , Web of Science , Scopus , and Google Scholar ( up to January 31st , 2015 ) to identify controlled clinical studies investigating the effects of oral tibolone treatment on Lp(a ) levels in postmenopausal women . R and om-effects meta-regression was performed using unrestricted maximum likelihood method for the association between calculated weighted mean difference ( WMD ) and potential moderators . RESULTS Meta- analysis of data from 12 trials ( 16 treatment arms ) suggested a significant reduction of Lp(a ) levels following tibolone treatment ( WMD : -25.28 % , 95 % confidence interval [ CI ] : -36.50 , -14.06 ; p tibolone dose , there were consistent significant reductions of Lp(a ) in the subsets of studies with doses oral tibolone treatment significantly lowers circulating Lp(a ) levels in postmenopausal women . Further studies are warranted to explore the mechanism of this effect and the potential value and place of tibolone or its analogues in the treatment of elevated Lp(a ) in individuals at risk of CVD | [
"Objective To assess the effects of tibolone on climacteric symptoms , endometrium and serum lipid/lipoproteins in postmenopausal women receiving tamoxifen after surgery for breast cancer",
"OBJECTIVE To assess the effect of tibolone on markers of vascular risk in postmenopausal women who were receiving hemodialysis . DESIGN One-year open-label study . SETTING \" Zvezdara \" University Medical Center , Bel grade , Serbia . PATIENT(S ) Twenty-eight postmenopausal women undergoing chronic hemodialysis . INTERVENTION(S ) Fifteen women received tibolone 2.5 mg three times per week ; 13 other women served as controls . MAIN OUTCOME MEASURE(S ) Mean arterial pressure and weight were measured at baseline and at 6 and 12 months , and blood was collected for insulin , total cholesterol , low-density lipoprotein , high-density lipoprotein , triglycerides , lipoprotein(a ) , high-sensitivity C-reactive protein ( hs-CRP ) , endothelin-1 ( ET-1 ) , vascular endothelial growth factor ( VEGF ) , and markers of renal function . RESULT ( S ) Mean arterial pressure fell in the tibolone but not in the control group at 6 and 12 months versus baseline ( mean [ SD ] : 93 [ 15 ] vs. 105 [ 11 ] mmHg and 94 [ 10 ] vs. 105 [ 11 ] mmHg , respectively ) . Weight , insulin , lipids , lipoprotein(a ) , hs-CRP , ET-1 , VEGF , and renal function remained unchanged within each group , but high-density lipoprotein concentrations fell in the tibolone group after 12 months ( 1.2 [ 0.3 ] vs. 1.6 [ 0.6 ] mmol/L ) . CONCLUSION ( S ) The effects of tibolone on markers of vascular risk in postmenopausal women who are receiving hemodialysis and healthy women appear to differ . This should be taken into account when tailoring menopausal therapies to the specific requirements of each individual",
"Background : Lipoprotein(a ) ( Lp(a ) ) has been regarded in some studies as an independent risk factor of atherosclerotic vascular disease . However , the use of a baseline plasma Lp(a ) concentration as a screening tool for future acute vascular events ( AVE ) is controversial . We therefore investigated whether progressively increasing change in plasma Lp(a ) concentration is associated with the development of AVE . Methods : We investigated prospect i ve analyses of 985 participants ( 464 women and 521 men ) who had either clinical ly evident vascular disease ( VD group , n=443 ) or its risk factor(s ) ( RF group , n=542 ) . Blood sample s were taken from all participants every six months to measure inflammatory markers such as Lp(a ) and C-reactive protein during a 10-year follow-up period . Results : During the follow-up , 223 new cases of myocardial infa rct ion , stroke , and peripheral arterial disease were identified . In the RF group , the relative risk of positive ∆ Lp(a ) for predicting AVE was 4.36 ( 95 % confidence interval [ CI ] 1.76 - 10.85 ; P=0.002 ) . In the VD group , the relative risk of positive ∆ Lp(a ) for predicting AVE was 6.35 ( 95 % CI 3.68 - 10.97 ; P change in Lp(a ) concentration has a highly significant predictive value in AVE in both the VD and the RF groups",
"The effects of hormone replacement therapy in hypertensive women are controversial . This r and omised placebo controlled trial assessed the effect of tibolone 2.5 mg on blood pressure and fasting plasma lipids in 29 hypertensive postmenopausal women over 6 months using a 2:1 r and omisation to tibolone . The primary clinical end-point was mean office blood pressure . At 6 months systolic blood pressure declined by 5.30 ± 2.87 % vs4.94 ± 3.37 % whilst diastolic blood pressure declined 5.38 ± 2.65 % vs 0.85 ± 3.69 % on tibolone and placebo respectively . These differences were not statistically significant . Triglycerides decreased by 33.3 ± 6.1 % vs 7.6 ± 7.9 % ( P ) and high-density lipoprotein (hdl)-cholesterol by 21.7 ± 3.8 % vs2.4 ± 2.6 % ( P with tibolone as opposed to placebo . no significant differences were observed in total cholesterol , low-density lipoprotein (ldl)-cholesterol and lipoprotein ( a ) . fibrinogen levels were reduced by 13.6 ± 6.8 % on tibolone compared to a 19.3 ± 15.4 % rise ( P on placebo . this study suggests that tibolone has no deleterious effect on blood pressure in women with hypertension but has contrasting effects on biochemical risk factors . large-scale studies are required to determine the overall effect of tibolone on cardiovascular morbidity and mortality",
"Tibolone , a synthetic steroid with estrogenic , and rogenic , and progestogenic properties relieves climacteric symptoms and prevents postmenopausal bone loss . The influence of tibolone treatment on coagulation , fibrinolysis , and lipid metabolism was investigated in 91 healthy late postmenopausal women . They were r and omly assigned in a double-blind , placebo-controlled 2-year study to receive either tibolone 1.25 mg ( n = 36 , 29 completed ) or 2.5 mg ( n = 35 , 28 completed ) or placebo ( n = 20 , 13 completed ) . The biochemical markers of lipid metabolism , fibrinolysis , and coagulation were measured every 3 months . In both tibolone groups a similar ( approximately 30 % ) decrease in high density lipoprotein cholesterol and a corresponding lowering of apolipoprotein A-1 ( P serum total cholesterol and triglycerides were reduced ( approximately 15 % ; P low density lipoprotein cholesterol , apolipoprotein B , and lipoprotein(a ) were unaffected by tibolone . The two dose levels of tibolone result ed in a similar , marked lowering ( approximately 30 % ) of tissue plasminogen activator and plasminogen activator inhibitor activity as compared with placebo ( P Plasminogen increased ( approximately 15 % ; P Fibrinogen was lowered ( P antithrombin III remained unchanged . The overall effect on hemostatic factors of the present doses of tibolone in healthy , late postmenopausal women tends towards increased fibrinolysis and unchanged coagulation . This may be beneficial and might theoretically counterbalance the potentially negative effect of the decrease in high density lipoprotein cholesterol",
"Background Lipoprotein(a ) [ Lp(a ) ] is a low density lipoprotein-like particle whose apolipoprotein B ( apo B ) moiety is disulfide-linked to apo(a ) , a plasminogen-like inhibitor of fibrinolysis in vitro . We hypothesized that plasma concentrations of Lp(a ) are acutely affected by intravenous tissue-type plasminogen activator ( t-PA ) . Methods and Results Patients with unstable angina were r and omized to receive either intravenous t-PA ( n = 15 ) or placebo ( n = 11 ) . Two-way ANOVA using repeated measures revealed a significant effect of t-PA on concentrations of Lp(a ) ( p=0.026 ) . There was a 48 % fall in Lp(a ) from baseline concentrations in the t-PA group at 12 hours ( p=0.031 ) but not at 72 hours . Lp(a ) in the placebo group was unchanged . Conclusions We conclude that t-PA produces a sharp and substantial but reversible reduction in plasma Lp(a ) . These data suggest that Lp(a ) concentration is not as static in vivo as had been believed and might be acutely modifiable through some mechanism that induces its removal from the freely circulating state",
"Aims The aims of the study were , first , to critically evaluate lipoprotein(a ) [ Lp(a ) ] as a cardiovascular risk factor and , second , to advise on screening for elevated plasma Lp(a ) , on desirable levels , and on therapeutic strategies . Methods and results The robust and specific association between elevated Lp(a ) levels and increased cardiovascular disease (CVD)/coronary heart disease ( CHD ) risk , together with recent genetic findings , indicates that elevated Lp(a ) , like elevated LDL-cholesterol , is causally related to premature CVD/CHD . The association is continuous without a threshold or dependence on LDL- or non-HDL-cholesterol levels . Mechanistically , elevated Lp(a ) levels may either induce a prothrombotic/anti-fibrinolytic effect as apolipoprotein(a ) resembles both plasminogen and plasmin but has no fibrinolytic activity , or may accelerate atherosclerosis because , like LDL , the Lp(a ) particle is cholesterol-rich , or both . We advise that Lp(a ) be measured once , using an isoform-insensitive assay , in subjects at intermediate or high CVD/CHD risk with premature CVD , familial hypercholesterolaemia , a family history of premature CVD and /or elevated Lp(a ) , recurrent CVD despite statin treatment , ≥3 % 10-year risk of fatal CVD according to European guidelines , and /or ≥10 % 10-year risk of fatal + non-fatal CHD according to US guidelines . As a secondary priority after LDL-cholesterol reduction , we recommend a desirable level for Lp(a ) be niacin 1–3 g/day , as a meta- analysis of r and omized , controlled intervention trials demonstrates reduced CVD by niacin treatment . In extreme cases , LDL-apheresis is efficacious in removing Lp(a ) . Conclusion We recommend screening for elevated Lp(a ) in those at intermediate or high CVD/CHD risk , a desirable level use of niacin for Lp(a ) and CVD/CHD risk reduction",
"Recent published studies have provided increasing evidence that lipoprotein(a ) [ Lp(a ) ] may be a potential causal , genetic , independent risk factor for cardiovascular disease ( CVD ) . Lp(a ) levels > 25 mg/dl are present in ∼30 % of Caucasians and 60 % to 70 % of Blacks . Lp(a ) is composed of apolipoprotein B-100 and apolipoprotein ( a ) [ ( apo(a ) ] . Circulating Lp(a ) levels are primarily influenced by the LPA gene without significant dietary or environmental effects , mediating CVD risk throughout the patient 's lifetime . Recent clinical outcomes studies , meta-analyses , and Mendelian r and omization studies , in which r and omization of Lp(a ) levels is achieved through the r and om assortment of LPA gene variants thereby removing confounders , have shown that genetically determined Lp(a ) levels are continuously and linearly related to risk of CVD . Currently , Lp(a ) pathophysiology is not fully understood , and specifically targeted therapies to lower Lp(a ) are not available . We provide a rationale for increased basic and clinical investigational efforts to further underst and Lp(a ) pathophysiology and assess whether reducing Lp(a ) levels minimizes CVD risk . First , a detailed underst and ing of Lp(a ) synthesis and clearance has not been realized . Second , several mechanisms of atherogenicity are known to varying extent , but the relative contributions of each are not known . Lp(a ) may be atherothrombotic through its low-density lipoprotein moiety , but also through apo(a ) , including its ability to be retained in the vessel wall and mediate pro-inflammatory and proapoptotic effects including those potentiated by its content of oxidized phospholipids , and antifibrinolytic effects . Finally , development of specific Lp(a)-lowering agents to potently lower Lp(a ) will allow testing of mechanistic hypotheses in animal models and the design of r and omized clinical trials to assess reduction in CVD . A convergence of academic , scientific , pharmaceutical , and National Institutes of Health priorities and efforts can make this a reality in the next decade",
"OBJECTIVE To examine the effects of unopposed estrogen ( E ) and tibolone therapy on coagulation and natural anticoagulant systems in surgical menopause . DESIGN A r and omized , double-blind , placebo-controlled study . SETTING University hospital clinic in Turkey . PATIENT(S ) Ninety healthy surgically postmenopausal women . INTERVENTION(S ) Ninety surgically postmenopausal women were r and omized into three groups : unopposed conjugated ET ( 0.625 mg/d , group 1 ) , tibolone ( 2.5 mg/d , group 2 ) , and identical tablets of placebo ( group 3 ) . MAIN OUTCOME MEASURE(S ) Effects on parameters in the clotting cascade at baseline and after 24 weeks of treatment . RESULT ( S ) After 6 months , fibrinogen , lipoprotein ( a ) , and factor VIIa were decreased , and activated partial thromboplastin time was increased significantly in the ET group compared with in the placebo group . However , tibolone significantly decreased only the serum levels of factor VIIa and factor IX and prolonged the activated partial thromboplastin time , compared with placebo group . In addition , conjugated ET caused a significantly greater decrease in serum fibrinogen level than did tibolone . CONCLUSION ( S ) Neither E nor tibolone therapy led to activation of coagulation in the surgically menopausal women . Both preparations changed the overall hemostatic balance to a more fibrinolytic state",
"Objective To assess changes in lipid-lipoprotein profile in postmenopausal women taking tibolone and estrogenprogestin , compared with untreated controls . Methods Sixty-three women were r and omized to take a combined estrogen-progestin preparation ( n = 31 ) or tibolone ( n = 32 ) , and 50 other women acted as controls . Fasting lipid-lipoprotein levels were measured over 96 weeks . Results The controls , who were older and postmenopausal longer than the therapy subjects , exhibited significant decreases in total ( P low-density lipoprotein ( LDL ) ( P cholesterol and increases in triglyceride ( P lipoprotein ( a ) ( P Lipoprotein ( a ) also decreased significantly in both treated groups ( P Total and LDL cholesterol decreased and triglyceride increased in the estrogenprogestin group , but , compared with controls , these changes were not significant . Total cholesterol decreased in the tibolone group , although decreases in low- and particularly high-density lipoprotein ( HDL ) ( P cholesterol and parallel decreases in apolipoprotein A1 ( P B ( P apolipoproteins A1 and B in all groups , and in lipoprotein ( a ) with tibolone . Conclusion Some changes accompanying tibolone may be favorable and may counter its adverse effect on HDL cholesterol . Lowering of lipoprotein ( a ) was the only significant change found with estrogen-progestin",
"BACKGROUND Low concentrations of lipoprotein(a ) in plasma are associated with increased risk of type 2 diabetes , but whether this association is causal is unclear . Variations in the LPA gene affect lipoprotein(a ) isoform size and concentrations in plasma . We therefore did a Mendelian r and omisation study to investigate whether large isoform size , low concentrations in plasma , or both , are causally associated with type 2 diabetes . METHODS We assessed data for adults from the Danish general population enrolled in the Copenhagen City Heart Study and the Copenhagen General Population Study , with and without type 2 diabetes . Eligible participants had data for lipoprotein(a ) concentrations in plasma , LPA kringle IV type 2 ( KIV-2 ) sums of repeats ( affecting both isoform size and plasma concentrations ) , and carrier status for the LPA single-nucleotide polymorphism rs10455872 ( mainly affecting concentrations in plasma ) . FINDINGS 77,901 individuals had lipoprotein(a ) data , of whom 28,567 ( 36·7 % ) had all three measurements . Low concentrations of lipoprotein(a ) in plasma were associated with risk of type 2 diabetes , with adjusted odds ratios of 1·26 ( 1·09 - 1·45 ) , 1·17 ( 1·01 - 1·36 ) , 1·04 ( 0·90 - 1·21 ) , and 1·05 ( 95 % CI 0·90 - 1·22 ) , respectively , for quintiles 1 - 4 , compared with quintile 5 concentrations . High KIV-2 sums of repeats were associated with risk of type 2 diabetes ( adjusted odds ratio 1·16 , 95 % CI 1·05 - 1·28 ) for KIV-2 quintile 5 versus quintiles 1 - 4 combined . Being a carrier of rs10455872 did not affect risk of type 2 diabetes . For a halving of lipoprotein(a ) concentrations , the instrumental variable estimate of the causal odds ratio for type 2 diabetes was 1·15 ( 95 % CI 1·05 - 1·27 ) for KIV-2 sum of repeats and 0·99 ( 0·95 - 1·03 ) for rs10455872 genotype . INTERPRETATION Low lipoprotein(a ) concentrations alone seem not to be causally associated with type 2 diabetes , but a causal association for large lipoprotein(a ) isoform size can not be excluded . FUNDING Danish Heart Foundation , Danish Council for Independent Research -Medical Sciences , IMK Almene Fund , and Johan and Lise Boserup 's Fund",
"Low HDL cholesterol increases the risk of coronary heart disease . Treatment of postmenopausal women with tibolone lowers HDL cholesterol . We eluci date d the consequences of this unwanted side effect in a r and omized , double-blind study , where 12 women received 2.5 mg tibolone per day and 6 women , placebo . Blood sample s were collected on days -1 ( i.e. baseline ) , 28 , 56 , and 84 for the analysis of various parameters of lipid metabolism and HDL function . Compared to placebo , treatment with tibolone led to statistically significant decreases of HDL cholesterol ( -22 % to -32 % ) , apoA-I ( -14 % to -22 % ) , and HDL subclass LpA-I ( -30 % to -40 % ) but to no significant changes in apoA-II and HDL subclass LpA-I , A-II . These changes were not associated with statistically significant changes in the activity of plasma to release 3H-cholesterol from radiolabeled fibroblasts or in the serum activity of the anti-oxidative enzyme paraoxonase/arylesterase . There were no significant changes in either serum levels of triglycerides , LDL cholesterol , apoB , and leptin , or in LDL size . We conclude that changes in insulin do not contribute to the lowering of HDL cholesterol by tibolone . Despite decreased HDL cholesterol , putatively anti-atherogenic activities of HDL remained unchanged",
"Objective : To study whether tibolone affects lipid profile and diffused intima media thickness ( IMT ) of the common carotid arteries ( CCA ) in postmenopausal women ( PMW ) . Methods : Twenty-two PMW and 20 premenopausal women participated in the study . The PMW were r and omly divided into 11 women who did not receive any treatment and 11 women who received tibolone ( 2.5 mg once a day ) . Results : After 6 months the treated women had lipoprotein(a ) ( Lpa ) , total-cholesterol ( total-C ) , and LDL-cholesterol ( LDL-C ) levels lower than before , while in the non-treated women Lpa was increased . The IMT of CCA was unmodified in the treated women , whereas it increased in non-treated women . Conclusions : This preliminary study suggests that a 6-month tibolone treatment could counteract the increase of the IMT of CCA observed in untreated PMW",
"BACKGROUND Tibolone has estrogenic , progestogenic , and and rogenic effects . Although tibolone prevents bone loss , its effects on fractures , breast cancer , and cardiovascular disease are uncertain . METHODS In this r and omized study , we assigned 4538 women , who were between the ages of 60 and 85 years and had a bone mineral density T score of -2.5 or less at the hip or spine or a T score of -2.0 or less and radiologic evidence of a vertebral fracture , to receive once-daily tibolone ( at a dose of 1.25 mg ) or placebo . Annual spine radiographs were used to assess for vertebral fracture . Rates of cardiovascular events and breast cancer were adjudicated by expert panels . RESULTS During a median of 34 months of treatment , the tibolone group , as compared with the placebo group , had a decreased risk of vertebral fracture , with 70 cases versus 126 cases per 1000 person-years ( relative hazard , 0.55 ; 95 % confidence interval [ CI ] , 0.41 to 0.74 ; P risk of nonvertebral fracture , with 122 cases versus 166 cases per 1000 person-years ( relative hazard , 0.74 ; 95 % CI , 0.58 to 0.93 ; P=0.01 ) . The tibolone group also had a decreased risk of invasive breast cancer ( relative hazard , 0.32 ; 95 % CI , 0.13 to 0.80 ; P=0.02 ) and colon cancer ( relative hazard , 0.31 ; 95 % CI , 0.10 to 0.96 ; P=0.04 ) . However , the tibolone group had an increased risk of stroke ( relative hazard , 2.19 ; 95 % CI , 1.14 to 4.23 ; P=0.02 ) , for which the study was stopped in February 2006 at the recommendation of the data and safety monitoring board . There were no significant differences in the risk of either coronary heart disease or venous thromboembolism between the two groups . CONCLUSIONS Tibolone reduced the risk of fracture and breast cancer and possibly colon cancer but increased the risk of stroke in older women with osteoporosis . ( Clinical Trials.gov number , NCT00519857 .",
"INTRODUCTION Although lipoprotein(a ) ( Lp(a ) ) is involved in cardiometabolic disease processes , the association between serum Lp(a ) and stroke and /or its subtypes has not yet been eluci date d among Japanese people . This study investigated the association between Lp(a ) and the incidence of stroke and /or its subtypes in the general Japanese population . MATERIAL S AND METHODS This population -based prospect i ve cohort study included 10,494 community-dwelling participants ( 4,030 males/6,464 females ) . The incidence of stroke and its subtypes was the primary outcome . The subjects were divided into tertiles based on their Lp(a ) levels , and the risk of all stroke and stroke subtypes was examined using Cox 's proportional hazard model . RESULTS A total of 393 subjects ( 199 males and 194 females ) with stroke were identified during a follow-up duration of 10.7years . The multivariate-adjusted hazard ratios for all stroke events were 0.55 ( 95 % confidence interval : 0.38 - 0.81 ) and 0.69 ( 0.49 - 0.99 ) in the 2nd ( 9 - 19mg/dl ) and 3rd tertiles ( ≥20mg/dl ) of Lp(a ) in reference to the 1st tertile ( multivariate-adjusted hazard ratios for cerebral hemorrhage were 0.26 ( 0.10 - 0.67 ) and 0.34 ( 0.15 - 0.76 ) in the 2nd and 3rd tertiles of Lp(a ) in reference to the 1st tertile in males , and were 0.48 ( 0.23 - 1.04 ) and 0.44 ( 0.21 - 0.96 ) in the 2nd and 3rd tertiles of Lp(a ) in females . CONCLUSIONS Lp(a ) was associated with the incidence of cerebral hemorrhage in the general Japanese population , particularly among males , while a similar trend was seen among females . A low Lp(a ) level may be a marker of the risk of cerebral hemorrhage in this population",
"Our objective was to investigate the effects of 5-year therapy with tibolone on the lipid profile in postmenopausal women with mild hypercholesterolemia ( total cholesterol , 241 ± 7 mg/dl ; LDL cholesterol , 153 ± 9 mg/dl ) . Eighty-two patients were divided into two groups . Group A ( 53 women ) received 2.5 mg of tibolone per day . Group B ( 29 women ) received no tibolone . Total , low- and high-density lipoprotein cholesterol and lipoprotein(a ) were found to be decreased in the tibolone group , by 17.7 % , 32 % , 15.5 % and 12 % , respectively ( p while triglycerides showed no significant change . The lipid profile in the control group remained at its initial values . Menopausal symptoms disappeared in the treatment group within the first 5 months , whereas they deteriorated in the control group during the first 2 years . Although a few unwanted side-effects on hormonedependent tissues were observed ( including vaginal spotting in 11.3 % and febrile hemorrhagic cystic mastopathy in 3.8 % ) long-term therapy with tibolone seemed to be well tolerated , and appeared to have a beneficial effect on the levels of serum lipids ",
"MGL-3196 is an oral , liver-targeted selective agonist for the thyroid hormone receptor-β ( THR-β ) that is being developed for the treatment of dyslipidemia . The safety profile and tolerability of THR-β agonist MGL-3196 was assessed in first-in humans studies , including a single ascending dose study ( NCT01367873 ) in which MGL-3196 appeared safe at all doses tested . A two-week multiple dose study was conducted at doses of 5 , 20 , 50 , 80 , 100 , and 200 mg per day in healthy subjects with mildly elevated low density lipoprotein ( LDL ) cholesterol ( > 110 mg/dL ) ( NCT01519531 ) . MGL-3196 was well-tolerated at all doses with no dose-related adverse events or liver enzyme , ECG or vital-sign changes . At the highest dose , there was a reversible reduction of ∼20 % in the level of pro-hormone , free thyroxine ( free T4 ) that was significantly different from placebo ( p increased hepatic metabolism of T4 . There was no change in thyrotropin ( TSH ) or triiodothyronine ( free T3 ) or other evidence of central thyroid axis dysfunction at any dose . Doses ranging from 50 to 200 mg demonstrated highly statistically significant reductions relative to placebo of up to : 30 % for LDL cholesterol ( range , p = 0.05- for non- high density lipoprotein ( HDL ) cholesterol ( range , p = 0.027 - 0.0001 ) ; 24 % for Apolipoprotein B ( range , p = 0.008 - 0.0004 ) , and statistical trends of up to 60 % reduction in triglycerides ( TG ) ( range , p = 0.13 - 0.016 ) . The near maximal lipid effects were observed at a dose of 80 mg daily . In summary , in a two-week study in healthy volunteers with mild LDL cholesterol elevation , MGL-3196 appeared safe , was well-tolerated and showed a beneficial effect on lipid parameters",
"objective And rogens and other drugs that reduce plasma concentrations of high density lipoprotein ( HDL ) cholesterol are often considered to be pro‐atherogenic . Tibolone lowers HDL‐cholesterol by 20 % but the clinical significance of this effect is unknown",
"Background / Aim : The aim of this prospect i ve controlled study was to compare the effects of two therapies for menopause on factor VII ( FVII ) and hemostatic variables . Methods : Postmenopausal women were assigned to receive one of the following treatments : transdermal estradiol ( TTS E2 ; 50 μg ) combined in a continuous sequential regimen with oral medroxyprogesterone acetate ( MPA ; 10 mg/day for 12 days ) ( group A ; n = 20 ) , tibolone ( 2.5 mg/day ) ( group B ; n = 21 ) or placebo ( group C ; n = 19 ) . Sixty women completed the 1-year treatment and underwent follow-up examinations after 3 , 6 and 12 months . Results : TTS E2/MPA induced various changes in procoagulatory factors . At 12 months , fibrinogen , activated FVII ( FVIIa ) and coagulative FVII ( FVIIc ) had increased by 10.7 , 12.9 and 3.7 % , respectively . Among the fibrinolytic factors , plasminogen and α2-antiplasmin increased by 11.3 and 7.2 % , respectively . Lipoprotein(a ) [ Lp(a ) ] and antithrombin III ( ATIII ) did not show any significant variation . Tibolone induced some changes toward a more homogeneous antithrombotic profile . Fibrinogen , FVIIa and FVIIc decreased significantly by 7.5 , 8.1 and 21.3 % , respectively . Plasminogen increased ( by 11.8 % ) and Lp(a ) decreased ( by 28.4 % ) . ATIII was unchanged with tibolone therapy . Conclusion : Our results show that tibolone induces a significant reduction in FVIIc and Lp(a ) and a greater enhancement of factors promoting fibrinolysis than the TTS E2/MPA regimen",
"We administered testosterone , with or without the aromatase inhibitor testolactone , to determine the effects of testosterone and its aromatization to estradiol on Lp(a ) levels in normal men . Average Lp ( a ) values decreased by 37 % during testosterone alone and by 28 % when testosterone and testolactone were combined , suggesting that testosterone reduces Lp(a ) in men primarily by an and rogenic effect and not by its conversion to estradiol"
] | 41169692-06ff-11f0-808a-c43d1ab1c353 |
Background and aim Because low serum zinc levels precipitate hepatic encephalopathy , zinc supplementation is considered a potential therapeutic option . The aim of this study was to assess the effects of oral zinc supplementation in the treatment of hepatic encephalopathy . Methods For this systematic review and meta- analysis , data sources included electronic data bases ( CENTRAL , MEDLINE , EMBASE ) and manual search ing . R and omized clinical trials of adult patients diagnosed with liver cirrhosis and hepatic encephalopathy were included . The types of interventions considered were any oral zinc supplementation versus no intervention , placebo , or other interventions for the management of hepatic encephalopathy . The data were analyzed by calculating the RR for each trial and expressing the uncertainty as 95 % CI . Continuous data were analyzed by calculating the st and ard mean differences ( SMD ) between groups within each trial and their 95 % CI . Statistical heterogeneity was defined as a P-value > 0.10 ( χ2 ) or I2 > 25 % . Results Four trials with a total of 233 patients were included . Oral zinc supplementation was associated with a significant improvement in performance on the number connection test ( SMD –0.62 ; 95 % CI –1.12 to –0.11 ) reported in three trials ( n = 189 ) , but not with encephalopathy recurrence reduction ( RR 0.64 ; 95 % CI 0.26 to 1.59 ) reported in two trials ( n = 169 ) . Other clinical ly significant outcomes ( mortality , liver related morbidity , quality of life ) were not reported . Conclusion Oral zinc supplementation improved performance on the number connection test , but no evidence about other clinical or biochemical outcomes was available | [
"OBJECTIVES The effect of long-term oral zinc supplementation , in addition to st and ard therapy ( protein-restricted diet and lactulose ) on recurrent hepatic encephalopathy , was assessed in a double-blind study . METHODS Ninety cirrhotic patients with stable recurrent hepatic encephalopathy , after following a one month period of st and ard therapy , were r and omized to receive oral zinc acetate supplementation ( 600 mg/day ) in addition to st and ard therapy or to continue only st and ard therapy ( a diet containing 0.8 g/kg/day of protein and 90 g/day of lactulose ) for six months . Psychometric tests , NCT ( number correction test ) and PSE ( portal-systemic encephalopathy ) Index , were used to evaluate the degree of hepatic encephalopathy , both at the beginning and the end of each treatment period . RESULTS Oral zinc supplementation in addition to st and ard therapy was able to normalize serum zinc levels . The patients who never showed clinical signs of hepatic encephalopathy during the trial were 88.6 % in zinc-group and 86 % in only st and ard therapy group . Psychometric tests , NCT and PSE Index , were statistically better than basal values either in zinc-group or in only st and ard therapy group . CONCLUSIONS Final values of psychometric tests were better in zinc-group than only st and ard therapy group but the differences were not statistically significant",
"Hepatic encephalopathy ( HE ) is normally diagnosed by neuropsychological ( NP ) tests , which are not very specific and do not reveal the underlying pathology . Magnetic resonance imaging ( MRI ) and spectroscopy ( MRS ) of the brain offer alternative and possibly more specific markers for HE . These methods were applied in conjunction with NP testing in order to determine their usefulness in the identification of HE and to underst and the pathogenesis of HE more clearly . MR imaging and spectroscopy examinations , in addition to a battery of 15 NP tests , were administered to investigate 31 patients awaiting liver transplantation and 23 healthy controls . MR image intensities from the globus pallidus region were calculated and normalized to those of the thalamus . Absolute concentrations and ratios with respect to creatine ( Cr ) of several metabolites were computed from MR spectra . The MR data were correlated with the results of NP tests . The patients showed impairment in NP tests of attention and visuospatial and verbal fluency . In T1 weighted MRI , the relative intensity of the globus pallidus with respect to that of the thalamus region was significantly elevated in patients and correlated ( negatively ) with three NP tests ( Hooper , FAS , and Trails B ) . The absolute concentrations of myo‐inositol ( mI ) and choline ( Ch ) were significantly reduced in three brain regions . In addition , the absolute concentrations of glutamine ( Gln ) and combined glutamate and glutamine ( Glx ) were increased in all three locations , with Gln increase being significant in all areas while that of Glx only in the occipital white matter . In summary , this study partially confirms a hypothesized mechanism of HE pathogenesis , an increased synthesis of glutamine by brain glutamate in astrocytes due to excessive blood ammonia , followed by a compensatory loss of myo‐inositol to maintain astrocyte volume homeostasis . It also indicates that the hyperintensity observed in globus pallidus could be used as complementary to the NP test scores in evaluating the mental health of HE patients . PACS number :",
"22 cirrhotic patients with chronic encephalopathy were given oral zinc supplementation or placebo in a double-blind r and omised trial . In the group which received zinc acetate 600 mg a day for 7 days , serum zinc had been restored to normal by day 8 . On day 8 hepatic encephalopathy , as assessed by a trailmaking test , was improved in the supplemented group but not in the placebo group . There was also a significant increase in blood urea nitrogen in the supplemented group . Short-term oral zinc supplementation probably improved hepatic encephalopathy by correcting the zinc deficiency that compromises conversion of ammonia to urea . The duration of this improvement requires further investigation",
"PURPOSE To determine whether hydrogen-1 magnetic resonance ( MR ) spectroscopy of the brain allows detection of sub clinical hepatic encephalopathy ( SCHE ) . MATERIAL S AND METHODS In a double-blind study , overt hepatic encephalopathy ( HE ) and SCHE ( defined with clinical and neuropsychiatric tests ) were compared by means of H-1 MR spectroscopic criteria --reduction in cerebral myo-inositol ( 1 SD from normal)--in 20 patients with cirrhosis . RESULTS Concordance between MR spectroscopic and neuropsychiatric test results was 94 % ( kappa = 0.84 ) . MR spectroscopy allowed diagnosis of SCHE in nine of nine patients ( 100 % ) and of HE in seven of eight ( 88 % ) . Myo-inositol depletion alone had 80%-85 % sensitivity for detection of HE and SCHE . CONCLUSION H-1 MR spectroscopy allows accurate diagnosis of SCHE , and the results suggest an important role for myo-inositol in psychomotor and visuopractic functions"
] | 411696d8-06ff-11f0-808a-c43d1ab1c353 |
CONTEXT Clinical decision support systems ( CDSSs ) can help clinicians assess cardiovascular disease ( CVD ) risk and manage CVD risk factors by providing tailored assessment s and treatment recommendations based on individual patient data . The goal of this systematic review was to examine the effectiveness of CDSSs in improving screening for CVD risk factors , practice s for CVD-related preventive care services such as clinical tests and prescribed treatments , and management of CVD risk factors . EVIDENCE ACQUISITION An existing systematic review ( search period , January 1975-January 2011 ) of CDSSs for any condition was initially identified . Studies of CDSSs that focused on CVD prevention in that review were combined with studies identified through an up date d search ( January 2011-October 2012 ) . Data analysis was conducted in 2013 . EVIDENCE SYNTHESIS A total of 45 studies qualified for inclusion in the review . Improvements were seen for recommended screening and other preventive care services completed by clinicians , recommended clinical tests completed by clinicians , and recommended treatments prescribed by clinicians ( median increases of 3.8 , 4.0 , and 2.0 percentage points , respectively ) . Results were inconsistent for changes in CVD risk factors such as systolic and diastolic blood pressure , total and low-density lipoprotein cholesterol , and hemoglobin A1C levels . CONCLUSIONS CDSSs are effective in improving clinician practice s related to screening and other preventive care services , clinical tests , and treatments . However , more evidence is needed from implementation of CDSSs within the broad context of comprehensive service delivery aim ed at reducing CVD risk and CVD-related morbidity and mortality | [
"Background Interventions design ed to narrow the gap between research findings and clinical practice may be effective , but also costly . Economic evaluations are necessary to judge whether such interventions are worth the effort . We have evaluated the economic effects of a tailored intervention to support the implementation of guidelines for the use of antihypertensive and cholesterol-lowering drugs . The tailored intervention was evaluated in a r and omized trial , and was shown to significantly increase the use of thiazides for patients started on antihypertensive medication , but had little or no impact on other outcomes . The increased use of thiazides was not expected to have an impact on health outcomes . Methods and Findings We performed cost-minimization and cost-effectiveness analyses on data from a r and omized trial involving 146 general practice s from two geographical areas in Norway . Each practice was r and omized to either the tailored intervention ( 70 practice s ; 257 physicians ) or control group ( 69 practice s ; 244 physicians ) . Only patients that were being started on antihypertensive medication were included in the analyses . A multifaceted intervention was tailored to address identified barriers to change . Key components were an educational outreach visit with audit and feedback , and computerized reminders . Pharmacists conducted the visits . A cost-minimization framework was adopted , where the costs of intervention were set against the reduced treatment costs ( principally due to increased use of thiazides rather than more expensive medication ) . The cost-effectiveness of the intervention was estimated as the cost per additional patient being started on thiazides . The net annual cost ( cost minimization ) in our study population was US$ 53,395 , corresponding to US$ 763 per practice . The cost per additional patient started on thiazides ( cost-effectiveness ) was US$ 454 . The net annual savings in a national program was modeled to be US$ 761,998 , or US$ 540 per practice after 2 y. In this scenario the savings exceeded the costs in all but two of the sensitivity analyses we conducted , and the cost-effectiveness was estimated to be US$ 183 . Conclusions We found a significant shift in prescribing of antihypertensive drugs towards the use of thiazides in our trial . A major reason to promote the use of thiazides is their lower price compared to other drugs . The cost of the intervention was more than twice the savings within the time frame of our study . However , we predict modest savings over a 2-y period",
"UNLABELLED What is already known about this subject . Computerized prompts and reminders have been shown to be effective in changing the behaviour of health professionals in a variety of setting s. There is little literature describing or evaluating electronic decision-support for pharmacists . What this study adds . An electronic prompt in dispensing software for a targeted clinical intervention has a significant effect on pharmacists ' behaviour . A markedly increased rate of recording and performing the targeted clinical intervention was found . The effect of the prompt reduces markedly once the prompt is deactivated . AIM To evaluate the effect of an electronic prompt in dispensing software on the frequency of clinical interventions recorded by community pharmacists . METHOD An electronic decision-support prompt identifying patients for a targeted proactive clinical intervention was developed and implemented . Each time an oral antidiabetic agent was dispensed , a prompt was displayed reminding pharmacists to discuss the suitability of aspirin therapy in eligible patients with diabetes . The prompt was r and omly assigned to 31 of 52 metropolitan pharmacies in Melbourne ( Australia ) for 6 weeks , with the remaining pharmacies as controls . RESULTS One hundred and fifty pharmacists in 52 pharmacies recorded a total of 2396 clinical interventions at an intervention rate of 0.92 interventions per 100 patients [ 95 % confidence interval ( CI ) 0.58 , 1.23 ] . Pharmacists recorded a total of 201 target interventions related to aspirin therapy in diabetes at an intervention rate of 2.55 interventions per 100 diabetic patients ( 95 % CI 0.85 , 4.24 ) . All of the targeted clinical interventions were recorded in the prompt arm ; no targeted interventions were recorded in the control group . The effect of the prompt decreased over the study period and was not maintained after prompt deactivation . CONCLUSION An electronic prompt significantly increased pharmacists ' recording of the targeted clinical intervention in diabetic patients . An electronic decision-support prompt has significant potential to promote community pharmacists ' contribution to the quality use of medicines",
"OBJECTIVES To apply and evaluate the effects of a program for computer generated physician reminders , integrated with an electronic patient record ( EPR ) system , for opportunistic health screening in elderly patients . DESIGN A pilot study design ed as a 20-month clinical trial with a control group and a 20-month non-intervention follow-up using a computer reminder program that selects patients for screening in five intervention areas ( diabetes , hypertension , cobalamin deficiency , hypothyroidism and anaemia ) . SETTING Four primary health care ( PHC ) centres in suburban Stockholm . SUBJECTS The intervention was design ed for patients 70 years or older from one health care centre who visited a general practitioner ( GP ) during the first 20-month period . Patients from the three remaining centres served as controls . MAIN OUTCOME MEASURES The number of patients who underwent the tests , who had pathological test results , new diagnoses and new pharmacological treatments in both patient groups . RESULTS In total , 602 patients underwent screening and 1989 were controls . There was a statistically significant , moderate or marked increase ( 13 - 75 % ) in the number of patients who were tested in all five intervention areas . An increase in pathological test results ( 1 - 8 % ) was found in two areas : hypertension and cobalamin deficiency . There was an increase in the number of patients with the diagnosis of cobalamin deficiency during the study . At follow-up a decrease in new diagnoses for anaemia was found . CONCLUSION The system seems to be associated with a moderate to large increase in laboratory and manual screening tests for both established and new screening areas . The effect on clinical outcomes was found mainly in a not-yet-established screening area ( cobalamin deficiency ) , indicating that the system may be clinical ly useful when introducing new screening services",
"Background — Indirect evidence shows that alerting users with clinical decision support systems seems to change behavior more than requiring users to actively initiate the system . However , r and omized trials comparing these methods in a clinical setting are lacking . We studied the effect of both alerting and on-dem and decision support with respect to screening and treatment of dyslipidemia based on the guidelines of the Dutch College of General Practitioners . Methods and Results — In a clustered r and omized trial design , 38 Dutch general practice s ( 77 physicians ) and 87 886 of their patients ( 39 433 men 18 to 70 years of age and 48 453 women 18 to 75 years of age ) who used the ELIAS electronic health record participated . Each practice was assigned to receive alerts , on-dem and support , or no intervention . We measured the percentage of patients screened and treated after 12 months of follow-up . In the alerting group , 65 % of the patients requiring screening were screened ( relative risk versus control=1.76 ; 95 % confidence interval , 1.41 to 2.20 ) compared with 35 % of patients in the on-dem and group ( relative risk versus control=1.28 ; 95 % confidence interval , 0.98 to 1.68 ) and 25 % of patients in the control group . In the alerting group , 66 % of patients requiring treatment were treated ( relative risk versus control=1.40 ; 95 % confidence interval , 1.15 to 1.70 ) compared with 40 % of patients ( relative risk versus control=1.19 ; 95 % confidence interval , 0.94 to 1.50 ) in the on-dem and group and 36 % of patients in the control group . Conclusion — The alerting version of the clinical decision support systems significantly improved screening and treatment performance for dyslipidemia by general practitioners",
"OBJECTIVE —The purpose of this study was to determine whether implementation of a multicomponent organizational intervention can produce significant change in diabetes care and outcomes in community primary care practice s. RESEARCH DESIGN AND METHODS —This was a group-r and omized , controlled clinical trial evaluating the practical effectiveness of a multicomponent intervention ( TRANSLATE ) in 24 practice s. The intervention included implementation of an electronic diabetes registry , visit reminders , and patient-specific physician alerts . A site coordinator facilitated previsit planning and a monthly review of performance with a local physician champion . The principle outcomes were the percentage of patients achieving target values for the composite of systolic blood pressure ( SBP ) mmHg , LDL cholesterol A1C months , 69,965 visits from 8,405 adult patients with type 2 diabetes were recorded from 238 health care providers in 24 practice s from 17 health systems . Diabetes process measures increased significantly more in intervention than in control practice s , giving net increases as follows : foot examinations 35.0 % ( P annual eye examinations 25.9 % ( P renal testing 28.5 % ( P A1C testing 8.1%(P blood pressure monitoring 3.5 % ( P = 0.05 ) ; and LDL testing 8.6 % ( P Mean A1C adjusted for age , sex , and comorbidity decreased significantly in intervention practice s ( P recommended clinical values for SBP , A1C , and LDL than control clinics ( P = 0.002 ) . CONCLUSIONS — Introduction of a multicomponent organizational intervention in the primary care setting significantly increases the percentage of type 2 diabetic patients achieving recommended clinical outcomes ",
"Background Cardiovascular disease ( including coronary heart disease and stroke ) is a major cause of death and disability in the United Kingdom , and is to a large extent preventable , by lifestyle modification and drug therapy . The recent st and ardisation of electronic codes for cardiovascular risk variables through the United Kingdom 's new General Practice contract provides an opportunity for the application of risk algorithms to identify high risk individuals . This r and omised controlled trial will test the benefits of an automated system of alert messages and practice search es to identify those at highest risk of cardiovascular disease in primary care data bases . Design Patients over 50 years old in practice data bases will be r and omised to the intervention group that will receive the alert messages and search es , and a control group who will continue to receive usual care . In addition to those at high estimated risk , potentially high risk patients will be identified who have insufficient data to allow a risk estimate to be made . Further groups identified will be those with possible undiagnosed diabetes , based either on elevated past recorded blood glucose measurements , or an absence of recent blood glucose measurement in those with established cardiovascular disease . Outcome measures The intervention will be applied for two years , and outcome data will be collected for a further year . The primary outcome measure will be the annual rate of cardiovascular events in the intervention and control arms of the study . Secondary measures include the proportion of patients at high estimated cardiovascular risk , the proportion of patients with missing data for a risk estimate , and the proportion with undefined diabetes status at the end of the trial",
"BACKGROUND Optimal care for patients with diabetes is difficult to achieve in clinical practice . OBJECTIVE To evaluate the impact of a registry and decision support system on processes of care , and physiologic control . PARTICIPANTS R and omized trial with clustering at the practice level , involving 7,412 adults with diabetes in 64 primary care practice s in the Northeast . INTERVENTIONS Provider decision support ( reminders for overdue diabetes tests , alerts regarding abnormal results , and quarterly population reports with peer comparisons ) and patient decision support ( reminders and alerts ) . MEASUREMENTS AND MAIN RESULTS Process and physiologic outcomes were evaluated in all subjects . Functional status was evaluated in a r and om patient sample via question naire . We used multiple logistic regression to quantify the effect , adjusting for clustering and potential confounders . Intervention subjects were significantly more likely to receive guideline -appropriate testing for cholesterol ( OR = 1.39 ; [ 95%CI 1.07 , 1.80 ] P = 0.012 ) , creatinine ( OR = 1.40 ; [ 95%CI 1.06 , 1.84 ] P = 0.018 ) , and proteinuria ( OR = 1.74 ; [ 95%CI 1.13 , 1.69 ] P = 0.012 ) , but not A1C ( OR = 1.17 ; [ 95 % CI 0.80 , 1.72 ] P = 0.43 ) . Rates of control of A1C and LDL cholesterol were similar in the two groups . There were no differences in blood pressure , body mass index , or functional status . CONCLUSIONS A chronic disease registry and decision support system based on easily obtainable laboratory data was feasible and acceptable to patients and providers . This system improved the process of laboratory monitoring in primary care , but not physiologic control",
"Abstract Objectives : To investigate the effect of a computer based clinical decision support system and a risk chart on absolute cardiovascular risk , blood pressure , and prescribing of cardiovascular drugs in hypertensive patients . Design : Cluster r and omised controlled trial . Setting : 27 general practice s in Avon . Participants : 614 patients aged between 60 and 79 years with high blood pressure . Interventions : Patients were r and omised to computer based clinical decision support system plus cardiovascular risk chart ; cardiovascular risk chart alone ; or usual care . Main outcome measures : Percentage of patients in each group with a five year cardiovascular risk≥10 % , systolic blood pressure , diastolic blood pressure , prescribing of cardiovascular drugs . Results : Patients in the computer based clinical decision support system and chart only groups were no more likely to have cardiovascular risk reduced to below 10 % than patients receiving usual care . Patients in the computer based clinical decision support group were more likely to have a cardiovascular risk≥10 % than chart only patients , odds ratio 2.3 ( 95 % confidence interval 1.1 to 4.8 ) . The chart only group had significantly lower systolic blood pressure compared with the usual care group ( difference in means−4.6 mm Hg ( 95 % confidence interval−8.4 to−0.8 ) . Reduction of diastolic blood pressure did not differ between the three groups . The chart only group were twice as likely to be prescribed two classes of cardiovascular drugs and over three times as likely to be prescribed three or more classes of drugs compared with the other groups . Conclusions : The computer based clinical decision support system did not confer any benefit in absolute risk reduction or blood pressure control and requires further development and evaluation before use in clinical care can be recommended . Use of chart guidelines are associated with a potentially important reduction in systolic blood pressure ",
"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 —The Diabetes Care Protocol combines task delegation ( a practice nurse ) , computerized decision support , and feedback every 3 months . We studied the effect of the Diabetes Care Protocol on A1C and cardiovascular risk factors in type 2 diabetic patients in primary care . RESEARCH DESIGN AND METHODS —In a cluster r and omized trial , mean changes in cardiovascular risk factors between the intervention and control groups after 1 year were calculated by generalized linear models . RESULTS —Throughout the Netherl and s , 26 intervention practice s included 1,699 patients and 29 control practice s 1,692 patients . The difference in A1C change was not significant , whereas total cholesterol , LDL cholesterol , and blood pressure improved significantly more in the intervention group . The 10-year coronary heart disease risk estimate of the UK Prospect i ve Diabetes Study improved 1.4 % more in the intervention group . CONCLUSIONS —Delegation of routine diabetes care to a practice nurse combined with computerized decision support and feedback did not improve A1C but reduced cardiovascular risk in type 2 diabetes patients",
"BACKGROUND Decision-support information technology is often adopted to improve clinical decision making , but it is rarely rigorously evaluated . Congress m and ated the evaluation of Problem-Knowledge Couplers ( PKC Corp , Burlington , Vt ) , a decision-support tool proposed for the Department of Defense 's new health information network . METHODS This was a patient-level r and omized trial conducted at 2 military practice s. A total of 936 patients were allocated to the intervention group and 966 to usual care . Couplers were applied before routine ambulatory clinic visits . The primary outcome was quality of care , which was assessed based on the total percentage of any of 24 health care quality process measures ( opportunities to provide evidence -based care ) that were fulfilled . Secondary outcomes included medical re sources consumed within 60 days of enrollment and patient and provider satisfaction . RESULTS There were 4639 health care opportunities ( 2374 in the Coupler group and 2265 in the usual-care group ) , with no difference in the proportion of opportunities fulfilled ( 33.9 % vs 30.7 % ; P = .12 ) . Although there was a modest improvement in performance on screening/preventive measures , it was offset by poorer performance on some measures of acute care . Coupler patients used more laboratory and pharmacy re sources than usual-care patients ( logarithmic mean difference , 71 dollars ) . No difference in patient satisfaction was observed between groups , and provider satisfaction was mixed . CONCLUSION This study provides no strong evidence to support the utility of this decision-support tool , but it demonstrates the value of rigorous evaluation of decision-support information technology",
"Disease-specific st and ards for directing patient management are becoming increasingly important . These st and ards , however , are often not followed because they are not sufficiently integrated into the clinical care setting . In this study we describe the development and evaluation of a Computer-Assisted Management Protocol ( CAMP ) of care guidelines for diabetes mellitus . While other studies have shown improved compliance with rule-based reminders , the CAMP customizes disease-specific care guidelines to individual patients over time . We evaluated the effect of the CAMP on compliance with guidelines in a prospect i ve , r and omized controlled study . The study was performed at a family practice clinic where much of the patient record is maintained electronically on The Medical Record ( TMR ) . The management protocol was developed from st and ards published by the American Diabetes Association . Fifty-eight providers were r and omized to either receive or not receive the CAMP for diabetes . Compliance with st and ards was assessed by chart audits of all encounters with diabetic patients during the study interval . The following conclusion was made : the Computer-Assisted Management Protocol result ed in a statistically significant improvement in compliance with diabetes care st and ards",
"OBJECTIVE To evaluate whether an electronic reminder integrated into a routine computer system increases the use of antiplatelet drugs for diabetic patients among Italian general practitioners ( GPs ) . RESEARCH DESIGN AND METHODS A r and omized controlled trial was carried out among 300 GPs and their patients selected from the Health Search Data base . Among these , 150 GPs ( intervention group ) received instructions to activate an electronic reminder plus a letter summarizing the beneficial effects of antiplatelet drugs in diabetic patients with at least one additional cardiovascular risk factor ( \" high risk \" ) , whereas the other 150 GPs ( control group ) received only the letter . The electronic reminder , integrated into a st and ard software system for the management of the daily clinical practice , was displayed when every participating GP opened the medical record of diabetic patients aged > or = 30 years . Only high-risk diabetic patients were included in the analysis . Patients were considered under antiplatelet treatment if they received two or more prescriptions at baseline and during the follow-up . RESULTS We selected 15,343 high-risk diabetic patients , 7,313 belonging to GPs of the control group and 8,030 belonging to GPs of the intervention group . Overall , 1,672 patients ( 22.9 % ) of the control group and 1,886 ( 23.5 % ) patients of the intervention group received antiplatelet drugs at baseline ( P = N.S. ) . At the end of the follow-up , the number of treated patients was significantly increased in the intervention group ( odds ratio 1.99 , 95 % CI 1.79 - 2.22 ) versus the control group . The effect of the electronic reminder was more relevant among those patients with one or more cardiovascular risk factors but without previous cardiovascular diseases ( CVDs ) , compared with those with CVDs . CONCLUSIONS These findings provide evidence for the effect of an electronic reminder in affecting the prescriptive behavior of GPs",
"OBJECTIVE Management of diabetes is frequently suboptimal in primary care setting s , where providers often fail to intensify therapy when glucose levels are high , a problem known as clinical inertia . We asked whether interventions targeting clinical inertia can improve outcomes . RESEARCH DESIGN AND METHODS A controlled trial over a 3-year period was conducted in a municipal hospital primary care clinic in a large academic medical center . We studied all patients ( 4,138 ) with type 2 diabetes who were seen in continuity clinics by 345 internal medicine residents and were r and omized to be control subjects or to receive one of three interventions . Instead of consultative advice , the interventions were hard copy computerized reminders that provided patient-specific recommendations for management at the time of each patient 's visit , individual face-to-face feedback on performance for 5 min every 2 weeks , or both . RESULTS Over an average patient follow-up of 15 months within the intervention site , improvements in and final HbA1c ( A1C ) with feedback + reminders ( deltaA1C 0.6 % , final A1C 7.46 % ) were significantly better than control ( deltaA1C 0.2 % , final A1C 7.84 % , P systolic blood pressure ( sBP ) and LDL cholesterol . Multivariable analysis showed that the feedback intervention independently facilitated attainment of American Diabetes Association goals for both A1C and sBP . Over a 2-year period , overall glycemic control improved in the intervention site but did not change in other primary care sites ( final A1C 7.5 vs. 8.2 % , P internal medicine resident primary care providers improves glycemic control . Partnering generalists with diabetes specialists may be important to enhance diabetes management in other primary care setting",
"CONTEXT Computerized systems to remind physicians to provide appropriate care have not been widely evaluated in large numbers of patients in multiple clinical setting s. OBJECTIVE To examine whether a computerized reminder system operating in multiple Veterans Affairs ( VA ) ambulatory care clinics improves resident physician compliance with st and ards of ambulatory care . DESIGN , SETTING , AND PARTICIPANTS A total of 275 resident physicians at 12 VA medical centers were r and omly assigned in firms or half-day clinic blocks to either a reminder group ( n = 132 ) or a control group ( n = 143 ) . During a 17-month study period ( January 31 , 1995-June 30 , 1996 ) , the residents cared for 12,989 unique patients for whom at least 1 of the studied st and ards of care ( SOC ) was applicable . MAIN OUTCOME MEASURES Compliance with 13 SOC , tracked using hospital data bases and encounter forms completed by residents , compared between residents in the reminder group vs those in the control group . RESULTS Measuring compliance as the proportion of patients in compliance with all applicable SOC by their last visit during the study period , the reminder group had statistically significantly higher rates of compliance than the control group for all st and ards combined ( 58.8 % vs 53.5 % ; odds ratio [ OR ] , 1.24 ; 95 % confidence interval [ CI ] , 1.08 - 1.42 ; P = .002 ) and for 5 of the 13 st and ards examined individually . Measuring compliance as the proportion of all visits for which care was indicated in which residents provided proper care , the reminder group also had statistically significantly higher rates of compliance than the control group for all st and ards combined ( 17.9 % vs 12.2 % ; OR , 1.57 ; 95 % CI , 1.45 - 1.71 ; P reminder systems installed at multiple sites can improve residents ' compliance to multiple SOC . The benefits of such systems , however , appear to deteriorate over time . Future research needs to explore methods to better sustain the benefits of reminders . JAMA . 2000;284:1411 - 1416",
"OBJECTIVE To evaluate the implementation of clinical guidelines for hypertension in general practice by use of a computer-based clinical decision support system ( CDSS ) and a specific implementation strategy . Evaluation of patient outcome . DESIGN R and omised study with health centres as units . The intervention group had the CDSS installed and made ready for use , doctors and assistants were trained and received a user-manual , the doctors were offered telephone repetitions , a seminar in risk intervention and , at the same seminar , further demonstration of the CDSS . The doctors received baseline registration s with information of how they treated their own hypertensive patients , and use of the CDSS was checked repeatedly . SETTING General practice in Sør- and Nord-Trøndelag counties in Norway , 380,000 inhabitants . PARTICIPANTS Seventeen health centres with 24 doctors and 984 patients in the intervention group . Data from 879 patients used in the final analyses . Twelve health centres with 29 doctors and 1255 patients in the control group . Data from 1119 patients used in the final analyses . MAIN OUTCOME MEASURES After an intervention period of 18 months , group differences in level of systolic and diastolic blood pressure , serum cholesterol , body mass index , and risk score for myocardial infa rct ion were calculated , as well as group differences in fractions of smokers . RESULTS Significant group difference in favour of intervention group : diastolic blood pressure 1 mmHg ( 95 % CI -1.89 , -0.17 ) . However , a significant baseline difference in systolic blood pressure in favour of control group of 2.7 mmHg ( 95 % CI 1.0 , 4.5 ) had been reduced to 1.2 mmHg ( 95 % CI -0.6 , 3.0 ) after intervention . CONCLUSION Implementation of clinical guidelines in the treatment of hypertensive patients in general practice by means of a CDSS and several other procedures for implementation did not affect patient outcome in any clinical ly significant way",
"OBJECTIVE To explore the feasibility of conducting unobtrusive interventional research in community practice setting s by integrating firm-system techniques with time-series analysis of relational-repository data . STUDY SETTING A satellite teaching clinic divided into two similar , but geographically separated , primary care group practice s called firms . One firm was selected by chance to receive the study intervention . Forty-two providers and 2,655 patients participated . STUDY DESIGN A nonr and omized controlled trial of computer-generated preventive reminders . Net effects were determined by quantitatively combining population -level data from parallel experimental and control interrupted time series extending over two-month baseline and intervention periods . DATA COLLECTION Mean rates at which mammography , colorectal cancer screening , and cholesterol testing were performed on patients due to receive each maneuver at clinic visits were the trial 's outcome measures . PRINCIPAL FINDINGS Mammography performance increased on the experimental firm by 154 percent ( 0.24 versus 0.61 , p = .03 ) . No effect on fecal occult blood testing was observed . Cholesterol ordering decreased on both the experimental ( 0.18 versus 0.1 1 , p = .02 ) and control firms ( 0.13 versus 0.07 , p = .03 ) coincident with national guidelines retreating from recommending screening for young adults . A traditional uncontrolled interrupted time-series design would have incorrectly attributed the experimental-firm decrease to the introduction of reminders . The combined analysis properly indicated that no net prompting effect had occurred , as the difference between firms in cholesterol testing remained stochastically stable over time ( 0.05 versus 0.04 , p = .75 ) . A logistic-regression analysis applied to individual-level data produced equivalent findings . The trial incurred no supplementary data collection costs . CONCLUSIONS The apparent validity and practicability of our reminder implementation study should encourage others to develop computerized firm systems capable of conducting controlled time-series trials",
"OBJECTIVES This study aim ed to assess the uptake and effect in primary care of a computerized decision support system ( DSS ) for the management of hyperlipidaemia . METHOD A prospect i ve controlled trial was conducted in 25 practice s covering a population of 150,000 in the city of Birmingham . The Primed system , a specialist developed , rule based DSS for general practice , was introduced prospect ively after a 3-month baseline data collection . The main outcome measures were nine months ' data on prescribing of lipid lowering agents ; use of laboratory tests ; and referrals to secondary care for the investigation of hyperlipidaemia . RESULTS System use was lower than expected . A shift was observed towards requests for appropriate follow-up of previously abnormal lipid results and a greater emphasis on full lipid profiles , in line with the DSS guidelines . Referrals showed a 55 % decrease on those expected ( NS ) . The prescribing evaluation revealed a large variation between practice s , but no significant alteration following system use . Views of users favoured decision support as a concept , but criticised technical problems with the system . CONCLUSIONS Greater integration of DSS software and practice based data h and ling systems is needed . The mode of data capture , and hence both the content and form of knowledge representation , in DSS must take greater account of the primary care consultation process if such systems are to be of use to practitioners",
"BACKGROUND Physician adherence to National Cholesterol Education Program clinical practice guidelines has been poor . METHODS We recruited 68 primary care family and internal medicine practice s ; 66 were r and omly allocated to a study arm ; 5 practice s withdrew , result ing in 29 receiving the Third Adult Treatment Panel ( ATP III ) intervention and 32 receiving an alternative intervention focused on the Seventh Report of the Joint National Committee on the Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( JNC-7 ) . The ATP III providers received a personal digital assistant providing the Framingham risk scores and ATP III-recommended treatment . All practice s received copies of each clinical practice guideline , an introductory lecture , 1 performance feedback report , and 4 visits for intervention-specific academic detailing . Data were abstract ed at 61 practice s from r and om sample s of medical records of patients treated from June 1 , 2001 , through May 31 , 2003 ( baseline ) , and from May 1 , 2004 , through April 30 , 2006 ( follow-up ) . The proportion screened with subsequent appropriate decision making ( primary outcome ) was calculated . Generalized estimating equations were used to compare results by arm , accounting for clustering of patients within practice s. RESULTS We examined 5057 baseline and 3821 follow-up medical records . The screening rate for lipid levels increased from 43.6 % to 49.0 % ( ATP III practice s ) and from 40.1 % to 50.8 % ( control practice s ) ( net difference , -5.3 % [ P = .22 ] ) . Appropriate management of lipid levels decreased slightly ( 73.4 % to 72.3 % ) in ATP III practice s and more markedly ( 79.7 % to 68.9 % ) in control practice s. The net change in appropriate management favored the intervention ( + 9.7 % ; 95 % confidence interval [ CI ] , 2.8%-16.6 % [ P Appropriate drug prescription within 4 months decreased in both arms ( 38.8 % to 24.8 % in ATP III practice s and 45.3 % to 24.1 % in control practice s ; net change , + 7.2 % [ P = .37 ] ) Overtreatment declined from 6.6 % to 3.9 % in ATP III and rose from 4.2 % to 6.4 % in control practice s ( net change , -4.9 % [ P = .01 ] ) . CONCLUSIONS A multifactor intervention including personal digital assistant-based decision support may improve primary care physician adherence to the ATP III guidelines . Trial Registration clinical trials.gov Identifier : NCT00224848",
"OBJECTIVE Errors of omission are a common cause of systems failures . Physicians often fail to order tests or treatments needed to monitor/ameliorate the effects of other tests or treatments . The authors hypothesized that automated , guideline -based reminders to physicians , provided as they wrote orders , could reduce these omissions . DESIGN The study was performed on the inpatient general medicine ward of a public teaching hospital . Faculty and housestaff from the Indiana University School of Medicine , who used computer workstations to write orders , were r and omized to intervention and control groups . As intervention physicians wrote orders for 1 of 87 selected tests or treatments , the computer suggested corollary orders needed to detect or ameliorate adverse reactions to the trigger orders . The physicians could accept or reject these suggestions . RESULTS During the 6-month trial , reminders about corollary orders were presented to 48 intervention physicians and withheld from 41 control physicians . Intervention physicians ordered the suggested corollary orders in 46.3 % of instances when they received a reminder , compared with 21.9 % compliance by control physicians ( p acceptance of suggested orders , readily accepting some while rejecting others . There were one third fewer interventions initiated by pharmacists with physicians in the intervention than control groups . CONCLUSION This study demonstrates that physician workstations , linked to a comprehensive electronic medical record , can be an efficient means for decreasing errors of omissions and improving adherence to practice guidelines",
"Actionable reminders ( electronic reminders linked to computerized order entry ) might improve care by facilitating direct ordering of recommended tests . The authors implemented four enhanced actionable reminders targeting performance of annual mammography , one-time bone-density screening , and diabetic testing . There was no difference in rates of appropriate testing between the four intervention and four matched , control primary care clinics for screening mammography ( OR 0.81 , 95 % CI 0.64 to 1.02 ) , bone-density exams ( OR 1.29 , 95 % CI 0.82 to 2.02 ) , HbA1c monitoring ( OR 0.91 , 95 % CI 0.58 to 1.42 ) and LDL cholesterol monitoring ( OR 1.40 , 95 % CI 0.76 to 2.59 ) . Of the survey respondents , 79 % almost never used the system or were unaware of the functionality . In the 9/228 ( 3.9 % ) cases with indirect evidence of mammography reminder use , there was a significantly lower proportion with test performance . Our actionable reminders did not improve receipt of overdue testing , potentially due to limitations of workflow integration",
"OBJECTIVE We evaluated the impact of an automated decision support tool ( DST ) on clinicians ’ ability to identify glycemic abnormalities in structured self-monitoring of blood glucose ( SMBG ) data and then make appropriate therapeutic changes based on the glycemic patterns observed . RESEARCH DESIGN AND METHODS In this prospect i ve , r and omized , controlled , multicenter study , 288 clinicians ( 39.6 % family practice physicians , 37.9 % general internal medicine physicians , and 22.6 % nurse practitioners ) were r and omized to structured SMBG alone ( STG ; n = 72 ) ; structured SMBG with DST ( DST ; n = 72 ) ; structured SMBG with an educational DVD ( DVD ; n = 72 ) ; and structured SMBG with DST and the educational DVD ( DST+DVD ; n = 72 ) . Clinicians analyzed 30 patient cases ( type 2 diabetes ) , identified the primary abnormality , and selected the most appropriate therapy . RESULTS A total of 222 clinicians completed all 30 patient cases with no major protocol deviations . Significantly more DST , DVD , and DST+DVD clinicians correctly identified the glycemic abnormality and selected the most appropriate therapeutic option compared with STG clinicians : 49 , 51 , and 55 % , respectively , vs. 33 % ( all P DST , DVD , and DST+DVD clinicians . CONCLUSIONS Use of structured SMBG , combined with the DST , the educational DVD , or both , enhances clinicians ’ ability to correctly identify significant glycemic patterns and make appropriate therapeutic decisions to address those patterns . Structured testing interventions using either the educational DVD or the DST are equally effective in improving data interpretation and utilization . The DST provides a viable alternative when comprehensive education is not feasible , and it may be integrated into medical practice s with minimal training",
"Background A gap exists between evidence and practice regarding the management of cardiovascular risk factors . This gap could be narrowed if systematic ally developed clinical practice guidelines were effectively implemented in clinical practice . We evaluated the effects of a tailored intervention to support the implementation of systematic ally developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease . Methods and Findings We conducted a cluster-r and omized trial comparing a tailored intervention to passive dissemination of guidelines in 146 general practice s in two geographical areas in Norway . Each practice was r and omized to either the tailored intervention ( 70 practice s ; 257 physicians ) or control group ( 69 practice s ; 244 physicians ) . Patients started on medication for hypertension or hypercholesterolemia during the study period and all patients already on treatment that consulted their physician during the trial were included . A multifaceted intervention was tailored to address identified barriers to change . Key components were an educational outreach visit with audit and feedback , and computerized reminders linked to the medical record system . Pharmacists conducted the visits . Outcomes were measured for all eligible patients seen in the participating practice s during 1 y before and after the intervention . The main outcomes were the proportions of ( 1 ) first-time prescriptions for hypertension where thiazides were prescribed , ( 2 ) patients assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs , and ( 3 ) patients treated for hypertension or hypercholesterolemia for 3 mo or more who had achieved recommended treatment goals . The intervention led to an increase in adherence to guideline recommendations on choice of antihypertensive drug . Thiazides were prescribed to 17 % of patients in the intervention group versus 11 % in the control group ( relative risk 1.94 ; 95 % confidence interval 1.49–2.49 , adjusted for baseline differences and clustering effect ) . Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals . Conclusions Our tailored intervention had a significant impact on prescribing of antihypertensive drugs , but was ineffective in improving the quality of other aspects of managing hypertension and hypercholesterolemia in primary care",
"The American Diabetes Association ( ADA ) first released its St and ards of Medical Care in Diabetes for health professionals in 1989 . These practice guidelines provide an extensive set of evidence -based recommendations that are up date d annually for the diagnosis and management of patients with diabetes . The 2017 St and ards cover all aspects of patient care ( 1 ) ; this guideline synopsis focuses on pharmacologic approaches for patients with type 2 diabetes . Guideline Development and Evidence Grading To develop the 2017 St and ards , the ADA Professional Practice Committee , which comprises physicians , adult and pediatric endocrinologists , diabetes educators , registered dietitians , epidemiologists , and public health experts , systematic ally search ed MEDLINE from 1 January 2016 ( date of last previous search ) to November 2016 . The committee revised recommendations based on the new evidence or , in some cases , to clarify prior ones or match the strength of the wording to the strength of the evidence . It also solicited feedback from the larger clinical community . The recommendations are rated as A , B , C , or E. Those with an A rating are based on large , well- design ed , multicenter clinical trials or high- quality meta-analyses . Recommendations with lower- quality evidence may be equally important and are based on well-conducted cohort studies ( B rating ) or uncontrolled studies ( C rating ) . Those assigned an E rating are consensus recommendations for which there is no evidence from clinical trials , in which clinical trials may be impractical , or in which there is conflicting evidence . The ADA funds development of the St and ards from its general revenues with no industry support or involvement . Details on the methodology , information about the committee members and their conflict-of-interest disclosures , and the complete St and ards can be downloaded at professional.diabetes.org/annals . Pharmacologic Therapy for Type 2 Diabetes : Recommendations Metformin , if not contraindicated and if tolerated , is the preferred initial pharmacologic agent for the treatment of type 2 diabetes ( A rating ) . Long-term use of metformin may be associated with biochemical vitamin B12 deficiency , and periodic measurement of vitamin B12 levels should be considered in patients treated with metformin , especially those with anemia or peripheral neuropathy ( B rating ) . Providers should consider initiating insulin therapy ( with or without additional agents ) in patients with newly diagnosed type 2 diabetes who are symptomatic , have a hemoglobin A1c ( HbA1c ) level of 10 % or greater , or have a blood glucose level of 16.7 mmol/L ( 300 mg/dL ) or greater ( E rating ) . If noninsulin monotherapy at the maximum tolerated dose does not achieve or maintain the HbA1c target after 3 months , adding a second oral agent , a glucagon-like peptide-1 (GLP-1)receptor agonist , or basal insulin should be considered ( A rating ) . For patients with type 2 diabetes who are not achieving glycemic goals , insulin therapy should be instituted without delay ( B rating ) . A patient-centered approach should be used to guide the choice of pharmacologic agents ( E rating ) . Initial Treatment Approach : Metformin Metformin monotherapy should be initiated at the time of diagnosis of type 2 diabetes for most patients unless there are contraindications . It is effective , safe , and inexpensive and may reduce the risk for cardiovascular events and death ( 2 ) . A large meta- analysis ( 3 ) supports the use of metformin monotherapy as first-line therapy . It may be safely used in patients with an estimated glomerular filtration rate as low as 30 mL/min/1.73 m2 ( 4 ) ; the U.S. label of metformin was recently revised to reflect its safety in patients with an estimated glomerular filtration rate of 30 mL/min/1.73 m2 or greater ( 5 ) . Gastrointestinal side effects are common in patients receiving metformin . In the authors ' experience , these side effects can be reduced if metformin monotherapy is started at a dose of 500 mg once or twice daily with food and titrated gradually to the maximum effective dose ( 2 g/d ) . Patients should be advised to stop taking their medication if they experience nausea , vomiting , or dehydration . The Diabetes Prevention Program Outcomes Study found that long-term users of metformin may develop vitamin B12 deficiency . Periodic testing of vitamin B12 levels should be considered in metformin users , especially those with anemia or peripheral neuropathy ( 6 ) . Using Pharmacotherapies Other Than or in Addition to Metformin If the patient does not tolerate or has a contraindication to metformin , another option should be considered . The ADA/European Association for the Study of Diabetes position statement ( 7 ) recommends a patient-centered approach , including assessment of efficacy , hypoglycemia risk , effect on weight , side effects , cost , and patient preferences . A table detailing characteristics of all available glucose-lowering agents in the United States that may guide individualized treatment choices is available in section 8 of the St and ards ( 8) . Tables 1 and 2 depict the costs of antihyperglycemic agents that were extracted from the Red Book ( 9 ) . With so many choices , patients and providers should be able to find a mutually agreeable treatment option . Table 1 . Median Monthly Cost of Maximum Approved Daily Dose of Noninsulin Glucose-Lowering Agents in the United States * Table 2 . Median Cost of Insulins in the United States , Calculated as the AWP per 1000 Units of Specified Dosage Form/Product * For patients with an HbA1c level of 9 % or greater who are not acutely symptomatic , initiation of dual combination therapy ( Figure 1 ) should be considered to more quickly achieve the target HbA1c level . If the patient has a r and om glucose level of 16.7 mmol/L ( 300 mg/dL ) or greater or an HbA1c level of 10 % or greater and has acute symptoms of polyuria , polydipsia , or weight loss , combination therapy that includes insulin should be considered ( Figure 2 ) . Figure 1 . Antihyperglycemic therapy for type 2 diabetes : general recommendations . The order in the chart was determined by historical availability and the route of administration , with injectables to the right ; it is not meant to denote any specific preference . Potential sequences of antihyperglycemic therapy for patients with type 2 diabetes are displayed , with the usual transition moving vertically from top to bottom ( although horizontal movement within therapy stages is also possible , depending on the circumstances ) . Adapted with permission from Inzucchi and colleagues ( 7 ) . DPP-4-i= dipeptidyl peptidase-4 inhibitor ; GI= gastrointestinal ; GLP-1-RA= glucagon-like peptide-1receptor agonist ; GU= genitourinary ; HbA1c= hemoglobin A1c ; HF= heart failure ; SGLT-2-i= sodiumglucose contransporter-2 inhibitor . * See Dieuzeide and colleagues ( 21 ) for description of efficacy and cost categorizations . Usually a basal insulin ( such as neutral protamine Hagedorn , glargine , detemir , or degludec ) . Figure 2 . Combination injectable therapy for type 2 diabetes . Adapted with permission from Inzucchi and colleagues ( 7 ) . GLP-1-RA= glucagon-like peptide-1receptor agonist ; HbA1c= hemoglobin A1c ; SMBG= self-monitored blood glucose . Assessing Response and Deciding to Intensify Therapy Providers should assess whether the HbA1c target has been achieved within approximately 3 months of therapy initiation ( Figure 1 ) ; if it has not , therapy should be intensified ( Figure 2 ) . They should use shared decision making and a patient-centered approach when selecting a second agent . Potential combination therapies include a sulfonylurea , thiazolidinedione , dipeptidyl peptidase-4 ( DPP-4 ) inhibitor , sodiumglucose contransporter-2 ( SGLT-2 ) inhibitor , GLP-1receptor agonist , or basal insulin . Insulin should also be considered as part of any combination regimen for patients with severe hyperglycemia , especially if symptoms or catabolic features ( such as weight loss or ketosis ) are present . Patients should be reassessed within 3 months for achievement of the HbA1c target . Recent Evidence From Cardiovascular Outcomes Trials Major cardiovascular outcomes trials have studied patients with type 2 diabetes and established cardiovascular disease , including EMPA-REG ( Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients ) ( 10 ) and the LEADER ( Liraglutide Effect and Action in Diabetes : Evaluation of Cardiovascular Outcome Results ) trial ( 11 ) . These 2 studies found that , compared with placebo and st and ard treatment , empagliflozin and liraglutide reduced composite outcomes for myocardial infa rct ion , stroke , and cardiovascular death in population s in which most , if not all , patients had established atherosclerotic cardiovascular disease . Whether other agents in the same class as empagliflozin and liraglutide have similar benefits , and whether the treatments benefit patients at lower risk for cardiovascular disease , is unknown . Cardiovascular outcomes trial data for the DPP-4 inhibitors sitagliptin ( 12 ) , saxagliptin ( 13 ) , and alogliptin ( 14 ) showed no statistically significant differences in rates of major cardiovascular events between treatment and placebo groups . Recent Warnings About Pharmacotherapies In May 2015 , the U.S. Food and Drug Administration ( FDA ) issued a warning that SGLT-2 inhibitors may lead to ketoacidosis in the absence of significant hyperglycemia ( termed euglycemic diabetic ketoacidosis ) . Patients who develop symptoms of ketoacidosis , which may include dyspnea , nausea , vomiting , and abdominal pain , should stop taking SGLT-2 inhibitors and immediately seek medical attention ( 15 ) . In April 2016 , the FDA also warned that the DPP-4 inhibitors saxagliptin and alogliptin may increase the risk for heart failure , especially in patients with preexisting heart failure or renal impairment ( 16 ) . Insulin Therapy Diabetes is a progressive condition , and many patients with type 2 diabetes eventually require and benefit from insulin therapy . Early patient education about expected disease progression",
"OBJECTIVE To assess the effect of a specialist telemedicine intervention for improving diabetes care using the chronic care model ( CCM ) . PARTICIPANTS AND METHODS As part of the CCM , 97 primary care physicians at 6 primary care practice s in Rochester , MN , referred 639 patients to an on-site diabetes educator between July 1 , 2001 , and December 31 , 2003 . On first referral , physicians were central ly r and omized to receive a telemedicine intervention ( specialty advice and evidence -based messages regarding medication management for cardiovascular risk ) or no intervention , keeping outcome assessors and data analysts blinded to group assignment . After each subsequent clinical encounter , endocrinologists review ed an abstract from the patient 's electronic medical record and provided management recommendations and supporting evidence to intervention physicians via e-mail . Control physicians received e-mail with periodic generic information about cardiovascular risk reduction in diabetes . Outcome measures included diabetes care processes ( diabetes test completion ) , outcomes ( metabolic and cardiovascular risk factors , estimated coronary artery disease risk ) , and patient costs ( payer perspective ) . RESULTS During the intervention , 951 ( 70 % ) of the 1361 endocrinology review s detected performance gaps and result ed in a message ; primary care physicians reported using 49 % of messages in patient care . With a mean of 21 months ' follow-up , the intervention , compared with control , did not significantly enhance metabolic outcomes or reduce estimated risk of coronary artery disease ( adjusted mean difference , -1 % ; 95 % confidence interval , -19 % to 17 % ) . The intervention group incurred lower costs ( P=.02 ) but not in diabetes-related costs . CONCLUSION Specialty telemedicine did not significantly enhance the value of CCM in primary care",
"PURPOSE We wanted to determine whether an intervention based on patient activation and a physician decision support tool was more effective than usual care for improving adherence to National Cholesterol Education Program guidelines . METHODS A 1-year cluster r and omized controlled trial was performed using 30 primary care practice s ( 4,105 patients ) in southeastern New Engl and . The main outcome was the percentage of patients screened for hyperlipidemia and treated to their low-density lipoprotein ( LDL ) and non – high-density lipoprotein ( HDL ) cholesterol goals . RESULTS After 1 year of intervention , both r and omized practice groups improved screening ( 89 % screened ) , and 74 % of patients in both groups were at their LDL and non-HDL cholesterol goals ( P screening or percentage of patients who achieved LDL and non-HDL cholesterol goals . Post hoc analysis showed practice s who made high use of the patient activation kiosk were more likely to have patients screened ( odds ratio [ OR ] = 2.54 ; 95 % confidence interval [ CI ] , 1.97–3.27 ) compared with those who made infrequent or no use . Additionally , physicians who made high use of decision support tools were more likely to have their patients at their LDL cholesterol goals ( OR = 1.27 ; 95 % CI , 1.07–1.50 ) and non-HDL goals ( OR = 1.23 ; 95 % CI , 1.04–1.46 ) than low-use or no-use physicians . CONCLUSION This study showed None results with the intent-to-treat analysis regarding the benefits of a patient activation and a decision support tool in improving cholesterol management in primary care practice s. Post hoc analysis showed a potential benefit in practice s that used the e-health tools more frequently in screening and management of dyslipidemia . Further research on how to incorporate and increase adoption of user-friendly , patient-centered e-health tools to improve screening and management of chronic diseases and their risk factors is warranted",
"OBJECTIVE To examine whether Palm Prevention , a free software tool for Palm OS personal digital assistants ( PDAs ) that provides quick access to preventive guidelines in a patient-specific manner at the point of care , improved adherence to five preventive measures in primary care . DESIGN Prospect i ve intervention pilot study . SETTING Vancouver , BC , and surrounding area . PARTICIPANTS Eight general practitioners . INTERVENTIONS Each physician used Palm Prevention for five preventive measures during routine preventive health visits with 10 patients ( n = 80 ) . Charts of consenting patients were review ed for documentation of recommended maneuvers . MAIN OUTCOME MEASURES Rates of adherence to five evidence -based guidelines selected from the Canadian and American task forces on preventive care and incorporated into Palm Prevention . RESULTS Intervention and control physicians were similar in their familiarity with and use of PDAs , and they recruited similar patients for the study . Intervention and control groups had similar rates of screening for hypertension . Intervention improved adherence to the remaining four guidelines : cervical cancer screening increased 22 % ( only absolute increases are reported ) ; hyperlipidemia screening increased 30 % ; colorectal cancer screening increased 27 % ; and prophylaxis with acetylsalicylic acid in high-risk patients increased 38 % . Participants were surveyed after the study ; all reported that they found the software helpful and would continue using Palm Prevention . Usage statistics showed that study participants used the tool outside the trial : users entered between 28 and 68 unique patients into the program during the 2-month intervention . CONCLUSION This pilot study suggests PDAs are useful in improving preventive care and facilitating translation of knowledge into practice . This was particularly apparent with newer guidelines",
"A computer was used to prospect ively detect and suggest responses to simple , medication-related events as reflected in a computerized record in a prospect i ve , r and omized study of a diabetes clinic with primary -care responsibility . There were two categories of event/suggestions : when the last observation of a test required for medication control was too old , the computer suggested a repeat ; and when an abnormality with therapeutic implication s was detected , the computer suggested a specific change in therapeutics . Clinicians responded to 36 % of events in the first category with computer reminders and 11 % without ( P less than 0.0001 ) ; they responded to 28 % of events in the second category with computer assistance and 13 % without ( P less than 0.026 ) . For the most clinical ly significant of these second category events , the difference was even greater : 47 % with and 4 % without computer assistance ( P less than 0.0004 ) . I believe that computer detection and response ( in the form of reminders ) to simple clinical events will change clinician behavior",
"BACKGROUND Among the 60 million Americans with hypertension , only approximately 31 % have their blood pressure ( BP ) under control ( BP control have had limited success . OBJECTIVES A r and omized controlled health services intervention trial with a split-plot design is being conducted to improve BP control . This 4-year trial evaluates both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans . METHODS In a cluster-r and omization , 30 primary care providers in the Durham VAMC Primary Care Clinic were r and omly assigned to receive the provider intervention or control . The provider intervention is a patient-specific electronically generated hypertension decision support system ( DSS ) delivering guideline -based recommendations to the provider at each patient 's visit , design ed to improve guideline -concordant therapy . For these providers , a sample of their hypertensive patients ( n=588 ) was r and omly assigned to receive a telephone-administered patient intervention or usual care . The patient intervention incorporates patients ' need assessment s and involves tailored behavioral and education modules to promote medication adherence and improve specific health behaviors . All modules are delivered over the telephone bi-monthly for 24 months . In this trial , the primary outcome is the proportion of patients who achieve a BP or = 140/90 mm Hg at each outpatient clinic visit over 24 months . CONCLUSION Despite the known risk of poor BP control , a majority of adults still do not have their BP controlled . This study is an important step in testing the effectiveness of a patient and provider intervention to improve BP control among veterans in the primary care setting",
"BACKGROUND Primary care data bases contain cardiovascular disease risk factor data , but practical tools are required to improve identification of at-risk patients . AIM To test the effects of a system of electronic reminders ( the ' e-Nudge ' ) on cardiovascular events and the adequacy of data for cardiovascular risk estimation . DESIGN OF STUDY R and omised controlled trial . SETTING Nineteen general practice s in the West Midl and s , UK . METHOD The e-Nudge identifies four groups of patients aged over 50 years on the basis of estimated cardiovascular risk and adequacy of risk factor data in general practice computers . Screen messages highlight individuals at raised risk and prompt users to complete risk profiles where necessary . The proportion of the study population in the four groups was measured , as well as the rate of cardiovascular events in each arm after 2 years . RESULTS Over 38 000 patients ' electronic records were r and omised . The intervention led to an increase in the proportion of patients with sufficient data who were identifiably at risk , with a difference of 1.94 % compared to the control group ( 95 % confidence interval [ CI ] = 1.38 to 2.50 , P proportion potentially at risk but requiring further data for a risk estimation ( difference = -3.68 % , 95 % CI = -4.53 to -2.84 , P incidence of cardiovascular events ( rate ratio = 0.96 , 95 % CI = 0.85 to 1.10 , P = 0.59 ) . CONCLUSION Automated electronic reminders using routinely collected primary care data can improve the adequacy of cardiovascular risk factor information during everyday practice and increase the visibility of the at-risk population ",
"OBJECTIVES To evaluate the implementation of clinical guidelines for diabetes mellitus in general practice with a specific computer-based clinical decision support system ( CDSS ) as part of the intervention . METHODS R and omized study with health center as unit . General practice in Sør- and Nord-Trøndelag counties in Norway , 380,000 inhabitants . Seventeen health centers with 24 doctors and 499 patients with diabetes mellitus were in the intervention group and 12 health centers with 29 doctors and 535 patients were in the control group . Main outcome measures were group differences in fractions of patients without registration s ( process evaluation ) and mean group differences for the same variables ( patient outcome evaluation ) . RESULTS Statistically significant group differences were experienced for fractions of patients without registration of cigarette smoking ( intervention group , 82.6 % ; control group 94.5 % ) , body mass index ( 78.2 % vs. 93.0 % ) , and sufficient registration s for calculation of risk score for myocardial infa rct ion ( 91.1 % vs. 98.3 % ) ; all during 18 months . Large center variations were shown for all variables . The only statistically significant group difference was -2.3 mm Hg ( 95 % CI , -3.8 , -0.8 ) in diastolic blood pressure in favor of the intervention group . Statistically insignificant differences in favor of the intervention group were HbA1c , -0.1 % ( 95 % CI , -0.4 , 0.1 ) , systolic blood pressure , -1.2 mm Hg ( 95 % CI , -4.4 , 2.0 ) . Statistically insignificant differences in favor of the control group were fractions of smokers , + 3.0 % ( 95 % CI , -4.0 , 10.0 ) , body mass index , + 0.3 kg/m2 ( 95 % CI , -0.8 , 1.4 ) , risk score in female + 0.1 ( 95 % CI , -5.1 , 5.2 ) , and risk score in male + 2.6 ( 95 % CI , -14.2 , 19.5 ) . CONCLUSIONS Implementation of clinical guidelines for diabetes mellitus in general practice , by means of a CDSS and several procedures for implementation , did not result in a clinical ly significant change in doctors ' behavior or in patient outcome",
"BACKGROUND Less than one third of the 65 million Americans with hypertension have adequate blood pressure ( BP ) control . This study examined the effectiveness of 2 interventions for improving patient BP control . METHODS This was a 2-level ( primary care provider and patient ) cluster r and omized trial with 2-year follow-up occurring among patients with hypertension enrolled from a Veterans Affairs Medical Center primary care clinic . Primary care providers ( n = 17 ) in the intervention received computer-generated decision support design ed to improve guideline concordant medical therapy at each visit ; control providers ( n = 15 ) received a reminder at each visit . Patients received usual care or a bimonthly tailored nurse-delivered behavioral telephone intervention to improve hypertension treatment . The primary outcome was proportion of patients who achieved a BP ( 816 eligible patients contacted , 190 refused and 38 were excluded . The 588 enrolled patients had a mean age of 63 years , 43 % had adequate baseline BP control , and 482 ( 82 % ) completed the 24-month follow-up . There were no significant differences in amount of change in BP control in the 3 intervention groups as compared to the hypertension reminder control group . In secondary analyses , rates of BP control for all patients receiving the patient behavioral intervention ( n = 294 ) improved from 40.1 % to 54.4 % at 24 months ( P = .03 ) ; patients in the nonbehavioral intervention group improved from 38.2 % to 43.9 % ( P = .38 ) , but there was no between-group differences at the end of the study . CONCLUSION The brief behavioral intervention showed improved outcomes over time , but there were not significant between group differences",
"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 It is difficult to control drug-prescribing behaviour in general practice , despite the development and distribution of guidelines . The purpose of this study was to assess the effect on drug-prescribing behaviour of implementing prescribing guidelines by means of a reactive computer reminder system ( CRS ) . DESIGN Cluster-r and omised controlled trial with an incomplete block design in the south of the Netherl and s : 25 GPs ( 7 GP practice s ) received reminders about antibiotics and asthma/ COPD prescriptions , 28 GPs ( 7 GP practice s ) received reminders about cholesterol prescriptions . Prescription guidelines were integrated into the computerised GP information system . MEASUREMENTS Both performance indicators and prescription volumes were calculated as the main outcome measures . Next to individual volume measure , sum scores were constructed on the volume measures per drug group ( antibiotics , asthma/ COPD and cholesterol ) . RESULTS Variation between GPs turned out to be larger and more skewed than expected . No differences between groups were found for indicators and volumes related to recommendations advocating certain drugs . Although there was a tendency towards clinical ly relevant results for prescription volumes that were supposed to drop , the difference in sum score between the groups was not significant . For antibiotic prescriptions that were supposed to drop , the sum score for the intervention group was 28.2 ( 95 % CI : 20.8 - 44.5 ) prescriptions per 1000 patients per GP , while this was 39.7 ( 95 % CI : 29.7 - 64.1 ) for the control group ( p 0.2 ) . For prescriptions asthma/ COPD that were supposed to drop , the sum score for the intervention group was 1.1 ( 95 % CI : 0.6 - 2.6 ) prescriptions per 1000 patients per GP , while this was 2.2 ( 95 % CI : 1.4 - 4.3 ) for the control group ( p 0.1 ) . On three specific recommendations ( on quinolones for cystitis , corticosteroids for CPOD , and antibiotics for acute sore throat ) significant differences were found . CONCLUSIONS This study turned out to be underpowered due to high inter doctor variation in prescribing behaviour . Nevertheless , computerised reminders sometimes have a favourable effect on restricting certain drugs that are not or no longer indicated in general practice",
"OBJECTIVE To compare the effectiveness of three computerized reminder systems in the delivery of five preventive procedures in family practice . DESIGN Prospect i ve , r and omized , controlled study . SETTING Ottawa Civic Hospital Family Medicine Centre . PARTICIPANTS Of 8502 patients 15 years of age or more who were not in a hospital or institution 5883 were r and omly assigned , by family , to a control group , a physician reminder group ( passive ) or a telephone or letter reminder group ( active ) . The remaining 2619 patients were not included in the r and omized portion of the study but were monitored . INTERVENTION During 1 year the patients in the active reminder groups received a telephone call or letter reminding them of any overdue preventive procedures ; for those in the passive reminder group the physician was reminded at an office visit to provide any overdue service . OUTCOME MEASURE Rates of completion of the preventive procedures required . MAIN RESULTS All three reminder systems significantly improved the delivery of preventive services ( p less than 0.001 ) . The procedure completion rates were 42.0 % in the letter reminder group , 42.0 % in the telephone reminder group , 33.7 % in the physician reminder group and 14.1 % in the r and omized control group . The use of a letter was more cost-effective than the telephone system , but the physician reminder system was the most cost-effective . CONCLUSION Computerized reminder systems do improve the delivery of preventive services in family practice",
"Abstract BACKGROUND : In New Zeal and , more than 5 % of people aged 50 years and older have undiagnosed diabetes ; most of them attend family practitioners ( FPs ) at least once a year . OBJECTIVES : To test the effectiveness of patients or computers as reminders to screen for diabetes in patients attending FPs . DESIGN : A r and omized-controlled trial compared screening rates in 4 intervention arms : patient reminders , computer reminders , both reminders , and usual care . The trial lasted 2 months . The patient reminder was a diabetes risk self- assessment sheet filled in by patients and given to the FP during the consultation . The computer reminder was an icon that flashed only for patients considered eligible for screening . PARTICIPANTS : One hundred and seven FPs . MEASUREMENTS : The primary outcome was whether each eligible patient , who attended during the trial , was or was not tested for blood glucose . Analysis was by intention to treat and allowed for clustering by FP . RESULTS : Patient reminders ( odds ratio [ OR ] 1.72 , 95 % confidence interval [ CI ] 1.21 , 2.43 ) , computer reminders ( OR 2.55 , 1.68 , 3.88 ) , and both reminders ( OR 1.69 , 1.11 , 2.59 ) were all effective compared with usual care . Computer reminders were more effective than patient reminders ( OR 1.49 , 1.07 , 2.07 ) . Patients were more likely to be screened if they visited the FP repeatedly , if patients were non-European , if they were “ regular ” patients of the practice , and if their FP had a higher screening rate prior to the study . CONCLUSIONS : Patient and computer reminders were effective methods to increase screening for diabetes . However , the effects were not additive",
"OBJECTIVE To evaluate whether a new documentation-based clinical decision support system ( CDSS ) is effective in addressing deficiencies in the care of patients with coronary artery disease ( CAD ) and diabetes mellitus ( DM ) . STUDY DESIGN Controlled trial r and omized by physician . METHODS We assigned primary care physicians ( PCPs ) in 10 ambulatory practice s to usual care or the CAD/DM Smart Form for 9 months . The primary outcome was the proportion of deficiencies in care that were addressed within 30 days after a patient visit . RESULTS The Smart Form was used for 5.6 % of eligible patients . In the intention-to-treat analysis , patients of intervention PCPs had a greater proportion of deficiencies addressed within 30 days of a visit compared with controls ( 11.4 % vs 10.1 % , adjusted and clustered odds ratio = 1.14 ; 95 % confidence interval , 1.02 - 1.28 ; P = .02 ) . Differences were more pronounced in the \" on-treatment \" analysis : 17.0 % of deficiencies were addressed after visits in which the Smart Form was used compared with 10.6 % of deficiencies after visits in which it was not used ( P documentation of smoking status and prescription of antiplatelet agents when appropriate . CONCLUSIONS Overall use of the CAD/DM Smart Form was low , and improvements in management were modest . When used , documentation-based decision support shows promise , and future studies should focus on refining such tools , integrating them into current electronic health record platforms , and promoting their use , perhaps through organizational changes to primary care practice",
"BACKGROUND Although clinical trials have shown that proper management of diabetes can improve outcomes , and treatment guidelines are widespread , glycated hemoglobin ( HbA1c ) levels in the United States are rising . Since process measures are improving , poor glycemic control may reflect the failure of health care providers to intensify diabetes therapy when indicated-- clinical inertia . We asked whether interventions aim ed at health care provider behavior could overcome this barrier and improve glycemic control . METHODS In a 3-year trial , 345 internal medicine residents were r and omized to be controls or to receive computerized reminders providing patient-specific recommendations at each visit and /or feedback on performance every 2 weeks . When glucose levels exceeded 150 mg/dL ( 8.33 mmol/L ) during visits of 4038 patients , health care provider behavior was characterized as did nothing , did anything ( any intensification of therapy ) , or did enough ( if intensification met recommendations ) . RESULTS At baseline , residents did anything for 35 % of visits and did enough for 21 % of visits when changes in therapy were indicated , and there were no differences among intervention groups . During the trial , intensification increased most during the first year and then declined . However , intensification increased more in the feedback alone and feedback plus reminders groups than for reminders alone and control groups ( P health care provider behavior in the reminders alone and control groups returned to baseline , whereas improvement with feedback alone and feedback plus reminders groups was sustained : 52 % did anything , and 30 % did enough ( P feedback on performance contributed independently to intensification and that intensification contributed independently to fall in HbA1c ( P medical resident primary care providers improved provider behavior and lowered HbA1c levels . Similar approaches may aid health care provider behavior and improve diabetes outcomes in other primary care setting",
"Despite an emerging consensus on appropriate preventive services , a minority of patients receive them . A study was undertaken to assess the impact of computer-generated reminders to adult patients , their physicians , or both patients and physicians on adherence to five recommended preventive services : cholesterol measurements , fecal occult blood testing , mammography , Papanicolaou smears , and tetanus immunization . During the academic year 1988 - 1989 , all 7397 adult patients and their 49 physicians in a university family medicine clinical practice were r and omized by practice group into one of four study groups : control , physician reminders , patient reminders , and both physician and patient reminders . Adherence was defined in community-oriented terms : the percentage of patients within each group who had received the preventive service in the recommended interval . During the study period , adherence to four of the five preventive services increased significantly , with the largest increases in the physician and patient reminder group : cholesterol measurements increased from 19.5 % to 38.1 % , fecal occult blood testing 9.3 % to 27.0 % , mammography 11.4 % to 27.1 % , and tetanus immunization 23.4 % to 35.4 % ( for each increase , P less than .0001 , McNemar 's chi-square test ) . In general , increases were greater in blacks and in patients with any form of insurance coverage . Computer-based physician and patient reminder systems have great promise of improving adherence to preventive services in primary care setting",
"BACKGROUND We conducted a cluster r and omized controlled trial to examine the effectiveness of computerized decision support ( CDS ) design ed to improve hypertension care and outcomes in a racially diverse sample of primary care patients . METHODS We r and omized 2,027 adult patients receiving hypertension care in 14 primary care practice s to either 18 months of their physicians receiving CDS for each hypertensive patient or to usual care without computerized support for the control group . We assessed prescribing of guideline -recommended drug therapy and levels of blood pressure control for patients in each group and examined if the effects of the intervention differed by patients ’ race/ethnicity using interaction terms . MEASUREMENTS AND MAIN RESULTS Rates of blood pressure control were 42 % at baseline and 46 % at the outcome visit with no significant differences between groups . After adjustment for patients ’ demographic and clinical characteristics , number of prior visits , and levels of baseline blood pressure control , there were no differences between intervention groups in the odds of outcome blood pressure control . The use of CDS to providers significantly improved Joint National Committee ( JNC ) guideline adherent medication prescribing compared to usual care ( 7 % versus 5 % , P overall blood pressure control . Future work focusing on improvement of these interventions and the study of other practical interventions to reduce disparities in hypertension-related outcomes is needed",
"OBJECTIVE : To describe the effect of the Vermont Diabetes Information System ( VDIS ) on hospital and emergency room use DATA SOURCE : Statewide discharge data base STUDY DESIGN : R and omized controlled trial of a decision support system for 7,412 adults with diabetes and their 64 primary care providers . DATA COLLECTION / DATA EXTRACTION : Charges and date s for hospital admissions and emergency room care in Vermont during an average of 32 months of observation . Data from New York hospitals were not available . PRINCIPAL FINDINGS : Patients r and omized to VDIS were admitted to the hospital less often than control subjects ( 0.17 admissions vs. 0.20 ; P=0.01 ) and generated lower hospital charges ( $ 3,113 vs. $ 3,480 ; P=0.019 ) . VDIS patients also had lower emergency room utilization ( 0.27 visits vs. 0.36 ; P charges ( $ 304 vs. $ 414 ; P men and in older subjects . CONCLUSIONS : In spite of data limitations that tended to reduce the apparent effect of the system ; this r and omized , controlled trial showed that VDIS reduces hospitalization and emergency room utilization and expenses",
"BACKGROUND Hospitalizations are an opportunity to provide preventive care . OBJECTIVE To determine if computer reminders , which we have shown to be effective in our ambulatory care setting , increasing the provision of inpatient preventive care . METHODS R and omized , controlled trial on the general medicine inpatient service of an urban , university-affiliated public hospital . Study subjects were 78 house staff rotating on the 6 general medicine services . The intervention was reminders to physicians printed on daily rounds reports about preventive care for which their patients were eligible , and suggested orders for preventive care provided through the physicians ' workstations . The preventive care guidelines were derived from the US Preventive Care Task Force recommendations . Compliance with preventive care guidelines and house staff attitudes toward providing preventive care to hospitalized patients were the main outcome measures . RESULTS No significant differences were seen between intervention and control physicians in compliance with preventive care guidelines in the aggregate or when individual preventive care actions individual preventive care actions were analyzed . This was true even though most physicians endorsed providing most kinds of preventive care for hospitalized patients . CONCLUSIONS Despite past success in increasing preventive care in the outpatient setting , we were unable , using a moderately intensive intervention , to increase the provision of preventive care during hospitalizations . The physicians providing care during the hospitalization were not the patients ' primary care physicians , which proved to be an important barrier . More intensive interventions , or more direct linkages between inpatient and outpatient care providers , may be required to overcome this resistance",
"BACKGROUND Errors involving medication use are common . Computerized physician order entry ( CPOE ) can improve prescribing practice s. Few studies have examined the effect of CPOE in combination with decision support tools on prescribing practice s in the outpatient setting . Less is known about prescribers ' adherence to laboratory monitoring recommendations . OBJECTIVE To evaluate if reminders presented during CPOE for medications would increase physicians ' compliance with guidelines for laboratory monitoring at initiation of therapy . STUDY DESIGN R and omized prospect i ve intervention study . METHODS Two hundred seven primary care physicians in a group-model managed care organization were r and omized to receive or not receive drug laboratory monitoring alerts within the CPOE system . Adherence to laboratory monitoring recommendations for patients prescribed selected medications was compared between physician groups . RESULTS There was no significant difference between the control and intervention group physicians in the overall rate of compliance with ordering the recommended laboratory monitoring for patients prescribed study medications . Laboratory monitoring was performed as recommended 56.6 % of the time in the intervention group compared with 57.1 % of the time in the control group ( P = .31 ) . In cases in which a statistically significant difference was demonstrated , improved compliance favored the intervention group ( eg , 71.2 % vs 62.3 % [ P = .003 ] for gemfibrozil and 75.7 % vs 73.9 % [ P = .05 ] for statins ) . CONCLUSIONS As CPOE becomes more prevalent , additional research is needed to determine effective decision support tools . These findings then should be communicated to the developers and users of computerized medical record systems",
"OBJECTIVE To compare computer-based with manual health maintenance tracking systems to determine whether ( 1 ) a computer-based system will result in better provider compliance with the practice health maintenance protocol , ( 2 ) the incremental cost of operating a computer-based vs a manual health maintenance tracking system differs , and ( 3 ) inactive patients will respond to health maintenance reminders . DESIGN Two-year prospect i ve , r and omized , controlled trial . SETTING Rural , multiple-office , nonprofit , fee-for-service family practice . PATIENTS Adult members of families in which at least one member had been seen by the practice within the past 2 years . INTERVENTION A computer-based health maintenance tracking system that generated annual provider and patient reminders for all patients regardless of appointment status compared with a manual flowchart-based tracking system in which patient reminders were triggered by provider request . OUTCOME MEASURES Provider compliance with the health maintenance protocol determined by preintervention and postintervention chart audits , costs of computer-based tracking , and response of inactive patients to health maintenance reminders . RESULTS Overall provider compliance with the health maintenance protocol increased 15 percentage points in the computer-based tracking group and four percentage points in the manual group . The computer-based tracking group had significantly higher provider compliance than the manual group for eight of 11 procedures . The computer-based tracking system cost 78 cents per patient per year to operate . It was not associated with increased office visits or patient billings . CONCLUSIONS Computer-based health maintenance tracking improved provider health maintenance compliance compared with a manual system . The finding that health maintenance compliance improved without a significant increase in patient visits or billings requires confirmation in other setting s but suggests that considerable health maintenance can be incorporated into ongoing patient care",
"BACKGROUND Preventive care is an important role for general practitioners , yet opportunities for prevention are often missed . METHOD We provided an automatic electronic record preventive care reminder system for 12 preventive care activities for one 10 doctor practice . All patients who attended were r and omised by the terminal digit of their record number . RESULTS The control uptake of opportunistic prevention was low ; ranging from 1.5 % ( tetanus immunisation ) to 27 % ( influenza immunisation ) . The reminders increased this by significant but small amounts for four out of 12 activities ( immunisation for tetanus and pneumococcus and recording of allergies and weight ) , insignificant increases for four ( mumps , measles and rubella immunisation , recording of smoking , and taking of cervical smears and of blood pressure ) , and insignificantly decreased influenza immunisation , and screening for diabetes and hyperlipidaemia . DISCUSSION Opportunistic electronic reminders have the potential to increase preventive care in general practice ",
"STUDY OBJECTIVE To assess the effects of evidence -based treatment suggestions for hypertension made to physicians and pharmacists using a comprehensive electronic medical record system . DESIGN R and omized controlled trial with a 2 x 2 factorial design of physician and pharmacist interventions , which result ed in four groups of patients : physician intervention only , pharmacist intervention only , intervention by physician and pharmacist , and intervention by neither physician nor pharmacist ( control ) . SETTING Academic primary care internal medicine practice . SUBJECTS Seven hundred twelve patients with uncomplicated hypertension . MEASUREMENTS AND MAIN RESULTS Suggestions were displayed to physicians on computer workstations used to write outpatient orders and to pharmacists when filling prescriptions . The primary end point was generic health-related quality of life . Secondary end points were symptom profile and side effects from antihypertensive drugs , number of emergency department visits and hospitalizations , blood pressure measurements , patient satisfaction with physicians and pharmacists , drug therapy compliance , and health care charges . In the control group , implementation of care changes in accordance with treatment suggestions was observed in 26 % of patients . In the intervention groups , compliance with suggestions was poor , with treatment suggestions implemented in 25 % of patients for whom suggestions were displayed only to pharmacists , 29 % of those for whom suggestions were displayed only to physicians , and 35 % of the group for whom both physicians and pharmacists received suggestions ( p=0.13 ) . Intergroup differences were neither statistically significant nor clinical ly relevant for generic health-related quality of life , symptom and side-effect profiles , number of emergency department visits and hospitalizations , blood pressure measurements , charges , or drug therapy compliance . CONCLUSION Computer-based intervention using a sophisticated electronic physician order-entry system failed to improve compliance with treatment suggestions or outcomes of patients with uncomplicated hypertension ",
"Discrepancies between clinical guidelines and clinical practice call for practical implementation strategies . This study evaluates the implementation of clinical guidelines for hypertension in general practice with a specific computer-based clinical decision support system ( CDSS ) as part of the intervention . We carried out a r and omized study of general practice health centres in Sør- and Nord-Trøndelag counties in Norway ( population 380000 ) . A total of 17 health centres were included , with 24 doctors and 984 patients in the intervention group . Data from 887 patients was used in the analyses . There were 12 health centres with 29 doctors and 1255 patients in the control group . Data from 1127 control patients was used in the analyses . The main outcome measures were doctor 's behaviour , measured by adherence to registration of recommended variables in the Norwegian clinical guidelines for hypertension . The aim of the intervention was to lower the fractions of patients without registration s. However , there were no clinical ly significant differences between the intervention group and the control group for fractions of patients without registration of blood pressure ( intervention group 14.3 % , control group 14.2 % ) or serum cholesterol ( 62.3 % vs. 56.8 % ) during 12 months , nor , during 18 months , for fractions of patients without a registration of cigarette smoking ( 82.9 % vs. 87.1 % ) , cardiovascular inheritance ( 79.5 % vs. 73.4 % ) and body mass index ( 81.5 % vs. 89.2 % ) . One or several variables necessary for calculation of risk score for myocardial infa rct ion were missing in 91.7 % of patients in the intervention group and 91.9 % of patients in the control group . Large centre variations were shown for all variables . Implementation of clinical guidelines in the treatment of hypertensive patients in general practice , by means of a CDSS and several procedures for implementation did not result in clinical ly significant changes in the doctors ' behaviour . Of importance are both the lack of user-friendliness of the specific CDSS and problems in performing time-consuming multidimensional procedures",
"Background . Adherence with antihypertensive and lipid-lowering therapy is poor , result ing in an almost 2-fold increase in hospitalization . Treatment side effects , cost , and complexity are common reasons for nonadherence , and physicians are often unaware of these potentially modifiable problems . Objective . To determine if a cardiovascular medication tracking and nonadherence alert system , incorporated into a computerized health record system , would increase drug profile review by primary care physicians , increase the likelihood of therapy change , and improve adherence with antihypertensive and lipid-lowering drugs . Methods . There were 2293 primary care patients prescribed lipid-lowering or antihypertensive drugs who were r and omized to the adherence tracking and alert system or active medication list alone to determine if the intervention increased drug profile review , changes in cardiovascular drug treatment , and refill adherence in the first 6 months . An intention to treat analysis was conducted using generalized estimating equations to account for clustering within physician . Results . Overall , medication adherence was below 80 % for 36.3 % of patients using lipid-lowering drugs and 40.8 % of patients using antihypertensives at the start of the trial . There was a significant increase in drug profile review in the intervention compared to the control group ( 44.5 % v. 35.5 % ; P drug discontinuations due to side effects ( 2.3 % v. 2.0 % ; P = 0.61 ) , and a reduction in therapy increases ( 28.5 % v. 29.1 % ; P = 0.86 ) . There was no significant change in refill adherence after 6 months of follow-up . Conclusion . An adherence tracking and alert system increases drug review but not therapy changes or adherence in prevalent users of cardiovascular drug treatment . Targeting incident users where adverse treatment effects are more common and combining adherence tracking and alert tools with motivational interventions provided by multidisciplinary primary care teams may improve the effectiveness of the intervention",
"In a r and omized , controlled trial ( N = 8,298 ) the authors compared three ways of encouraging patients in a large family practice to obtain a blood pressure check . Working from computerized medical records at a teaching familymedicine center , the study included patients aged 18 years and over who had not had a blood pressure measurement during the previous year . In a normalcare control group , 21.1 % of those due for a blood pressure reading obtained one during the trial year . In one intervention group , a computer-generated message reminded the doctor to check the blood pressure of patients who happened to visit the center for an appointment ; 30.7 % of patients allocated to this group were checked . In the second group , the nurse contacted patients by telephone and encouraged 24.1 % of those who were due for a check to obtain one . Sending a letter to patients in the third group yielded a 35.7 % compliance rate . Considering the costs of the three interventions , the physician reminder was the most cost effective , followed by the letter reminder . Although statistically significant , the impact of the reminders was modest . A better approach might involve a combination of routine reminders to the physician , followed by letters to noncompliant patients",
"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 wanted to assess the impact of an electronic health record – based diabetes clinical decision support system on control of hemoglobin A1c ( glycated hemoglobin ) , blood pressure , and low-density lipoprotein ( LDL ) cholesterol levels in adults with diabetes . METHODS We conducted a clinic-r and omized trial conducted from October 2006 to May 2007 in Minnesota . Included were 11 clinics with 41 consenting primary care physicians and the physicians ’ 2,556 patients with diabetes . Patients were r and omized either to receive or not to receive an electronic health record (EHR)–based clinical decision support system design ed to improve care for those patients whose hemoglobin A1c , blood pressure , or LDL cholesterol levels were higher than goal at any office visit . Analysis used general and generalized linear mixed models with repeated time measurements to accommo date the nested data structure . RESULTS The intervention group physicians used the EHR-based decision support system at 62.6 % of all office visits made by adults with diabetes . The intervention group diabetes patients had significantly better hemoglobin A1c ( intervention effect −0.26 % ; 95 % confidence interval , −0.06 % to −0.47 % ; P=.01 ) , and better maintenance of systolic blood pressure control ( 80.2 % vs 75.1 % , P=.03 ) and borderline better maintenance of diastolic blood pressure control ( 85.6 % vs 81.7 % , P = .07 ) , but not improved low-density lipoprotein cholesterol levels ( P = .62 ) than patients of physicians r and omized to the control arm of the study . Among intervention group physicians , 94 % were satisfied or very satisfied with the intervention , and moderate use of the support system persisted for more than 1 year after feedback and incentives to encourage its use were discontinued . CONCLUSIONS EHR-based diabetes clinical decision support significantly improved glucose control and some aspects of blood pressure control in adults with type 2 diabetes"
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Background The purpose of this systematic review and meta- analysis is to investigate the effects of vitamin D3 supplementation on skeletal muscle strength in athletes . Vitamin D3 supplements or vitamin D3 fortified foods always have cl aims for bringing people health benefits including bone and muscle health . An up-to- date rigorous systematic review and meta- analysis is important to better underst and the effect of vitamin D3 supplementation on muscle strength . Methods English written r and omized controlled trials ( RCTs ) that looked at effects of vitamin D3 supplementation on muscle strength in healthy athletes were search ed using three data bases ( PubMed , Embase and Cochrane Library ) . Serum 25(OH)D above 30 ng/mL is considered to be sufficient in this systematic review and meta- analysis . Results Five RCTs with 163 athletes ( vitamin D3 n = 86 , placebo n = 77 ) met inclusion criteria . Fourteen athletes were lost to follow-up and 149 athletes ( vitamin D3 n = 80 , placebo n = 69 ) were documented with complete result . Among athletes with baseline serum 25(OH)D values suggesting insufficiency , vitamin D3 daily dosage at 5000 IU for over 4 weeks led to a serum 25(OH)D concentration of 31.7 ng/mL. Athletes with sufficient serum 25(OH)D level at baseline were recruited in only one study , and the participants of which were assigned to either vitamin D3 at a daily dosage of 3570 IU or placebo for 12 weeks , their serum 25(OH)D sufficiency ( VD : 37.2 ± 7.6 vs. 45.6 ± 7.6 ; PL : 38 ± 6.8 vs. 32 ± 8.4 ) was well maintained above the cut-off boundary . One repetition maximum Bench Press ( 1-RM BP ) was not improved significantly ( SMD 0.07 , 95 % CI : − 0.32 to 0.47 , P = 0.72 ) and there was no significant increase in maximal quadriceps contraction ( SMD -2.14 , 95 % CI : − 4.87 to 0.59 , P = 0.12 ) . Furthermore , there was no significant overall effect of vitamin D3 intervention on muscle strength in this meta- analysis ( SMD -0.75 , 95 % CI : − 1.82 to 0.32 , P = 0.17 ) . Conclusion Although , serum 25(OH)D concentrations after supplementation reached sufficiency was observed , muscle strength did not significantly improve at this point of current meta- analysis . Additional well- design ed RCTs with large number of participants examined for the effect of vitamin D3 supplementation on serum 25(OH)D concentrations , muscle strength in a variety of sports , latitudes and diverse multicultural population s are needed | [
"Young male jockeys compromise bone health by engaging in caloric restriction and high volumes of physical activity during periods of musculoskeletal growth and development . The aim of this r and omised , double-blinded , placebo-controlled trial was to establish whether calcium and vitamin D supplementation would improve bone properties of young male jockeys . We conducted a 6-month trial with two groups of weight- , height- and age-matched apprentice male jockeys ( age=20.2 ± 3.2 yrs ) . Participants were supplemented with 800 mg of calcium and 400 IU of vitamin D ( S , n=8 ) or a placebo ( cellulose ) ( P , n=9 ) daily for 6-months . Baseline calcium intake was ( 669.7 ± 274.3 ( S ) vs 790.4 ± 423.9 ( P ) and vitamin D 64.6 ± 19.5 ( S ) vs 81.2 ± 24.4 ( P ) with no statistical differences . Peripheral quantitative computed tomography ( pQCT ) measured ultra-distal ( 4 % ) and proximal ( 66 % ) tibial bone properties at baseline and 6 months . Blood-borne markers of bone turnover , P1NP and CTX and vitamin D concentration were assessed . After co-varying for height , weight and baseline bone measurements , the supplemented group displayed greater post-intervention bone properties at the 66 % proximal site with cortical content ( mgmm ) 6.6 % greater ( p cortical density ( mgcm(2 ) ) 1.3 % greater ( p=0.001 ) , and total area ( mm(2 ) ) 4 % larger ( p=0.003 ) . No other between group differences in bone variables were observed . Blood analysis indicated higher vitamin D levels ( 18.1 % , p=0.014 ) and lower CTx ( ng/L ) ( -24.8 % , p=0.011 ) in the supplemented group with no differences observed in P1NP . This is the first r and omised controlled trial to examine the efficacy of calcium and vitamin D supplementation in improving bone properties in a highly vulnerable , young athletic , weight-restricted population . Results using pQCT indicate beneficial effects of supplementation on bone properties in as little as six months . Although the study size is small , this intervention appears promising as a strategy for improving bone health in young athletes in weight-restricted sports",
"Vitamin D insufficiency is common in athletes and may lower physical performance . Many cross-sectional studies associate vitamin D status with physical performance in athletes ; however , there have been few prospect i ve r and omized controlled trials with adequate statistical power to test this relationship , and none in the southern hemisphere . Thus , a prospect i ve double-blind , r and omized , placebo-controlled intervention trial was conducted involving 57 professional rugby union players in New Zeal and . Participants were r and omized to receive 50,000 IU of cholecalciferol ( equivalent to 3,570 IU/day ) or placebo once every two weeks over 11 - 12 weeks . Serum 25(OH)D concentrations and physical performance were measured at baseline , weeks 5 - 6 , and weeks 11 - 12 . Mean ( SD ) serum 25(OH)D concentrations for all participants at baseline was 94 ( 18 ) nmol/L , with all players above 50 nmol/L. Vitamin D supplementation significantly increased serum 25(OH)D concentrations compared to placebo , with a 32 nmol/L difference between groups at 11 - 12 weeks ( 95 % CI , 26 - 38 ; p Performance in five of the six tests at study completion , including the primary outcome variable of 30-m sprint time , did not differ between the vitamin D supplemented and placebo groups ( p > 0.05 ) . Performance on the weighted reverse-grip chin up was significantly higher in players receiving vitamin D compared with placebo , by 5.5 kg ( 95 % CI , 2.0 - 8.9 ; p = 0.002 ) . Despite significantly improving vitamin D status in these professional rugby union players , vitamin D supplementation had little impact on physical performance outcomes . Thus , it is unlikely that vitamin D supplementation is an ergogenic aid in this group of athletes",
"In all species tested , except humans , biological differences between vitamins D2 and D3 are accepted as fact . To test the presumption of equivalence in humans , we compared the ability of equal molar quantities of vitamin D2 or D3 to increase serum 25-hydroxyvitamin D [ 25(OH)D ] , the measure of vitamin D nutrition . Subjects took 260 nmol ( approximately 4000 IU ) vitamin D2 ( n=17 ) or vitamin D3 ( n=55 ) daily for 14 d. 25(OH)D was assayed with a method that detects both the vitamin D2 and D3 forms . With vitamin D3 , mean ( + /-SD ) serum 25(OH)D increased from 41.3+/-17.7 nmol/L before to 64.6+/-17.2 nmol/L after treatment . With vitamin D2 , the 25(OH)D concentration went from 43.7+/-17.7 nmol/L before to 57.4+/-13.0 nmol/L after . The increase in 25(OH)D with vitamin D3 was 23.3+/-15.7 nmol/L , or 1.7 times the increase obtained with vitamin D2 ( 13.7+/-11.4 nmol/L ; P=0.03 ) . There was an inverse relation between the increase in 25(OH)D and the initial 25(OH)D concentration . The lowest 2 tertiles for basal 25(OH)D showed larger increases in 25(OH)D : 30.6 and 25.5 nmol/L , respectively , for the first and second tertiles . In the highest tertile [ 25(OH)D > 49 nmol/L ] the mean increase in 25(OH)D was 13.3 nmol/L ( P vitamin D3 shown here may seem small , it is more than what others have shown for 25(OH)D increases when comparing 2-fold differences in vitamin D3 dose . The assumption that vitamins D2 and D3 have equal nutritional value is probably wrong and should be reconsidered",
"This study determined if 6-weeks vitamin D2 supplementation ( vitD2 , 3800 IU/day ) had an influence on muscle function , eccentric exercise-induced muscle damage ( EIMD ) , and delayed onset of muscle soreness ( DOMS ) in National Association for Stock Car Auto Racing ( NASCAR ) NASCAR pit crew athletes . Subjects were r and omized to vitD2 ( n = 13 ) and placebo ( n = 15 ) , and ingested supplements ( double-blind ) for six weeks . Blood sample s were collected and muscle function tests conducted pre- and post- study ( leg-back and h and grip dynamometer strength tests , body weight bench press to exhaustion , vertical jump , 30-s Wingate test ) . Post- study , subjects engaged in 90 min eccentric-based exercise , with blood sample s and DOMS ratings obtained immediately after and 1- and 2-days post-exercise . Six weeks vitD2 increased serum 25(OH)D2 456 % and decreased 25(OH)D3 21 % versus placebo ( p function test scores . The post- study eccentric exercise bout induced EIMD and DOMS , with higher muscle damage biomarkers measured in vitD2 compared to placebo ( myoglobin 252 % , 122 % increase , respectively , p = 0.001 ; creatine phosphokinase 24 h post-exercise , 169 % , 32 % , p 25(OH)D2 and decreased 25(OH)D3 , had no effect on muscle function tests , and amplified muscle damage markers in NASCAR pit crew athletes following eccentric exercise",
"Public health recommendations do not distinguish between vitamin D2 and vitamin D3 , yet disagreement exists on whether these two forms should be considered equivalent . The objective of the present study was to evaluate the effect of a daily physiological dose of vitamin D2 or vitamin D3 on 25-hydroxyvitamin D ( 25(OH)D ) status over the winter months in healthy adults living in Dunedin , New Zeal and ( latitude 46 ° S ) . Participants aged 18 - 50 years were r and omly assigned to 25 μg ( 1000 IU ) vitamin D3 ( n 32 ) , 25 μg ( 1000 IU ) vitamin D2 ( n 31 ) or placebo ( n 32 ) daily for 25 weeks beginning at the end of summer . A per- protocol approach , which included ≥ 90 % supplement compliance , was used for all analyses . Serum 25-hydroxyvitamin D3 ( 25(OH)D3 ) , 25-hydroxyvitamin D2 ( 25(OH)D2 ) and parathyroid hormone ( PTH ) were measured at baseline and at 4 , 8 , 13 and 25 weeks . Geometric mean total serum 25(OH)D concentrations ( sum of 25(OH)D2 and 25(OH)D3 ) at baseline was 80 nmol/l . After 25 weeks , participants r and omised to D2 and placebo had a significant reduction in serum 25(OH)D3 concentrations over the winter months compared with vitamin D3-supplemented participants ( both P Supplementation with vitamin D2 increased serum 25(OH)D2 but produced a 9 ( 95 % CI 1 , 17 ) nmol/l greater decline in the 25(OH)D3 metabolite compared with placebo ( P 0.036 ) . Overall , total serum 25(OH)D concentrations were 21 ( 95 % CI 14 , 30 ) nmol/l lower in participants receiving vitamin D2 compared with those receiving D3 ( P whom total serum 25(OH)D concentrations remained unchanged . No intervention-related changes in PTH were observed . Daily supplementation of vitamin D3 was more effective than D2 ; however , the functional consequence of the differing metabolic response warrants further investigation",
"Abstract : The first part of this study consisted of an 18 month follow-up of the vitamin D status and parathyroid function in a group of 54 French male adolescents , aged from 13 to 16 years old and all pupils of a jockey training school . During the 18 month period four samplings were made , one every 6 months . The first was during September of the first year , the second and third during March and October of the second year , and the last in March of the third year . Therefore we had two main periods : summer and winter . The summer 25-hydroxyvitamin D ( 25(OH)D ) concentrations were higher ( 71.6 ± 19.9 and 52.4 ± 16.5 nmol/l ) than the winter ones ( 20.4 ± 6.9 and 21.4 ± 6.1 nmol/l ) . Conversely , the winter intact parathyroid hormone ( iPTH ) serum levels ( 4.18 ± 1.18 and 4.11 ± 1.35 pmol/l ) were higher than the summer ones ( 2.44 ± 0.82 and 2.71 ± 0.71 pmol/l ) . At the two winter time points the 25(OH)D concentrations were lower than 25 nmol/l ( 10 ng/ml ) in 72 % ( 2nd year ) and 68 % ( 3rd year ) of the adolescents . In the second part of the study we tried a vitamin D3 supplementation procedure design ed to maintain the 25(OH)D and iPTH postsummer serum levels throughout the winter . Pairs of male adolescents matched for height , weight and Tanner pubertal stage were r and omly assigned to either vitamin D3 supplementation ( 2.5 mg , i.e. , 100 000 IU ) administered orally at three specific periods ( end of September , November and January ) or no vitamin D3 treatment ( control subjects ) . Blood was collected just before the first intake of vitamin D3 and 2 months after the last intake ( March ) . The control subjects had blood drawn at the same time points . In the vitamin D3-treated subjects , the concentrations of 25 (OH)D ( 55.3 ± 11.5 nmol/l ) and of iPTH ( 3.09 ± 1.16 pmol/l ) in March and September ( 53.8 ± 12.3 nmol/l and 2.75 ± 1.26 pmol/l ) were not significantly different . In the control subjects , March 25(OH)D levels ( 21.0 ± nmol/l were low , with values below 25 nmol/l in 78 % of subjects , and iPTH concentrations ( 3.97 ± 1.08 pmol/l ) were significantly ( p vitamin D wintertime deficiency and wintertime rise in iPTH in adolescent French males throughout puberty has been demonstrated . In adolescents with low dairy calcium intakes , the vitamin D3 treatment was sufficient to maintain 25(OH)D concentrations at their summer levels throughout winter and to prevent an excessive wintertime rise in iPTH levels ",
"The purpose of this 6-month r and omized , placebo-controlled trial was to determine the effect of season-long ( September-March ) vitamin D supplementation on changes in vitamin D status , which is measured as 25(OH ) D , body composition , inflammation , and frequency of illness and injury . Forty-five male and female athletes were r and omized to 4,000 IU vitamin D ( n = 23 ) or placebo ( n = 22 ) . Bone turnover markers ( NTx and BSAP ) , 25(OH)D , and inflammatory cytokines ( TNF-alpha , IL-6 , and IL1-β ) were measured at baseline , midpoint , and endpoint . Body composition was assessed by DXA and injury and illness data were collected . All athletes had sufficient 25(OH)D ( > 32 ng/ml ) at baseline ( mean : 57 ng/ml ) . At midpoint and endpoint , 13 % and 16 % of the total sample had 25(OH)D respectively . 25(OH)D was not positively correlated with bone mineral density ( BMD ) in the total body , proximal dual femur , or lumbar spine . In men , total body ( p = .04 ) and trunk ( p = .04 ) mineral-free lean mass ( MFL ) were positively correlated with 25(OH)D. In women , right femoral neck BMD ( p = .02 ) was positively correlated with 25(OH)D. 25(OH)D did not correlate with changes in bone turnover markers or inflammatory cytokines . Illness ( n = 1 ) and injury ( n = 13 ) were not related to 25(OH)D ; however , 77 % of injuries coincided with decreases in 25(OH)D. Our data suggests that 4,000 IU vitamin D supplementation is an inexpensive intervention that effectively increased 25(OH)D , which was positively correlated to bone measures in the proximal dual femur and MFL . Future studies with larger sample sizes and improved supplement compliance are needed to exp and our underst and ing of the effects of vitamin D supplementation in athletes",
"The age-related change in hormone concentrations has been hypothesized to play a role in the loss of muscle mass and muscle strength with aging , also called sarcopenia . The aim of this prospect i ve study was to investigate whether low serum 25-hydroxyvitamin D ( 25-OHD ) and high serum PTH concentration were associated with sarcopenia . In men and women aged 65 yr and older , participants of the Longitudinal Aging Study Amsterdam , grip strength ( n = 1008 ) and appendicular skeletal muscle mass ( n = 331 , using dual-energy x-ray absorptiometry ) were measured in 1995 - 1996 and after a 3-yr follow-up . Sarcopenia was defined as the lowest sex-specific 15th percentile of the cohort , translating into a loss of grip strength greater than 40 % or a loss of muscle mass greater than 3 % . After adjustment for physical activity level , season of data collection , serum creatinine concentration , chronic disease , smoking , and body mass index , persons with low ( 25-OHD levels were 2.57 ( 95 % confidence interval 1.40 - 4.70 , based on grip strength ) and 2.14 ( 0.73 - 6.33 , based on muscle mass ) times more likely to experience sarcopenia , compared with those with high ( > 50 nmol/liter ) levels . High PTH levels ( > or=4.0 pmol/liter ) were associated with an increased risk of sarcopenia , compared with low PTH ( grip strength , odds ratio = 2.35 ( 1.05 - 5.28 ) based on muscle mass . The associations were similar in men and women . The results of this prospect i ve , population -based study show that lower 25-OHD and higher PTH levels increase the risk of sarcopenia in older men and women",
"Few foods contain ergocalciferol or cholecalciferol . Treatment of mushrooms with UV light increases ergocalciferol content and could provide a dietary source of vitamin D. We evaluated the impact of consuming UV-treated white button mushrooms ( Agaricus bisporus ) on the vitamin D status of healthy adults . Thirty-eight volunteers were r and omized to 4 treatments consumed with a st and ard meal for 6 wk : the control ( C ) group received untreated mushrooms providing 0.85 μg/d ergocalciferol ( n = 10 ) ; groups M1 and M2 received UV-treated mushrooms providing 8.8 ( n = 10 ) and 17.1 μg/d ( n = 9 ) , respectively ; and the supplement ( S ) group received purified ergocalciferol plus untreated mushrooms , providing a total of 28.2 μg/d ( n = 9 ) . Serum total 25-hydroxyvitamin D [ 25(OH)D ] and 25-hydroxyergocalciferol [ 25(OH)D2 ] were 83 ± 38 and 2.4 ± 2.0 nmol/L , respectively , at baseline ( mean ± SD ) . At wk 6 , 25(OH)D2 had increased and was higher in all treatment groups than in the C group , whereas 25-hydroxycholecalciferol [ 25(OH)D3 ] had decreased and was lower in the M2 and S groups than in the C group . Increases in 25(OH)D2 for groups C , M1 , M2 , and S were 1.2 ± 5.2 , 13.8 ± 7.3 , 12.7 ± 3.7 , and 32.8 ± 3.3 nmol/L and decreases in 25(OH)D3 were -3.9 ± 16.3 , -10.4 ± 6.4 , -20.6 ± 14.6 , and -29.5 ± 15.9 nmol/L , respectively . Concentrations did not change in group C. In summary , ergocalciferol was absorbed and metabolized to 25(OH)D2 but did not affect vitamin D status , because 25(OH)D3 decreased proportionally",
"OBJECTIVE Suboptimal mitochondrial function has been implicated in several disorders in which fatigue is a prominent feature . Vitamin D deficiency is a well-recognized cause of fatigue and myopathy . The aim of this study was to examine the effects of cholecalciferol therapy on skeletal mitochondrial oxidative function in symptomatic , vitamin D-deficient individuals . DESIGN This longitudinal study assessed mitochondrial oxidative phosphorylation in the gastrosoleus compartment using phosphorus-31 magnetic resonance spectroscopy measurements of phosphocreatine recovery kinetics in 12 symptomatic , severely vitamin D-deficient subjects before and after treatment with cholecalciferol . All subjects had serum assays before and after cholecalciferol therapy to document serum 25-hydroxyvitamin D ( 25OHD ) and bone profiles . Fifteen healthy controls also underwent (31)P-magnetic resonance spectroscopy and serum 25OHD assessment . RESULTS The phosphocreatine recovery half-time ( τ1/2PCr ) was significantly reduced after cholecalciferol therapy in the subjects indicating an improvement in maximal oxidative phosphorylation ( 34.44 ± 8.18 sec to 27.84 ± 9.54 sec , P improvement in mean serum 25OHD levels ( 8.8 ± 4.2 nmol/L to 113.8 ± 51.5 nmol/L , P difference in phosphate metabolites at rest . A linear regression model showed that decreasing serum 25OHD levels was associated with increasing τ1/2PCr ( r = -0.41 , P = .009 ) . All patients reported an improvement in fatigue after cholecalciferol therapy . CONCLUSIONS Cholecalciferol therapy augments muscle mitochondrial maximal oxidative phosphorylation after exercise in symptomatic , vitamin D-deficient individuals . This finding suggests that changes in mitochondrial oxidative phosphorylation in skeletal muscle could at least be partly responsible for the fatigue experienced by these patients . For the first time , we demonstrate a link between vitamin D and the mitochondria in human skeletal muscle",
"We investigated the effects of vitamin D3 supplementation on physical performance during winter training in vitamin D insufficient taekwondo athletes . Thirty-five collegiate male and female taekwondo athletes , aged 19 - 22 years with low serum 25(OH)D concentration ( 28.8 ± 1.10 nmol/L ) , were r and omly assigned to a vitamin D group ( n = 20 ) or a placebo group ( n = 15 ) . Subjects received either a vitamin D3 capsule ( 5,000 IU/day ) or a placebo during 4 weeks of winter training . Blood sample s were collected for analyzing serum 25(OH)D concentration . Physical performance tests included Wingate anaerobic test , isokinetic muscle strength and endurance , a countermovement jump test , sit-ups , agility test , and 20-m pacer . Serum 25(OH)D concentrations increased significantly in the vitamin D group ( 96.0 ± 3.77 nmol/L ) after 4 weeks of supplementation , but no changes were found in the placebo group ( F = 242.44 , p = .000 ) . There were significant interaction effects for anaerobic peak power ( F = 7.49 , p = .010 ) and isokinetic knee extension at 180 deg/s ( F = 6.08 , p = .019 ) . Changes in serum 25(OH)D concentration were positively associated with changes in peak power and isokinetic knee extension at 180 deg/s . However , no significant interaction effects were observed in other performance variables . This study suggests that 4 weeks of vitamin D supplementation elevates serum 25(OH)D concentration to sufficient levels . Correcting vitamin D insufficiency improves some but not all aspects of performance . Thus , efficacy of vitamin D supplementation to enhance performance remains unclear",
"• The recommended level for serum 25-hydroxyvitamin D ( 25(OH)D ) in infants , children , adolescents and during pregnancy and lactation is ≥ 50 nmol/L. This level may need to be 10 - 20 nmol/L higher at the end of summer to maintain levels ≥ 50 nmol/L over winter and spring . • Sunlight is the most important source of vitamin D. The US recommended dietary allowance for vitamin D is 600 IU daily in children aged over 12 months and during pregnancy and lactation , assuming minimal sun exposure . • Risk factors for low vitamin D are : lack of skin exposure to sunlight , dark skin , southerly latitude , conditions affecting vitamin D metabolism and storage ( including obesity ) and , for infants , being born to a mother with low vitamin D and exclusive breastfeeding combined with at least one other risk factor . • Targeted measurement of 25(OH)D levels is recommended for infants , children and adolescents with at least one risk factor for low vitamin D and for pregnant women with at least one risk factor for low vitamin D at the first antenatal visit . • Vitamin D deficiency can be treated with daily low-dose vitamin D supplements , although barriers to adherence have been identified . High-dose intermittent vitamin D can be used in children and adolescents . Treatment should be paired with health education and advice about sensible sun exposure . Infants at risk of low vitamin D should be supplemented with 400 IU vitamin D₃ daily for at least the first year of life . • There is increasing evidence of an association between low vitamin D and a range of non-bone health outcomes , however there is a lack of data from robust r and omised controlled trials of vitamin D supplementation",
"Objective : Indoor athletes have been shown to be prone to vitamin D3 deficiency . The aim of the study was to examine the acute effects of vitamin D supplementation on muscle function using isokinetic dynamometry . Design : R and omized placebo-controlled , double-blind study . Setting : Institutional . Participants : Adult male white national level judoka athletes ( n = 22 ) who were involved in full-time training . Exclusion criteria were vitamin supplementation , overseas travel to sunny climes , and /or an injury incurred during the last 3 months before testing . Interventions : Subjects were r and omly allocated to the treatment ( 150 000IU vitamin D3 ) or placebo and given blinded supplements by an independent research er . Participants were tested twice , 8 days apart , on a Monday morning before the start of judo training and after 2 days of rest . A 5 to 7 mL of blood sample was collected followed by isokinetic concentric quadriceps and hamstring muscle function assessment s on the right leg at 30 and 200 ° ·s−1 . Main Outcome Measures : Repeated- measures analysis of variance was used to analyze isokinetic muscle force and serum 25(OH)D3 . Regression to the mean was used to examine changes in 25(OH)D3 levels over the study period . Results : The treatment group demonstrated a significant increase in serum 25(OH)D levels ( 34 % , P ⩽ 0.001 ) and muscle strength ( 13 % , P = 0.01 ) between days 1 and 8 . No significant differences were found for the placebo group for the same period . Conclusions : A single bolus of 150 000IU vitamin D3 had a significant positive effect on serum 25(OH)D levels and muscle function in vitamin D insufficient elite indoor athletes . Clinical Relevance : Serum 25(OH)D3 levels of indoor athletes should be monitored throughout the year and especially during winter months . Beneficial responses , in muscle strength and serum 25(OH)D3 , to 1 dose of vitamin D3 supplementation can be observed within 1 week of ingestion . Muscle strength is linked to serum 25(OH)D levels",
"Abstract Incidence of vitamin D deficiency is increasing worldwide . The purpose of this study was to determine if supplementation with vitamin D2 from Portobello mushroom powder would enhance skeletal muscle function and attenuate exercise-induced muscle damage in low vitamin D status high school athletes . Participants were r and omised to Portobello mushroom powder ( 600 IU/d vitamin D2 ) or placebo for 6 weeks . Participants then completed a 1.5-h exercise session design ed to induce skeletal muscle damage . Blood sample s and measures of skeletal muscle function were taken pre-supplementation , post-supplementation/pre-exercise and post-exercise . Six weeks supplementation with vitamin D2 increased serum 25(OH)D2 by 9.9-fold and decreased serum 25(OH)D3 by 28 % . Changes in skeletal muscle function and circulating markers of skeletal muscle damage did not differ between groups . In conclusion , 600 IU/d vitamin D2 increased 25(OH)D2 with a concomitant decrease in 25(OD)D3 , with no effect on muscular function or exercise-induced muscle damage in high school athletes",
"Background / Objectives : To assess the prevalence of vitamin D deficiency in Dutch athletes and to define the required dosage of vitamin D3 supplementation to prevent vitamin D deficiency over the course of a year . Subjects/ Methods : Blood sample s were collected from 128 highly trained athletes to assess total 25(OH)D concentration . Of these 128 athletes , 54 male and 48 female athletes ( 18–32 years ) were included in a r and omized , double blind , dose – response study . Athletes with either a deficient ( were r and omly assigned to take 400 , 1100 or 2200 IU vitamin D3 per day orally for 1 year . Athletes who had a total 25(OH)D concentration above 75 nmol/l at baseline continued with the study protocol without receiving vitamin D supplements . Serum total 25(OH)D concentration was assessed every 3 months , as well as dietary vitamin D intake and sunlight exposure . Results : Nearly 70 % of all athletes showed an insufficient ( 50–75 nmol/l ) or a deficient ( months , serum 25(OH)D concentration had increased more in the 2200 IU/day group ( + 50±27 nmol/l ) than the sufficient group receiving no supplements ( + 4±17 nmol/l ; P vitamin D result ed in a sufficient 25(OH)D concentration in 80 % of the athletes after 12 months . Conclusions : Vitamin D deficiency is highly prevalent in athletes . Athletes with a deficient or an insufficient 25(OH)D concentration can achieve a sufficient 25(OH)D concentration within 3 months by taking 2200 IU/day",
"Abstract Heavy training is associated with increased respiratory infection risk and antimicrobial proteins are important in defence against oral and respiratory tract infections . We examined the effect of 14 weeks of vitamin D3 supplementation ( 5000 IU/day ) on the resting plasma cathelicidin concentration and the salivary secretion rates of secretory immunoglobulin A ( SIgA ) , cathelicidin , lactoferrin and lysozyme in athletes during a winter training period . Blood and saliva were obtained at the start of the study from 39 healthy men who were r and omly allocated to vitamin D3 supplement or placebo . Blood sample s were also collected at the end of the study ; saliva sample s were collected after 7 and 14 weeks . Plasma total 25(OH)D concentration increased by 130 % in the vitamin D3 group and decreased by 43 % in the placebo group ( both P = 0.001 ) . The percentage change of plasma cathelicidin concentration in the vitamin D3 group was higher than in the placebo group ( P = 0.025 ) . Only in the vitamin D3 group , the saliva SIgA and cathelicidin secretion rates increased over time ( both P = 0.03 ) . A daily 5000 IU vitamin D3 supplement has a beneficial effect in up-regulating the expression of SIgA and cathelicidin in athletes during a winter training period , which could improve resistance to respiratory infections"
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Background : Chronic pain is highly prevalent . Current management is challenged by lack of vali date d objective measures like biological markers . Clinical pain studies employing exercise interventions have evaluated biomarkers ; however , it is unclear how exercise impacts biomarkers involved in pain pathways and whether these markers are associated with relevant pain-related outcomes . This systematic review evaluates data from clinical studies employing exercise interventions in chronic musculoskeletal nonmalignant pain conditions in which biomarkers in pain pathways were measured . Method : Published research studies from several data bases were examined using the Jadad Scale for assessing the quality of clinical studies . Results : Twelve research studies were review ed . Jadad scores ranged from 5 to 11 out of 13 points . Inflammatory markers were most commonly measured followed by neurotransmitter-related genes and metabolite-detecting genes . After exercise interventions , changes in biomarkers involved in neurotransmission and inflammation suggest a hypoalgesic exercise effect . Significant biomarker associations were found with pain intensity , fatigue , depression , anxiety , and quality of life . However , there were varying method ologies in the studies review ed . Discussion : It remains a question whether biomarkers can be used as objective measures for risk assessment , diagnosis , or evaluation or as surrogate endpoints in chronic pain . Adequate sample sizes , optimal exercise dose determination , study replications , and longitudinal research studies with consistent method ologies are warranted . Regardless , the potential translational value of biomarkers in chronic pain is evident . Advancing nursing research in biomarkers is vital for moving the nursing discipline and clinical chronic pain practice forward . Developing a biobehavioral perspective in chronic pain is also necessary for comprehensive management | [
"Study Design . Single blind r and omized study . Objectives . To compare the effectiveness of lumbar instrumented fusion with cognitive intervention and exercises in patients with chronic low back pain and disc degeneration . Summary of Background Data . To the authors ’ best knowledge , only one r and omized study has evaluated the effectiveness of lumbar fusion . The Swedish Lumbar Spine Study reported that lumbar fusion was better than continuing physiotherapy and care by the family physician . Patients and Methods . Sixty-four patients aged 25–60 years with low back pain lasting longer than 1 year and evidence of disc degeneration at L4–L5 and /or L5–S1 at radiographic examination were r and omized to either lumbar fusion with posterior transpedicular screws and postoperative physiotherapy , or cognitive intervention and exercises . The cognitive intervention consisted of a lecture to give the patient an underst and ing that ordinary physical activity would not harm the disc and a recommendation to use the back and bend it . This was reinforced by three daily physical exercise sessions for 3 weeks . The main outcome measure was the Oswestry Disability Index . Results . At the 1-year follow-up visit , 97 % of the patients , including 6 patients who had either not attended treatment or changed groups , were examined . The Oswestry Disability Index was significantly reduced from 41 to 26 after surgery , compared with 42 to 30 after cognitive intervention and exercises . The mean difference between groups was 2.3 ( −6.7 to 11.4 ) ( P = 0.33 ) . Improvements inback pain , use of analgesics , emotional distress , life satisfaction , and return to work were not different . Fear-avoidance beliefs and fingertip-floor distance were reduced more after nonoperative treatment , and lower limb pain was reduced more after surgery . The success rateaccording to an independent observer was 70 % after surgery and 76 % after cognitive intervention and exercises . The early complication rate in the surgical group was 18 % . Conclusion . The main outcome measure showed equal improvement in patients with chronic low back pain and disc degeneration r and omized to cognitive intervention and exercises , or lumbar fusion",
"OBJECTIVES This report presents health statistics from the 2001 National Health Interview Survey for the civilian noninstitutionalized adult population classified by sex , age , race and Hispanic origin , poverty status , and region of residence for chronic condition prevalence , health status and functional limitations , health care access and utilization , health behaviors , and human immunodeficiency virus ( HIV ) testing . Also , health statistics by education , income , health insurance coverage , marital status , and place of residence are presented for health status and limitations in activity , health care access and utilization , health behaviors , and knowledge and attitudes toward HIV . SOURCE OF DATA The National Health Interview Survey is a multistage probability sample survey conducted annually by interviewers of the U.S. Census Bureau for the Centers for Disease Control and Prevention 's National Center for Health Statistics and is representative of the civilian noninstitutionalized U.S. population . Sociodemographic data are collected for everyone in the family during face-to-face interviews with adults present at the time of the interview . The health information for adults in this report was obtained from one r and omly selected adult per family . HIGHLIGHTS In 2001 , 64 % of adults 18 years of age and over reported excellent or very good health . Fifty-eight percent of adults never participated in any type of vigorous leisure-time physical activity , and 13 % of adults did not have a usual place of health care . Twelve percent of adults had been told by a doctor or health professional that they had heart disease , and 21 % had been told on two or more visits that they had hypertension . Nearly a quarter of all adults were current smokers , and 22 % were former smokers . Based on estimates of body mass index , 36 % of adults were overweight and 23 % were obese",
"OBJECTIVES This report presents health statistics from the 2010 National Health Interview Survey ( NHIS ) for the civilian noninstitutionalized adult population , classified by sex , age , race and Hispanic origin , education , family income , poverty status , health insurance coverage , marital status , and place and region of residence . Estimates are presented for selected chronic conditions and mental health characteristics , functional limitations , health status , health behaviors , health care access and utilization , and human immunodeficiency virus testing . Percentages and percent distributions are presented in both age-adjusted and unadjusted versions . DATA SOURCE NHIS is a household , multistage probability sample survey conducted annually by interviewers of the U.S. Census Bureau for the Centers for Disease Control and Prevention 's National Center for Health Statistics . In 2010 , data were collected on 27,157 adults in the Sample Adult question naire . The conditional response rate was 77.3 % , and the final response rate was 60.8 % . The health information for adults in this report was obtained from one r and omly selected adult per family . In very rare instances where the sample adult was not able to respond for himself or herself , a proxy was used . HIGHLIGHTS In 2010 , 61 % of adults aged 18 years and over had excellent or very good health . Twelve percent of adults had been told by a doctor or health professional that they had heart disease , 25 % had been told on two or more visits that they had hypertension , 9 % had been told they had diabetes , and 22 % had been told they had some form of arthritis , rheumatoid arthritis , gout , lupus , or fibromyalgia . Twenty-one percent of adults were current smokers , and 21 % were former smokers . Based on estimates of body mass index , 35 % of adults were overweight and 27 % were obese",
"OBJECTIVE To investigate the effects of squat exercises combined with whole-body vibration on the plasma concentration of inflammatory markers and the functional performance of elderly individuals with knee osteoarthritis ( OA ) . DESIGN Clinical , prospect i ve , r and omized , single-blinded study . SETTING Exercise physiology laboratory . PARTICIPANTS Elderly subjects with knee OA ( N=32 ) were divided into 3 groups : ( 1 ) squat exercises on a vibratory platform ( platform group , n=11 ) ; ( 2 ) squat exercises without vibration ( squat group , n=10 ) ; and ( 3 ) the control group ( n=11 ) . INTERVENTIONS The structured program of squat exercises in the platform and squat groups was conducted 3 times per week , on alternate days , for 12 weeks . MAIN OUTCOME MEASURES Plasma soluble tumor necrosis factor-α receptors 1 ( sTNFR1 ) and 2 ( sTNFR2 ) were measured using immunoassays ( the enzyme-linked immunosorbent assay method ) . The Western Ontario and McMaster Universities Osteoarthritis Index question naire was used to evaluate self-reported physical function , pain , and stiffness . The 6-minute walk test , the Berg Balance Scale , and gait speed were used to evaluate physical function . RESULTS In the platform group , there were significant reductions in the plasma concentrations of the inflammatory markers sTNFR1 and sTNFR2 ( P and self-reported pain ( P increase in balance ( P and speed and distance walked ( P improves self-perception of pain , balance , gait quality , and inflammatory markers in elderly subjects with knee OA",
"IMPORTANCE Knee osteoarthritis ( OA ) , a common cause of chronic pain and disability , has biomechanical and inflammatory origins and is exacerbated by obesity . OBJECTIVE To determine whether a ≥10 % reduction in body weight induced by diet , with or without exercise , would improve mechanistic and clinical outcomes more than exercise alone . DESIGN , SETTING , AND PARTICIPANTS Single-blind , 18-month , r and omized clinical trial at Wake Forest University between July 2006 and April 2011 . The diet and exercise interventions were center-based with options for the exercise groups to transition to a home-based program . Participants were 454 overweight and obese older community-dwelling adults ( age ≥55 years with body mass index of 27 - 41 ) with pain and radiographic knee OA . INTERVENTIONS Intensive diet-induced weight loss plus exercise , intensive diet-induced weight loss , or exercise . MAIN OUTCOMES AND MEASURES Mechanistic primary outcomes : knee joint compressive force and plasma IL-6 levels ; secondary clinical outcomes : self-reported pain ( range , 0 - 20 ) , function ( range , 0 - 68 ) , mobility , and health-related quality of life ( range , 0 - 100 ) . RESULTS Three hundred ninety-nine participants ( 88 % ) completed the study . Mean weight loss for diet + exercise participants was 10.6 kg ( 11.4 % ) ; for the diet group , 8.9 kg ( 9.5 % ) ; and for the exercise group , 1.8 kg ( 2.0 % ) . After 18 months , knee compressive forces were lower in diet participants ( mean , 2487 N ; 95 % CI , 2393 to 2581 ) compared with exercise participants ( 2687 N ; 95 % CI , 2590 to 2784 , pairwise difference [Δ](exercise vs diet ) = 200 N ; 95 % CI , 55 to 345 ; P = .007 ) . Concentrations of IL-6 were lower in diet + exercise ( 2.7 pg/mL ; 95 % CI , 2.5 to 3.0 ) and diet participants ( 2.7 pg/mL ; 95 % CI , 2.4 to 3.0 ) compared with exercise participants ( 3.1 pg/mL ; 95 % CI , 2.9 to 3.4 ; Δ(exercise vs diet + exercise ) = 0.39 pg/mL ; 95 % CI , -0.03 to 0.81 ; P = .007 ; Δ(exercise vs diet ) = 0.43 pg/mL ; 95 % CI , 0.01 to 0.85 , P = .006 ) . The diet + exercise group had less pain ( 3.6 ; 95 % CI , 3.2 to 4.1 ) and better function ( 14.1 ; 95 % CI , 12.6 to 15.6 ) than both the diet group ( 4.8 ; 95 % CI , 4.3 to 5.2 ) and exercise group ( 4.7 ; 95 % CI , 4.2 to 5.1 , Δ(exercise vs diet + exercise ) = 1.02 ; 95 % CI , 0.33 to 1.71 ; P(pain ) = .004 ; 18.4 ; 95 % CI , 16.9 to 19.9 ; Δ(exercise vs diet + exercise ) , 4.29 ; 95 % CI , 2.07 to 6.50 ; P(function ) ) . The diet + exercise group ( 44.7 ; 95 % CI , 43.4 to 46.0 ) also had better physical health-related quality of life scores than the exercise group ( 41.9 ; 95 % CI , 40.5 to 43.2 ; Δ(exercise vs diet + exercise ) = -2.81 ; 95 % CI , -4.76 to -0.86 ; P = .005 ) . CONCLUSIONS AND RELEVANCE Among overweight and obese adults with knee OA , after 18 months , participants in the diet + exercise and diet groups had more weight loss and greater reductions in IL-6 levels than those in the exercise group ; those in the diet group had greater reductions in knee compressive force than those in the exercise group . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00381290"
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OBJECTIVE Because of blood lipid concerns , diabetes associations discourage fructose at high intakes . To quantify the effect of fructose on blood lipids in diabetes , we conducted a systematic review and meta- analysis of experimental clinical trials investigating the effect of isocaloric fructose exchange for carbohydrate on triglycerides , total cholesterol , LDL cholesterol , and HDL cholesterol in type 1 and 2 diabetes . RESEARCH DESIGN AND METHODS We search ed MEDLINE , EMBASE , CINAHL , and the Cochrane Library for relevant trials of ≥7 days . Data were pooled by the generic inverse variance method and expressed as st and ardized mean differences with 95 % CI . Heterogeneity was assessed by χ2 tests and quantified by I2 . Meta-regression models identified dose threshold and independent predictors of effects . RESULTS Sixteen trials ( 236 subjects ) met the eligibility criteria . Isocaloric fructose exchange for carbohydrate raised triglycerides and lowered total cholesterol under specific conditions without affecting LDL cholesterol or HDL cholesterol . A triglyceride-raising effect without heterogeneity was seen only in type 2 diabetes when the reference carbohydrate was starch ( mean difference 0.24 [ 95 % CI 0.05–0.44 ] ) , dose was > 60 g/day ( 0.18 [ 0.00–0.37 ] ) , or follow-up was ≤4 weeks ( 0.18 [ 0.00–0.35 ] ) . Piecewise meta-regression confirmed a dose threshold of 60 g/day ( R2 = 0.13)/10 % energy ( R2 = 0.36 ) . A total cholesterol – lowering effect without heterogeneity was seen only in type 2 diabetes under the following conditions : no r and omization and poor study quality ( −0.19 [ −0.34 to −0.05 ] ) , dietary fat > 30 % energy ( −0.33 [ −0.52 to −0.15 ] ) , or crystalline fructose ( −0.28 [ −0.47 to −0.09 ] ) . Multivariate meta-regression analyses were largely in agreement . CONCLUSIONS Pooled analyses demonstrated conditional triglyceride-raising and total cholesterol – lowering effects of isocaloric fructose exchange for carbohydrate in type 2 diabetes . Recommendations and large-scale future trials need to address the heterogeneity in the data | [
"BACKGROUND A high fructose intake can lead to postpr and ial hypertriacylglycerolemia . The underlying mechanism is unclear . OBJECTIVE The objective of the study was to investigate the mechanisms involved in fructose-induced hypertriacylglycerolemia and the contribution of de novo lipogenesis in an acute setting . DESIGN In a r and omized , crossover study , 14 subjects were given a fructose or glucose test meal after an overnight fast . [(2)H2]Palmitate and [U(13)C]d-fructose or [U(13)C]d-glucose were added to trace the h and ling of dietary fats and the fate of dietary sugars in the body . Blood sample s were taken before and after the meal . Respiratory exchange ratio was measured by using indirect calorimetry , and breath sample s were collected . RESULTS Plasma triacylglycerol and VLDL-triacylglycerol concentrations were significantly higher ( P = 0.001 for both ) , whereas the concentrations of insulin and [(2)H2]palmitate in nonesterified fatty acids were significantly lower after fructose than after glucose ( P = 0.002 and 0.03 , respectively ) . The respiratory exchange ratio was higher after fructose ( P = 0.04 ) ; significantly ( P = 0.003 ) more carbon from sugars was recovered in breath carbon dioxide over 6 h after fructose ( 30.5 % ) than after glucose ( 24.5 % ) . At 240 min , newly synthesized fatty acids from fructose made up approximately 0.4 % of circulating VLDL-triacylglycerol , whereas newly synthesized triacylglycerol-glycerol made up 38 % . Newly synthesized fatty acids and triacylglycerol-glycerol from glucose contributed almost none of VLDL-triacylglycerol ( P = 0.002 and 0.007 for glucose and fructose , respectively ) . CONCLUSIONS The lower insulin excursion after fructose may result in less activation of adipose tissue lipoprotein lipase , which led to impaired triacylglycerol clearance . The contribution of de novo lipogenesis to fructose-induced hypertriacylglycerolemia is small , but its effect on altering the partitioning of fatty acids toward esterification may be considerable",
"OBJECTIVE In normal adults , a small ( catalytic ) dose of fructose administered with glucose decreases the glycemic response to a glucose load , especially in those with the poorest glucose tolerance . We hypothesized that an acute catalytic dose of fructose would also improve glucose tolerance in individuals with type 2 diabetes . RESEARCH DESIGN AND METHODS Five adults with type 2 diabetes underwent an oral glucose tolerance test ( OGTT ) on two separate occasions , at least 1 week apart . Each OGTT consisted of 75 g glucose with or without the addition of 7.5 g fructose ( OGTT + F or OGTT - F ) , in r and om order . Arterialized blood sample s were collected from a heated dorsal h and vein twice before ingestion of the carbohydrate and every 15 min for 3 h afterward . RESULTS The area under the curve ( AUC ) of the plasma glucose response was reduced by fructose administration in all subjects ; the mean AUC during the OGTT + F was 14 % less than that during the OGTT - F ( P insulin AUC was decreased 21 % with fructose administration ( P = 0.2 ) . Plasma glucagon concentrations declined similarly during OGTT - F and OGTT + F. The incremental AUC of the blood lactate response during the OGTT - F was approximately 50 % of that observed during the OGTT + F ( P nonesterified fatty acid nor triglyceride concentrations differed between the two OGTTs . CONCLUSIONS Low-dose fructose improves the glycemic response to an oral glucose load in adults with type 2 diabetes , and this effect is not a result of stimulation of insulin secretion",
"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"
] | 411697f0-06ff-11f0-808a-c43d1ab1c353 |
Background Omega-3 fatty acids are central to brain-development of children . Evidence from clinical trials and systematic review s demonstrates the potential of long-chain Omega-3 supplementation for learning and behavior . However , findings are inconclusive and in need of robust replication studies since such work is lacking . Objectives Replication of the 2012 DOLAB 1 study findings that a dietary supplementation with the long-chain omega-3 docosahexaenoic acid ( DHA ) had beneficial effects on the reading , working memory , and behavior of healthy schoolchildren . Design Parallel group , fixed-dose , r and omized ( minimization , 30 % r and om element ) , double-blind , placebo-controlled trial ( RCT ) . Setting Mainstream primary schools ( n = 84 ) from five counties in the UK in 2012–2015 . Participants Healthy children aged 7–9 underperforming in reading ( Intervention 600 mg/day DHA ( from algal oil ) , placebo : taste/color matched corn/soybean oil ; for 16 weeks . Main outcome measures Age-st and ardized measures of reading , working memory , and behavior , parent-rated and as secondary outcome teacher-rated . Results 376 children were r and omized . Reading , working memory , and behavior change scores showed no consistent differences between intervention and placebo group . Some behavioral subscales showed minor group differences . Conclusions This RCT did not replicate results of the earlier DOLAB 1 study on the effectiveness of nutritional supplementation with DHA for learning and behavior . Possible reasons are discussed , particularly regarding the replication of complex interventions . Trial registration and protocol www.controlled-trials.com ( IS RCT N48803273 ) and protocol s.io ( https://dx.doi.org/10.17504/ protocol s.io.k8kczuw | [
"This pilot study evaluated the effects of supplementation with PUFA on blood FA composition and behavior in children with Attention-Deficit/Hyperactivity Disorder (AD/HD)-like symptoms also reporting thirst and skin problems . Fifty children were r and omized to treatment groups receiving either a PUFA supplement providing a daily dose of 480 mg DHA , 80 mg EPA , 40 mg arachidonic acid ( AA ) , 96 mg GLA , and 24 mg α-tocopheryl acetate , or an olive oil placebo for 4 mon of doubleblind parallel treatment . Supplementation with the PUFA led to a substantial increase in the proportions of EPA , DHA , and α-tocopherol in the plasma phospholipids and red blood cell ( RBC ) total lipids , but an increase was noted in the plasma phospholipid proportions of 18∶3n-3 with olive oil as well . Significant improvements in multiple but outcomes ( as rated by parents ) were noted in both groups , but a clear benefit from PUFA supplementation for all behaviors characteristic of AD/HD was not observed . For most outcomes , improvement of the PUFA group was consistently nominally better than that of the olive oil group ; but the treatment difference was significantly , by secondary intent-to-treat analysis on only 2 out of 16 outcome measures : conduct problems rated by parents ( −42.7 vs. −9.9 % , n=47 , P=0.05 ) , and attention symptoms rated by teachers ( −14.8 vs. + 3.4 % , n=47 , P=0.03 ) . PUFA supplementation led to a greater number of participants showing improvement in oppositional defiant behavior from a clinical to a non clinical range compared with olive oil supplementation ( 8 out of 12 vs. 3 out of 11 , n=33 , P=0.02 ) . Also , significant correlations were observed when comparing the magnitude of change between increasing proportions of EPA in the RBC and decreasing disruptive behavior as assessed by the Abbreviated Symptom Question naire ( ASQ ) for parents ( r=−0.38 , n=31 , P ) , and for EPA and DHA in the RBC and the teachers ' Disruptive Behavior Disorders ( DBD ) Rating Scale for Attention ( r=−0.49 , n=24 , P increase in α-tocopherol concentrations in the RBC and a decrease in scores for all four subscales of the teacher 's DBD ( Hyperactivity , r=−0.45 ; Attention , r=−0.60 ; Conduct , r=−0.41 ; Oppositional/Defiant Disorder , r=−0.54 ; n=24 , P as well as the ASQ for teachers ( r=−0.51 , n=24 , P both n−3 FA and vitamin E in children with behavioral disorders",
"BACKGROUND Previous research has shown positive effects of Omega 3/6 fatty acids in children with inattention and reading difficulties . We aim ed to investigate if Omega 3/6 improved reading ability in mainstream schoolchildren . METHODS We performed a 3-month parallel , r and omized , double-blind , placebo-controlled trial followed by 3-month active treatment for all subjects . Mainstream schoolchildren aged 9 - 10 years were r and omized 1:1 to receive three Omega 3/6 capsules twice daily or identical placebo . Assessment s were made at baseline , 3 months , and 6 months . The primary outcome measure was the Logos test battery for evaluating reading abilities . The trial is registered with Clinical Trials.gov , number NCT02557477 . RESULTS The study enrolled 154 children ( active n = 78 ; placebo n = 76 ) , of whom 122 completed the first 3 months ( active n = 64 ; placebo n = 58 ) and 105 completed the whole study ( active/active n = 55 ; placebo/active n = 50 ) . Outcomes were assessed by per protocol ( PP ) and intention-to-treat ( ITT ) analyses . Active treatment was superior to placebo at 3 months for improvement in phonologic decoding time ( PP active/placebo difference -0.16 ; 95 % CI -0.03 , -0.29 ; effect size ( ES ) .44 ; p = .005 ; and ITT ES .37 ; p = .036 ) , in visual analysis time ( PP active/placebo difference -0.19 ; 95 % CI -0.05 , -0.33 ; ES .49 ; p = .013 ; and ITT ES .40 ; p = .01 ) , and for boys in phonologic decoding time ( PP -0.22 ; 95 % CI -0.03 , -0.41 ; ES .62 ; p = .004 ) . Children with ADHD-RS scores above the median showed treatment benefits in visual analysis time ( PP ES .8 , p = .009 ) , reading speed per word ( PP ES .61 , p = .008 ) , and phonologic decoding time per word ( PP ES .85 , p = .006 ) . Adverse events were rare and mild , mainly stomach pain/diarrhea ( active n = 9 , placebo n = 2 ) . CONCLUSIONS Compared with placebo , 3 months of Omega 3/6 treatment improved reading ability - specifically the clinical ly relevant ' phonologic decoding time ' and ' visual analysis time ' - in mainstream schoolchildren . In particular , children with attention problems showed treatment benefits",
"Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials",
"Objective : To investigate effects of omega-3 polyunsaturated fatty acids ( n-3 PUFA ) docosahexaenoic acid ( DHA ) and eicosapentaenoic acid ( EPA ) on attention , literacy , and behavior in children with ADHD . Method : Ninety children were r and omized to consume supplements high in EPA , DHA , or linoleic acid ( control ) for 4 months each in a crossover design . Erythrocyte fatty acids , attention , cognition , literacy , and Conners ’ Parent Rating Scales ( CPRS ) were measured at 0 , 4 , 8 , 12 months . Results : Fifty-three children completed the treatment . Outcome measures showed no significant differences between the three treatments . However , in children with blood sample s ( n = 76 - 46 ) , increased erythrocyte EPA + DHA was associated with improved spelling ( r = .365 , p ) and attention ( r = −.540 , p ( r = −.301 , p ( r = −.310 , p ( r = −.326 , p ( r = −.270 , p = .002 ) and DSM-IV inattention ( r = −.343 , p improve behavior , attention , and literacy in children with ADHD",
"Fe and n-3 long-chain PUFA ( n-3 LCPUFA ) have both been associated with cognition , but evidence remains inconclusive in well-nourished school-aged children . In the Optimal Well-Being , Development and Health for Danish Children through a Healthy New Nordic Diet ( OPUS ) School Meal Study , the 3-month intervention increased reading performance , inattention , impulsivity and dietary intake of fish and Fe . This study investigated whether the intervention influenced n-3 LCPUFA and Fe status and , if so , explored how these changes correlated with the changes in cognitive performance . The study was a cluster-r and omised cross-over trial comparing school meals with packed lunch ( control ) . At baseline and after each treatment , we measured serum ferritin , whole-blood n-3 LCPUFA and Hb , and performance in reading , mathematics and d2-test of attention . Data were analysed using mixed models ( n 726 ) and principal component analysis of test performances ( n 644 ) , which showed two main patterns : ' school performance ' and ' reading comprehension ' . The latter indicated that children with good reading comprehension were also more inattentive and impulsive ( i.e. higher d2-test error% ) . The intervention improved ' school performance ' ( P=0·015 ) , ' reading comprehension ' ( P=0·043 ) and EPA+DHA status 0·21 ( 95 % CI 0·15 , 0·27 ) w/w % ( P affect serum ferritin or Hb . At baseline , having small Fe stores was associated with poorer ' school performance ' in girls , but with better ' reading comprehension ' in both boys and girls . Both baseline EPA+DHA status and the intervention-induced increase in EPA+DHA status was positively associated with ' school performance ' , suggesting that n-3 LCPUFA could potentially explain approximately 20 % of the intervention effect . These exploratory associations indicate that increased fish intake might explain some of the increase in reading performance and inattention in the study",
"Background Omega-3 fatty acids are dietary essentials , and the current low intakes in most modern developed countries are believed to contribute to a wide variety of physical and mental health problems . Evidence from clinical trials indicates that dietary supplementation with long-chain omega-3 may improve child behavior and learning , although most previous trials have involved children with neurodevelopmental disorders such as attention-deficit/hyperactivity disorder ( ADHD ) or developmental coordination disorder ( DCD ) . Here we investigated whether such benefits might extend to the general child population . Objectives To determine the effects of dietary supplementation with the long-chain omega-3 docosahexaenoic acid ( DHA ) on the reading , working memory , and behavior of healthy schoolchildren . Design Parallel group , fixed-dose , r and omized , double-blind , placebo-controlled trial ( RCT ) . Setting Mainstream primary schools in Oxfordshire , UK ( n = 74 ) . Participants Healthy children aged 7–9 years initially underperforming in reading ( ≤33rd centile ) . 1376 invited , 362 met study criteria . Intervention 600 mg/day DHA ( from algal oil ) , or taste/color matched corn/soybean oil placebo . Main Outcome Measures Age-st and ardized measures of reading , working memory , and parent- and teacher-rated behavior . Results ITT analyses showed no effect of DHA on reading in the full sample , but significant effects in the pre-planned subgroup of 224 children whose initial reading performance was ≤20th centile ( the target population in our original study design ) . Parent-rated behavior problems ( ADHD-type symptoms ) were significantly reduced by active treatment , but little or no effects were seen for either teacher-rated behaviour or working memory . Conclusions DHA supplementation appears to offer a safe and effective way to improve reading and behavior in healthy but underperforming children from mainstream schools . Replication studies are clearly warranted , as such children are known to be at risk of low educational and occupational outcomes in later life . Trial Registration Clinical Trials.gov NCT01066182 and Controlled-Trials.com IS RCT",
"Objective Clinical trials and inconclusive meta-analyses have investigated the effects of omega-3 supplements in children with Attention-Deficit Hyperactivity Disorder ( ADHD ) . We performed a r and omised placebo-controlled trial to evaluate the efficacy of omega-3 fatty acids . Methods Children aged 6–15 years with established diagnosis of ADHD were r and omised 1:1 to receive either supplements containing docosahexaenoic acid ( DHA ) and eicosapentaenoic acid ( EPA ) or a placebo for 3 months . Psychotropic or omega-3-containing treatments were not authorised during the study . The primary outcome was the change in the Attention-Deficit Hyperactivity Disorder Rating Scale version 4 ( ADHD-RS-IV ) . Other outcomes included safety , lexical level ( Alouette test ) , attention ( Test of Attentional Performance for Children — KiTAP ) , anxiety ( 48-item Conners Parent Rating Scale-Revised — CPRS-R ) , and depression ( Children ’s Depression Inventory — CDI ) . Results Between 2009 and 2011 , 162 children were included in five French child psychiatry centres . The mean age was 9.90 ( SD 2.62 ) years and 78.4 % were boys . The inclusion ADHD-RS-IV at was 37.31 ( SD 8.40 ) . The total ADHD-RS-IV score reduction was greater in the placebo group than in the DHA – EPA group : −19 ( −26 , −12 ) % and −9.7 ( −16.6 , −2.9 ) % , respectively , p = 0.039 . The other components of the Conners score had a similar variation but the differences between groups were not significant . Two patients in the DHA – EPA group and none in the placebo group experienced a severe adverse event ( hospitalisation for worsening ADHD symptoms ) . Conclusion This study did not show any beneficial effect of omega-3 supplement in children with mild ADHD symptoms",
"The frequency and severity of 17 side effects presumably associated with stimulant medication were assessed during a rigorous , triple-blind , placebo-controlled , crossover evaluation of methylpheni date , 0.3 and 0.5 mg/kg twice a day , in 83 children with attention deficit hyperactivity disorder . Side effects were rated by parents and teachers at the end of each weekly drug condition . Three children ( 3.6 % ) had side effects that were sufficiently serious to warrant immediate discontinuation of medication . Parent ratings indicated that only the side effects of decreased appetite , insomnia , stomachaches , and headaches increased significantly in frequency and severity during the two active medication doses as compared with the placebo condition . Fewer than half of the children experienced these side effects and among those who did , ratings of mean severity remained in the mild range . Teacher ratings showed little change over drug conditions , except on ratings of staring , sadness , and anxiety , which declined with increasing dose of medication . Parent ratings indicated that only the side effects of decreased appetite , insomnia , stomachaches , and headaches increased significantly in frequency and severity during the two active medication doses as compared with the placebo condition . Fewer than half of the children experienced these side effects and among those who did , ratings of mean severity remained in the mild range . Teacher ratings showed little change over drug conditions , except on ratings of staring , sadness , and anxiety , which declined with increasing dose of medication . Surprisingly , a high frequency of these behavior side effects were reported during the placebo condition . Stimulant medication within this therapeutic range , therefore , results in few , generally mild side effects . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Omega-3 fatty acids are essential for brain function . We recruited 409 children aged 3 - 13 years ( M=8.27 , SD=2.17 ) for a r and omised controlled trial supplementing with placebo or fish oil capsules ( providing 750 mg docosahexaenoic plus eicosapentaenoic acids , and 60 mg gamma linolenic acid/school day ) for 20 school weeks ( Phase 1 ) followed by one-way crossover to fish oil ( Phase 2 ) . Children undertook assessment s of reading , spelling and non-verbal cognitive development ( Draw-A-Person ) at baseline , 20 and 40 weeks . Teachers completed Conners Behaviour Rating Scales ( CBRS ) . The treatment group showed improvements in Draw-A-Person compared with the placebo during Phase 1 ( p=0.029 ) , with strongest effects in Indigenous 7 - 12 year olds ( p=0.008 ) . The placebo group showed significant within-group improvements after switching to treatment ( p reading or spelling , and CBRS data were unable to be analysed . These findings may be understood in the context that sustained school attendance and nutrition interact to produce school-related achievement",
"There is a growing recognition that insufficient attention has been paid to the selection of the outcomes to measure in clinical trials and clinical audit . Outcomes need to be relevant to patients , clinicians , purchasers and policy-makers if the findings of research are to influence practice and future research . In addition , st and ardization of outcomes is needed to combine data from different studies to allow evidence synthesis and to compare data sets . Inconsistent choice of outcome measures means that many meta-analyses are unable to include data from all the relevant studies . For example , the five most accessed Cochrane review s in 2009 , together with the top cited review in that year , all described inconsistencies in the outcomes reported in eligible trials . A call for the st and ardization of outcomes is a regular conclusion of systematic review s. Furthermore , outcome reporting bias , defined as the bias arising from selecting outcomes for publication based on the results , affects many r and omized trials and ‘ is an under-recognized problem that affects the conclusions in a substantial proportion of Cochrane review s ’ . That bias is likely to affect systematic review s more widely as well as affecting individual studies when considered on their own . Similar problems occur with clinical audit , highlighting the importance of establishing national audits that use and report the same outcomes for all participants . All these issues could be addressed with the development and application of agreed st and ardized sets of outcomes that have been termed ‘ core outcome sets ’ . These should be measured and reported , as a minimum , in all relevant clinical trials and national clinical audits for a specific condition . Adopting a core outcome set does not imply that a particular study , review or audit should be restricted to only those outcomes . Rather , the expectation is that , as a minimum , core outcomes will always be collected and reported to allow the results of trials to be compared , contrasted and combined as appropriate . The adoption of core outcomes would have implication s across all areas of research in health and health care , reduce heterogeneity between trials , and lead to research that is more likely to have measured relevant outcomes . Importantly , they would enhance the value of evidence synthesis by reducing the risk of outcome reporting bias and ensuring that all trials contribute usable information . In addition , they will increase the efficiency and value of research . An important rationale for core outcome sets is that outcomes currently reported for trials do not consistently reflect endpoints that are meaningful for patients . Examples exist where trials failed to include all outcomes important to patients and where involvement of patients has identified an outcome that might not have been considered by practitioners on their own . Despite increasing recognition of the importance of incorporating patients ’ opinions , their involvement has been limited . Recent regulatory guidance in the USA requires documented evidence of patient input during the development of instruments to measure patient reported outcomes ( PROs ) . However , measurement of PROs in clinical trials is hampered by the multiplicity and heterogeneity of tools currently available . Many generic , disease and domain-specific instruments have been developed and vali date d , each containing multiple scales and items . As a result , synthesis of PRO data from trials is difficult and review s aim ing to summarize treatment effect according to PROs may fail . There is synergy between the development of core outcome sets for trials and work to select up to seven outcomes that are important to patients for inclusion in Summary of Findings tables in systematic review s. Developed by the GRADE group ( http://www . grade workinggroup.org ) , Cochrane review s have featured such tables since 2008 , and they play a key role in presenting research in guidelines , such as those produced by the World Health Organization ( WHO ) . The development of core outcome sets needs to be accelerated and undertaken in ways that maximize efficiency . The COMET ( Core Outcome Measures in Effectiveness Trials , http://www.comet-initiative.org ) Initiative in the UK brings together research ers interested in the development and application of core outcome sets . These include key participants in a collaboration of research ers in rheumatology who have done the most notable work to date in this area . The COMET Initiative was launched in January 2010 , with a second meeting in July 2011 . Attendees included trialists , systematic review ers , patients , clinicians , journal editors , research funders , policy-makers , people responsible for trials registries and regulators . Data on individual studies , both published and ongoing , are being included in a free , publically available internet-based re source . This will be up date d periodically , to minimize the risk of duplication . Seventy-eight published or ongoing studies have already been entered into the repository . In addition , published review s of outcomes used in clinical trials or studies examining patients ’ views , will be entered",
"OBJECTIVE To determine the effects of an eicosapentaenoic acid (EPA)-rich oil and a docosahexaenoic acid (DHA)-rich oil versus an ω-6 polyunsaturated fatty acid-rich safflower oil ( control ) on literacy and behavior in children with attention-deficit/hyperactivity disorder ( ADHD ) in a r and omized controlled trial . METHODS Supplements rich in EPA , DHA , or safflower oil were r and omly allocated for 4 mo to 90 Australian children 7 to 12 y old with ADHD symptoms higher than the 90th percentile on the Conners Rating Scales . The effect of supplementation on cognition , literacy , and parent-rated behavior was assessed by linear mixed modeling . Pearson correlations determined associations between the changes in outcome measurements and the erythrocyte fatty acid content ( percentage of total ) from baseline to 4 mo . RESULTS There were no significant differences between the supplement groups in the primary outcomes after 4 mo . However , the erythrocyte fatty acid profiles indicated that an increased proportion of DHA was associated with improved word reading ( r = 0.394 ) and lower parent ratings of oppositional behavior ( r = 0.392 ) . These effects were more evident in a subgroup of 17 children with learning difficulties : an increased erythrocyte DHA was associated with improved word reading ( r = 0.683 ) , improved spelling ( r = 0.556 ) , an improved ability to divide attention ( r = 0.676 ) , and lower parent ratings of oppositional behavior ( r = 0.777 ) , hyperactivity ( r = 0.702 ) , restlessness ( r = 0.705 ) , and overall ADHD symptoms ( r = 0.665 ) . CONCLUSION Increases in erythrocyte ω-3 polyunsaturated fatty acids , specifically DHA , may improve literacy and behavior in children with ADHD . The greatest benefit may be observed in children who have comorbid learning difficulties"
] | 41169836-06ff-11f0-808a-c43d1ab1c353 |
Contact force ( CF ) monitoring can be useful in accomplishing circumferential pulmonary vein ( PV ) isolation for atrial fibrillation ( AF ) . This meta- analysis aim ed to assess the efficacy and safety of a CF-sensing catheter in treating AF . R and omized controlled trials or non-r and omized observational studies comparing AF ablation using CF-sensing or st and ard non-CF (NCF)-sensing catheters were identified from PubMed , EMBASE , Cochrane Library , Wanfang Data , and China National Knowledge Infrastructure ( January 1 , 1998–2016 ) . A total of 19 studies were included . The primary efficacy endpoint was AF recurrence within 12 months , which significantly improved using CF-sensing catheters compared with using NCF-sensing catheters [ 31.1 % vs. 40.5 % ; risk ratio (RR)=0.82 ; 95 % confidence interval ( CI ) , 0.73–0.93 ; p the acute PV reconnection ( 10.1 % vs. 24.2 % ; RR=0.45 ; 95 % CI , 0.32–0.63 ; p incidence of major complications ( 1.8 % vs. 3.1 % ; OR=0.59 ; 95 % CI , 0.37–0.95 ; p CF-sensing catheters compared with using NCF-sensing catheters . Procedure parameters such as procedure duration [ mean difference (MD)=-28.35 ; 95 % CI , -39.54 to -17.16 ; p ] , ablation time ( MD=-3.8 ; 95 % CI , -6.6 to -1.0 ; p fluoroscopy duration ( MD=-8.18 ; 95 % CI , -14.11 to -2.24 ; p ) , and radiation dose ( st and ard MD=-0.75 ; 95 % CI , -1.32 to -0.18 ; p using CF-sensing catheters . CF-sensing catheter ablation of AF can reduce the incidence of major complications and generate better outcomes compared with NCF-sensing catheters during the 12-month follow-up period | [
"BACKGROUND Contact force ( CF ) monitoring could be useful in accomplishing circumferential pulmonary vein ( PV ) isolation ( CPVI ) for atrial fibrillation ( AF ) . OBJECTIVE The purpose of this study was to compare procedure parameters and outcomes between CF-guided and non-guided CPVI . METHODS Thirty-eight consecutive AF patients ( mean age 60 ± 11 years , 28 paroxysmal AF ) undergoing CPVI were r and omized to non-CF-guided ( n = 19 ) and CF-guided ( n = 19 ) groups . CPVI was performed with the ThermoCool SmartTouch catheter in both groups . The end-point was bidirectional block between the left atrium ( LA ) and PV . In the CF group , CF was kept between 10 and 20 g during CPVI , whereas in the non-CF group , all CF information was blanked . Radiofrequency energy at 30 W in the anterior and 25 W in the posterior LA wall was applied for 20 - 25 seconds at each point . RESULTS CPVI was successfully accomplished without any major complications in both groups . Mean CF in the non-CF and CF groups were 5.9 ± 4.5 g and 11.1 ± 4.3 g , respectively , for left-side CPVI , and 9.8 ± 6.6 g and 12.1 ± 4.8 g , respectively , for right-side CPVI ( both P The procedure and fluoroscopy times for CPVI in the non-CF and CF groups were 96 ± 39 minutes and 59 ± 16 minutes , respectively ( P respectively . Total number of residual conduction gaps was 6.3 ± 3.0 in the non-CF group and 2.8 ± 1.9 in the CF group ( P free from any atrial tachyarrhythmias ( P = .34 ) . CONCLUSION CF-guided CPVI is effective in reducing procedure time and additional touch-up ablation and may improve long-term outcome ",
"Background The aim of this study was to evaluate the impact of contact force ( CF ) visualization on the incidence of low and high CF during left atrial ( LA ) mapping and pulmonary vein isolation ( PVI ) . Methods CF was assessed in 70 patients who underwent PVI . Three highly experienced operators performed all procedures . The operators were blinded to CF in group A ( 35 patients ) , and CF was displayed in group B ( 35 patients ) . In group B , optimal CF was defined as mean CF between 10 and 39 g , and operators attempted to acquire points and ablate within this range . Results A total of 8401 mapping points were analyzed during LA mapping ( group A : 4104 , group B : 4297 ) . Low CF , CF was significantly lower ( 7.7 vs. 12.2 g , P PVI was successfully achieved in all patients . There were significant site-dependent CF differences between the two groups . Optimal CF was achieved in significantly more applications in group B ( P in atrial fibrillation ( AF ) recurrence rates after a minimum follow-up of 1 year between the two groups in this cohort ( P = 0.24 ) . No significant peri-procedural complications occurred in either group . Conclusions CF visualization can assist in avoiding both low and high CF , which may have the potential to improve lesion formation and patient safety profile . In this study , CF-guided ablation did not affect AF recurrence",
"Purpose We prospect ively investigated the differences in pulmonary vein reconnections ( PVRs ) and clinical outcomes between contact force (CF)-guided and conventional circumferential PV isolation ( CPVI ) of atrial fibrillation ( AF ) . Methods One hundred twenty consecutive AF patients ( 63 ± 10 years ; 88 males ) undergoing an initial CPVI were r and omized to ablation with a target CF of 20 g ( CF group ; n = 60 ) or that with operators blinded to the CF information ( blind group ; n = 60 ) . Results The CF group had fewer PVRs ( 0.67 ± 0.91/patient vs. 1.16 ± 1.16/patient ; P = 0.007 ) , a lower incidence of persistent PVRs ( 13.2 vs. 41.2 % ; P shorter procedural time for the CPVI ( 50 vs. 56 min ; P = 0.019 ) than the blind group . The mean CF was higher in the CF group than the blind group ( 18.0 vs. 16.1 g ; P the mean CF was a negative predictor of PVRs along the P-RPVs and A-LPVs in the blind group ( odds ratios , 0.728 and 0.786 ; P , the arrhythmia-free survival rate at 12 months was 89.9 % in the CF group and 88.2 % in the blind group , respectively ( P = 0.624 ) . Conclusions CF-guided CPVI can reduce PVRs and the procedural time and be particularly beneficial along regions where a relatively low CF tends to be applied : the P-RPVs and A-LPVs . The comparable clinical outcomes may be due to the learning curve effect obtained by the CF-guided technique and repeated provocation of dormant PV conduction",
"Aims A challenge of pulmonary vein isolation ( PVI ) in catheter ablation for paroxysmal atrial fibrillation ( PAF ) is electrical reconnection of the PV . EFFICAS I showed correlation between contact force ( CF ) parameters and PV durable isolation but no prospect i ve evaluation was made . EFFICAS II was a multicentre study to prospect ively assess the impact of CF guidance for an effective reduction of PVI gaps . Methods and results Pulmonary vein isolation using a radiofrequency ( RF ) ablation catheter with an integrated force sensor ( TactiCath ™ ) was performed in patients with PAF . Operators were provided EFFICAS I-based CF guidelines [ target 20 g , range 10–30 g , minimum 400 g s force-time integral ( FTI ) ] . Conduction gaps were assessed by remapping of PVs after 3 months , and gap rate was compared with EFFICAS I outcome . At follow up , 24 patients had 85 % of PVs remaining isolated , compared with 72 % in EFFICAS I ( P = 0.037 ) in which CF guidelines were not used . The remaining 15 % of gaps correlated to the number of catheter moves at creating the PVI line , quantified as Continuity Index . For PV lines with contiguous lesions and low catheter moves , durable isolation was 81 % in EFFICAS I and 98 % in EFFICAS II ( P = 0.005 ) . At index procedure , the number of lesions was reduced by 15 % in EFFICAS II vs. EFFICAS I. Conclusion The use of CF with the above guidelines and contiguous deployment of RF lesions in EFFICAS II study result ed in more durable PVI in catheter ablation of PAF",
"AIMS The aim of this study was to evaluate the ' real-world ' impact of a novel contact force (CF)-sensing ( SmartTouch ™ , Biosense Webster , Diamond Bar , CA , USA ) catheter coupled with an advanced catheter location ( ACL ) system on fluoroscopy time and fluoroscopy dose during atrial fibrillation ( AF ) ablation . METHODS AND RESULTS This was a retrospective observational cohort study of prospect ively collected data of 1515 consecutive patients undergoing paroxysmal AF ( PAF ) and persistent AF ( PerAF ) ablation at a single institution between 2009 and 2014 . Patients undergoing AF ablation with the SmartTouch catheter and the ACL system ( SmartTouch group , n = 510 ) were compared with those undergoing AF ablation without this technology ( control group , n = 1005 ) . The primary outcomes were total fluoroscopy time ( min ) and fluoroscopy dose as measured by the dose-area product ( mGy cm(2 ) ) . Secondary endpoints included total procedure time , total ablation time , and major cardiac complications ( tamponade , pericardial effusion , and urgent cardiac surgery ) . The SmartTouch group had significantly lower fluoroscopy times ( 9.5 vs. 41 min , P radiation doses ( 1044 vs. 3571 mGy cm(2 ) , P shorter procedural time ( 195 vs. 240 min , P a median fluoroscopy time of 3.5 min ( interquartile range 6 ) for all AF ablations was achieved . There was no difference in the rate of cardiac complications ( ∼ 1.5 % ) . CONCLUSION SmartTouch ™ CF-sensing catheter use with ACL ™ during AF ablation significantly reduces fluoroscopy times by 77 % , radiation dose by 71 % , and procedural time by 19 % but does not improve overall safety or the risk of cardiac complications",
"BACKGROUND Electrode-tissue contact is crucial for adequate lesion formation in radiofrequency catheter ablation ( RFCA ) . OBJECTIVE We assessed the impact of direct catheter force measurement on acute procedural parameters during RFCA of atrial fibrillation ( AF ) . METHODS Fifty consecutive patients ( 28 male ) with paroxysmal AF who underwent their first procedure of circumferential pulmonary vein ( PV ) isolation ( PVI ) were assigned to either RFCA using ( 1 ) a st and ard 3.5-mm open-irrigated-tip catheter or ( 2 ) a catheter with contact force measurement capabilities . Using the endpoint of PVI with entry and exit block , acute procedural parameters were assessed . RESULTS Procedural data showed a remarkable decline in ablation time ( radiofrequency time needed for PVI ) from 50.5 ± 15.9 to 39.0 ± 11.0 minutes ( P = 0.007 ) with a reduction in overall procedure duration from 185 ± 46 to 154 ± 39 minutes ( P = 0.022 ) . In parallel , the total energy delivered could be significantly reduced from 70,926 ± 19,470 to 58,511 ± 14,655 Ws ( P = 0.019 ) . The number of acute PV reconnections declined from 36 % to 12 % ( P = 0.095 ) . CONCLUSIONS The use of contact force sensing technology is able to significantly reduce ablation and procedure times in PVI . In addition , energy delivery is substantially reduced by avoiding radiofrequency ablation in positions with insufficient surface contact . Procedural efficacy and safety of this new feature have to be evaluated in larger cohorts",
"Purpose Use of online contact force ( CF ) measurement during circumferential pulmonary vein ( PV ) isolation ( CPVI ) for atrial fibrillation ( AF ) has demonstrated improvements in procedural parameters and mid-term clinical outcome . However , it is unknown if experience gained with CF measuring catheters improves the efficacy of subsequent CPVI procedures performed without CF measurement . Methods This prospect i ve trial compared procedural results of CPVI performed without a CF measuring catheter to a control group performed with a CF measuring catheter , by an operator with prior experience with CF technology .. Results Thirty-six eligible paroxysmal ( n = 27 ) or persistent ( n = 9 ) AF patients were consecutively enrolled . Twelve patients underwent CPVI with the non-CF catheter ( CF− group ) in a recall period and 24 with the CF catheter ( CF+ group ) . After the first circumferential lesion set , the number of PV pairs requiring additional touch-up lesions to achieve electrical isolation was significantly less in the CF+ group ( 2 of 48 ( 4.2 % ) vs. 7 of 24 ( 29.2 % ) in the CF+ and CF− groups , respectively , p = 0.005 ) . The procedure time was significantly lower in the CF+ group ( 117.9 ± 23.3 vs. 134.1 ± 25.3 min , p = 0.033 ) . Radiofrequency ( RF ) and fluoroscopy time did not differ between groups ( 31.5 ± 7.1 vs. 31.8 ± 7.0 min and 11.8 ± 5.6 vs. 11.0 ± 5.8 min in the CF+ and the CF− group , respectively ) Conclusions With the use of online CF measurement , PV isolation is more frequently complete following the first circumferential lesion set . A previous learning period with direct CF feedback is not a substitute for real-time direct CF measurement to maintain this advantage",
"BACKGROUND Sufficient electrode-tissue contact is crucial for adequate lesion formation in radiofrequency catheter ablation ( RFCA ) . OBJECTIVE We assessed the impact of direct catheter force measurement on acute procedural parameters and outcome of RFCA for paroxysmal and persistent atrial fibrillation ( AF ) . METHODS Ninety-nine consecutive patients ( 70 % men ) with paroxysmal ( 63.6 % ) or persistent AF underwent left atrial RFCA using a 3.5-mm open-irrigated-tip ( OIT ) catheter with contact force measurement capabilities ( group 1 ) . For comparison a case-matched cohort with st and ard OIT catheters was used ( 99 patients ; group 2 ) . Case matching included gender , type of AF , number or RFCA procedures , and type of procedure . RESULTS Procedural data showed a significant decline in radiofrequency ablation time from 52 ± 20 to 44 ± 16 minutes ( P = 0.003 ) with a remarkable mean reduction in overall procedure time of 34 minutes ( P = 0.0001 ; 225.8 ± 53.1 vs 191.9 ± 53.3 minutes ) . In parallel , the total fluoroscopy time could be significantly reduced from 28.5 ± 11.0 to 19.9 ± 9.3 minutes ( P = 0.0001 ) as well as fluoroscopy dose from 74.1 ± 58.0 to 56.7 ± 38.9 Gy/cm(2 ) ( P = 0.016 ) . Periprocedural complications were similar in both groups . CONCLUSIONS The use of contact force sensing technology is able to significantly reduce ablation , procedure , and fluoroscopy times as well as dose in RFCA of AF in a mixed case-matched group of paroxysmal and persistent AF . Energy delivery is substantially reduced by avoiding radiofrequency ablation in positions with insufficient surface contact . Additionally 12-month outcome data showed increased efficacy . Such time saving and equally safe technology may have a relevant impact on laboratory management and increased cost effectiveness",
"BACKGROUND Catheter-based contact force sensing ( CFS ) technology gives detailed information regarding contact between the catheter tip and myocardium . This may result in more effective ablation procedures . The primary objective of this study was comparison of remote robotic navigation ( RRN ) and Manual CFS ablation . The secondary objective was to compare CFS with non-CFS ablation for both navigation modes . METHODS Prospect i ve registries of consecutive cases undergoing their first ablation for persistent atrial fibrillation ( AF ) from six hospitals in the United Kingdom and South Africa were analyzed : 50 Manual/CFS and 50 RRN/CFS cases were included . Historical control non-CFS ablation patients were matched by propensity score , giving a total 200 patient cohort . RESULTS RRN/CFS was associated with improved single procedure 1-year success rates ( 64 % vs 36 % , P = 0.01 ) and shorter fluoroscopy times ( 41 % reduction , P procedure times ( P = 0.8 ) . The mean contact force was higher in RRN/CFS than Manual/CFS cases ( 16 [ 15 - 18 g ] vs 13 [ 12 - 15 g ] , respectively , P = 0.003 ) . Compared with non-CFS historical controls , CFS cases had higher 1-year success rates for RRN ( 64 % vs 36 % , P = 0.01 ) , but not Manual ablation ( 36 % vs 38 % , P = 1 ) . Procedure times were reduced for CFS cases ( 20 % , P fluoroscopy times ( Manual : 43 % , RRN 83 % , P rates of major or minor complications for either comparison ( P > 0.5 ) . CONCLUSIONS A combination of RRN and CFS is associated with improved success rates at 1 year and fluoroscopy times for persistent AF ablation , compared with Manual ablation and non-CFS RRN ablation",
"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 )",
"Background — Contact force ( CF ) is a major determinant of lesion size and transmurality and has the potential to improve efficacy of atrial fibrillation ablation . This study sought to evaluate the safety and effectiveness of a novel irrigated radiofrequency ablation catheter that measures real-time CF in the treatment of patients with paroxysmal atrial fibrillation . Methods and Results — A total of 300 patients with symptomatic , drug-refractory , paroxysmal atrial fibrillation were enrolled in a prospect i ve , multicenter , r and omized , controlled trial and r and omized to radiofrequency ablation with either a novel CF-sensing catheter or a non-CF catheter ( control ) . The primary effectiveness end point consisted of acute electrical isolation of all pulmonary veins and freedom from recurrent symptomatic atrial arrhythmia off all antiarrhythmic drugs at 12 months . The primary safety end point included device-related serious adverse events . End points were powered to show noninferiority . All pulmonary veins were isolated in both groups . Effectiveness was achieved in 67.8 % and 69.4 % of subjects in the CF and control arms , respectively ( absolute difference , −1.6 % ; lower limit of 1-sided 95 % confidence interval , −10.7 % ; P=0.0073 for noninferiority ) . When the CF arm was stratified into optimal CF ( ≥90 % ablations with ≥10 g ) and nonoptimal CF groups , effectiveness was achieved in 75.9 % versus 58.1 % , respectively ( P=0.018 ) . The primary safety end point occurred in 1.97 % and 1.40 % of CF patients and control subjects , respectively ( absolute difference , 0.57 % ; upper limit of 1-sided 95 % confidence interval , 3.61 % ; P=0.0004 for noninferiority ) . Conclusions — The CF ablation catheter met the primary safety and effectiveness end points . Additionally , optimal CF was associated with improved effectiveness . Clinical Trial Registration — http://www . clinical trials.gov . Unique identifier : NCT01278953",
"INTRODUCTION The additional benefit of contact force ( CF ) technology during pulmonary vein isolation ( PVI ) for paroxysmal atrial fibrillation ( AF ) to improve mid-term clinical outcome is unclear . METHODS AND RESULTS Eligible patients with symptomatic paroxysmal AF were enrolled in this prospect i ve trial , comparing circular antral catheter ablation ( guided by Carto 3 System , Biosense Webster ) using either a new open-irrigated CF catheter ( SmartTouch Thermocool , Biosense Webster ) ( CF group ) or a non-CF open-irrigated catheter ( EZ Steer Thermocool , Biosense Webster ) ( control group ) . Overall , 30 patients were enrolled in each group , with a st and ardized 12-month follow-up , free of antiarrhythmic therapy . Demographic , cardiovascular and anatomic characteristics were similar in both groups . Though complete PVI was eventually achieved in all cases in both groups , success using an exclusive anatomic approach was 80.0 % in CF group versus 36.7 % in control group ( P fluoroscopy exposure ( P radiofrequency time ( P = 0.01 ) . The incidence rates of AF recurrence were 10.5 % ( 95 % CI , 1.38 - 22.4 ) in the CF group , and 35.9 % ( 95 % CI , 12.4 - 59.4 ) in the control group ( log rank test , P = 0.04 ) . After adjustment on potential confounders , the use of CF catheter was found to be associated with a lower AF recurrence ( OR 0.18 , 95 % CI 0.04 - 0.94 , P = 0.04 ) . CONCLUSION Our findings suggest a potential benefit of real-time CF sensing technology , in reducing AF recurrence during the first year after PVI",
"BACKGROUND Contact force ( CF ) sensing catheters provide advantages with regard to safety and efficacy . This study aim ed to evaluate if CF catheters reduce cardiac perforations and other major complications and offer equal safety compared to the magnetic navigation system ( MNS ) . METHODS Data from 1.517 ablation procedures from our prospect i ve registry was analyzed . Ablations were performed using either CF guided catheters ( CF group , n=248 ) , non-CF catheters ( NCF group , n=813 ) , or MNS ( n=456 ) . Four subgroups were analyzed : atrial fibrillation ( AF , n=557 ) , supraventricular tachycardia ( SVT , n=715 ) , ventricular tachycardia ( VT , n=190 ) and patients with congenital heart defects ( CHD , n=55 ) . The primary endpoint of this study was incidence of cardiac perforation . Secondary endpoints were major and minor complications within 30 days of the procedure . RESULTS Complications occurred in 11.3 % ( n=172 ) of the procedures . In 2.8 % ( n=43 ) a major complication occurred , 0.9 % ( n=13 ) had a perforation , 8.5 % ( n=129 ) had a minor complication and 2 patients died ( 0.1 % ) . No cardiac perforation occurred in the CF group , which was significantly different from NCF procedures ( 0.0 % vs. 1.6 % ; relative risk 0.76 , 95 % CI 0.74 - 0.79 , P=0.031 ) and equal to MNS ( 0.0 % ) . This was also observed in the AF subgroup ( 0.0 % vs. 3.3 % ; RR 0.67 , 95 % CI 0.63 - 0.72 , P=0.021 ) , and the occurrence of major complications was lower for CF versus NCF procedures ( 2.1 % vs. 7.8 % , P=0.010 ) . CONCLUSIONS CF-guided catheter ablation is superior to NCF with regard to procedural safety and avoidance of cardiac perforation . This difference is due to a reduction of cardiac perforation and major complications in the AF subgroup",
"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"
] | 41169872-06ff-11f0-808a-c43d1ab1c353 |
Background Patients often ask their doctors when they can safely return to driving after orthopaedic injuries and procedures , but the data regarding this topic are diverse and sometimes conflicting . Some studies provide observer-reported outcome measures , such as brake response time or simulators , to estimate when patients can safely resume driving after surgery , and patient survey data describing when patients report a return to driving , but they do not all agree . We performed a systematic review and quality appraisal for available data regarding when patients are safe to resume driving after common orthopaedic surgeries and injuries affecting the ability to drive . Questions / purpose sBased on the available evidence , we sought to determine when patients can safely return to driving after ( 1 ) lower extremity orthopaedic surgery and injuries ; ( 2 ) upper extremity orthopaedic surgery and injuries ; and ( 3 ) spine surgery . Methods A search was performed using PubMed and EMBASE ® , with a list of 20 common orthopaedic procedures and the words “ driving ” and “ brake ” . Selection criteria included any article that evaluated driver safety or time to driving after major orthopaedic surgery or immobilization using observer-reported outcome measures or survey data . A total of 446 articles were identified from the initial search , 48 of which met inclusion criteria ; abstract -only publications and non-English- language articles were not included . The evidence base includes data for driving safety on foot , ankle , spine , and leg injuries , knee and shoulder arthroscopy , hip and knee arthroplasty , carpal tunnel surgery , and extremity immobilization . Thirty-four of the articles used observer-reported outcome measures such as total brake time , brake response time , driving simulator , and st and ardized driving track results , whereas the remaining 14 used survey data . Results Observer-reported outcome measures of total brake time , brake response time , and brake force postoperatively suggested patients reached presurgical norms 4 weeks after right-sided procedures such as TKA , THA , and ACL reconstruction and approximately 1 week after left-sided TKA and THA . The collected survey data suggest patients resumed driving 1 month after right-sided and left-sided TKAs . Patients who had THA reported returning to driving between 6 days and 3 months postoperatively . Observer-reported outcome measures showed that patients ’ driving abilities often are impaired when wearing an immobilizing cast above or below the elbow or a shoulder sling on their dominant arm . Patients reported a return to driving on average 2 months after rotator cuff repair procedures and approximately 1–3 months postoperatively for total shoulder arthroplasties . Most patients with spine surgery had normal brake response times at the time of hospital discharge . Patients reported driving 6 weeks after total disc arthroplasty and anterior cervical discectomy and fusion procedures . Conclusions The available evidence provides a best-case scenario for when patients can return to driving . It is important for observer-reported outcome measures to have normalized before a patient can consider driving , but other factors such as strength , ROM , and use of opioid analgesics need to be considered . This review can provide a guideline for when physicians can begin to consider evaluating these other factors and discussing a return to driving with patients . Survey data suggest that patients are returning to driving before observer-reported outcome measures have normalized , indicating that physicians should tell patients to wait longer before driving . Further research is needed to correlate observer-reported outcome measures with adverse events , such as motor vehicle accidents , and clinical tests that can be performed in the office . Level of Evidence Level III , therapeutic | [
"OBJECTIVE To show the possible effect of left- and right-side total hip arthroplasty ( THA ) on the ability to perform an emergency stop when driving a car . DESIGN Inception cohort . SETTING A driving simulator using an actual car cabin , specifically developed for the experiment , was used for testing driving ability . PARTICIPANTS Patients ( N=40 ; 20 left-side THA/20 right-side THA ) were tested preoperatively and in increments of 8 days and 6 , 12 , and 52 weeks after surgery . INTERVENTIONS Left- and right-side THA . MAIN OUTCOME MEASURES Reaction time , movement time , total brake response time ( TBRT ) , and maximum brake force . RESULTS Eight days postoperatively , measurements on driving performance indicated a slight worsening for all outcome parameters in patients after left-side THA and considerably more worsening in patients after right-side THA . For both patient groups , significant improvements in outcome measures were noted during the 1-year follow-up . Brake force declined significantly in patients with left-side THA ( P=.012 ) and in patients after right-side THA ( P right-side THA and 15 % with left-side THA could not meet the 600 ms TBRT threshold 6 weeks postoperatively . CONCLUSIONS Most patients who underwent right-side THA reached their preoperative baseline 6 weeks after surgery . Most of the patients with left-side THA showed no TBRT limitations 8 days postoperatively . Because of the patients ' highly individual rehabilitation course and considering the possible consequences of the premature resumption of driving a motor vehicle , individual examination and recommendation are necessary",
"Doctors are frequently asked by patients whether it is safe to drive with an upper limb immobilised in a cast . In the literature there are no objective measurements of the effects of upper-limb immobilisation upon driving performance . Eight healthy volunteers performed four 20-min driving circuits in a driving simulator ( STISIM 400W ) , circuits 1 and 4 without immobilisation and circuits 2 and 3 with immobilisation . Immobilisation involved a lightweight below-elbow cast with the thumb left free . Volunteers were r and omised to right or left immobilisation for circuit 2 , and the contralateral wrist was immobilised for circuit 3 . Circuits included urban and rural environments and specific hazards ( pedestrians crossing , vehicles emerging from a concealed entrance , traffic lights changing suddenly , avoidance of an oncoming vehicle in the driver 's carriageway ) . Limb immobilisation led to more cautious rural and urban driving , with less adjustment of speed and lateral road position than when unrestricted . However when responding to hazards immobilisation caused less safe driving , with higher speeds , a greater proximity to the hazard before action was taken and less steering adjustment . The effects of restriction upon performance were more prevalent and severe with right-arm immobilisation . Upper-limb immobilisation appears to have little effect on the ability to drive a car unchallenged , but to adversely affect responses to routine hazards . Advice on ability to drive safely should be cautious , as the impact of immobilisation appears to be more subtle and wide ranging than previously thought",
"PROBLEM To develop appropriate assessment criteria to measure the performance of older drivers using an interactive PC-based driving simulator , and to determine which measures were associated with the occurrence of motor-vehicle crash . METHOD One hundred and twenty-nine older drivers residing in a metropolitan city volunteered to participate in this retrospective cohort study . Using the driving simulator , appropriate driving tasks were devised to test the older drivers , whose performances were assessed by 10 reliable assessment criteria . Logistic regression analysis was then undertaken to determine those criteria that influence the self-reported crash outcome . RESULTS As expected , driving skill of older drivers was found to decline with age . Over 60 % of the sample participants reported having at least one motor-vehicle crash during the past year . Adjusting for age in a logistic regression analysis , the cognitive abilities associated with the crash occurrence were working memory , decision making under pressure of time , and confidence in driving at high speed . SUMMARY The findings of this retrospective study indicated those individuals at inflated risk of vehicle crashes could be identified using the PC-based interactive driving simulator . Prospect i ve studies need to be undertaken to determine whether the driving simulator can predict future crash events . IMPACT ON INDUSTRY This study demonstrated an economical driving simulator approach to screen out problematic or unsafe older drivers before a more detailed but expensive road test is considered",
"Patients undergoing total knee arthroplasty often ask when they can safely resume car driving . There is little evidence available on which physicians can rely when advising patients on this issue . In a prospect i ve study we assessed the brake response time of 24 patients admitted to the clinic for left total knee arthroplasty preoperatively and then 10 days after surgery . On each measurement day the patients performed two tasks , a simple and a complex brake response time task in a car simulator . Ten days after left TKA the brake response time for the simple task had decreased by 3.6 % ( p=0.24 ) , the reaction time by 3.1 % ( p=0.34 ) and the movement time by 6.6 % ( p=0.07 ) . However , the performance improvement was not statistically significant . Task complexity increased brake response time at both time points . A 5.8 % increase was significant ( p=0.01 ) at 10 days after surgery . Based on our results , we suggest that patients who have undergone left total knee arthroplasty may resume car driving 10 days after surgery as long as they drive a car with automatic transmission",
"BACKGROUND The purpose of this study was to evaluate the effect of sling immobilization on driving performance with use of a driving simulator . METHODS This is a prospect i ve trial with a cohort of 21 healthy volunteers comparing their driving ability with and without sling immobilization on their dominant ( driving ) extremity . Multiple variables , including number of collisions , off-road excursions , and centerline crossings , were measured with a vali date d driving simulator . Trials were separated by 2 weeks to control for \" adaptations \" to the simulator . Statistical significance was found in collisions between sling and no-sling tests . RESULTS The total number of collisions for trial 1 ( no sling ) was 36 ( mean , 1.7 ± 1.2 ) compared with 73 ( 3.7 ± 1.6 ) ( P ( sling immobilization ) . Approximately 70 % of participants with upper extremity immobilization were involved in ≥3 collisions ; approximately 70 % of no-sling participants were involved in ≤2 collisions . There was no statistically significant difference between groups with respect to overall vehicle road position and control . CONCLUSION Sling immobilization of the dominant driving arm results in a decrease in driving performance and safety with respect to the number of collisions in a simulated driving circuit ( P driving performance with respect to the number of collisions is likely to be related to the effect the immobilized arm has on effectively performing evasive maneuvers during hazardous driving conditions",
"Study Design Prospect i ve study . Objective Surgeons ’ recommendations for a safe return to driving following cervical and lumbar surgery vary and are based on empirical data . Driver reaction time ( DRT ) is an objective measure of the ability to drive safely . There are limited data about the effect of cervical and lumbar surgery on DRT . The purpose of our study was to use the DRT to determine when the patients undergoing a spinal surgery may safely return to driving . Methods We tested 37 patients ’ DRT using computer software . Twenty-three patients ( mean 50.5 ± 17.7 years ) received lumbar surgery , and 14 patients had cervical surgery ( mean 56.7 ± 10.9 years ) . Patients were compared with 14 healthy male controls ( mean 32 ± 5.19 years ) . The patients having cervical surgery were subdivided into the anterior versus posterior approach and myelopathic versus nonmyelopathic groups . Patients having lumbar spinal surgery were subdivided by decompression versus fusion with or without decompression and single-level versus multilevel surgery . The patients were tested preoperatively and at 2 to 3 , 6 , and 12 weeks following the surgery . The use of opioids was noted . Results Overall , the patients having cervical and lumbar surgery showed no significant differences between pre- and postoperative DRT ( cervical p = 0.49 , lumbar p = 0.196 ) . Only the patients having single-level procedures had a significant improvement from a preoperative DRT of 0.951 seconds ( st and ard deviation 0.255 ) to 0.794 seconds ( st and ard deviation 0.152 ) at 2 to 3 weeks ( p = 0.012 ) . None of the other subgroups had a difference in the DRT . Conclusions Based on these findings , it may be acceptable to allow patients having a single-level lumbar fusion who are not taking opioids to return to driving as early as 2 weeks following the spinal surgery ",
"OBJECTIVE Recommendations on safe driving after anterior cruciate ligament ( ACL ) reconstruction have been largely intuitive . We studied brake response time in patients who participated in outpatient rehabilitation after right ACL reconstruction . DESIGN Prospect i ve , repeated measures design comparing 14 patients post-ACL reconstruction with 21 subjects with normal knees . INTERVENTIONS AND MAIN OUTCOME MEASURES The following measures were assessed every 2 weeks for 10 weeks : brake response time , 6-meter walk time , knee range of motion , pain , and joint effusion . Statistical testing used analysis of covariance with repeated measures . Significant variables were analyzed separately and post hoc tests conducted using the least squares differences method . Both groups were compared with published norms from the American Automobile Association . RESULTS No significant gender differences across main effects were detected . Brake response times for men improved significantly after week 6 ( p Brake response times for women in the ACL treatment group matched controls at 6 weeks . Six-meter walk times for control subjects were faster than those for the ACL group preoperatively ( 2.6 sec vs 5.5 sec ) , but equalized by week 6 . CONCLUSIONS After right ACL reconstruction , brake reaction times of rehabilitated men and women matched those of established controls after 4 to 6 weeks . Measuring brake response times during rehabilitation may ensure that individual patients return to driving in a safe and timely manner",
"Study Design . Prospect i ve observational pilot study . Objective . To investigate the effect of right and left radiculopathy on driver reaction time ( DRT ) , and the effect of selective nerve root block ( SNRB ) on DRT . Summary of Background Data . The effect of many orthopedic procedures on DRT has already been assessed . To date the effect of radiculopathy and SNRB on DRT has not been studied . Methods . DRTs of 20 radiculopathic patients ( 10 right , 10 left ) were measured using a custom-built car simulator . Each patient was tested pre-SNRB , immediately post-SNRB , and 2 and 6 weeks post-SNRB . As controls 20 age- and sex-matched normal subjects were tested once . Full departmental , institutional , and ethical committee approval were obtained . Results . Mean DRT of the control group was 452 milliseconds . Mean DRT of patients with right or left radiculopathy pre-SNRB was 521 milliseconds ( P stopping distance of 3.8 and 1.9 m , respectively at the speed of 100 km/h . In the left radiculopathic group , the measurements immediately post-SNRB , 2 weeks , and 6 weeks were 585 milliseconds ( P stopping distance of 1.4 m at the speed of 100 km/h . Conclusion . The study identified significant DRTs ’ changes both in radiculopathy and after SNRB . Right and left radiculopathic patients should be advised about the possible changes in their DRTs post-SNRB . Future research with regard to the suitability for radiculopathic patients to drive and the best time to resume driving post-SNRB is needed",
"Purpose Reduced driving reaction time ( DRT ) has already been studied in context with lumbar disc surgeries . Data on whether cervical spine pathologies impair driving abilities are still lacking . In addition , no return-to-driving recommendations after anterior cervical fusion procedures have been published . Therefore , we assessed DRT before and after anterior cervical discectomy and fusion . Methods We performed a prospect i ve study with 12 patients ( mean age 47.2 years ; female 7 , male 5 ) . DRT as well as arm and neck pain were evaluated before surgery , on the day before discharge from hospital and at the 4–6-week follow-up examinations . 31 healthy subjects were tested for DRT as a control group . Results All patients showed significant improvement in DRT in the longitudinal course ( p DRT was 601 ms ( median , IQR : 63 ) before surgery , which was reduced to 580 ms ( median , IQR : 112 ) on the day before discharge from hospital and to 532 ms ( median , IQR : 48 ) at follow-up examination . Control subjects had a driving reaction time of 487 ms ( median , IQR : 116 ) , which differed significantly from that of patients at all three testing times ( p 0.05 ) . VAS for arm and neck pain showed significant improvement ( p anterior cervical discectomy and fusion on driving safety . Based on our data we state that it appears to be safe to resume driving after discharge from hospital . However , patients scheduled to undergo anterior cervical discectomy and fusion should be informed about increased DRT as compared to healthy individuals",
"Background : Because of specific method ological difficulties in conducting r and omized trials , surgical research remains dependent predominantly on observational or non‐r and omized studies . Few vali date d instruments are available to determine the method ological quality of such studies either from the reader 's perspective or for the purpose of meta‐ analysis . The aim of the present study was to develop and vali date such an instrument",
"BACKGROUND CONTEXT The effect of many types of surgeries on driving reaction time ( DRT ) has been reported . Although lumbar disc herniation is one of the most common spinal diseases , the effect on DRT has not been investigated . PURPOSE To assess the effect of left- and right-sided pareses caused by lumbar disc herniation on DRT before and after surgery . STUDY DESIGN Controlled prospect i ve clinical trial . PATIENT SAMPLE Patients undergoing disc surgery . OUTCOME MEASURES Impact of paresis caused by lumbar disc herniation and disc surgery on DRT . METHODS Forty-two consecutive patients ( mean age , 50.3 years ) were tested for DRT 1 day before surgery , postoperatively before hospital discharge , and 5 weeks after surgery . Visual analogue scale ( VAS ) for back and leg pain as well as pain medication and patients ' driving frequency were recorded . RESULTS Significant improvement of DRT after surgery was seen in patients with left- and right-sided pareses ( p preoperative DRT was 761 ms ( median , interquartile range [ IQR ] : 490 ) , 711 ms ( median , IQR : 210 ) immediately postoperatively , and 645 ms ( median , IQR : 150 ) at follow-up ( FU ) . For the left-sided paresis group , DRT was 651 ms ( median , IQR : 270 ) preoperatively , 592 ms ( median , IQR : 260 ) postoperatively , and 569 ms ( median , IQR : 140 ) at FU . Significant differences between right- and left-sided pareses were identified preoperatively and at FU testing ( p correlation was found between VAS for leg or back pain and DRT . Historical control subjects had a DRT of 487 ( median , IQR : 116 ) , which differed significantly at all three test times ( p DRT in patients with right- and left-sided pareses was found after surgery , indicating a positive effect of surgery . The improvement in DRT seen immediately postoperatively and the lack of a generally accepted threshold for DRT would suggest that for both patient sample s , it is safe to continue driving after hospital discharge . However , patients should be informed accordingly",
"BACKGROUND The ability to perform an emergency stop is essential for safe driving and can be represented by total brake-response time , reaction time , and braking time . Immobilization of the lower extremities is routinely performed for a variety of musculoskeletal conditions . This study sought to investigate the effect of immobilization with a left-foot driving adapter , a controlled-ankle-motion device , and a short leg cast on braking times . Our hypothesis was that there would be a significant difference in braking-time values between individuals utilizing a left-foot driving adapter or immobilization device and control individuals wearing normal footwear . METHODS A prospect i ve , observational study was conducted to assess the effect of the immobilization devices on braking times . A driving simulator was used to assess total brake-response time , reaction time , and braking time in thirty-five volunteers . Volunteers were assessed while ( 1 ) wearing normal footwear ( control group ) , ( 2 ) wearing a controlled-ankle-motion boot , ( 3 ) wearing a removable short leg cast , and ( 4 ) employing a left-foot driving adapter . RESULTS The mean total brake-response time was significantly increased as compared with that of the control group in all three study groups . The mean reaction time was significantly increased for the short leg cast and controlled-ankle-motion groups as compared with reaction time in the control group . The mean braking time was significantly increased in the controlled-ankle-motion and left-foot driving-adapter groups as compared with braking time in the control group . CONCLUSIONS Total brake-response time while wearing a controlled-ankle-motion boot or a short leg cast or while utilizing a left-foot driving adapter is significantly increased , or worsened , as compared with the response time while wearing normal footwear . This information may prove valuable to physicians when counseling patients on when it may be safe to return to driving",
"To assess the potential recovery rate of a minimally invasive total hip replacement technique with minimal soft tissue disruption , an accelerated rehabilitation protocol was implemented with weightbearing as tolerated on the day of surgery . One hundred consecutive patients were enrolled in this prospect i ve study . Ninety-seven patients ( 97 % ) met all the inpatient physical therapy goals required for discharge to home on the day of surgery ; 100 % of patients achieved these goals within 23 hours of surgery . Outpatient therapy was initiated in 9 % of patients immediately , 62 % of patients by 1 week , and all patients by 2 weeks . The mean time to discontinued use of crutches , discontinued use of narcotic pain medications , and resumed driving was 6 days postoperatively . The mean time to return to work was 8 days , discontinued use of any assistive device was 9 days , and resumption of all activities of daily living was 10 days . The mean time to walk ½ mile was 16 days . Furthermore , there were no readmissions , no dislocations , and no reoperations . Therefore , a rapid rehabilitation protocol is safe and fulfills the potential benefits of a rapid recovery with minimally invasive total hip arthroplasty",
"OBJECTIVE To study the effects of an increase in task complexity on brake response time ( BRT ) in patients undergoing total knee arthroplasty ( TKA ) . DESIGN A prospect i ve repeated- measures design was used . The measurements took place 1 day before and 10 and 30 days after surgery . SETTING Clinic . PARTICIPANTS The data of patients ( N=21 ) who were admitted for primary total arthroplasty of the right knee were pooled for analysis . INTERVENTIONS On each measurement day patients performed 5 practice and 10 test trials for 2 tasks ( 1 simple , 1 complex ) in a car simulator . Task complexity was increased by adding a second movement to the first task performed . MAIN OUTCOME MEASURES BRT , reaction time ( RT ) , and movement time were assessed . RESULTS An increase in task complexity increased BRT , RT , and movement time at all measurement times . Right TKA increased BRT by increasing movement time . Thirty days after surgery BRT was no longer increased compared with preoperative values in both tasks . CONCLUSIONS Task complexity consistently increased BRT and its components . The effects of task complexity remained constant throughout the 3 measurements . After right TKA , we suggest patients should be advised to wait 30 days after surgery before resuming driving",
"We measured the driver reaction times of 40 patients before total knee replacement ( TKR ) and 4 , 6 , 8 and 10 weeks after operation . The ability to perform an emergency stop was assessed as the time taken to achieve a brake pressure of 100 N after a visual stimulus . There were 18 drivers and 11 non-drivers ; the latter had longer reaction times . In drivers , the ability to transfer the right foot from accelerator to brake pedal did not recover to preoperative levels for eight weeks after right TKR and was unchanged after left TKR . Patients should be advised that they should not drive for at least eight weeks after right TKR",
"This study assessed recovery from open carpal tunnel surgery . One hundred and twelve operations in 75 patients ( 38 unilateral , 37 bilateral ) were review ed prospect ively . A vali date d question naire was completed pre- and postoperatively . Additional information was collected regarding symptom severity at regular intervals following surgery . The time to regain all evaluated activities of daily living was 13 ( range 1–90 , median 7 ) days . Return to driving took 9 days and return to work 17 days , even although exactly half of the patients underwent simultaneous bilateral operations . We did not find any significant differences in the time to resumption of activities of daily living or work between the patients who underwent unilateral or bilateral procedures , or between those who underwent surgery to the dominant or non-dominant h and . Overall improvement in symptoms and function was no worse in patients undergoing simultaneous bilateral procedures as compared with unilateral procedures",
"BACKGROUND The aim of this study was to determine whether immobilization of an arm has detrimental effects on driving performance . METHODS Thirty-six healthy officers-in-training were assigned a sequence of fiberglass splints ( left and right-sided above-the-elbow thumb spica and below-the-elbow splints ) with use of a r and omized higher-order crossover design . Runs were scored on a cone-marked driving course used for officer certification with predetermined passing requirements . Driving time , the number of cones hit per course section , and the cone-adjusted total time ( a five-second penalty per hit cone ) were recorded . A linear mixed-effect model with r and om environmental and learning effects for cone-adjusted time analysis was used . Participants rated perceived driving difficulty and safety with each splint , and ratings were compared with the Wilcoxon signed-rank test . RESULTS Thirty participants completed the entire set of runs . Analysis of total cone-adjusted time revealed a significant performance decrease with the left arm in an above-the-elbow thumb spica splint ( average , 22.2 seconds ; p left arm in a below-the-elbow splint ( average , 16.2 ; p = 0.007 ) . Analysis of forward-only course sections revealed poorer performance trends with all splints , with the worst performance with the left arm in an above-the-elbow thumb spica splint . Driving with the left arm in an above-the-elbow thumb spica splint had the highest perceived difficulty ( median , 8.0 ) and lowest perceived safety ( median , 3.0 ) . CONCLUSIONS Driving performance as measured with a st and ardized track and scoring system was significantly de grade d with splint immobilization of the left arm . Further studies are required to determine the effect of arm immobilization on normal driving conditions",
"Purpose Although patients scheduled to undergo lumbar disc surgery often ask when they are allowed to drive a motor vehicle again , there are no published recommendations on this subject . Methods We conducted a prospect i ve study in 46 consecutive patients ( mean age 48.9 years ) to determine driving reaction time ( DRT ) before and after surgery in patients with lumbar disc herniation . Of the patients 23 had left-side radiculopathy and 23 right-side radiculopathy . Driving reaction time as well as back and leg pain were evaluated preoperatively , on the day of discharge from hospital and at the 5-week follow-up examination ( FU ) . 31 healthy subjects were tested as controls . Results Significant improvement in DRT was seen for both patient sample s ( p preoperative DRT was 664 ms ( median , IQR : 241 ) , which was reduced to 605 ms ( median , IQR : 189 ) immediately postoperatively and to 593 ms ( median , IQR : 115 ) at FU . For patients with a left-side radiculopathy DRT was 675 ms ( median , IQR : 247 ) preoperatively , 638 ms ( median , IQR : 242 ) postoperatively and 619 ms ( median , IQR : 162 ) at FU . Pain was moderately correlated to DRT . Control subjects had a driving reaction time of 487 ( median , IQR : 116 ) , which differed significantly from patients at all three testing times ( p driving ability . Therefore , we would suggest that for both patient sample s it is safe to continue driving after hospital discharge . However , patients have to be informed about increased DRT caused by radiculopathy already before surgery",
"Abstract Purported advantages of THA performed with minimally invasive surgical approaches include less muscle damage and faster recovery . The purpose of this preliminary investigation was to determine if differences existed between minimally invasive approaches in hospital discharge and early functional recovery in THA patients with a rapid rehabilitation protocol . Twenty-four consecutive patients were r and omized to one of three minimally invasive surgical approaches ( two-incision , mini-posterior , and mini-anterolateral ) and enrolled in an aggressive postoperative rehabilitation program . Hospital discharge , early functional milestone recovery , and vali date d outcome measures ( SF-36 , WOMAC , Harris hip score , lower extremity activity scale ) were collected . All patients met hospital discharge criteria no later than the first postoperative day . There was no difference in hospital discharge , functional milestone recovery , or vali date d outcome measures during the first year after surgery with the numbers available . There were no complications directly related to early hospital discharge or the aggressive rehabilitation protocol . While the data suggest earlier hospital discharge and rapid rehabilitation protocol s may be implemented successfully we found no difference between the three minimally invasive approaches in early hospital discharge or early functional recovery utilizing a rapid rehabilitation protocol . Level of Evidence : Level IV , therapeutic study . See the Guidelines for Authors for a complete description of levels of evidence",
"INTRODUCTION A new method of treating acute rupture of the Achilles tendon using polyester tape is reported . This requires no postoperative splintage , allows earlier mobilisation and prompt return to work and sport . PATIENTS AND METHODS Thirty patients were review ed prospect ively and at a mean of 3 years from surgery . RESULTS The average time of return to work , full weight-bearing and to driving was 40 days , 45 days and 49 days , respectively . The average time for return to sport was 122 days . Three patients required further surgery , two for infected wounds and one for scar release . There was one sural nerve injury . Twenty-two patients regained a normal range of ankle and subtalar movement , with the mean power of plantar flexion 84 % of the opposite side . Of the 22 patients who played sport , 14 were still performing at the same or a higher level . There were no re-ruptures over this period . CONCLUSIONS The technique is straightforward and avoids splintage . It also conveys other short- and long-term advantages over more established methods",
"Total knee arthroplasty ( TKA ) dramatically decreases pain and improves mobility and quality of life . However , little has been reported on its effect on driving ability in the early postoperative period . This prospect i ve study was conducted to compare preoperative and postoperative brake response times ( BRTs ) in patients undergoing TKA for osteoarthritis . The results showed that patients returned to preoperative BRT as early as 3 weeks after surgery , and at 9 weeks after surgery , BRTs were significantly improved over baseline . Based on BRT analysis patients undergoing TKA may be allowed to return to driving 6 weeks after surgery",
"PURPOSE To assess driving ability ( brake response time [ BRT ] ) with commonly used knee braces . METHODS Sixty-four healthy participants ( 32 women and 32 men ) participated in our study . BRT was assessed using a custom-made driving simulator . We assessed BRT for 5 different commonly used knee braces ( right leg ) used in 9 different setting s : without a knee brace ( control group ) ; with a typical postoperative knee brace with adjustable range of motion ( ROM ) and the setting s of 0 ° to 30 ° , 0 ° to 60 ° , 0 ° to 90 ° , and 20 ° to 90 ° ( extension and flexion ) ; and with an unloading knee brace for moderate to severe unicompartmental osteoarthritis , an orthosis for ligament instabilities , a knee brace for patellofemoral disorders , and an elastic knee b and age . RESULTS The 64 participants ( mean age , 33.5 years ) showed significantly impaired BRT with the typical postoperative brace set at an ROM of 0 ° to 30 ° ( 673 milliseconds , P impaired BRT was found for any other investigated knee brace . CONCLUSIONS Right-sided ROM-restricting knee braces involve significant impairment of BRT in healthy participants . No such prolonged BRT was found for a patellofemoral realignment brace , a ligament brace , a valgus/osteoarthritis brace , or an elastic knee b and age . However , our findings should be viewed in light of the limitations of the study , which are ( 1 ) the lack of a defined decrease in BRT that could lead to an accident and ( 2 ) uncertainty of whether the statistical differences are also clinical ly important . LEVEL OF EVIDENCE Level II , lesser- quality r and omized controlled trial",
"Study Design . Controlled prospect i ve study . Objective . To determine whether driving reaction time ( DRT ) is influenced by primary lumbar fusion . Summary of Background Data . The effects of radiculopathy and nerve root blocks on DRT have been reported recently . To our knowledge , the relationship between lumbar fusion and DRT has not been previously studied although it is important for driving safety . The aim of the present study was to test the hypotheses that DRT after lumbar fusion is ( 1 ) altered after the operation , ( 2 ) influenced by pain , ( 3 ) influenced by the patient 's driving skill , and ( 4 ) differs from the DRT of healthy controls . Methods . Twenty-one consecutive patients ( mean age , 53.5 years ; SD 10.8 ) receiving primary lumbar fusion were tested for their DRT 1 day before surgery ( preoperative ) , the day before discharge ( postoperative ) and 3 months after surgery ( follow-up ; FU ) . DRT was assessed using a custom-made driving simulator . The severity of back pain was determined on visual analogue scales separately for usual pain ( VAS-U ) and pain during testing ( VAS-T ) . We also determined the patients ' subjective driving frequency . Normative DRT data from 31 age-matched healthy controls were used for comparison . Results . The preoperative DRT was 685 milliseconds ( Md ; IQR 246 ) and the postoperative DRT 728 milliseconds ( Md ; IQR 264 ) , which was further reduced to 671 milliseconds ( Md ; IQR 202 ) after the FU period . Statistical significance was registered between postoperative and FU DRT ( P = 0.007 ) . Moderate to high correlations ( 0.537 VAS rating of back pain and DRT . Control subjects had a DRT of 487 milliseconds ( Md ; IQR 116 ) , which differed significantly from the DRT of patients at all 3 time points of testing ( P DRT improved significantly during FU , indicating a positive effect of the intervention on driving skills . DRT correlates with the severity of back pain",
"Old studies recommend 6weeks post-operative before patients can return to driving safely . This is a prospect i ve study assessing brake reaction time ( BRT ) after THA . 38 patients underwent a pre-operative , 2 , 4 and 6weeks post-operative BRT test . General linear repeated measurement was used . The mean pre-operative reaction time was 0.635±0.160seconds SD and 2-week was 0.576±0.137seconds SD ( P=0.029 ) ; 33 patients ( 87 % ) were able to reach their baseline time by 2weeks . The remaining five patients ( 13 % ) reached their baseline at the 4-week post-operative . No differences were found with respect to age , gender , and the use of assistive devices . With new techniques in THA , most of patients return to normal times within the 2-week"
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BACKGROUND Although supervised exercise therapy is considered to be of significant benefit for people with leg pain ( peripheral arterial disease ( PAD ) ) , implementing supervised exercise programs ( SETs ) in daily practice has limitations . This is an up date of a review first published in 2006 . OBJECTIVES The main objective of this review was to provide an accurate overview of studies evaluating the effects of supervised versus non-supervised exercise therapy on maximal walking time or distance on a treadmill for people with intermittent claudication . SEARCH METHODS For this up date , the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator search ed the Specialised Register ( last search ed September 2012 ) and CENTRAL ( 2012 , Issue 9 ) . In addition , we h and search ed the reference lists of relevant articles for additional trials . No restriction was applied to language of publication . SELECTION CRITERIA R and omized clinical trials comparing supervised exercise programs with non-supervised exercise programs ( defined as walking advice or a structural home-based exercise program ) for people with intermittent claudication . Studies with control groups , which did not receive exercise or walking advice or received usual care ( maintained normal physical activity ) , were excluded . DATA COLLECTION AND ANALYSIS Two review authors ( HJPF and BLWB ) independently selected trials and extracted data . Three review authors ( HJPF , BLWB , and GJL ) assessed trial quality , and this was confirmed by two other review authors ( MHP and JAWT ) . For all continuous outcomes , we extracted the number of participants , the mean differences , and the st and ard deviation . The 36-Item Short Form Health Survey ( SF-36 ) outcomes were extracted to assess quality of life . Effect sizes were calculated as the difference in treatment normalized with the st and ard deviation ( st and ardized mean difference ) using a fixed-effect model . MAIN RESULTS A total of 14 studies involving a total of 1002 male and female participants with PAD were included in this review . Follow-up ranged from six weeks to 12 months . In general , supervised exercise regimens consisted of three exercise sessions per week . All trials used a treadmill walking test as one of the outcome measures . The overall quality of the included trials was moderate to good , although some trials were small with respect to the number of participants , ranging from 20 to 304.Supervised exercise therapy ( SET ) showed statistically significant improvement in maximal treadmill walking distance compared with non-supervised exercise therapy regimens , with an overall effect size of 0.69 ( 95 % confidence interval ( CI ) 0.51 to 0.86 ) and 0.48 ( 95 % CI 0.32 to 0.64 ) at three and six months , respectively . This translates to an increase in walking distance of approximately 180 meters that favored the supervised group . SET was still beneficial for maximal and pain-free walking distances at 12 months , but it did not have a significant effect on quality of life parameters . AUTHORS ' CONCLUSIONS SET has statistically significant benefit on treadmill walking distance ( maximal and pain-free ) compared with non-supervised regimens . However , the clinical relevance of this has not been demonstrated definitively ; additional studies are required that focus on quality of life or other disease-specific functional outcomes , such as walking behavior , patient satisfaction , costs , and long-term follow-up . Professionals in the vascular field should make SET available for all patients with intermittent claudication | [
"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",
"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 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 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 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 Serum markers of inflammation and platelet activation are related to cardiovascular risk . Cardiovascular risk reduction is a major treatment goal in patients with peripheral arterial disease ( PAD ) . Although current guidelines recommend supervised exercise training ( SET ) for PAD patients with intermittent claudication , its contribution to risk reduction remains unclear . Aim of the present study was to assess the impact of SET on inflammation and platelet activation as surrogates for cardiovascular risk . METHODS Fifty-three patients with intermittent claudication were r and omly assigned to SET on top of best medical treatment ( BMT ) for 6 months ( SET-group ) or to BMT only ( BMT-group ) . High sensitivity C-reactive protein ( hs-CRP ) , interleukin-6 ( IL-6 ) and fibrinogen as well as soluble P-selectin ( sP-sel ) , prothrombin fragment 1 + 2 ( F1.2 ) and monocyte-platelet aggregates ( MPA ) were determined at study entry , after 3 , 6 and 12 months . RESULTS While clinical improvement , reflected by an increase of walking capacity , was observed upon SET , no lasting changes of markers of inflammation and platelet activation were found within the SET-group during the training period . Compared to the BMT-group no improvements of these markers were observed in response to training at any time point ( all p > 0.05 ) . CONCLUSION Regular SET added no further anti-inflammatory effect and had no effect on platelet activation when provided on top of BMT in PAD patients with intermittent claudication",
"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",
"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",
"Objectives . To determine whether different levels of the ankle-brachial pressure index ( ABPI ) are associated with an increased risk for progressive limbischemia , nonfatal and fatal cardiovascular events . To investigate the prognostic value of signs and symptoms associated with peripheral arterial occlusive disease ( PAOD ) . Design . Prospect i ve follow-up study . Setting . Eighteen general practice centers in the Netherl and s. Participants . Three thous and six hundred forty-nine participants ( 53 % female ) with a mean age of 59 years ( range : 40 - 78 years ) . Main outcome measures . Progressive limbischemia , cardiovascular morbidity and mortality . Results . At baseline , 458 participants had PAOD , defined as an ABPI Among these , 148 ( 32.2 % ) had an ABPI 0.70 . Cox proportional hazards models showed that after a mean follow-up period of 7.2 years , PAOD patients with an ABPI cardiovascular death , compared with participants with a moderately reduced ABPI ( of intermittent claudication , abnormal pedal pulses , elevated blood pressure , and coexisting cardiovascular disease at baseline were also significant independent prognostic factors for one or more of the adverse outcome events in these patients . Conclusion . The ABPI is inversely associated with cardiovascular mortality in PAOD patients . A low ABPI is an independent predictor for cardiovascular mortality in PAOD patients",
"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",
"OBJECTIVE The purpose of this study was to delineate the natural history of claudication and determine risk factors for ischemic rest pain ( IRP ) and ischemic ulceration ( IU ) among patients with claudication . METHODS We prospect ively collected data on 1244 men with claudication during a 15-year period , including demographics , clinical risk factors , and ankle-brachial index ( ABI ) . We followed these patients serially with ABIs , self-reported walking distance ( WalkDist ) , and monitoring for IRP and IU . We used Kaplan-Meier and proportional hazards modeling to find independent predictors of IRP and IU . RESULTS Mean follow-up was 45 months ; statistically valid follow-up could be carried out for as long as 12 years . ABI declined an average of 0.014 per year . WalkDist declined at an average rate of 9.2 yards per year . The cumulative 10-year risks of development of IU and IRP were 23 % and 30 % , respectively . In multivariate analysis using several clinical risk factors , we found that only DM ( relative risk [ RR ] , 1.8 ) and ABI ( RR , 2.2 for 0.1 decrease in ABI ) predicted the development of IRP . Similarly , only DM ( RR , 3.0 ) and ABI ( RR , 1.9 for 0.1 decrease in ABI ) were significant predictors of IU . CONCLUSION This large serial study of claudication is , to our knowledge , the longest of its kind . We documented an average rate of ABI decline of 0.014 per year and a decline in WalkDist of 9.2 yards per year . Two clinical factors , ABI and DM , were found to be associated with the development of IRP and IU . Our findings may be useful in predicting the clinical course of claudication",
"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",
"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",
"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",
"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",
"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",
"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",
" 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",
"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",
"Intermittent claudication is a common condition leading to significant functional impairment and enhanced risk of cardiovascular morbidity and mortality . However , despite the functional impairment caused by intermittent claudication , the natural history in the affected limb is fairly benign . Only about 25 % of patients show symptomatic deterioration and only 2 % eventually lose the affected limb.1 This epidemiological evidence has led most clinicians in both primary and hospital care to manage intermittent claudication conservatively , addressing cardiovascular risk factors2 and giving advice on exercise . This may well be appropriate but merely giving advice about exercise is unlikley to be the most effective treatment . Exercise as a treatment for intermittent claudication is not new , with improvements in walking described from as early as 1898 . A recent Cochrane review of 10 r and omised trials of exercise therapy estimated an overall improvement in walking distance of about 150%.3 The exercise component in all but one of these",
"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",
"INTRODUCTION Treatment of intermittent claudication ( IC ) due to peripheral arterial disease ( PAD ) is aim ed at improving walking distance and includes secondary prevention of cardiovascular disease . Both supervised exercise therapy ( SET ) and percutaneous transluminal angioplasty ( PTA ) have proven to be effective in increasing maximum and pain-free walking distance in IC . However , the optimal treatment strategy in patients with IC due to iliac artery stenosis or occlusion remains unclear . OBJECTIVE To compare the ( cost- ) effectiveness of initial PTA versus initial SET in patients with disabling IC due to an iliac artery obstruction . DESIGN In a multicentre r and omised controlled trial 400 consecutive patients with IC will be r and omly assigned to PTA ( with additional stent placement on indication ) or SET . Primary outcomes are maximum walking distance and health-related quality of life measured using the disease-specific VascuQol instrument after 1 year . Secondary outcomes are pain-free walking distance , functional status , generic quality of life , complications related to each of the interventions , additional interventions , treatment failures and costs ( cost-effectiveness and cost-utility ) after 1 year . CONCLUSION AND IMPLICATION S Based on the results of this proposed large study well-founded adjustments of existing guidelines on the treatment of iliac artery occlusive disease can be implemented ( Clinical Trials.gov NCT01385774 ; Nederl and s Trial Register NTR2776 )",
"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",
"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",
"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"
] | 411698fe-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND This systematic review addresses the question " What is the optimal targeted therapy for female patients with early-stage human epidermal growth factor receptor 2 (her2)-positive breast cancer ? " METHODS The medline and embase data bases were search ed for the period January 2008 to May 2014 . The St and ards and Guidelines Evidence directory of cancer guidelines and the Web sites of major guideline organizations were also search ed . RESULTS Sixty publications relevant to the targeted therapy portion of the systematic review were identified . In four major trials ( hera , National Surgical Adjuvant Breast and Bowel Project B-31 , North Central Cancer Treatment Group N9831 , and Breast Cancer International Research Group 006 ) , adjuvant trastuzumab for 1 year was superior in disease-free survival ( dfs ) and overall survival ( os ) to no trastuzumab ; trastuzumab showed no benefit in one trial ( pacs 04 ) . A shorter duration of trastuzumab ( less than 1 year compared with 1 year ) was evaluated , with mixed results for dfs : one trial showed superiority ( finher ) , one trial could not demonstrate noninferiority ( phare ) , another trial showed equivalent results ( E 2198 ) , and one trial is still ongoing ( persephone ) . Longer trastuzumab duration ( hera : 2 years vs. 1 year ) showed no improvement in dfs or os and a higher rate of cardiac events . Newer her2-targeted agents ( lapatinib , pertuzumab , T-DM1 , neratinib ) have been or are still being evaluated in both adjuvant and neoadjuvant trials , either by direct comparison with trastuzumab alone or combined with trastuzumab . In the neoadjuvant setting ( neoaltto , GeparQuinto , Neosphere ) , trastuzumab alone or in combination with another anti-her2 agent ( lapatinib , pertuzumab ) was compared with either lapatinib or pertuzumab alone and showed superior or equivalent rates of pathologic complete response . In the adjuvant setting , lapatinib alone or in combination with trastuzumab , compared with trastuzumab alone ( altto ) or with placebo ( teach ) , was not superior in dfs . The results of the completed aphinity trial , evaluating the role of dual her2 blockade with trastuzumab and pertuzumab , are highly anticipated . Ongoing trials are evaluating trastuzumab as a single agent without adjuvant chemotherapy ( respect ) and in patients with low her2 expression ( National Surgical Adjuvant Breast and Bowel Project B-47 ) . CONCLUSIONS Taking into consideration disease characteristics and patient preference , 1 year of trastuzumab should be offered to all patients with her2-positive breast cancer who are receiving adjuvant chemotherapy . Cardiac function should be regularly assessed in this patient population | [
"Background Adjuvant treatment decision-making based on conventional clinical /pathological and prognostic single molecular markers or genomic signatures is a therapeutic area in which over-/under-treatment are still key clinical problems even though substantial and continuous improvement of outcome has been achieved over the past decades . Response to therapy is currently not considered in the decision-making procedure . ADAPT is one of the first new generation (neo)adjuvant trials dealing with individualization of (neo)adjuvant decision-making in early breast cancer and aims to establish early predictive surrogate markers , e.g. , Ki-67 , for therapy response under a short induction treatment in order to maximally individualize therapy and avoid unnecessary toxicity by ineffective treatment . Methods / design The prospect i ve , multi-center , controlled , non-blinded , r and omized , investigator initiated phase II/III ADAPT trial has an innovative “ umbrella ” protocol design . The “ umbrella ” is common for all patients , consisting of dynamic testing of early therapy response . ADAPT will recruit 4,936 patients according to their respective breast cancer subtype in four distinct sub-trials at 80 trial sites in Germany ; 4,000 patients with hormone receptor positive ( HR+ ) and HER2 negative disease will be included in the ADAPT HR+/HER2- sub-trial , where treatment decision is based on risk assessment and therapy response to induction therapy , and 380 patients will be included in ADAPT HER2+/HR+ . A further 220 patients will be included in ADAPT HER2+/HR- and 336 patients will be recruited for ADAPT Triple Negative . These three sub-trials focus on identification of early surrogate markers for therapy success in the neoadjuvant setting . Patients will be allocated to the respective sub-trial according to the result of their diagnostic core biopsy , as reported by local/ central pathology for HR and HER2 status . Discussion Recent trials , such as the GeparTrio , have shown that response-guided therapy using clinical response may improve outcome . For chemotherapy or HER2-targeted treatment , pathologic complete response in a neoadjuvant setting is an excellent predictor of outcome . For endocrine therapy , response to short induction treatment – as defined by decrease in tumor cell proliferation – strongly correlates with outcome . ADAPT now aims to combine static prognostic and dynamic predictive markers , focusing not just on single therapeutic targets , but also on general markers of proliferation and cell death . Biomarker analysis will help to optimize selection of subtype-specific treatment . Trial registration Clinical Trials.gov : ADAPT Umbrella : NCT01781338 ; ADAPT HR+/HER2- : NCT01779206 ; ADAPT HER2+/HR+ : NCT01745965 ; ADAPT HER2+/HR- : NCT01817452 ; ADAPT TN : NCT01815242",
"BACKGROUND Studies with pertuzumab , a novel anti-HER2 antibody , show improved efficacy when combined with the established HER2-directed antibody trastuzumab in breast cancer therapy . We investigated the combination of pertuzumab or trastuzumab , or both , with docetaxel and the combination of pertuzumab and trastuzumab without chemotherapy in the neoadjuvant setting . METHODS In this multicentre , open-label , phase 2 study , treatment-naive women with HER2-positive breast cancer were r and omly assigned ( 1:1:1:1 ) central ly and stratified by operable , locally advanced , and inflammatory breast cancer , and by hormone receptor expression to receive four neoadjuvant cycles of : trastuzumab ( 8 mg/kg loading dose , followed by 6 mg/kg every 3 weeks ) plus docetaxel ( 75 mg/m(2 ) , escalating , if tolerated , to 100 mg/m(2 ) every 3 weeks ; group A ) or pertuzumab ( loading dose 840 mg , followed by 420 mg every 3 weeks ) and trastuzumab plus docetaxel ( group B ) or pertuzumab and trastuzumab ( group C ) or pertuzumab plus docetaxel ( group D ) . The primary endpoint , examined in the intention-to-treat population , was pathological complete response in the breast . Neither patients nor investigators were masked to treatment . This study is registered with Clinical Trials.gov , number NCT00545688 . FINDINGS Of 417 eligible patients , 107 were r and omly assigned to group A , 107 to group B , 107 to group C , and 96 to group D. Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate ( 49 of 107 patients ; 45·8 % [ 95 % CI 36·1 - 55·7 ] ) compared with those given trastuzumab plus docetaxel ( group A ; 31 of 107 ; 29·0 % [ 20·6 - 38·5 ] ; p=0·0141 ) . 23 of 96 ( 24·0 % [ 15·8 - 33·7 ] ) women given pertuzumab plus docetaxel ( group D ) had a pathological complete response , as did 18 of 107 ( 16·8 % [ 10·3 - 25·3 ] ) given pertuzumab and trastuzumab ( group C ) . The most common adverse events of grade 3 or higher were neutropenia ( 61 of 107 women in group A , 48 of 107 in group B , one of 108 in group C , and 52 of 94 in group D ) , febrile neutropenia ( eight , nine , none , and seven , respectively ) , and leucopenia ( 13 , five , none , and seven , respectively ) . The number of serious adverse events was similar in groups A , B , and D ( 15 - 20 serious adverse events per group in 10 - 17 % of patients ) but lower in group C ( four serious adverse events in 4 % of patients ) . INTERPRETATION Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate compared with those given trastuzumab plus docetaxel , without substantial differences in tolerability . Pertuzumab and trastuzumab without chemotherapy eradicated tumours in a proportion of women and showed a favourable safety profile . These findings justify further exploration in adjuvant trials and support the neoadjuvant approach for accelerating drug assessment in early breast cancer . FUNDING F Hoffmann-La Roche",
"BACKGROUND We compared the efficacy and safety of the addition of lapatinib versus trastuzumab to anthracycline-taxane-based neoadjuvant chemotherapy . METHODS In the GeparQuinto r and omised phase 3 trial , patients with untreated HER2-positive operable or locally advanced breast cancer were enrolled between Nov 7 , 2007 , and July 9 , 2010 . Patients were eligible if their tumours were classified as cT3/4a-d , or hormone receptor (HR)-negative , HR-positive with clinical ly node-positive and cT2 disease ( cT2 cN+ ) , or HR-positive and pathologically node-positive in the sentinel lymph node for those with cT1 disease ( cT1 pN(SLN+ ) ) . Patients were r and omly assigned in a 1:1 ratio to receive neoadjuvant treatment with four cycles of EC ( epirubicin [ 90 mg/m(2 ) intravenously ] plus cyclophosphamide [ 600 mg/m(2 ) intravenously ] , every 3 weeks ) , and four cycles of docetaxel ( 100 mg/m(2 ) intravenously every 3 weeks ) with either trastuzumab ( 6 mg/kg intravenously , with a starting loading dose of 8 mg/kg , for eight cycles , every 3 weeks ) or lapatinib ( 1000 - 1250 mg per day orally ) throughout all cycles before surgery . R and omisation was done by dynamic allocation with the minimisation method of Pocock and patients were stratified by participating site , HR status , and extent of disease ( cT1 - 3 cN0 - 2 vs T4 or N3 ) . The primary endpoint was pathological complete response ( defined as ypT0 and ypN0 ) and was analysed in all patients who received at least one cycle of EC . Participants and investigators were not masked to treatment assignment . Pathologists in centres assessing surgery outcomes were masked to group assignment . This trial is registered with Clinical Trials.gov , number NCT00567554 . FINDINGS Of 620 eligible patients , 309 were r and omly assigned to chemotherapy with trastuzumab ( ECH-TH group ) and 311 to chemotherapy with lapatinib ( ECL-TL group ) . Two patients in the ECH-TH group and three patients in the ECL-TL group did not start treatment because of withdrawal of consent or immediate surgery . 93 ( 30·3 % ) of 307 patients in the ECH-TH group and 70 ( 22·7 % ) of 308 patients in the ECL-TL group had a pathological complete response ( odds ratio [ OR ] 0·68 [ 95%CI 0·47 - 0·97 ] ; p=0·04 ) . Chemotherapy with trastuzumab was associated with more oedema ( 119 [ 39·1 % ] vs 88 [ 28·7 % ] ) and dyspnoea ( 90 [ 29·6 % ] vs 66 [ 21·4 % ] ) , and ECL-TL with more diarrhoea ( 231 [ 75·0 % ] vs 144 [ 47·4 % ] ) and skin rash ( 169 [ 54·9 % ] vs 97 [ 31·9 % ] ) . 43 ( 14·0 % ) patients discontinued in the ECH-TH group and 102 ( 33·1 % ) in the ECL-TL group . 70 serious adverse events were reported in the ECH-TH group and 87 in the ECL-TL group . INTERPRETATION This direct comparison of trastuzumab and lapatinib showed that pathological complete response rate with chemotherapy and lapatinib was significantly lower than that with chemotherapy and trastuzumab . Unless long-term outcome data show different results , lapatinib should not be used outside of clinical trials as single anti-HER2-treatment in combination with neoadjuvant chemotherapy . FUNDING GlaxoSmithKline , Roche , and Sanofi-Aventis",
"BACKGROUND Neoadjuvant chemotherapy with trastuzumab for patients with HER2-positive breast cancer can produce a pathological complete response in the breast in 30 - 65 % of patients . We investigated the effect of the timing of trastuzumab administration with anthracycline and taxane neoadjuvant chemotherapy . METHODS This r and omised trial was done at 36 centres in the USA and Puerto Rico . Women with operable HER2-positive invasive breast cancer were r and omly assigned ( 1:1 ) with a biased coin minimisation algorithm , stratified for age , tumour size , and hormone receptor status . Neither patients nor investigators ( except for a cardiac safety review panel ) were masked to treatment assignment . Patients r and omly assigned to sequential treatment received fluorouracil 500 mg/m(2 ) , epirubicin 75 mg/m(2 ) , and cyclophosphamide 500 mg/m(2 ) ( FEC-75 ) on day 1 of a 21-day cycle for four cycles followed by paclitaxel 80 mg/m(2 ) and trastuzumab 2 mg/kg ( after a 4 mg/kg loading dose ) once per week for 12 weeks , while those r and omly assigned to the concurrent treatment group received paclitaxel and trastuzumab once per week for 12 weeks followed by four cycles of FEC-75 ( on day 1 of each 21-day cycle ) and once-weekly trastuzumab , in the same doses as the sequential group . Surgery , including evaluation of the axilla , was done within 6 weeks of completion of neoadjuvant treatment . The primary outcome was the percentage of patients who had a pathological complete response in the intention-to-treat population . The study is registered with Clinical Trials.gov , number NCT00513292 . FINDINGS From Sept 15 , 2007 , to Dec 15 , 2011 , 282 women were enrolled ( 140 in the sequential group , 142 in the concurrent group ) . Two patients in the sequential group withdrew consent before starting treatment . 78 of 138 ( 56·5 % , 95 % CI 47·8 - 64·9 ) patients who received sequential treatment had a pathological complete response in the breast versus 77 of 142 ( 54·2 % , 95 % CI 45·7 - 62·6 ) who received concurrent treatment ( difference 2·3 % , 95 % CI -9·3 to 13·9 ) . No treatment-related deaths occurred . The most common severe toxic effects were neutropenia ( 35 [ 25·3 % ] of 138 patients in the sequential group vs 45 [ 31·7 % ] of 142 patients in the concurrent group ) and fatigue ( six [ 4·3 % ] vs 12 [ 8·5 % ] ) . Left ventricular ejection fraction dropped below the institutional lower limit of normal at week 12 in one ( 0·8 % ) of 130 patients who received sequential treatment and four ( 2·9 % ) of 137 patients who received concurrent treatment ; by week 24 , it had dropped below this limit in nine ( 7·1 % ) of 126 patients and in six ( 4·6 % ) of 130 patients , respectively . INTERPRETATION Concurrent administration of trastuzumab with anthracyclines offers no additional benefit and is not warranted . FUNDING US National Cancer Institute",
"BACKGROUND We present the combined results of two trials that compared adjuvant chemotherapy with or without concurrent trastuzumab in women with surgically removed HER2-positive breast cancer . METHODS The National Surgical Adjuvant Breast and Bowel Project trial B-31 compared doxorubicin and cyclophosphamide followed by paclitaxel every 3 weeks ( group 1 ) with the same regimen plus 52 weeks of trastuzumab beginning with the first dose of paclitaxel ( group 2 ) . The North Central Cancer Treatment Group trial N9831 compared three regimens : doxorubicin and cyclophosphamide followed by weekly paclitaxel ( group A ) , the same regimen followed by 52 weeks of trastuzumab after paclitaxel ( group B ) , and the same regimen plus 52 weeks of trastuzumab initiated concomitantly with paclitaxel ( group C ) . The studies were amended to include a joint analysis comparing groups 1 and A ( the control group ) with groups 2 and C ( the trastuzumab group ) . Group B was excluded because trastuzumab was not given concurrently with paclitaxel . RESULTS By March 15 , 2005 , 394 events ( recurrent , second primary cancer , or death before recurrence ) had been reported , triggering the first scheduled interim analysis . Of these , 133 were in the trastuzumab group and 261 in the control group ( hazard ratio , 0.48 ; P disease-free survival between the trastuzumab group and the control group was 12 percent at three years . Trastuzumab therapy was associated with a 33 percent reduction in the risk of death ( P=0.015 ) . The three-year cumulative incidence of class III or IV congestive heart failure or death from cardiac causes in the trastuzumab group was 4.1 percent in trial B-31 and 2.9 percent in trial N9831 . CONCLUSIONS Trastuzumab combined with paclitaxel after doxorubicin and cyclophosphamide improves outcomes among women with surgically removed HER2-positive breast cancer . ( Clinical Trials.gov numbers , NCT00004067 and NCT00005970 .",
"BACKGROUND It is unknown how a very high tumor total HER2 ( human epidermal growth factor receptor-2 ) content ( H2 T ) influences outcome in early breast cancer treated with adjuvant trastuzumab plus chemotherapy . PATIENTS AND METHODS H2 T was measured using a novel quantitative assay ( HERmark ( ® ) ) from formalin-fixed tumor tissue of 899 women who participated in the FinHer trial ( IS RCT N76560285 ) . In a chromogenic in situ hybridization ( CISH ) test , 197 ( 21.9 % ) patients had HER2-positive cancer and were r and omly assigned to receive trastuzumab or control . RESULTS Cancer H2 T levels varied 1808-fold . High H2 T levels were correlated with a positive HER2 status by CISH ( P between H2 T and the hazard of distant recurrence in a sub population treatment effect pattern plot analysis in CISH-positive disease . Patients with very high H2 T ( defined by ≥22-fold the median of HER2-negative cancers ; 13 % of CISH-positive cancers ) did not benefit from adjuvant trastuzumab [ hazard ratio ( HR ) 1.23 ; 95 % confidence interval ( CI ) 0.33 - 4.62 ; P = 0.75 ] , whereas the rest of the patients with HER2-positive disease by CISH ( 87 % ) did benefit ( HR 0.52 ; 95 % CI 0.28 - 1.00 ; P = 0.050 ) . CONCLUSION Patients with HER2-positive breast cancer with very high tumor HER2 content may benefit less from adjuvant trastuzumab compared with those whose cancer has more moderate HER2 content",
"BACKGROUND Trastuzumab ( Herceptin(R ) ) improves disease-free survival ( DFS ) and overall survival for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer . We aim ed to assess the magnitude of its clinical benefit for sub population s defined by nodal and steroid hormone receptor status using data from the Herceptin Adjuvant ( HERA ) study . PATIENTS AND METHODS HERA is an international multicenter r and omized trial comparing 1 or 2 years of trastuzumab treatment with observation after st and ard chemotherapy in women with HER2-positive breast cancer . In total , 1703 women r and omized to 1-year trastuzumab and 1698 women r and omized to observation were included in these analyses . Median follow-up was 23.5 months . The primary endpoint was DFS . RESULTS The overall hazard ratio ( HR ) for trastuzumab versus observation was 0.64 [ 95 % confidence interval ( CI ) 0.54 - 0.76 ; P 3-year DFS in subgroups ranged from + 11.3 % to + 0.6 % . Patients with the best prognosis ( those with node-negative disease and tumors 1.1 - 2.0 cm ) had benefit similar to the overall cohort ( HR 0.53 , 95 % CI 0.26 - 1.07 ; 3-year DFS improvement + 4.6 % , 95 % CI -4.0 % to 13.2 % ) . CONCLUSIONS Adjuvant trastuzumab therapy reduces the risk of relapse similarly across subgroups defined by nodal status and steroid hormone receptor status , even those at relatively low risk for relapse",
"The 2007 American Society of Clinical Oncology and College of American Pathologists ( ASCO/CAP ) joint guidelines defined criteria for HER2 positivity of tumors that modified those of the US Food and Drug Administration ( FDA ) , causing some confusion and uncertainty among clinicians . Using data from the HER2-positive breast cancer adjuvant trial N9831 , we compared eligibility for patients who met both criteria , and disease-free survival ( DFS ) was assessed by Cox proportional hazards regression . The number of patients in the N9831 trial retrospectively eligible for trastuzumab therapy was decreased when ASCO/CAP criteria vs FDA criteria were applied to immunohistochemistry and /or fluorescence in situ hybridization results ( 107 [ 3.7 % ] of 2904 patients with immunohistochemistry results , 37 [ 1.3 % ] of 2809 patients with fluorescence in situ hybridization results , and 47 [ 1.7 % ] of 2809 patients with both results ) . Improvement in DFS was similar among patients treated with trastuzumab under either set of criteria ( concurrent trastuzumab and chemotherapy compared with chemotherapy alone : by ASCO/CAP criteria , hazard ratio of DFS = 0.59 , 95 % confidence interval = 0.48 to 0.73 ; by FDA criteria but not ASCO/CAP criteria , hazard ratio = 0.60 , 95 % confidence interval = 0.12 to 3.13 ; number needed to treat to prevent one additional DFS event at 5 years : 10 and 11.2 patients , respectively ) . Following the 2007 ASCO/CAP criteria for HER2 positivity would negate the option of potentially life-saving trastuzumab therapy for a small but meaningful group of patients . We recommend using FDA -approved HER2 criteria for therapeutic decision making",
"BACKGROUND The anti-HER2 monoclonal antibody trastuzumab and the tyrosine kinase inhibitor lapatinib have complementary mechanisms of action and synergistic antitumour activity in models of HER2-overexpressing breast cancer . We argue that the two anti-HER2 agents given together would be better than single-agent therapy . METHODS In this parallel groups , r and omised , open-label , phase 3 study undertaken between Jan 5 , 2008 , and May 27 , 2010 , women from 23 countries with HER2-positive primary breast cancer with tumours greater than 2 cm in diameter were r and omly assigned to oral lapatinib ( 1500 mg ) , intravenous trastuzumab ( loading dose 4 mg/kg [ DOSAGE ERROR CORRECTED ] , subsequent doses 2 mg/kg ) , or lapatinib ( 1000 mg ) plus trastuzumab . Treatment allocation was by stratified , permuted blocks r and omisation , with four stratification factors . Anti-HER2 therapy alone was given for the first 6 weeks ; weekly paclitaxel ( 80 mg/m(2 ) ) was then added to the regimen for a further 12 weeks , before definitive surgery was undertaken . After surgery , patients received adjuvant chemotherapy followed by the same targeted therapy as in the neoadjuvant phase to 52 weeks . The primary endpoint was the rate of pathological complete response ( pCR ) , analysed by intention to treat . This trial is registered with Clinical Trials.gov , NCT00553358 . FINDINGS 154 patients received lapatinib , 149 trastuzumab , and 152 the combination . pCR rate was significantly higher in the group given lapatinib and trastuzumab ( 78 of 152 patients [ 51·3 % ; 95 % CI 43·1 - 59·5 ] ) than in the group given trastuzumab alone ( 44 of 149 patients [ 29·5 % ; 22·4 - 37·5 ] ; difference 21·1 % , 9·1 - 34·2 , p=0·0001 ) . We recorded no significant difference in pCR between the lapatinib ( 38 of 154 patients [ 24·7 % , 18·1 - 32·3 ] ) and the trastuzumab ( difference -4·8 % , -17·6 to 8·2 , p=0·34 ) groups . No major cardiac dysfunctions occurred . Frequency of grade 3 diarrhoea was higher with lapatinib ( 36 patients [ 23·4 % ] ) and lapatinib plus trastuzumab ( 32 [ 21·1 % ] ) than with trastuzumab ( three [ 2·0 % ] ) . Similarly , grade 3 liver-enzyme alterations were more frequent with lapatinib ( 27 [ 17·5 % ] ) and lapatinib plus trastuzumab ( 15 [ 9·9 % ] ) than with trastuzumab ( 11 [ 7·4 % ] ) . INTERPRETATION Dual inhibition of HER2 might be a valid approach to treatment of HER2-positive breast cancer in the neoadjuvant setting . FUNDING GlaxoSmithKline",
"BACKGROUND This study aims to describe and compare health-related quality of life ( HRQL ) in patients with node-positive and high-risk node-negative HER2-positive early breast cancer receiving adjuvant docetaxel and trastuzumab-based or docetaxel-based regimens alone . METHODS Eligible patients ( n = 3,222 ) were r and omly assigned to either four cycles of adjuvant doxorubicin and cyclophosphamide followed by four cycles of docetaxel ( AC→T ) or one of two trastuzumab-containing regimens : adjuvant doxorubicin and cyclophosphamide followed by docetaxel plus trastuzumab administered for 1 year ( AC→TH ) or six cycles of docetaxel plus carboplatin combined with trastuzumab administered for 1 year ( TCH ) . The European Organization for Research and Treatment of Cancer ( EORTC ) Quality of Life Question naire C30 and BR-23 were administered at baseline , the start of cycle 4 ( mid ) , and the end of chemotherapy ( EOC ) , as well as at 6 , 12 , and 24 months after chemotherapy . RESULTS Compliance rates for the EORTC question naires were acceptable at 72%-93 % of eligible patients out to the 12-month assessment . Systemic side effect ( SE ) change scores were significantly improved for TCH-treated patients compared with AC→TH and AC→T at EOC , suggesting improved tolerability . Physical functioning ( PF ) was only slightly worse at midpoint for those receiving TCH , compared with patients who were just starting on taxane in an AC→TH regimen , but was otherwise similar between arms . All treatment arms recovered from the deterioration in SE , PF , and Global Health Scale scores by 1 year and median future perspective change scores continued to improve throughout treatment and follow-up . CONCLUSION HRQL outcomes for adjuvant docetaxel and trastuzumab-based regimens are favorable and support TCH as a more tolerable treatment option",
"PURPOSE Findings from the human epidermal growth factor receptor 2 ( HER2 ) -positive National Surgical Adjuvant Breast and Bowel Project ( NSABP ) B31 trial suggested that MYC/HER2 coamplification ( > 5.0 copies/nucleus ) was associated with additional benefit from adjuvant trastuzumab in patients with early-stage breast cancer . To further explore this relationship , we investigated associations between MYC amplification and disease-free survival ( DFS ) in a similar adjuvant trastuzumab HER2-positive breast cancer trial-North Central Cancer Treatment Group ( NCCTG ) N9831 . PATIENTS AND METHODS This analysis included 799 patients r and omly assigned to receive chemotherapy alone or with concurrent trastuzumab on N9831 . Fluorescence in situ hybridization ( FISH ) was performed by using a dual-probe mixture for MYC and centromere 8 ( MYC : CEP8 ) on tissue microarrays . MYC amplification was prespecified as MYC : CEP8 ratio > 2.2 or average MYC copies/nucleus > 5.0 . Exploratory variables included polysomy 8 . RESULTS In comparing DFS ( median follow-up , 4.0 years ) between treatments , patients with MYC : CEP8 ratio ≤ 2.2 ( n = 618 ; 77 % ) and > 2.2 ( n = 181 ; 23 % ) had hazard ratios ( HRs ) of 0.46 ( P MYC copies/nucleus ≤ 5.0 ( n = 534 ; 67 % ) and > 5.0 ( n = 265 ; 33 % ) had HRs of 0.52 ( P = .002 ) and 0.48 ( P = .02 ) , respectively ( interaction P = .94 ) . Patients with MYC : CEP8 ratio normal chromosome 8 copy number ( n = 141 ; 18 % ) and ≥ 1.3 or polysomy 8 ( n = 658 ; 82 % ) had HRs of 0.66 ( P = .28 ) and 0.44 ( P with MYC copies/nucleus MYC amplification and additional trastuzumab benefit . Exploratory analyses revealed potential associations between alternative MYC/chromosome 8 copy number alterations and differential benefit of adjuvant trastuzumab",
"BACKGROUND Since 2005 , 12 months of adjuvant trastuzumab has been the st and ard treatment for patients with HER2-positive early-stage breast cancer . However , the optimum duration of treatment has been debated . We did a non-inferiority trial of a shorter exposure of 6 months versus the st and ard 12 months of trastuzumab for patients with early breast cancer . METHODS We did an open-label , r and omised , phase 3 trial in 156 centres in France . Patients with HER2-positive early breast cancer who had received at least four cycles of chemotherapy , had breast-axillary surgery , and had received up to 6 months of trastuzumab ( administered by intravenous infusions over 30 - 90 min every 3 weeks ; initial loading dose 8 mg/kg ; 6 mg/kg thereafter ) before r and omisation were eligible . Patients were r and omly assigned via central r and omisation procedure with web-based software to continue trastuzumab for another 6 months ( 12 months total duration ; control group ) or to discontinue trastuzumab at 6 months ( 6 months total duration ; experimental group ) . R and omisation was stratified by concomitant or sequential administration of trastuzumab with chemotherapy , oestrogen-receptor status , and centre using a minimisation algorithm . The primary endpoint was disease-free survival , with a prespecified non-inferiority margin of 1·15 . Analyses were done in the intention-to-treat population . This study is registered at Clinical Trials.gov , number NCT00381901 . FINDINGS 1691 patients were r and omly assigned to receive 12 months of trastuzumab and 1693 to receive 6 months of trastuzumab ; 1690 patients in each group were included in the intention-to-treat analyses . After a median follow-up of 42·5 months ( IQR 30·1 - 51·6 ) , 175 disease-free survival events were noted in the 12-month group and 219 in the 6-month group . 2-year disease-free survival was 93·8 % ( 95 % CI 92·6 - 94·9 ) in the 12-month group and 91·1 % ( 89·7 - 92·4 ) in the 6-month group ( hazard ratio 1·28 , 95 % CI 1·05 - 1·56 ; p=0·29 ) . 119 ( 93 % ) of the 128 cardiac events ( clinical or based on assessment of left ventricular ejection fraction ) occurred while patients were receiving trastuzumab . Significantly more patients in the 12-month group experienced a cardiac event than did those in the 6-month group ( 96 [ 5·7 % ] of 1690 patients vs 32 [ 1·9 % ] of 1690 patients , p with trastuzumab was non-inferior to 12 months of trastuzumab . Despite the higher rates of cardiac events , 12 months of adjuvant trastuzmab should remain the st and ard of care . FUNDING French National Cancer Institute",
"TPS137 Background : The human epidermal growth factor receptors ( HER1 - 4 ) are frequently overexpressed in human tumors . Increased HER receptor signaling is associated with increased resistance to st and ard therapies and poor prognosis . TRAS , an anti-HER2 monoclonal antibody , reduces recurrences and improves disease-free survival ( DFS ) in patients ( pts ) with HER2 + early BC . However , 15 % to 25 % of TRAS-treated pts still experience relapsed disease at 5 yrs . NER is a small molecule , irreversible tyrosine kinase inhibitor of HER2 as well as HER1 and HER4 . In a phase II study , orally administered NER 240 mg/d was well tolerated with significant antitumor activity in pts with HER2 + BC , with or without prior TRAS ( objective response rates of 24 % and 56 % ; median progression-free survival of 22 wks and 40 wks , respectively ) . The current study will evaluate the efficacy and safety of NER in pts with early-stage HER2 + BC after adjuvant TRAS . METHODS This double-blind , placebo-controlled , multicenter , phase III study will include approximately 3,300 women with early-stage HER2-overexpressing/amplified , node-positive BC ( or no pathologic complete response after neoadjuvant therapy ) at high risk for recurrence . Pts will be r and omized within 1 yr of prior adjuvant TRAS to oral NER 240 mg or placebo daily for 1 yr . Pts will be followed for up to 5 yrs post-r and omization for recurrence and /or survival . Primary endpoint is DFS ( time to disease recurrence or death ) , using a 1-sided log-rank test to compare treatment arms and a Cox proportional hazards regression model for hazard ratio estimation . Other efficacy endpoints include DFS including ductal carcinoma in situ , time to distant recurrence , distant DFS , incidence of central nervous system recurrence , and overall survival . Safety will be monitored , with particular attention to diarrhea . Biomarker analyses ( including HER2 confirmation from archived sample s ) and health-related quality of life ( FACT-B and EQ-5D ) will also be assessed . RESULTS As of Jan 25 , 2011 , a total of 2,050 pts have been r and omized , including 934 high-risk pts . CONCLUSIONS Recruitment is planned to continue until late 2013 . As of Nov 3 , 2010 , the IDMC recommended the trial to continue",
"BACKGROUND Trastuzumab has established efficacy against breast cancer with overexpression or amplification of the HER2 oncogene . The st and ard of care is 1 year of adjuvant trastuzumab , but the optimum duration of treatment is unknown . We compared 2 years of treatment with trastuzumab with 1 year of treatment , and up date d the comparison of 1 year of trastuzumab versus observation at a median follow-up of 8 years , for patients enrolled in the HERceptin Adjuvant ( HERA ) trial . METHODS The HERA trial is an international , multicentre , r and omised , open-label , phase 3 trial comparing treatment with trastuzumab for 1 and 2 years with observation after st and ard neoadjuvant chemotherapy , adjuvant chemotherapy , or both in 5102 patients with HER2-positive early breast cancer . The primary endpoint was disease-free survival . The comparison of 2 years versus 1 year of trastuzumab treatment involved a l and mark analysis of 3105 patients who were disease-free 12 months after r and omisation to one of the trastuzumab groups , and was planned after observing at least 725 disease-free survival events . The up date d intention-to-treat comparison of 1 year trastuzumab treatment versus observation alone in 3399 patients at a median follow-up of 8 years ( range 0 - 10 ) is also reported . This study is registered with Clinical Trials.gov , number NCT00045032 . FINDINGS We recorded 367 events of disease-free survival in 1552 patients in the 1 year group and 367 events in 1553 patients in the 2 year group ( hazard ratio [ HR ] 0·99 , 95 % CI 0·85 - 1·14 , p=0·86 ) . Grade 3 - 4 adverse events and decreases in left ventricular ejection fraction during treatment were reported more frequently in the 2 year treatment group than in the 1 year group ( 342 [ 20·4 % ] vs 275 [ 16·3 % ] grade 3 - 4 adverse events , and 120 [ 7·2 % ] vs 69 [ 4·1 % ] decreases in left ventricular ejection fraction , respectively ) . HRs for a comparison of 1 year of trastuzumab treatment versus observation were 0·76 ( 95 % CI 0·67 - 0·86 , p disease-free survival and 0·76 ( 0·65 - 0·88 , p=0·0005 ) for overall survival , despite crossover of 884 ( 52 % ) patients from the observation group to trastuzumab therapy . INTERPRETATION 2 years of adjuvant trastuzumab is not more effective than is 1 year of treatment for patients with HER2-positive early breast cancer . 1 year of treatment provides a significant disease-free and overall survival benefit compared with observation and remains the st and ard of care . FUNDING F Hoffmann-La Roche ( Roche )",
"PURPOSE To assess cardiac safety and potential cardiac risk factors associated with trastuzumab in the NCCTG N9831 Intergroup adjuvant breast cancer trial . PATIENTS AND METHODS Patients with HER2-positive operable breast cancer were r and omly assigned to doxorubicin plus cyclophosphamide ( AC ) followed by either weekly paclitaxel ( arm A ) ; paclitaxel then trastuzumab ( arm B ) ; or paclitaxel plus trastuzumab then trastuzumab alone ( arm C ) . Left ventricular ejection fraction ( LVEF ) was evaluated at registration and 3 , 6 , 9 , and 18 to 21 months . RESULTS Of 2,992 patients completing AC , 5.0 % had LVEF decreases disallowing trastuzumab ( decrease below normal : 2.4 % , decrease > 15 % : 2.6 % ) . There were 1,944 patients with satisfactory or no LVEF evaluation who proceeded to post-AC therapy . Cardiac events ( congestive heart failure [ CHF ] or cardiac death [ CD ] ) : arm A , n = 3 ( 2 CHF , 1 CD ) ; arm B , n = 19 ( 18 CHF , 1 CD ) ; arm C , n = 19 ( all CHF ) ; 3-year cumulative incidence : 0.3 % , 2.8 % , and 3.3 % , respectively . Cardiac function improved in most CHF cases following trastuzumab discontinuation and cardiac medication . Factors associated with increased risk of a cardiac event in arms B and C : older age ( P asymptomatic LVEF decreases requiring holding trastuzumab was 8 % to 10 % ; LVEF recovered and trastuzumab was restarted in approximately 50 % . CONCLUSION The cumulative incidence of post-AC cardiac events at 3 years was higher in the trastuzumab-containing arms versus the control arm , but by less than 4 % . Older age , lower registration LVEF , and antihypertensive medications are associated with increased risk of cardiac dysfunction in patients receiving trastuzumab following AC",
"PURPOSE Trastuzumab is a humanized monoclonal antibody against the human epidermal growth factor receptor 2 ( HER2 ) . The clinical benefits of adjuvant trastuzumab have been demonstrated in interim analyses of four large trials . Initial data of the combined analysis of the North Central Cancer Treatment Group ( NCCTG ) N9831 Intergroup trial and National Surgical Adjuvant Breast and Bowel Project ( NSABP ) B-31 trial were reported in 2005 . Long-term follow-up results on disease-free survival ( DFS ) and overall survival ( OS ) have been awaited . PATIENTS AND METHODS Patients with HER2-positive operable breast cancer were r and omly assigned to doxorubicin plus cyclophosphamide followed by paclitaxel with or without trastuzumab in the NCCTG N9831 and NSABP B-31 trials . The similar design of both trials allowed data from the control and trastuzumab-containing arms to be combined in a joint analysis . RESULTS At 3.9 years of median follow-up , there continues to be a highly statistically significant reduction in DFS event rate in favor of the trastuzumab-containing arm ( P death rate in favor of the trastuzumab-containing arm ( P DFS and OS advantages of adjuvant trastuzumab over time , with the longest follow-up reported to date . The clinical benefits continue to outweigh the risks of adverse effects",
"BACKGROUND Trastuzumab -- a humanised monoclonal antibody against HER2 - -has been shown to improve disease-free survival after chemotherapy in women with HER2-positive early breast cancer . We investigated the drug 's effect on overall survival after a median follow-up of 2 years in the Herceptin Adjuvant ( HERA ) study . METHODS HERA is an international multicentre r and omised trial that compared 1 or 2 years of trastuzumab treatment with observation alone after st and ard neoadjuvant or adjuvant chemotherapy in women with HER2-positive node positive or high-risk node negative breast cancer . 5102 women participated in the trial ; we analysed data from 1703 women who had been r and omised for treatment with trastuzumab for 1 year and 1698 women from the control group , with median follow-up of 23.5 months ( range 0 - 48 months ) . The primary endpoint of the trial was disease-free survival . Here , we assess overall survival , a secondary endpoint . Analyses were done on an intent-to-treat basis . This trial is registered with the European Clinical Trials Data base , number 2005 - 002385 - 11 . FINDINGS 97 ( 5.7 % ) patients r and omised to observation alone and 58 ( 3.4 % ) patients r and omised to 1 year of treatment with trastuzumab were lost to follow-up . 172 women stopped trastuzumab prematurely . 59 deaths were reported for trastuzumab and 90 in the control group . The unadjusted hazard ratio ( HR ) for the risk of death with trastuzumab compared with observation alone was 0.66 ( 95 % CI 0.47 - 0.91 ; p=0.0115 ) . 218 disease-free survival events were reported with trastuzumab compared with 321 in the control group . The unadjusted HR for the risk of an event with trastuzumab compared with observation alone was 0.64 ( 0.54 - 0.76 ; p trastuzumab after adjuvant chemotherapy has a significant overall survival benefit after a median follow-up of 2 years . The emergence of this benefit after only 2 years reinforces the importance of trastuzumab in the treatment of women with HER2-positive early breast cancer",
"OBJECTIVE This trial is conducted to investigate the benefit of trastuzumab monotherapy compared with a combination therapy of trastuzumab and chemotherapy in women over 70 years with human epidermal growth factor receptor type-2-positive primary breast cancer . METHODS Inclusion criteria are the following : histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer ; Stage I , IIA , IIB or IIIA/M0 ; and baseline left ventricular ejection fraction is ≥55 % . Patients are r and omized to receive either trastuzumab ( 8 mg/kg loading dose , 6 mg/kg every 3 weeks for 1 year ) plus chemotherapy selected from regimens specified on the protocol or trastuzumab monotherapy . The primary endpoint is disease-free survival . Secondary endpoints are overall survival , relapse-free survival , safety , health-related quality of life , comprehensive geriatric assessment and cost effectiveness . RESULTS Patients recruitment has been commenced in October 2009 . Enrollment of 300 patients is planned during the 4-year recruitment period . CONCLUSIONS We hereby report the study concept",
"BACKGROUND Worldwide , many patients with HER2-positive early stage breast cancer do not receive trastuzumab-the st and ard adjuvant treatment . We investigated the efficacy and safety of adjuvant lapatinib for patients with trastuzumab-naive HER2-positive early-stage breast cancer , started at any time after diagnosis . METHODS This study was a placebo-controlled , multicentre , r and omised phase 3 trial . Women out patients from 405 [ corrected ] centres in 33 countries [ corrected ] with HER2-positive early-breast cancer who had previously received adjuvant chemotherapy but not trastuzumab were r and omly assigned ( 1:1 ) to receive daily lapatinib ( 1500 mg ) or daily placebo for 12 months . R and omisation was done with a computer-generated sequence , stratified by time since diagnosis , lymph node involvement at diagnosis , and tumour hormone-receptor status . Investigators , site staff , and patients were masked to treatment assignment . The primary endpoint was disease-free survival in the intention-to-treat population . This study is registered with Clinical Trials.gov , number NCT00374322 . FINDINGS Between August , 2006 , and May , 2008 , 3161 women were enrolled and 3147 were assigned to lapatinib ( n=1571 ) or placebo ( n=1576 ) . After a median follow-up of 47·4 months ( range 0·4 - 60·0 ) in the lapatinib group and 48·3 ( 0·7 - 61·3 ) in the placebo group , 210 ( 13 % ) disease-free survival events had occurred in the lapatinib group versus 264 ( 17 % ) in the placebo group ( hazard ratio [ HR ] 0·83 , 95 % CI 0·70 - 1·00 ; p=0·053 ) . Central review of HER2 status showed that only 2490 ( 79 % ) of the r and omised women were HER2-positive . 157 ( 13 % ) of 1230 confirmed HER2-positive patients in the lapatinib group and in 208 ( 17 % ) of 1260 in the placebo group had a disease-free survival event ( HR 0·82 , 95 % 0·67 - 1·00 ; p=0·04 ) . Serious adverse events occurred in 99 ( 6 % ) of 1573 patients taking lapatinib and 77 ( 5 % ) of 1574 patients taking placebo , with higher incidences of grade 3 - 4 diarrhoea ( 97 [ 6 % ] vs nine [ 1 % ] ) , rash ( 72 [ 5 % ] vs three [ disease-free survival between groups when analysed in the intention-to-treat population . However , exploratory analyses restricted to patients who had HER2-positive disease confirmed by central fluorescence in-situ hybridisation review suggested marginal benefit with lapatinib in terms of disease-free survival . Thus lapatinib might be an option for women with HER2-positive breast cancer who do not or can not receive adjuvant trastuzumab . FUNDING GlaxoSmithKline",
"BACKGROUND Trastuzumab improves survival in the adjuvant treatment of HER-positive breast cancer , although combined therapy with anthracycline-based regimens has been associated with cardiac toxicity . We wanted to evaluate the efficacy and safety of a new nonanthracycline regimen with trastuzumab . METHODS We r and omly assigned 3222 women with HER2-positive early-stage breast cancer to receive doxorubicin and cyclophosphamide followed by docetaxel every 3 weeks ( AC-T ) , the same regimen plus 52 weeks of trastuzumab ( AC-T plus trastuzumab ) , or docetaxel and carboplatin plus 52 weeks of trastuzumab ( TCH ) . The primary study end point was disease-free survival . Secondary end points were overall survival and safety . RESULTS At a median follow-up of 65 months , 656 events triggered this protocol -specified analysis . The estimated disease-free survival rates at 5 years were 75 % among patients receiving AC-T , 84 % among those receiving AC-T plus trastuzumab , and 81 % among those receiving TCH . Estimated rates of overall survival were 87 % , 92 % , and 91 % , respectively . No significant differences in efficacy ( disease-free or overall survival ) were found between the two trastuzumab regimens , whereas both were superior to AC-T. The rates of congestive heart failure and cardiac dysfunction were significantly higher in the group receiving AC-T plus trastuzumab than in the TCH group ( P acute leukemia were reported : seven in the groups receiving the anthracycline-based regimens and one in the TCH group subsequent to receiving an anthracycline outside the study . CONCLUSIONS The addition of 1 year of adjuvant trastuzumab significantly improved disease-free and overall survival among women with HER2-positive breast cancer . The risk-benefit ratio favored the nonanthracycline TCH regimen over AC-T plus trastuzumab , given its similar efficacy , fewer acute toxic effects , and lower risks of cardiotoxicity and leukemia . ( Funded by Sanofi-Aventis and Genentech ; BCIRG-006 Clinical Trials.gov number , NCT00021255 . )",
"BACKGROUND Treatment with adjuvant trastuzumab for 1 year improves disease-free survival and overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer . We aim ed to assess disease-free survival and overall survival after a median follow-up of 4 years for patients enrolled on the Herceptin Adjuvant ( HERA ) trial . METHODS The HERA trial is an international , multicentre , r and omised , open-label , phase 3 trial comparing treatment with trastuzumab for 1 and 2 years with observation after st and ard neoadjuvant , adjuvant chemotherapy , or both in patients with HER2-positive early breast cancer . The primary endpoint was disease-free survival . After a positive first interim analysis at a median follow-up of 1 year for the comparison of treatment with trastuzumab for 1 year with observation , event-free patients in the observation group were allowed to cross over to receive trastuzumab . We report trial outcomes for the 1-year trastuzumab and observation groups at a median follow-up of 48·4 months ( IQR 42·0 - 56·5 ) and assess the effect of the extensive crossover to trastuzumab . Our analysis was by intention-to-treat . The HERA trial is registered with the European Clinical Trials Data base , number 2005 - 002385 - 11 . FINDINGS The HERA trial population comprised 1698 patients r and omly assigned to the observation group and 1703 to the 1-year trastuzumab group . Intention-to-treat analysis of disease-free survival showed a significant benefit in favour of patients in the 1-year trastuzumab group ( 4-year disease-free survival 78·6 % ) compared with the observation group ( 4-year disease-free survival 72·2 % ; hazard ratio [ HR ] 0·76 ; 95 % CI 0·66 - 0·87 ; p analysis of overall survival showed no significant difference in the risk of death ( 4-year overall survival 89·3%vs 87·7 % , respectively ; HR 0·85 ; 95 % CI 0·70 - 1·04 ; p=0·11 ) . Overall , 885 patients ( 52 % ) of the 1698 patients in the observation group crossed over to receive trastuzumab , and began treatment at median 22·8 months ( range 4·5 - 52·7 ) from r and omisation . In a non-r and omised comparison , patients in the selective-crossover cohort had fewer disease-free survival events than patients remaining in the observation group ( adjusted HR 0·68 ; 95 % CI 0·51 - 0·90 ; p=0·0077 ) . Higher incidences of grade 3 - 4 and fatal adverse events were noted on 1-year trastuzumab than in the observation group . The most common grade 3 or 4 adverse events , each in less than 1 % of patients , were congestive cardiac failure , hypertension , arthralgia , back pain , central -line infection , hot flush , headache , and diarrhoea . INTERPRETATION Treatment with adjuvant trastuzumab for 1 year after chemotherapy is associated with significant clinical benefit at 4-year median follow-up . The substantial selective crossover of patients in the observation group to trastuzumab was associated with improved outcomes for this cohort . FUNDING F Hoffmann-La Roche , Michelangelo Foundation",
"BACKGROUND Several r and omised trials have confirmed the benefit of adjuvant trastuzumab for patients with HER2-positive early breast cancer . However , concern has been expressed that adjuvant trastuzumab might be associated with an increased frequency of CNS relapses . We assessed the frequency and course of CNS relapses , either as first event or at any time , using data from the HERA trial . METHODS We estimated the cumulative incidence of first disease-free survival ( DFS ) events in the CNS versus other sites by competing risks analysis in patients with HER2-positive early breast cancer who had been r and omly assigned to receive 1 year of trastuzumab or to observation in the HERA trial after a median follow-up of 4 years ( IQR 3·5 - 4·8 ) . To obtain further information about CNS relapse at any time before death , we circulated a data collection form to investigators to obtain st and ardised information about CNS events that occurred in all patients who had died before July , 2009 . We estimated the cumulative incidence of CNS relapse at any time with a competing risks analysis . RESULTS Of 3401 patients who had been assigned to receive 1 year of trastuzumab or to observation , 69 ( 2 % ) had a CNS relapse as first DFS event and 747 ( 22 % ) had a first DFS event not in the CNS . The frequency of CNS relapses as first DFS event did not differ between the group given 1 year of trastuzumab ( 37 [ 2 % ] of 1703 patients ) and the observation group ( 32 [ 2 % ] of 1698 ; p=0·55 [ Gray 's test ] ) . 481 data collection forms were distributed , of which 413 ( 86 % ) were returned . The proportion of patients who had died and experienced a CNS relapse was numerically higher in the observation group ( 129 [ 57 % ] of 227 ) than in the group given trastuzumab for 1 year ( 88 [ 47 % ] of 186 ; p=0·06 [ Gray 's test ] ) . Most CNS relapses were symptomatic ( 189 [ 87 % ] of 217 ) . CONCLUSION Adjuvant trastuzumab does not increase the risk of CNS relapse in patients with HER2-positive early breast cancer . FUNDING None",
"PURPOSE Docetaxel has not been compared with vinorelbine as adjuvant treatment of early breast cancer . Efficacy and long-term safety of a short course of adjuvant trastuzumab administered concomitantly with chemotherapy for human epidermal growth factor receptor 2 ( HER2 ) -positive cancer are unknown . PATIENTS AND METHODS One thous and ten women with axillary node-positive or high-risk node-negative breast cancer were r and omly assigned to receive three cycles of docetaxel or vinorelbine , followed in both groups by three cycles of fluorouracil , epirubicin , and cyclophosphamide ( FEC ) . Women with HER2-positive cancer ( n = 232 ) were further assigned to either receive or not receive trastuzumab for 9 weeks with docetaxel or vinorelbine . The median follow-up time was 62 months after r and om assignment . RESULTS Women assigned to docetaxel had better distant disease-free survival ( DDFS ) than those assigned to vinorelbine ( hazard ratio [ HR ] = 0.66 ; 95 % CI , 0.49 to 0.91 ; P = .010 ) . In the subgroup of HER2-positive disease , patients treated with trastuzumab tended to have better DDFS than those treated with chemotherapy only ( HR = 0.65 ; 95 % CI , 0.38 to 1.12 ; P = .12 ; with adjustment for presence of axillary nodal metastases , HR = 0.57 ; P = .047 ) . In exploratory analyses , docetaxel , trastuzumab , and FEC improved DDFS compared with docetaxel plus FEC ( HR = 0.32 ; P = .029 ) and vinorelbine , trastuzumab , and FEC ( HR = 0.31 ; P = .020 ) . The median left ventricular ejection fraction of trastuzumab-treated patients remained unaltered during the 5-year follow-up ; only one woman treated with trastuzumab was diagnosed with a heart failure . CONCLUSION Adjuvant treatment with docetaxel improves DDFS compared with vinorelbine . A brief course of trastuzumab administered concomitantly with docetaxel is safe and effective and warrants further evaluation",
"PURPOSE NCCTG ( North Central Cancer Treatment Group ) N9831 is the only r and omized phase III trial evaluating trastuzumab added sequentially or used concurrently with chemotherapy in resected stages I to III invasive human epidermal growth factor receptor 2-positive breast cancer . PATIENTS AND METHODS Patients received doxorubicin and cyclophosphamide every 3 weeks for four cycles , followed by paclitaxel weekly for 12 weeks ( arm A ) , paclitaxel plus sequential trastuzumab weekly for 52 weeks ( arm B ) , or paclitaxel plus concurrent trastuzumab for 12 weeks followed by trastuzumab for 40 weeks ( arm C ) . The primary end point was disease-free survival ( DFS ) . RESULTS Comparison of arm A ( n = 1,087 ) and arm B ( n = 1,097 ) , with 6-year median follow-up and 390 events , revealed 5-year DFS rates of 71.8 % and 80.1 % , respectively . DFS was significantly increased with trastuzumab added sequentially to paclitaxel ( log-rank P ) , with 6-year median follow-up and 313 events , revealed 5-year DFS rates of 80.1 % and 84.4 % , respectively . There was an increase in DFS with concurrent trastuzumab and paclitaxel relative to sequential administration ( arm C/arm B HR , 0.77 ; 99.9 % CI , 0.53 to 1.11 ) , but the P value ( .02 ) did not cross the prespecified O'Brien-Fleming boundary ( .00116 ) for the interim analysis . CONCLUSION DFS was significantly improved with 52 weeks of trastuzumab added to adjuvant chemotherapy . On the basis of a positive risk-benefit ratio , we recommend that trastuzumab be incorporated into a concurrent regimen with taxane chemotherapy as an important st and ard-of-care treatment alternative to a sequential regimen",
"PURPOSE We investigated the pattern of rash , diarrhea , and hepatic adverse events ( AEs ) secondary to lapatinib and their association with age and pathologic complete response ( pCR ) in the Neoadjuvant Lapatinib and /or Trastuzumab Treatment Optimisation ( NeoALLTO ) phase III trial . PATIENTS AND METHODS Patients with HER2-positive early breast cancer were r and omly assigned to receive lapatinib ( Arm A ) , trastuzumab ( Arm B ) , or their combination ( Arm C ) for 6 weeks followed by the addition of paclitaxel for 12 weeks before surgery . We investigated the frequency and time to developing each AE according to age ( ≤ 50 v > 50 years ) and their association with pCR in a logistic regression model adjusted for age , hormone receptors , tumor size , nodal status , planned breast surgery , completion of lapatinib administration , and treatment arm . RESULTS Only patients r and omly assigned to arms A and C were eligible ( n = 306 ) . Younger patients ( ≤ 50 years ) experienced significantly more rash compared with older patients ( 74.4 % v 47.9 % ; P were observed in 78.8 % and 41.2 % of patients , respectively , with no differences in rate or severity or time of onset according to age . Early rash ( ie , before starting paclitaxel ) was independently associated with a higher chance of pCR , mainly in patients older than 50 years ( odds ratio [ OR ] = 3.76 ; 95 % CI , 1.69 to 8.34 ) but not in those ≤ 50 years ( OR = 0.92 ; 95 % CI , 0.45 to 1.88 ; P for interaction = .01 ) . No significant association was observed between pCR and diarrhea or hepatic AEs . CONCLUSION Our results indicate that the frequency and clinical relevance of lapatinib-related rash is largely dependent on patient age",
"PURPOSE To document the rate and outcome of trastuzumab-associated cardiac dysfunction in patients following 1 or 2 years of adjuvant therapy . PATIENTS AND METHODS The Herceptin Adjuvant ( HERA ) trial is a three-arm , r and omized trial comparing 2 years or 1 year of trastuzumab with observation in 5,102 patients with human epidermal growth factor receptor 2 ( HER2 ) -positive early-stage breast cancer . Cardiac function was closely monitored . Eligible patients had left ventricular ejection fraction ( LVEF ) ≥ 55 % at study entry following neoadjuvant chemotherapy with or without radiotherapy . This 8-year median follow-up analysis considered patients r and omly assigned to 2 years or 1 year of trastuzumab or observation . RESULTS The as-treated safety population for 2 years of trastuzumab ( n = 1,673 ) , 1 year of trastuzumab ( n = 1,682 ) , and observation ( n = 1,744 ) is reported . Cardiac adverse events leading to discontinuation of trastuzumab occurred in 9.4 % of patients in the 2-year arm and 5.2 % of patients in the 1-year arm . Cardiac death , severe congestive heart failure ( CHF ) , and confirmed significant LVEF decrease remained low in all three arms . The incidence of severe CHF ( 0.8 % , 0.8 % , and 0.0 % , respectively ) and confirmed significant LVEF decrease ( 7.2 % , 4.1 % , and 0.9 % , respectively ) was significantly higher in the 2-year and 1-year trastuzumab arms compared with the observation arm . Severe CHF was the same for 2-year and 1-year trastuzumab . Of patients with confirmed LVEF decrease receiving 2-year trastuzumab , 87.5 % reached acute recovery . Of patients with confirmed LVEF decrease receiving 1-year trastuzumab , 81.2 % reached acute recovery . CONCLUSION Long-term assessment at 8-year median follow-up confirms the low incidence of cardiac events for trastuzumab given sequentially after chemotherapy and radiotherapy , and cardiac events were reversible in the vast majority of patients"
] | 41169944-06ff-11f0-808a-c43d1ab1c353 |
Background Adults in urban areas spend almost 77 % of their waking time being inactive at workplaces , which leaves little time for physical activity . The aim of this systematic review and meta- analysis was to synthesize evidence for the effect of workplace physical activity interventions on the cardio-metabolic health markers ( body weight , waist circumference , body mass index ( BMI ) , blood pressure , lipids and blood glucose ) among working adults . Methods All experimental studies up to March 2018 , reporting cardio-metabolic worksite intervention outcomes among adult employees were identified from PUBMED , EMBASE , COCHRANE CENTRAL , CINAHL and PsycINFO . The Cochrane Risk of Bias tool was used to assess bias in studies . All studies were assessed qualitatively and meta- analysis was done where possible . Forest plots were generated for pooled estimates of each study outcome . Results A total of 33 studies met the eligibility criteria and 24 were included in the meta- analysis . Multi-component workplace interventions significantly reduced body weight ( 16 studies ; mean diff : − 2.61 kg , 95 % CI : − 3.89 to − 1.33 ) BMI ( 19 studies , mean diff : − 0.42 kg/m2 , 95 % CI : − 0.69 to − 0.15 ) and waist circumference ( 13 studies ; mean diff : − 1.92 cm , 95 % CI : − 3.25 to − 0.60 ) . Reduction in blood pressure , lipids and blood glucose was not statistically significant . Conclusions Workplace interventions significantly reduced body weight , BMI and waist circumference . Non-significant results for biochemical markers could be due to them being secondary outcomes in most studies . Intervention acceptability and adherence , follow-up duration and exploring non- RCT design s are factors that need attention in future research . Prospero registration number : CRD42018094436 | [
"OBJECTIVE To evaluate the effectiveness of a worksite health promotion program on improving cardiovascular disease risk factors . METHODS In St Louis , Missouri from 2005 to 2006 , 151 employees ( 134 F , 17 M , 81 % overweight/obese ) participated in a cohort-r and omized trial comparing assessment s + intervention ( worksite A ) with assessment s only ( worksite B ) for 1 year . All participants received personal health reports containing their assessment results . The intervention was design ed to promote physical activity and favorable dietary patterns using pedometers , healthy snack cart , WeightWatchers(R ) meetings , group exercise classes , seminars , team competitions , and participation rewards . Outcomes included BMI , body composition , blood pressure , fitness , lipids , and Framingham 10-year coronary heart disease risk . RESULTS 123 participants , aged 45+/-9 yr , with BMI 32.9+/-8.8 kg/m(2 ) completed 1 year . Improvements ( P fitness , blood pressure , and total- , HDL- , and LDL-cholesterol . Additional improvements occurred at worksite A in BMI , fat mass , Framingham risk score , and prevalence of the metabolic syndrome ; only the changes in BMI and fat mass were different between worksites . CONCLUSION A multi-faceted worksite intervention promoted favorable changes in cardiovascular disease risk factors , but many of the improvements were achieved with worksite health assessment s and personalized health reports in the absence of an intervention",
"Background Worksite nutrition and physical activity interventions are important to help overweight and obese employees lose weight , but costs and insufficient sustained motivation prevent the majority of these programs from succeeding . Tailored text messaging in aiding weight management has been effective in several studies , but no studies have evaluated the effect of a tailored text message service on weight loss in a worksite health promotion program . Objective We studied the efficacy of a tailored text-messaging intervention for obese male participants in a worksite weight loss program of 6 months duration . Methods The study was an unblinded , r and omized controlled trial . Men with a body mass index greater than 25 kg/m2 were recruited from the Korea District Heating Corporation , the Korea Expressway Corporation , and the Korea Gas Corporation . The participants were identified by nurse managers . Participants were r and omly allocated to 1 of the following 2 groups for 24 weeks : ( 1 ) intervention group , which received tailored text message reminders every other day plus 4 offline education sessions and brief counseling with monthly weight check by nurses for weight control over 6 months and ( 2 ) control group , which received the 4 offline education sessions and brief counseling with monthly weight check by nurses about weight control over 6 months . The primary outcome was the difference in weight loss at 6 months . A mixed-model repeated- measures analysis was performed to evaluate the effect of the intervention group ’s weight loss compared with the control group . Results A total of 205 obese men were r and omized into either the intervention ( n=104 ) or the control group ( n=101 ) . At the end of 6 months , the intervention group ( n=63 ) had lost 1.71 kg ( 95 % CI –2.53 to –0.88 ) and the control group ( n=59 ) had lost 1.56 kg ( 95 % CI –2.45 to –0.66 ) ; the difference between the 2 groups was not significant ( mean difference –0.15 , 95 % CI –1.36 to 1.07 ) . At the end of the study , 60 % ( 34/57 ) of the intervention group rated the message program as helpful for weight control and 46 % ( 26/57 ) would recommend the text message service to their friends . Conclusions Tailored text message reminders did not have a significant effect on weight loss in obese men as part of a worksite weight loss program . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 39629189 ; http://www.is rct n.com/IS RCT N39629189?q=39629189&filters=&sort=&offset=1&total Results = 1&page=1&pageSize=10 & search Type = basic- search ( Archived by WebCite at http://www.webcitation.org/6VsFkwJH6 )",
"Background Young women are a group at high risk of weight gain . This study examined a range of perceived personal , social and environmental barriers to physical activity and healthy eating for weight maintenance among young women , and how these varied by socioeconomic status ( SES ) , overweight status and domestic situation . Methods In October-December 2001 , a total of 445 women aged 18–32 years , selected r and omly from the Australian electoral roll , completed a mailed self-report survey that included questions on 11 barriers to physical activity and 11 barriers to healthy eating ( relating to personal , social and environmental factors ) . Height , weight and socio-demographic details were also obtained . Statistical analyses were conducted mid-2003 . Results The most common perceived barriers to physical activity and healthy eating encountered by young women were related to motivation , time and cost . Women with children were particularly likely to report a lack of social support as an important barrier to physical activity , and lack of social support and time as important barriers to healthy eating . Perceived barriers did not differ by SES or overweight status . Conclusions Health promotion strategies aim ed at preventing weight gain should take into account the specific perceived barriers to physical activity and healthy eating faced by women in this age group , particularly lack of motivation , lack of time , and cost . Strategies targeting perceived lack of time and lack of social support are particularly required for young women with children",
"AIMS To investigate a virtual assistance-based lifestyle intervention to reduce risk factors for Type 2 diabetes in young employees in the information technology industry in India . METHODS LIMIT ( Lifestyle Modification in Information Technology ) was a parallel-group , partially blinded , r and omized controlled trial . Employees in the information technology industry with ≥3 risk factors ( family history of cardiometabolic disease , overweight/obesity , high blood pressure , impaired fasting glucose , hypertriglyceridaemia , high LDL cholesterol and low HDL cholesterol ) from two industries were r and omized to a control or an intervention ( 1:1 ) group . After initial lifestyle advice , the intervention group additionally received reinforcement through mobile phone messages ( three per week ) and e-mails ( two per week ) for 1 year . The primary outcome was change in prevalence of overweight/obesity , analysed by intention to treat . RESULTS Of 437 employees screened ( mean age 36.2 ± 9.3 years ; 74.8 % men ) , 265 ( 61.0 % ) were eligible and r and omized into control ( n=132 ) or intervention ( n=133 ) group . After 1 year , the prevalence of overweight/obesity reduced by 6.0 % in the intervention group and increased by 6.8 % in the control group ( risk difference 11.2 % ; 95 % CI 1.2 - 21.1 ; P=0.042 ) . There were also significant improvements in lifestyle measurements , waist circumference , and total and LDL cholesterol in the intervention group . The number-needed-to-treat to prevent one case of overweight/obesity in 1 year was 9 ( 95 % CI 5 - 82 ) , with an incremental cost of INR10665 ( £ 112.30 ) per case treated/prevented . A total of 98 % of participants found the intervention acceptable . CONCLUSIONS A virtual assistance-based lifestyle intervention was effective , cost-effective and acceptable in reducing risk factors for diabetes in young employees in the information technology industry , and is potentially scalable",
"Purpose . To evaluate the effectiveness of FUEL Your Life , a translation of the Diabetes Prevention Program for worksites . Design . A r and omized control group design was conducted in five worksites of a large transportation company . Measures were collected pretest , posttest ( 6 months ) , and follow-up ( 12 months ) . Setting . Railroad maintenance facilities of Union Pacific Railroad . Subjects . Participants consisted of 362 workers ( 227 treatment , 135 control ) . Intervention . FUEL Your Life was translated from the Diabetes Prevention Program to better fit within the context of the worksite . The primary difference was the use of peer health coaches to provide social support and reinforcement and an occupational nurse to provide lesson content ( six sessions of 10 minutes ) to participants instead of the lifestyle coaches employed by the Diabetes Prevention Program , result ing in a less structured meeting schedule . Measures . The primary outcomes were weight and body mass index ( BMI ) , with secondary outcomes including eating behaviors , physical activity , and social support . Analysis . Latent growth modeling was used to measure changes in the outcomes over time . Results . Participants in the intervention group maintained weight/ BMI ( –.1 pounds/–.1 BMI ) , whereas the control participants gained weight/ BMI ( + 2.6 pounds/+.3 BMI ) , result ing in a statistically significant difference between groups . Fifty-five percent of intervention participants lost some weight , whereas only 35 % of the control group lost weight . Conclusions . FUEL Your Life , a low intensity intervention , was not effective for promoting weight loss , but was effective for helping workers maintain weight over a 12-month period",
"OBJECTIVES We assessed the effects of a worksite multiple-component intervention addressing diet and physical activity on employees ' mean body mass index ( BMI ) and the percentage of employees who were overweight or obese . METHODS This group-r and omized trial ( n = 3799 ) was conducted at 10 worksites in the northeastern United States . Worksites were paired and allocated into intervention and control conditions . Within- and between-groups changes in mean BMI s and in the percentage of overweight or obese employees were examined in a volunteer sample . RESULTS Within-group mean BMI s decreased by 0.54 kilograms per meter squared ( P = .02 ) and 0.12 kilograms per meter squared ( P = .73 ) at the intervention and control worksites , respectively , result ing in a difference in differences ( DID ) decrease of 0.42 kilograms per meter squared ( P = .33 ) . The within-group percentage of overweight or obese employees decreased by 3.7 % ( P = .07 ) at the intervention worksites and increased by 4.9 % ( P = .1 ) at the control worksites , result ing in a DID decline of 8.6 % ( P = .02 ) . CONCLUSIONS Our findings support a worksite population strategy that might eventually reduce the prevalence of overweight and obesity by minimizing environmental exposures to calorically dense foods and increasing exposures to opportunities for energy expenditure within worksite setting",
"Background U.S. adults are at unprecedented risk of becoming overweight or obese , and most scientists believe the primary cause is an obesogenic environment . Worksites provide an opportunity to shape the environments of adults to reduce obesity risk . The goal of this group-r and omized trial was to implement a four-component environmental intervention at the worksite level to positively influence weight gain among employees over a two-year period . Environmental components focused on food availability and price , physical activity promotion , scale access , and media enhancements . Methods Six worksites in a U.S. metropolitan area were recruited and r and omized in pairs at the worksite level to either a two-year intervention or a no-contact control . Evaluations at baseline and two years included : 1 ) measured height and weight ; 2 ) online surveys of individual dietary intake and physical activity behaviors ; and 3 ) detailed worksite environment assessment . Results Mean participant age was 42.9 years ( range 18 - 75 ) , 62.6 % were women , 68.5 % were married or cohabiting , 88.6 % were white , 2.1 % Hispanic . Mean baseline BMI was 28.5 kg/m2 ( range 16.9 - 61.2 kg/m2 ) . A majority of intervention components were successfully implemented . However , there were no differences between sites in the key outcome of weight change over the two-year study period ( p = .36 ) . Conclusions Body mass was not significantly affected by environmental changes implemented for the trial . Results raise questions about whether environmental change at worksites is sufficient for population weight gain prevention . Trial Registration Clinical Trials.gov :",
"OBJECTIVE To describe the effectiveness , reach and implementation of a weight gain prevention intervention among public school employees . METHOD A multi-level intervention was tested in a cluster r and omized trial among 782 employees in 12 central Massachusetts public high schools from 2009 to 2012 . The intervention targeted the nutrition and physical activity environment and policies , the social environment and individual knowledge , attitudes and skills . The intervention was compared to a material s only condition . The primary outcome measures were change in weight and body mass index ( BMI ) at 24-month follow-up . Implementation of physical environment , policy and social environment strategies at the school and interpersonal levels , and intervention participation at the individual level were assessed . RESULTS At 24-month follow-up , there was a net change ( difference of the difference ) of -3.03 pounds ( p=.04 ) and of -.48 BMI units ( p=.05 ) between intervention and comparison conditions . The majority of intervention strategies were successfully implemented by all intervention schools , although establishing formal policies was challenging . Employee participation in programs targeting the physical and social environment was maintained over time . CONCLUSION This study supports that a multi-level intervention integrated within the organizational culture can be successfully implemented and prevent weight gain in public high school employees",
"OBJECTIVES This study tested a feasible method for screening for cardiovascular risk at the worksite and investigated the effects of a long-term comprehensive program of life-style intervention to prevent cardiovascular disease . METHODS Employees in the public sector filled out a self-administered question naire with questions on social , medical , and work-related factors . The respondents numbered 454 ( 80 % ) . A score sum for cardiovascular risk was calculated ( range 1 - 20 , median 7.0 ) , and the 128 subjects with a sum above 8 were invited to a health examination including blood sampling . Thereafter the subjects were invited to participate , following r and omization , in a comprehensive , 18-month , life-style intervention program to improve cardiovascular risk or in a control group . RESULTS The intervention group significantly decreased body mass index , diastolic blood pressure , heart rate , low-density lipoprotein ( LDL ) cholesterol , and smoking habits during the intervention . The initially elevated serum cortisol , as a marker of stress reaction , normalized in the intervention group . In the control group LDL cholesterol also decreased , but the glucose and triglyceride levels increased , and smoking habits were unchanged . Sick days for a given period decreased after 1 year in the intervention group but not in the control group . CONCLUSIONS Several cardiovascular risk factors can be improved and morning serum cortisol normalized during a long-term life-style intervention program with a r and omized design using a worksite population of middle-aged subjects . The use of a 2-step screening program , with an initial question naire followed by a health check of subjects with elevated risk , is feasible for worksite setting",
"OBJECTIVE To present the effects of a relatively modest environmental intervention on biological cardiovascular risk indicators . METHOD A controlled trial , including two worksites . Measurements ( i.e. , body composition , blood pressure and serum cholesterol ) took place at baseline and at 3- and 12-month follow-up . The 12-month environmental intervention ( The Hague , The Netherl and s , 2004 ) consisted of : a ' Food'-part : to stimulate healthier food choices by means of product information in the canteen , and a ' Steps'-part : focused on stimulating stair use by means of motivational prompts in staircases and on elevator doors . RESULTS Significant differences in change between groups ( n=540 ) in favor of the intervention group were found on : [ 1 ] total cholesterol for women ( -0.35 mmol/l ) ; [ 2 ] HDL for men at 3 months ( 0.05 mmol/l ) and 12 months ( 0.10 mmol/l ) ; and [ 3 ] the total-HDL ratio for the total intervention group at 3 and 12 months ( -0.45 mmol/l ) . Both groups showed a decrease in all body composition values at both follow-ups . A significant difference in change in systolic BP was found in favor of the control group ( approximately 4 mm Hg ) , due to an increase in the intervention group at both follow-ups . CONCLUSIONS Based on the contrasting results , this modest environmental intervention was ineffective in reducing cardiovascular risk in a population of office workers",
"Purpose : To determine the effects of an environmental intervention on obesity , disease risk factors , and dietary intake in an employee population . Design : R and omized controlled community trial . Setting : Eight manufacturing companies in Kentucky with ~ 150 to 350 employees each . Subjects : R and omly selected employees . Intervention : Multicomponent environmental intervention that included employee advisory committees , point-of-decision prompts , walking paths , cafeteria/vending changes , and educational material s. Measures : Height ; weight ; body fat ; blood pressure ; fasting lipids , glucose and insulin ; and dietary intake were assessed prior to and 3 , 6 , and 12 months after initiation of the intervention . Analysis : Mixed-model repeat-measure analyses of covariance were used to analyze data collected over the study period . Categorical data were analyzed in contingency tables . A p value of .05 was used to judge statistical significance . Results : There were no intervention effects for outcome variables , with the exception of lower intake of saturated fat and dietary cholesterol in the intervention group compared to the control group . Over the course of the study , changes in anthropometry and bio measures were similar in both groups . Conclusions : Findings indicate that subtle environmental changes alone may not impact employees ' weight and health ; however , such institutional-level approaches may be essential to support healthy lifestyle habits that are initiated by more intensive efforts . Academic research ers should continue to partner with employers and practitioners to develop , implement , and evaluate innovative health promotion strategies including environmental interventions . ( Am J Health Promot 2011;25[5]:334 - 340 .",
"Cardiac rehabilitation and exercise training ( CRET ) provides health risk intervention in cardiac patients over a relatively short time frame . Worksite health programs offer a unique opportunity for health intervention , but these programs remain underused due to concerns over recouping the costs . We evaluated the clinical efficacy and cost-effectiveness of a 6-month worksite health intervention using staff from CRET . Employees ( n = 308 ) and spouses ( n = 31 ) of a single employer were r and omized to active intervention ( n = 185 ) consisting of worksite health education , nutritional counseling , smoking cessation counseling , physical activity promotion , selected physician referral , and other health counseling versus usual care ( n = 154 ) . Health risk status was assessed at baseline and after the 6-month intervention program , and total medical cl aim costs were obtained in all participants during the year before and the year after intervention . Significant improvements were demonstrated in quality -of-life scores ( + 10 % , p = 0.001 ) , behavioral symptoms ( depression -33 % , anxiety -32 % , somatization -33 % , and hostility -47 % , all p values body fat ( -9 % , p = 0.001 ) , high-density lipoprotein cholesterol ( + 13 % , p = 0.0001 ) , diastolic blood pressure ( -2 % , p = 0.01 ) , health habits ( -60 % , p = 0.0001 ) , and total health risk ( -25 % , p = 0.0001 ) . Of employees categorized as high risk at baseline , 57 % were converted to low-risk status . Average employee annual cl aim costs decreased 48 % ( p = 0.002 ) for the 12 months after the intervention , whereas control employees ' costs remained unchanged ( -16 % , p = NS ) , thus creating a sixfold return on investment . In conclusion , worksite health intervention using CRET staff decreased total health risk and markedly decreased medical cl aim costs within 12 months",
"Objective To determine the effectiveness of an individually-targeted Internet-based intervention with monetary incentives ( INCENT ) at reducing weight of overweight and obese employees when compared to a less-intensive intervention ( Livin ’ My Weigh [ LMW ] ) 6-months after program initiation . Design and Methods Twenty-eight worksites were r and omly assigned to either INCENT or LMW conditions . Both programs used evidence -based strategies to support weight loss . INCENT was delivered via daily e-mails over 12 months while LMW was delivered quarterly via both newsletters and onsite educational sessions . Generalized linear mixed models were conducted for weight change from baseline to 6-month post program and using an intention-to-treat ( ITT ) analysis to include all participants with baseline weight measurements . Results Across 28 worksites , 1,790 employees ( M=47 years of age ; 79 % Caucasian ; 74 % women ) participated . Participants lost an average of 2.27 lbs ( p BMI decrease of 0.36 kg/m2 ( p BMI decrease of 0.20 kg/m2 ( p INCENT and LMW group in weight loss and BMI reduction were not statistically significant . Conclusion The current study suggests that INCENT and a minimal intervention alternative may be effective approaches to help decrease the overall obesity burden within worksites",
"Background There was an increasing trend in the prevalence of obesity and its comorbidities over the past decades in Malaysia . Effective intervention for obesity remains limited . This study aim ed to compare the effectiveness of a group based lifestyle modification programme amongst obese individuals with an existing dietary counseling programme . Methods We recruited one hundred and ninety four overweight and obese ( BMI > 27.5 kg/m2 ) employees from a local university . They were r and omly allocated to either Group Support Lifestyle Modification ( GSLiM ) (intervention)(n = 97 ) or dietary counseling (comparison)(n = 97 ) . The GSLIM activities included self monitoring , cognitive-behaviour sessions , exercise as well as dietary change advocacy , which were conducted through seminars and group sessions over 24 weeks . The comparison group was given dietary counselling once in 12 weeks . Both groups were followed up for additional 12 weeks to check for intervention effect sustenance . Anthropometric and biochemical parameters were measured at baseline , 12 , 24 and 36 weeks ; while dietary intake , physical activities , psychological measures and quality of life measured at baseline , 24 and 36 weeks . Data analysis was conducted using ANOVA repeated measures with intention to treat principle . Results The participants were predominantly women with mean ( st and ard deviation ) age of 40.5 ( 9.3 ) years . A total of 19.6 % of the participants in GSLiM achieved 6 % weight loss compared to 4.1 % in the comparison group ( Risk Ratio 4.75 ; 95 % CI : 1.68 , 13.45 ) . At 24 weeks , the retention rate was 83.5 % for GSLiM and 82.5 % for comparison group . GSLiM participants also achieved significant improvement in total weight self-efficacy score , negative emotions and physical discomfort subscales , MDPSS friend subscale and all domains in quality of life . Participants in the comparison group experienced reduction in negative self-thoughts . Conclusion The GSLiM programme proved to be more effective in achieving targeted weight loss , improving weight self-efficacy , friend social support , and quality of life compared to dietary counseling . Trial Registration Iranian Registry of Clinical Trials I RCT",
"Background Weight management constitutes a substantial problem particularly among groups of low socio-economic status . Interventions at work places may be a solution , but high quality worksite interventions documenting prolonged weight loss are lacking . This paper presents results of an intervention aim ed to achieve a 12 months weight loss among overweight health care workers . Methods Ninety-eight overweight female health care workers were r and omized into an intervention or a reference group . The intervention consisted of diet , physical exercise and cognitive behavioral training during working hours 1 hour/week . The reference group was offered monthly oral presentations . Several anthropometric measures , blood pressure , cardiorespiratory fitness , maximal muscle strength , and musculoskeletal pain were measured before and after the 12-months intervention period . Data were analyzed by intention-to-treat analysis . Results The intervention group significantly reduced body weight by 6 kg ( p BMI by 2.2 ( p body fat percentage by 2.8 ( p body weight , BMI and body fat percentage among overweight female health care workers over 12 months . The positive results support the workplace as an efficient arena for weight loss among overweight females . Trial registration NCT01015716",
"Introduction Working adults spend much time at the workplace , an ideal setting for wellness programs targeting weight loss and disease prevention . Few r and omized trials have evaluated the efficacy of worksite diabetes prevention programs . This study evaluated the efficacy of a worksite lifestyle intervention on metabolic and behavioral risk factors compared with usual care . Methods A pretest – posttest control group design with 3-month follow-up was used . Participants with prediabetes were recruited from a university worksite and r and omized to receive a 16-week lifestyle intervention ( n = 35 ) or usual care ( n = 34 ) . Participants were evaluated at baseline , postintervention , and 3-month follow-up . Dietary intake was measured by a food frequency question naire and level of physical activity by accelerometers . Repeated measures analysis of variance compared the change in outcomes between and within groups . Results Mean ( st and ard error [ SE ] ) weight loss was greater in the intervention ( −5.5 % [ 0.6 % ] ) than in the control ( −0.4 % [ 0.5 % ] ) group ( P ) . Mean ( SE ) reductions in fasting glucose were greater in the intervention ( −8.6 [ 1.6 ] mg/dL ) than in the control ( −3.7 [ 1.6 ] mg/dL ) group ( P = .02 ) postintervention ; both groups had significant glucose reductions at 3-month follow-up ( P the intake of total energy and the percentage of energy from all fats , saturated fats , and trans fats decreased , and the intake of dietary fiber increased ( all P worksite intervention improved metabolic and behavioral risk factors among employees with prediabetes . The long-term impact on diabetes prevention and program sustainability warrant further investigation",
"OBJECTIVES To improve nutrition and physical activity of county employees and promote weight loss . DESIGN R and om assignment to begin the program when first offered or after 3 months ( \" wait control \" group ) . SETTING Worksite . PARTICIPANTS Onondaga County employees ( n = 45 ) at risk for diabetes ( n = 35 ) or with diabetes ( n = 10 ) . Mean ( ±SD ) age = 51.2 ( ± 8.0 ) years and body mass index ( BMI ) = 37.3 ± ( 6.8 kg/m ) . INTERVENTION Twelve weekly healthy lifestyle sessions based on the Diabetes Prevention Program curriculum , followed by monthly sessions for up to 12 months . OUTCOMES Medical : Weight , BMI , waist circumference , blood pressure , fasting glucose , lipid , and hemoglobin A1c levels . Psychosocial/behavioral : Health-related quality of life Short Form-12 , Impact of Weight on Quality of Life Scale ) , physical activity ( International Physical Activity Question naire ) , eating behavior ( 3-Factor Eating Question naire , National Cancer Institute Fat Screener ) , job satisfaction . RESULTS The intervention group lost significant weight compared to the wait control group over the first 3 months ( mean [ 95 % CI ] , -2.23 kg [ -3.5 to 0.97 ] ) vs [ + 0.73 kg ( + 0.17 to + 1.28 ) ] , with a decrease in BMI ( P and waist circumference ( P = .004 ) , an increase in physical activity ( International Physical Activity Question naire , P = .011 ) and lower dietary fat intake ( P = .018 ) . Over 12 months , 22.5 % ( 9/40 ) lost more than 5 % body weight and 12.5 % ( 5/40 ) lost more than 7 % body weight . After the first 3 months , there was gradual partial weight regain but reduction in waist circumference was maintained . The intervention group demonstrated significant improvement in Impact of Weight on Quality of Life Scale ( P , 3-Factor Eating ( cognitive restraint P .003 , and emotional eating P = .001 ) , International Physical Activity Question naire ( P = .011 ) , and Short Form-12 Physical Component Summary ( P = .048 ) . No improvements were observed in blood pressure , lipid , hemoglobin A1c , or glucose levels . Job satisfaction was inversely related to BMI at baseline ( P = .001 ) with a trend for improvement with the modest weight loss . CONCLUSIONS A worksite intervention program can help government employees adopt healthier lifestyles and achieve modest weight loss",
"Purpose . We assessed the effectiveness of a worksite management intervention ( the 3W program ) for overweight and obese hotel employees . Design . The program was tested in a 2-year cluster-r and omized trial involving 30 hotels that employed nearly 12,000 individuals . Setting . All participating hotels were on Oahu , Hawaii . The intervention was implemented within hotel worksites . Subjects . Participants were included in the analysis if they had an initial body mass index ( BMI ) ≥ 25 , were assessed at least twice , were not missing other data needed for the analysis , and did not switch to employment at a hotel in a different experimental condition . Of the 6519 employees we assessed , data from 1207 individuals ( intervention : 598 ; control : 610 ) met these criteria and contributed to the analysis . Intervention . The intervention had two components : ( 1 ) group meetings and ( 2 ) a workplace environment intervention . Measures . Weight and waist to height ratio ( WHtR ) were measured at three annual assessment s. Analysis . The effect of the intervention on change in BMI and WHtR was estimated in hierarchical mixed regression models using full maximum likelihood to estimate model parameters . Results . The effects on change in BMI and WHtR were in the expected direction but were not statistically significant . Conclusion . The 3W program was not effective . The low intensity of the intervention may have contributed to its ineffectiveness",
"OBJECTIVE To evaluate the feasibility and efficacy of a workplace-based weight loss program ( Workplace POWER-WP ) for male shift workers . METHOD A prospect i ve , two-armed r and omized controlled trial of 110 overweight/obese ( BMI 25 - 40 ) ( mean [ SD ] age = 44.4 [ 8.6 ] years ; BMI = 30.5 [ 3.6 ] ) male employees at Tomago Aluminium aged 18 - 65 . In October ( 2009 ) men were r and omized to either ( i ) WP program ( n=65 ) or ( ii ) a 14-week wait-list control group ( n=45 ) . The 3-month program involved one information session , program booklets , group-based financial incentives and an online component . Men were assessed at baseline and at 14-week follow-up for weight ( primary outcome ) , waist circumference , BMI , blood pressure , resting heart rate , self-reported physical activity and dietary variables , and physical activity and dietary cognitions . RESULTS Intention-to-treat analysis using linear mixed models revealed significant between group differences for weight loss after 14 weeks ( P waist circumference ( P BMI ( P systolic blood pressure ( P = .02 , d = 0.48 ) , resting heart rate ( P physical activity ( P = .03 , d = 0.77 ) , sweetened beverages ( P physical activity-related cognitions ( P The WP program was feasible and efficacious and result ed in significant weight loss and improved health-related outcomes and behaviours in overweight male shift workers",
"BACKGROUND The long-term effectiveness of multicomponent worksite health promotion programs targeting cardiovascular disease risk factors remains unclear in Japan . This study was conducted to evaluate the effectiveness of such a health promotion program consisting of a main program provided over 4 days and a follow-up program provided over 1 year . METHODS The subjects of this r and omized controlled trial were male employees working for a building maintenance company in Japan . The intervention group ( n = 152 ) and the control group ( n = 150 ) consisted of employees having abnormal findings in at least one of the following items at baseline health examination : body mass index ( BMI ) , systolic ( SBP ) or diastolic blood pressure , total cholesterol , HDL cholesterol , triglycerides , and fasting blood glucose . Evaluation was conducted at 18 months after the main program . RESULTS BMI , SBP , total cholesterol , and triglycerides improved significantly in the intervention group compared with the control group ( P BMI , total cholesterol , and triglycerides improved significantly in the intervention group ( P multicomponent health promotion program provided to employees was shown to be effective in improving obesity , high blood pressure , and hyperlipidemia when evaluated 18 months after the main intervention program",
"OBJECTIVES We used a participatory process to develop an obesity intervention appropriate for elementary school personnel . METHODS A r and omized controlled trial included 16 school worksites ( 8 intervention , 8 control ) . Intervention schools formed committees to develop and implement health promotion activities for employees . Anthropometric and self-report data were collected at baseline and postintervention ( 2 years later ) . The primary outcome measures were body mass index ( BMI ) , waist-hip ratio , physical activity , and fruit and vegetable consumption . RESULTS After adjustment for age , ethnicity , and job classification , employees in intervention schools reduced their BMI by an average of 0.04 kg/m2 , and those in control schools increased their BMI by an average of 0.37 kg/m2 . Comparisons for waist-hip ratio , weekly physical activity minutes , and fruit and vegetable consumption were not significant . CONCLUSIONS The participatory process appeared to be an effective means for stimulating change . The intervention may have slowed and perhaps reversed the tendency of adults to gain weight progressively with age",
"Purpose : To evaluate the effectiveness of an individually tailored intervention for improvement in lifestyle behavior , health indicators , and prevention and reduction of overweight among construction workers . Design : R and omized controlled trial . Setting : Various blue-collar departments of a large construction company in the Netherl and s. Participants : Blue-collar workers r and omized to an intervention ( n = 162 ) or a control group ( n = 152 ) . Intervention : The intervention group received individual coaching sessions , tailored information , and material s to improve lifestyle behavior during a 6-month period , and the control group received usual care . Measures : Body weight , body mass index ( BMI ) , waist circumference , physical activity ( PA ) levels , dietary behavior , blood pressure , and blood cholesterol were assessed . Analysis : Effectiveness of the intervention on outcome measures at 6- and 12-month follow-up was assessed by using linear and logistic regression models adjusting for baseline levels . Results : After 6 months , a statistically significant intervention effect was found on body weight ( B = −1.06 , P = .010 ) , BMI ( B = −0.32 , P = .010 ) , and waist circumference ( B = −1.38 , P = .032 ) . At 6 months , the percentage of those meeting public health guidelines for PA increased significantly in the intervention group compared to the control group ( B = 2.06 , P = .032 ) , and for sugar-sweetened beverages , an intervention effect was found at 6 months as well ( B = −2.82 , P = .003 ) . At 12 months , for weight-related outcomes , these differences were slightly smaller and no longer statistically significant . The intervention was not effective on the total amount of moderate to vigorous PA and other dietary and health outcomes . Conclusion : Intervention participants showed positive changes in vigorous PA and intake of sugar-sweetened beverages compared to controls , as well as effects on weight-related outcomes at 6 months . Long-term effects were still promising but not statistically significant",
" Objective : To determine whether an evidence -based , behavioral lifestyle intervention program delivered at a worksite setting is effective in improving type 2 diabetes and cardiovascular disease risk factors . Methods : A r and omized 6-month delayed control design was utilized , with two thirds of the participants assigned to begin intervention immediately , and one third beginning 6 months later . The year-long program ( weekly for 3 months transitioning to monthly ) focused on weight loss and increasing physical activity . Results : The immediate intervention group had greater mean weight loss ( −10.4 lb , 5.1 % , vs −2.3 lb , 1 % ; P = 0.0001 ) than the delayed control group at 6 months and relatively greater improvements in activity , HbA1c , and other risk factors . The delayed group experienced similar improvements after completing the intervention program . Conclusions : A worksite behavioral lifestyle intervention is feasible and effective in significantly improving risk factors for type 2 diabetes and cardiovascular disease",
"Overweight and physical inactivity are risk factors for increased disease burden and health care expenditure . Well- design ed studies are still needed to determine the treatment efficacy of worksite interventions targeting such risk factors . This r and omized controlled trial was conducted at one of Australia 's casinos in 2002 - 2003 , to investigate the effects of a comprehensive exercise and lifestyle intervention on physical fitness . Only 6.4 % of the workforce expressed interest in being study participants . Seventy-three employees ( aged 32 + /- 8 years , 51 % overweight/obese , 73 % shift workers and 52 % women ) were recruited and r and omized to treatment or wait-list control groups for 24 weeks , 44 of whom completed the intervention . Components of the intervention include supervised moderate-to-high intensity exercise including combined aerobic ( at least 20 min duration 3 days/week ) and weight-training ( for an estimated 30 min completed 2 - 3 days/week ) , and dietary/health education ( delivered via group seminars , one-on-one counselling and literature through the provision of a worksite manual ) . ANCOVA , by intention-to-treat and of study completers , found significant between-group differences in the mean waist circumference and predicted maximal oxygen uptake ( VO2max ) , favouring the intervention , but effects were concentrated in one subject . For study completers , between-group differences in the mean waist circumference ( 82.3 + /- 9.2 versus 90.5 + /- 17.8 cm , p = 0.01 ) and predicted VO2max ( 47 versus 41 ml/kg/min , p intervention compliance predicted greater improvements in physical fitness . No significant effects on body mass or body mass index were found . This worksite intervention significantly improved waist circumference and aerobic fitness in healthy but sedentary employees , most of whom were shift workers . Worksite interventions have the potential to counter the increasing burden of overweight and obesity , particularly visceral adiposity , as well as physical inactivity ; however , substantial barriers to adoption/adherence need to be overcome for greater feasibility and impact on employee physical health",
"OBJECTIVE The results of an 18-month worksite intervention to prevent obesity among metropolitan transit workers are reported . METHODS Four garages in a major metropolitan area were r and omized to intervention or control groups . Data were collected during the fall of 2005 prior to the start of the intervention and during the fall of 2007 , after the intervention ended . Intervention program components at the garage included enhancement of the physical activity facilities , increased availability of and lower prices on healthy vending machine choices , and group behavioral programs . Mixed model estimates from cross-sectional and cohort sample s were pooled with weights inverse to the variance of their respective estimates of the intervention effects . RESULTS Measurement participation rates were 78 % at baseline and 74 % at follow-up . The intervention effect on garage mean BMI change was not significant ( -0.14 kg/m(2 ) ) . Energy intake decreased significantly , and fruit and vegetable intake increased significantly in intervention garages compared to control garages . Physical activity change was not significant . CONCLUSION Worksite environmental interventions for nutrition and physical activity behavior change may have limited impact on BMI among transit workers who spend most of their workday outside the worksite",
"Individuals who are physically fit or engage in regular physical activity have a lower incidence of cardiovascular disease and risk of mortality . We conducted a large-scale controlled trial of interventions to decrease cardiovascular risk factors , during which we assessed the effect of a workplace-based intervention program , which was part of a population strategy for promoting long-term increases in physical activity , on the blood lipid profiles of participating employees . Data were collected from 2929 participants and this report presents the results of a survey conducted in five factories for the intervention group and five factories for the control group at baseline and year 5 . The absolute/proportional changes in HDL-cholesterol were 2.7 mg/dL ( 4.8 % ) in the intervention group and -0.6 mg/dL ( -1.0 % ) in the control group . The differences between the two groups in the change in serum levels of HDL-cholesterol were highly significant ( p daily walking time increased significantly ( p daily walking time in the control group over the identical period . Our results show that an intervention program promoting physical activity raises serum HDL-cholesterol levels of middle-aged employees . Increased awareness of the benefits of physical activity , using environmental rearrangement and health promotion campaigns , which especially target walking , may have contributed to a beneficial change in serum HDL-cholesterol levels in the participants"
] | 4116998a-06ff-11f0-808a-c43d1ab1c353 |
The effectiveness of lifestyle interventions within secondary prevention of coronary heart disease ( CHD ) remains unclear . This systematic review aim ed to determine their effectiveness and included r and omized controlled trials of lifestyle interventions , in primary care or community setting s , with a minimum follow-up of three months , published since 1990 . 21 trials with 10,799 patients were included ; the interventions were multifactorial ( 10 ) , educational ( 4 ) , psychological ( 3 ) , dietary ( 1 ) , organisational ( 2 ) , and exercise ( 1 ) . The overall results for modifiable risk factors suggested improvements in dietary and exercise outcomes but no overall effect on smoking outcomes . In trials that examined mortality and morbidity , significant benefits were reported for total mortality ( in 4 of 6 trials ; overall risk ratio ( RR ) 0.75 ( 95 % confidence intervals ( CI ) 0.65 , 0.87 ) ) , cardiovascular mortality ( 3 of 8 trials ; overall RR 0.63 ( 95 % CI 0.47 , 0.84 ) ) , and nonfatal cardiac events ( 5 of 9 trials ; overall RR 0.68 ( 95 % CI 0.55 , 0.84 ) ) . The heterogeneity between trials and generally poor quality of trials make any concrete conclusions difficult . However , the beneficial effects observed in this review are encouraging and should stimulate further research | [
"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 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",
"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",
"BACKGROUND The Lyon Diet Heart Study is a r and omized secondary prevention trial aim ed at testing whether a Mediterranean-type diet may reduce the rate of recurrence after a first myocardial infa rct ion . An intermediate analysis showed a striking protective effect after 27 months of follow-up . This report presents results of an extended follow-up ( with a mean of 46 months per patient ) and deals with the relationships of dietary patterns and traditional risk factors with recurrence . METHODS AND RESULTS Three composite outcomes ( COs ) combining either cardiac death and nonfatal myocardial infa rct ion ( CO 1 ) , or the preceding plus major secondary end points ( unstable angina , stroke , heart failure , pulmonary or peripheral embolism ) ( CO 2 ) , or the preceding plus minor events requiring hospital admission ( CO 3 ) were studied . In the Mediterranean diet group , CO 1 was reduced ( 14 events versus 44 in the prudent Western-type diet group , P=0.0001 ) , as were CO 2 ( 27 events versus 90 , P=0.0001 ) and CO 3 ( 95 events versus 180 , P=0 . 0002 ) . Adjusted risk ratios ranged from 0.28 to 0.53 . Among the traditional risk factors , total cholesterol ( 1 mmol/L being associated with an increased risk of 18 % to 28 % ) , systolic blood pressure ( 1 mm Hg being associated with an increased risk of 1 % to 2 % ) , leukocyte count ( adjusted risk ratios ranging from 1.64 to 2.86 with count > 9x10(9)/L ) , female sex ( adjusted risk ratios , 0.27 to 0 . 46 ) , and aspirin use ( adjusted risk ratios , 0.59 to 0.82 ) were each significantly and independently associated with recurrence . CONCLUSIONS The protective effect of the Mediterranean dietary pattern was maintained up to 4 years after the first infa rct ion , confirming previous intermediate analyses . Major traditional risk factors , such as high blood cholesterol and blood pressure , were shown to be independent and joint predictors of recurrence , indicating that the Mediterranean dietary pattern did not alter , at least qualitatively , the usual relationships between major risk factors and recurrence . Thus , a comprehensive strategy to decrease cardiovascular morbidity and mortality should include primarily a cardioprotective diet . It should be associated with other ( pharmacological ? ) means aim ed at reducing modifiable risk factors . Further trials combining the 2 approaches are warranted",
"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",
"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",
"Objectives : To evaluate the effects of nurse-led secondary prevention clinics for coronary heart disease ( CHD ) in primary care on total mortality and coronary event rates after 10 years . Design : Follow-up of a r and omised controlled trial by review of national data sets . Setting : Stratified r and om sample of 19 general practice s in northeast Scotl and . Participants : Original study cohort of 1343 patients , aged Intervention : Nurse-led secondary prevention clinics promoted medical and lifestyle aspects of secondary prevention and offered regular follow-up for 1 year , Main outcome measures : Total mortality and coronary events ( non-fatal myocardial infa rct ions ( MIs ) and coronary deaths ) . Results : Mean ( SD ) follow-up was at 10.2 ( 0.19 ) years . No significant differences in total mortality or coronary events were found at 10 years . 254 patients in the intervention group and 277 patients in the control group had died : cumulative death rates were 38 % and 41 % , respectively ( p = 0.177 ) . 196 coronary events occurred in the intervention group and 195 in the control group : cumulative event rates were 29.1 % and 29.1 % , respectively ( p = 0.994 ) . When Kaplan – Meier survival analysis , adjusted for age , sex and general practice , was used , proportional hazard ratios were 0.88 ( 0.74 to 1.04 ) for total mortality and 0.96 ( 0.79 to 1.18 ) for coronary death or non-fatal MI . No significant differences in the distribution of cause of death classifications was found at either 4 or 10 years . Conclusions : After 10 years , differences between groups were no longer significant . Total mortality survival curves for the intervention and control groups had not converged , but the coronary event survival curves had . Possibly , therefore , the earlier that secondary prevention is optimised , the less likely a subsequent coronary event is to prove fatal",
"OBJECTIVES We sought to describe the various cardiovascular complications that occurred in the Lyon Diet Heart Study ( a secondary prevention trial testing the protective effects of a Mediterranean type of diet ) , to analyze their relations with the associated drug treatments and to gain insights into the possible mechanisms underlying the beneficial effects of certain nutriments . BACKGROUND Dietary habits are implicated in coronary heart disease , and the traditional Mediterranean diet is thought to be cardioprotective . However , the exact mechanisms of this protection are unknown . METHODS A total of 605 patients ( 303 control subjects and 302 study patients ) were studied over a mean period of 27 months . Major primary end points ( cardiovascular death and nonfatal acute myocardial infa rct ion ) , secondary end points ( including unstable angina , stroke , heart failure and embolisms ) and minor end points ( stable angina , need for myocardial revascularization , postangioplasty restenosis and thrombophlebitis ) were analyzed separately and in combination . RESULTS When major primary and secondary end points were combined , there were 59 events in control subjects and 14 events in the study patients , showing a risk reduction of 76 % ( p risk reduction of 37 % ( p aspirin among the medications appeared to be significantly protective ( risk ratio after adjustment for prognosis factors 0.45 ; 95 % confidence interval 0.25 to 0.80 ) . CONCLUSIONS These data show a protective effect of the Mediterranean diet . However , the risk reduction varied depending on the type of end point considered . Our hypothesis is that different pathogenetic mechanisms were responsible for the development of the various complications . It is likely that certain nutriments characteristic of the Mediterranean diet ( omega-3 fatty acids , oleic acid antioxidant vitamins ) have specific cardioprotective effects",
"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",
"Objective To test the effectiveness of a complex intervention design ed , within a theoretical framework , to improve outcomes for patients with coronary heart disease . Design Cluster r and omised controlled multicentre trial . Setting General practice s in Northern Irel and and the Republic of Irel and , regions with different healthcare systems . Participants 903 patients with established coronary heart disease registered with one of 48 practice s. Intervention Tailored care plans for practice s ( practice based training in prescribing and behaviour change , administrative support , quarterly newsletter ) , and tailored care plans for patients ( motivational interviewing , goal identification , and target setting for lifestyle change ) with review s every four months at the practice s. Control practice s provided usual care . Main outcome measures The proportion of patients at 18 month follow-up above target levels for blood pressure and total cholesterol concentration , and those admitted to hospital , and changes in physical and mental health status ( SF-12 ) . Results At baseline the numbers ( proportions ) of patients above the recommended limits were : systolic blood pressure greater than 140 mm Hg ( 305/899 ; 33.9 % , 95 % confidence interval 30.8 % to 33.9 % ) , diastolic blood pressure greater than 90 mm Hg ( 111/901 ; 12.3 % , 10.2 % to 14.5 % ) , and total cholesterol concentration greater than 5 mmol/l ( 188/860 ; 20.8 % , 19.1 % to 24.6 % ) . At the 18 month follow-up there were no significant differences between intervention and control groups in the numbers ( proportions ) of patients above the recommended limits : systolic blood pressure , intervention 98/360 ( 27.2 % ) v control , 133/405 ( 32.8 % ) , odds ratio 1.51 ( 95 % confidence interval 0.99 to 2.30 ; P=0.06 ) ; diastolic blood pressure , intervention 32/360 ( 8.9 % ) v control , 40/405 ( 9.9 % ) , 1.40 ( 0.75 to 2.64 ; P=0.29 ) ; and total cholesterol concentration , intervention 52/342 ( 15.2 % ) v control , 64/391 ( 16.4 % ) , 1.13 ( 0.63 to 2.03 ; P=0.65 ) . The number of patients admitted to hospital over the 18 month study period significantly decreased in the intervention group compared with the control group : 107/415 ( 25.8 % ) v 148/435 ( 34.0 % ) , 1.56 ( 1.53 to 2.60 ; P=0.03 ) . Conclusions Admissions to hospital were significantly reduced after an intensive 18 month intervention to improve outcomes for patients with coronary heart disease , but no other clinical benefits were shown , possibly because of a ceiling effect related to improved management of the disease . Trial registration Current Controlled Trials IS RCT N24081411",
"BACKGROUND There are approximately 1.8 million patients with angina in the United Kingdom , many of whom report a poor quality of life , including raised levels of anxiety and depression . AIM To evaluate the effect of a cognitive behavioural disease management programme , the Angina Plan , on psychological adjustment in patients newly diagnosed with angina pectoris . DESIGN OF STUDY R and omised controlled trial . SETTING Patients from GP practice s in a Northern UK city ( York ) between April 1999 and May 2000 . METHOD Recruited patients were r and omised to receive the Angina Plan or to a routine , practice nurse-led secondary prevention educational session . RESULTS Twenty of the 25 practice s invited to join the study supplied patients ' names ; 142 patients attended an assessment clinic and were r and omised There were no significant differences in any baseline measures . At the six month post-treatment follow-up , 130 ( 91 % ) patients were reassessed . When compared with the educational session patients ( using analysis of covariance adjusted for baseline scores in an intention-to-treat analysis ) Angina Plan patients showed a greater reduction in anxiety ( P = 0.05 ) and depression ( P = 0.01 ) , the frequency of angina ( reduced by three episodes per week , versus a reduction of 0.4 per week , P = 0.016 ) the use of glyceryl trinitrate ( reduced by 4.19 fewer doses per week versus a reduction of 0.59 per week , P = 0.018 ) , and physical limitations ( P changed their diet ( 41 versus 21 , P their daily walking ( 30 versus 2 , P Seattle Angina Question naire or in any of the medical variables measured . CONCLUSION The Angina Plan appears to improve the psychological , symptomatic , and functional status of patients newly diagnosed with angina",
"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",
"In patients with coronary artery disease ( CAD ) , a rate of restenosis as high as 50 % is observed after percutaneous transluminal coronary angioplasty ( PTCA ) . Frequently , this results in further revascularization procedures . Lifestyle intervention has been shown to slow the progression of CAD and to reduce cardiovascular events after myocardial infa rct ion . However , no information exists whether such treatment influences the rate of restenosis in patients with CAD . The present study was performed to investigate the effects of an intensified lifestyle intervention on the need for further revascularization procedures in patients with established CAD after successful PTCA",
"BACKGROUND The long-term effects of disease management programmes for coronary heart disease on health status are unknown . In a r and omized trial of nurse-led secondary prevention clinics , we found significantly improved health status at 1 year . Participants were followed-up again at 4 years to determine if improvements had been sustained . OBJECTIVE Our aim was to evaluate the effects on health of nurse-led clinics for the secondary prevention of coronary heart disease in primary care . METHODS A total of 1343 patients with coronary heart disease were r and omized to nurse-led secondary prevention clinics or usual care , with follow-up at 1 and 4 years by review of medical case notes and national data sets , and postal question naires . The study involved a stratified , r and om sample of 19 general practice s in north-east Scotl and . Health status was 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 . RESULTS At 1 year , there were significant improvements in five of eight SF-36 domains ( all functioning scales , pain and general health ) in patients r and omized to clinics . Role limitations attributed to physical problems improved the most [ adjusted difference 8.52 , 95 % confidence interval ( CI ) 4.16 - 12.9 ] . At 4 years , the intervention group scored higher than control in all domains , but differences were no longer significant . At 1 year , fewer patients in the intervention group reported worsening chest pain ( odds ratio 0.59 , 95 % C1 0.37 - 0.94 ) . At 4 years , there were no significant differences between the proportion of intervention or control group patients who reported chest pain in the last week or who reported worsening chest pain . No significant effects were observed on anxiety or depression at 1 or 4 years . CONCLUSION We have demonstrated previously a significantly greater survival in attendees at nurse-led secondary prevention clinics . Despite this , improvements in health status achieved in the first year of the study were reduced at 4 years . The case for nurse-led clinics remains strong , but further research is required on ways to optimize current health status",
"BACKGROUND Most studies that have analysed the effect of secondary prevention of coronary heart disease come from hospitals . Those that are community-based have been conducted mainly by nurses and follow-up was generally too short to show impact on cardiovascular events . METHODS This is a multi-centre r and omised controlled clinical trial in which patients in the intervention group received periodic postal reminders to see their general practitioner every three months during a 3-year follow-up . General practitioners reinforced healthy lifestyle recommendations to patients and review ed drug therapies at these quarterly intervals . Patients in the control group received usual care . RESULTS A total of 983 patients aged 30 - 79 were included . During the 3-year follow-up , 67 patients died and 156 experienced a non-fatal cardiovascular event . The event rates and all-cause mortality were similar in the intervention and control groups ( 24.0 % and 23.5 % , and 8.1 % and 9.9 % , respectively ) . Improvement in quality of life was similar in both groups . Blood pressure and high-density lipoprotein cholesterol were more frequently within recommended levels in the intervention group than in controls : odds ratio 1.63 , 95 % confidence interval 1.05 - 2.51 , and odds ratio 2.61 , 95 % confidence interval 1.32 - 5.18 , respectively . CONCLUSIONS Intensive secondary prevention conducted by general practitioners may improve long-term blood pressure control and increase high-density lipoprotein cholesterol in patients with stable coronary disease",
"The study was set up to evaluate the long-term effects on mortality of a comprehensive rehabilitation and secondary prevention programme lasting 3 years after acute myocardial infa rct ion . The study group consisted of 375 consecutive , non-selected patients under 65 years of age r and omly allocated to an intervention group ( 188 patients ) or a control group ( 187 patients ) . After 15 years follow-up significantly lower incidence of sudden death ( 16.5 % vs 28.9 % , P = 0.006 ) and coronary mortality ( 47.9 % vs 58.5 % , P = 0.04 ) were seen in the intervention group compared with controls . Total mortality was 64.4 % and 66.8 % , respectively ( ns ) . The incidence of cancer death was 16 in the intervention group and three in the controls . Cardiac failure , enlarged heart , New York Heart Association functional class II or more and membership in the control group were significantly associated with coronary mortality during the first 3 years , and after 3 years enlarged heart , diabetes and reinfa rct ion were associated with late coronary death . Thus , comprehensive multifactorial intervention after acute myocardial infa rct ion had favourable long-term effects on coronary mortality and sudden death but no effect on total mortality",
"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",
"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",
"BACKGROUND Secondary prevention is not adequately implemented after myocardial infa rct ion ( MI ) . We assessed the effect on quality of care and prognosis of a long-term , relatively intensive rehabilitation strategy after MI . METHODS We conducted a multicenter , r and omized controlled trial in patients following st and ard post-MI cardiac rehabilitation , comparing a long-term , reinforced , multifactorial educational and behavioral intervention with usual care . A total of 3241 patients with recent MI were r and omized to a 3-year multifactorial continued educational and behavioral program ( intervention group ; n = 1620 ) or usual care ( control group ; n = 1621 ) . The combination of cardiovascular ( CV ) mortality , nonfatal MI , nonfatal stroke , and hospitalization for angina pectoris , heart failure , or urgent revascularization procedure was the primary end point . Other end points were major CV events , major cardiac and cerebrovascular events , lifestyle habits , and drug prescriptions . RESULTS End point events occurred in 556 patients ( 17.2 % ) . Compared with usual care , the intensive intervention did not decrease the primary end point significantly ( 16.1 % vs 18.2 % ; hazard ratio [ HR ] , 0.88 ; 95 % confidence interval [ CI ] , 0.74 - 1.04 ) . However , the intensive intervention decreased several secondary end points : CV mortality plus nonfatal MI and stroke ( 3.2 % vs 4.8 % ; HR , 0.67 ; 95 % CI , 0.47 - 0.95 ) , cardiac death plus nonfatal myocardial infa rct ion ( 2.5 % vs 4.0 % ; HR , 0.64 ; 95 % CI , 0.43 - 0.94 ) , and nonfatal MI ( 1.4 % vs 2.7 % ; HR , 0.52 ; 95 % CI , 0.31 - 0.86 ) . A marked improvement in lifestyle habits ( ie , exercise , diet , psychosocial stress , less deterioration of body weight control ) and in prescription of drugs for secondary prevention was seen in the intervention group . CONCLUSION The GOSPEL Study is the first trial to our knowledge to demonstrate that a multifactorial , continued reinforced intervention up to 3 years after rehabilitation following MI is effective in decreasing the risk of several important CV outcomes , particularly nonfatal MI , although the overall effect is small . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT00421876",
"PURPOSE Despite demonstrated benefits of cardiac rehabilitation and risk factor reduction , only 11 % to 38 % of eligible patients with cardiovascular disease ( CVD ) participate in cardiac rehabilitation programs . Women and older adults are particularly less likely to participate in cardiac rehabilitation . In an effort to broaden access to cardiac rehabilitation , the authors developed an alternative Internet-based program that allows nurse case managers to provide risk factor management training , risk factor education , and monitoring services to patients with CVD . METHODS The evaluation consisted of a r and omized , clinical trial involving 104 patients with CVD , 53 of whom used the program as a special intervention ( SI ) for 6 months and 51 of whom received usual care ( UC ) . RESULTS The results indicate that fewer cardiovascular events occurred among the SI subjects ( 15.7 % ) than among the UC subjects ( 4.1 % ) ( P = .053 ) , result ing in a gross cost savings of $ 1418 US dollars per patient . With a projected program cost of $ 453 USD per patient , the return on investment is estimated at 213 % . More weight loss occurred in the SI group ( -3.68 pounds ) than in the UC group ( + .47 pounds ) ( P = .003 ) . The differences between the two groups in terms of blood pressure , lipid levels , depression scores , minutes of exercise , and dietary habits were not statistically significant . CONCLUSION An Internet-based case management system could be used as a cost-effective intervention for patients with CVD , either independently or in conjunction with traditional cardiac rehabilitation",
"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 Cardiac rehabilitation includes interventions aim ed at facilitating physical , psychological and emotional recovery following the acute phase of myocardial infa rct ion ( AMI ) . To date , optimal cardiac rehabilitation program duration and frequency of patient contact has yet to be identified . Objective The present study was performed to evaluate the effects of two different strategies of secondary prevention ( 2 years , multifactorial continued educational and behavioral intervention versus usual care ) implemented into a cardiac rehabilitation setting on several cardiovascular endpoints indicating cardiovascular functional exercise capacity and coronary risk profile in patients with recent AMI . Methods This was a prospect i ve r and omized study including 52 postinfa rct ion patients . Initially , all patients were enrolled in a 3-month outpatient cardiac rehabilitation program . Thereafter , they were r and omly subdivided into two groups ( I = intervention group ; C = control group ) , each composed of 26 patients , and followed for 24 months . Results At the end of the 3-month outpatient cardiac rehabilitation program , both groups showed a significant ( P cardiopulmonary parameters ( maximal oxygen consumption , maximal workload ) and in cardiovascular risk profile ( BMI , lipid profile ) . During the 24-month study period , group I showed stabilization or even improvement ( P cardiopulmonary parameters and cardiovascular risk profile , whereas group C patients showed a deterioration or significant impairment ( P Long-term , multifactorial educational and behavioral intervention maintained for 2 years in a multicomprehensive cardiac rehabilitation setting represents a valid strategy for improving long-term cardiovascular functional capacity and cardiovascular risk profile in postinfa rct ion patients",
"Background Lifestyle measures of coronary heart disease ( CHD ) prevention have been overshadowed by the efficacy of drug treatments . This is particularly the case in the setting of secondary prevention where the benefits of lipid lowering , anti-platelet and anti-hypertensive drugs have been emphasised in numerous trials . Lifestyle measures address several CHD risk factors at once and are generally free of serious side effects . Objectives The objective of the present study was to determine whether a comprehensive programme of lifestyle modification could favourably influence dietary and exercise habits in addition to smoking cessation over two years . In addition , an attempt was made to evaluate if this programme could favourably influence the five-year CHD-risk in the male population included in the study . Design A total of 197 patients with proven coronary heart disease were included and r and omised to a lifestyle intervention programme or to usual care . Follow-up was after a period of two years . Methods Intervention comprised a low fat diet , regular exercise , smoking cessation , psychosocial support and education , delivered by nurses on the rationale for pharmacological and lifestyle measures . Usual care comprised follow-up in the routine outpatient clinic . Both groups were given the same comprehensive medication according to recent guidelines . Results Patients in the lifestyle intervention group reduced the intake of saturated fat , sugar and cholesterol ( P exercise level ( P stopped smoking ( P care group . A sub analysis of the influence of five-year CHD calculated risk in males result ed in a relative risk reduction of 22 % ( 95 % confidence intervals 9 - 35 ) . Although significant , this result must be interpreted with caution due to poor statistical power and reproducibility of the method . Conclusions In the presence of modern drug treatments for secondary cardiovascular disease prevention it remains possible through a favourable diet , exercise and smoking cessation to show an additional reduction in the five-year risk for CHD in males",
"Abstract Objectives : To evaluate the effects of nurse led clinics in primary care on secondary prevention , total mortality , and coronary event rates after four years . Design : Follow up of a r and omised controlled trial by postal question naires and review of case notes and national data sets . Setting : Stratified , r and om sample of 19 general practice s in north east Scotl and . Participants : 1343 patients ( 673 intervention and 670 control ) under 80 years with a working diagnosis of coronary heart disease but without terminal illness or dementia and not housebound . Intervention : Nurse led secondary prevention clinics promoted medical and lifestyle components of secondary prevention and offered regular follow up for one year . Main outcome measures : Components of secondary prevention ( aspirin , blood pressure management , lipid management , healthy diet , exercise , non-smoking ) , total mortality , and coronary events ( non-fatal myocardial infa rct ions and coronary deaths ) . Results : Mean follow up was at 4.7 years . Significant improvements were shown in the intervention group in all components of secondary prevention except smoking at one year , and these were sustained after four years except for exercise . The control group , most of whom attended clinics after the initial year , caught up before final follow up , and differences between groups were no longer significant . At 4.7 years , 100 patients in the intervention group and 128 in the control group had died : cumulative death rates were 14.5 % and 18.9 % , respectively ( P=0.038 ) . 100 coronary events occurred in the intervention group and 125 in the control group : cumulative event rates were 14.2 % and 18.2 % , respectively ( P=0.052 ) . Adjusting for age , sex , general practice , and baseline secondary prevention , proportional hazard ratios were 0.75 for all deaths ( 95 % confidence intervals 0.58 to 0.98 ; P=0.036 ) and 0.76 for coronary events ( 0.58 to 1.00 ; P=0.049 ) Conclusions : Nurse led secondary prevention improved medical and lifestyle components of secondary prevention and this seemed to lead to significantly fewer total deaths and probably fewer coronary events . Secondary prevention clinics should be started sooner rather than later . What is already known on this topic Several effective interventions exist for the secondary prevention of coronary heart disease , but implementing them in practice has proved difficult Secondary prevention programmes for coronary heart disease have improved short term outcomes such as processes of care and quality of life What this study adds Short term improvements in uptake of secondary prevention produced by nurse led clinics are maintained in the longer term Improved medical and lifestyle components of secondary prevention produced by nurse led clinics seem to lead to fewer total deaths and coronary",
"In a prospect i ve , r and omised single-blinded secondary prevention trial we compared the effect of a Mediterranean alpha-linolenic acid-rich diet to the usual post-infa rct prudent diet . After a first myocardial infa rct ion , patients were r and omly assigned to the experimental ( n = 302 ) or control group ( n = 303 ) . Patients were seen again 8 weeks after r and omisation , and each year for 5 years . The experimental group consumed significantly less lipids , saturated fat , cholesterol , and linoleic acid but more oleic and alpha-linolenic acids confirmed by measurements in plasma . Serum lipids , blood pressure , and body mass index remained similar in the 2 groups . In the experimental group , plasma levels of albumin , vitamin E , and vitamin C were increased , and granulocyte count decreased . After a mean follow up of 27 months , there were 16 cardiac deaths in the control and 3 in the experimental group ; 17 non-fatal myocardial infa rct ion in the control and 5 in the experimental groups : a risk ratio for these two main endpoints combined of 0.27 ( 95 % CI 0.12 - 0.59 , p = 0.001 ) after adjustment for prognostic variables . Overall mortality was 20 in the control , 8 in the experimental group , an adjusted risk ratio of 0.30 ( 95 % CI 0.11 - 0.82 , p = 0.02 ) . An alpha-linolenic acid-rich Mediterranean diet seems to be more efficient than presently used diets in the secondary prevention of coronary events and death",
"Background and aims : Coronary heart disease ( CHD ) is common and the maprity of CHD patients are 65 years or older . There exist only a few r and omized , controlled intervention studies on secondary prevention of CHD among elderly CHD patients . Our study assessed the effects of health advocacy , counseling , and activation programs with outcome variables of changes in the use of fats , lipid-lowering medications , frequency of exercise , cigarette smoking , serum cholesterol and triglyceride concentrations , blood pressure , and symptoms of late-life CHD among CHD patients of the Lieto Study . Methods : R and omized , controlled intervention study . Late-life ( > 65 yrs ) CHD patients were r and omized into intervention group ( IG ) ( n=118 ) and control group ( CG ) ( n=109 ) . Intervention consisted of 16 lectures by experts , eight group discussion s , six group exercise sessions , and three social activity events . Results : The use of lipid-lowering medications became more common in IG than in CG among men ( p=0.041 ) , with a similar tendency among women . Among women , decreases in the means of total serum cholesterol ( p=0.009 ) and LDL-cholesterol ( p=0.049 ) were greater in IG than in CG . Conclusions : The program produced no positive effects on health behavior . Positive effects were gained by the increase in lipid-lowering medications , which reduced mean total serum cholesterol and LDL-cholesterol concentrations . More intensive counseling on health behavior should be planned , implemented , and evaluated",
"Objective : To determine the effect of a new CHOICE ( Choice of Health Options In prevention of Cardiovascular Events ) programme on cardiovascular risk factors in acute coronary syndrome ( ACS ) survivors . Design : Single-blind r and omised controlled trial . Setting : Tertiary referral hospital in Sydney Australia . Patients : 144 ACS survivors who were not accessing st and ard cardiac rehabilitation . Data were also collected on a further 64 ACS survivors attending st and ard cardiac rehabilitation . Intervention : The CHOICE group ( n = 72 ) participated in a brief , patient-centred , modular programme comprising a clinic visit plus telephone support , encompassing m and atory cholesterol lowering and tailored preferential risk modification . The control group ( n = 72 ) participated in continuing conventional care but no central ly coordinated secondary prevention . Main outcome measures : Values for total cholesterol , systolic blood pressure , smoking status and physical activity . Results : CHOICE and control groups were well matched at baseline . At 12 months , the CHOICE group ( n = 67 ) had significantly better risk factor levels than controls ( n = 69 ) for total cholesterol ( TC ) ( mean ( SEM ) 4.0 ( 0.1 ) vs 4.7 ( 0.1 ) mmol/l , p systolic blood pressure ( 131.6 ( 1.8 ) vs 143.9 ( 2.3 ) mm Hg , p body mass index ( 28.9 ( 0.7 ) vs 31.2 ( 0.7 ) kg/m2 , p = 0.025 ) and physical activity ( 1369.1 ( 167.2 ) vs 715.1 ( 103.5 ) METS/kg/min , p = 0.001 ) as well as a better knowledge of risk factor targets . Also at 1 year , fewer CHOICE participants ( 21 % ) had three or more risk factors above widely recommended levels then controls ( 72 % ) ( p CHOICE programme significantly improved the modifiable risk profiles and risk factor knowledge of ACS survivors over 12 months . CHOICE is an effective alternative for dealing with the widespread underuse of existing secondary prevention programmes . Trial registration number : IS RCT"
] | 411699d0-06ff-11f0-808a-c43d1ab1c353 |
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